Regulation of Fat Content in Food:  Recent History and Cultural Commentary
Stacy R. Anderson
Harvard Law School Class of 2006
May 5, 2006
This paper is submitted in satisfaction of the Food & Drug Law 
class paper and third year writing requirements.

ABSTRACT
	Fat content in food has been one of the most hotly contested areas of nutrition labeling.  This paper traces the changes in fat content labeling requirements for packaged food from the optional disclosure system in place prior to the National Labeling and Education Act of 1990 (“NLEA”) through the recent addition of trans fat content to food labeling requirements, which became effective in January 2006.   A discussion of the labeling requirements and the political processes involved in their development alone would not provide the whole story, however.  Questions arise as to whether those concerned about nutrition should be more concerned about fat, cholesterol, nutrients, or simply calories.  An examination of the consumer use of information is included.  After all, why provide information unless consumers understand it and actually use the information to inform their behavior?  Finally, the fact that so many of today’s meals are consumed outside the home brings the inevitable question of whether restaurants should no longer be exempt from the FDA’s nutrition labeling and fat content disclosure requirements.

TABLE OF CONTENTS
I.  INTRODUCTION
II.  WHAT IS FAT AND WHY DO WE CARE IF IT’S ON A FOOD LABEL?
A.  THE DIFFERENT TYPES OF FAT
B.  FAT CONSUMPTION AND HEALTH IMPLICATIONS
III. FAT LABELING BEFORE 1990
A.  LABELING HISTORY AND PRE-NLEA REQUIREMENTS
B.  PLAYERS – WHO CARED AND PUSHED FOR REGULATION
IV.  THE NUTRITION LABELING AND EDUCATION ACT OF 1990 (NLEA)
	A.  LEGISLATIVE HISTORY
B.  CONTENT OF THE NLEA FAT-RELATED MANDATES
C.  REGULATORY HISTORY  
V.  FDA’S FAT CONTENT REGULATIONS POST-NLEA
A.  GENERAL DISCLOSURE REQUIREMENTS
B.  FAT CONTENT CLAIMS
		i.  TOTAL FAT CLAIMS
		ii.  SATURATED FAT CLAIMS
		iii.  LIGHT CLAIMS
		iv.  LEAN CLAIMS
		v.  RELATED CLAIMS (CHOLESTEROL AND FIBER)
	C.  HEALTH CLAIMS
	D.  QUALIFIED HEALTH CLAIMS
VI.  TRANS FAT REGULATION
A.  MEDIA ATTENTION
B.  REGULATORY HISTORY
C.  CONTENT OF THE REGULATION
D.  IMPLEMENTATION OF THE REGULATION
VII.  THE FUTURE OF FAT CONTENT DISCLOSURE
A.  CURRENT REGULATORY ENVIRONMENT
		i.  TRANS FATTY ACID NUTRIENT CONTENT CLAIMS
		ii.  LEAN CLAIMS
B.  CONTINUED CALLS FOR CHANGE
C.  EFFECTIVENESS – CONSUMER USE OF INFORMATION
D.  THE BIG QUESTION:  SHOULD RESTAURANTS HAVE TO PROVIDE NUTRITION INFORMATION FOR THEIR FOOD PRODUCTS?
VIII.  CONCLUSION

I.  INTRODUCTION
Fat is an important nutrient contributing to all diets.  It is a rich source of calories, makes food taste better, and satisfies some basic nutritional needs.  But fat intake is also linked to overweight, obesity, and diseases such as heart attack, stroke, and cancer.  This paper traces the FDA’s regulation of fat content from the 1970s until the present time.  The specific requirements of food label disclosures are discussed, as well as the legislative and regulatory procedures that brought them about.  Special attention is given to the Nutrition Labeling and Education Act of 1990 and its sweeping changes to food labeling mandates.  More recent controversies such as qualified health claims and the addition of trans fat to the food label are covered as well.  Finally, future directions of fat content labeling are questioned, including proposals for restaurant nutrition labeling.  This paper is meant to be written so any reader could understand it, and no assumptions about prior knowledge are made.  For this reason, a basic discussion about fat is the most logical place to start.

II.  WHAT IS FAT AND WHY DO WE CARE IF IT’S ON A FOOD LABEL?
	To fully frame the following discussion, it’s important to know what fat is, how it contributes to our daily diets, and what health impacts follow from the consumption of different types of fat.  The nutrition information provided on food labels is worthless unless people can understand and use the information to make good dietary choices.  Knowledge about fat and fatty acids can inform a decision as to how much information about it should be on American food labels.

A.  THE DIFFERENT TYPES OF FAT
	Fat is an essential nutrient that provides energy (i.e. calories) and helps transport fat-soluble nutrients to destinations throughout the body.  It is found in both animal- and plant-based foods.  A gram of fat delivers more than twice as many calories as a gram of carbohydrate or protein, making fat a very energy-rich food source.  This high calorie density is a beneficial attribute when energy needs are high, such as during infancy, when great bodily growth is occurring.  Calories from fat add up quickly for adults, though, and adults who wish to lose weight sometimes cut back on their amount of daily fat intake.
Fats add to the flavor and texture of food, which means that when fat is removed from a food, manufacturers often have to add sugar, sodium, or other additives to make the lower-fat version of the food comparable in taste to the original version.  For this reason, it is important to look at both calorie and fat content when evaluating reduced fat foods, as the added nutrients may approach or equal the number of calories saved from eliminating fat. 
All fats and oils are made up of building blocks called fatty acids, which can come in several forms, including saturated, monounsaturated, polyunsaturated fatty acids.  A food may contain more than one of the different fatty acids within it.  All fatty acids are made up of a hydrocarbon chain of varying length with a carboxyl or acid group at one end.  The only difference between the types of fatty acids is the number of carbon-carbon double bonds in the hydrocarbon chain.
Saturated fatty acids have exclusively single carbon-carbon bonds, which means that hydrogen atoms fill all the available bonding sites.  Unsaturated fats contain at least one double carbon-carbon bond; the term unsaturated means that there are places on the molecule where hydrogen could be added via a chemical process.  There are several types of unsaturated fat.  When there is only one carbon-carbon double bond, the fatty acid is monounsaturated, and when more than one double bond exists, the fatty acid is polyunsaturated.  See FIGURE 1 for chemical diagram examples.  Double bonds are indicated in red.    
FIGURE 1:  Fatty Acid Chemical Structure Examples

Saturated Fatty Acid

Monounsaturated Fatty Acid

Polyunsaturated Fatty Acid

Unsaturated fats can have two different double bond positions, referred to as “cis” or “trans” formations.  Cis bonds have both hydrogen atoms on the same side of the carbon atoms, whereas trans bonds have the hydrogen atoms on opposite sides.  A cis double bond causes the molecule to form a U-shape because the hydrogen atoms repel one another, forcing a bend into the molecule.  A trans double bond remains in a more linear formation, which appears more similar to a saturated fatty acid molecule.  See FIGURE 2 for a picture of the two configurations.  Most naturally occurring unsaturated fats contain cis isomers.  A commercial process called partial hydrogenation turns liquid oils into solid or semisolid fats.   Hydrogen atoms are added to unsaturated fat in the presence of a catalyst; some of the double bonds become saturated, while others are changed into a trans configuration.  Partial hydrogenation creates most of the trans fatty acids in the food supply; some dairy products and meats contain a small amount of trans fat as well. 

FIGURE 2:  CIS AND TRANS ISOMER CONFIGURATIONS

cis configuration		trans configuration

Saturated fat is usually solid at room temperature.  In fact, the longer the hydrocarbon chain length is, the more solid the saturated fatty acid will be at room temperature.  Milk fat, meat fat, and tropical oils such as palm oil and coconut oil are high in saturated fat but low in polyunsaturated fat.  Although animal fats are usually referred to as saturated fats, they do contain large amounts of monounsaturated fatty acids (44% in lard).
Olive oil, canola oil, and rapeseed oil are particularly high in monounsaturated fat.  Plant foods are generally rich in polyunsaturated fatty acids.  Fish oil and many vegetable oils are high in polyunsaturated fat and low in saturated fat.  Omega-3 and omega-6 fatty acids are two types of unsaturated fatty acids which are essential for our bodies.  Omega-3 fatty acids can be found in soybean oil, canola oil, walnuts, flaxseed oil, fatty fish (such as salmon, tuna, and mackerel), and fish oil supplements.  Omega-6 fatty acids are found in seeds, nuts, common vegetable oils such as corn oil, meats, poultry, and eggs.
Trans fat may be found in vegetable shortenings, some margarines, crackers, cookies, snack foods, and other foods made with or fried in partially hydrogenated oils.  Partially hydrogenated oil is attractive to food manufacturers because of its long shelf life, stability in deep-frying, and semisolidity.
Following are some basic Dietary Guidelines recommended by the National Academy of Sciences in 2005:
•	Consume less than 10 percent of calories from saturated fats and less than 300 mg/day of cholesterol; Keep trans fatty acid consumption as low as possible
•	Keep total fat intake between 20 and 35 percent of calories, with most fats coming from sources of polyunsaturated and monounsaturated fatty acids, such as fish, nuts, and vegetable oils
•	When selecting and preparing meat, poultry, dry beans, and milk or milk products, make choices that are lean, low-fat, or fat-free
•	Limit intake of fats and oils high in saturated and/or trans fatty acids, and choose products low in such fats and oils

B.  FAT CONSUMPTION AND HEALTH IMPLICATIONS
Over 61% of Americans were considered overweight or obese in 1999.  An estimated 300,000 deaths each year in the United States are associated with obesity.  Overweight and obesity are associated with heart disease, certain types of cancer, type 2 diabetes, stroke, arthritis, breathing problems, and psychological disorders, such as depression.  Overweight is a preventable condition for the most part, though, and fat intake is one piece in the prevention puzzle.  The caloric density of fat makes it a prime target for reduction by those attempting weight management.  For this reason, a person who knows the fat content of his/her food would be better able to reduce intake of fat.  
But perhaps an even better justification for including fat on food labels is the connection between the different types of fat with blood cholesterol and cardiovascular disease.  Heart disease and stroke, the main types of cardiovascular disease (CVD), are the first and third leading causes of death in the United States, accounting for more than 35% of all deaths in 2002.  Although there are hereditary components to developing CVD, understanding the impact that dietary intake of nutrients such as fat have on CVD is of utmost importance.  If dietary intake of fat is linked to CVD (and most agree that it is), people can affirmatively lower their risk of CVD by managing their levels of fatty acid consumption.
Blood cholesterol level has several components which are important when discussing links to heart disease.  Elevated low-density lipoprotein (LDL) cholesterol levels are associated with atherosclerosis (cholesterol accumulation which thickens and narrows arteries) and heart disease.  For this reason, LDL is often called “bad” cholesterol.  High density lipoprotein (HDL) cholesterol has earned the nickname of “good” cholesterol because it appears to protect against atherosclerosis and because high levels of HDL are associated with low rates of heart disease and stroke.  
Saturated and trans fatty acids raise total and LDL cholesterol; replacing saturated fats with monounsaturated fats such as olive oil lowers total and LDL cholesterol without lowering HDL cholesterol.  Trans fatty acids raise LDL cholesterol and lower HDL cholesterol, which produces a stronger negative effect than saturated fat alone.
The effects of the two essential unsaturated fatty acids are very different from one another.  Omega-6 fatty acids form hormone-like compounds which increase blood pressure, heart rat, blood clotting, immune response, and inflammation; on the other hand, the compounds formed by omega-3 fatty acid consumption have “heart healthy” effects. 
A number of studies have linked increased blood cholesterol with an increased risk of coronary heart disease (CHD).  In fact, high blood cholesterol is one of the principal risk factors for cardiovascular disease, along with smoking and high blood pressure.
Trans fat in particular has been singled out as being linked with increased risk of CHD.  In a longitudinal of women nurses, Dr. Walter Willett and his colleagues found that a higher dietary intake of saturated fat and trans fat was associated with an increased risk of CHD, whereas a higher intake of polyunsaturated and monounsaturated fats was associated with a lower risk of CHD.  Ascherio and Willett estimate that 30,000 deaths per year in the United States are attributable to consumption of trans fatty acids.  A recent study stated that on a per-calorie basis, trans fats appear to increase the risk of CHD more than any other macronutrient.  Even as compared with saturated fat, trans fat worsens the lipid profile by raising LDL cholesterol and lowering HDL. 
Given today’s strong medical evidence about the link between fat intake and heart disease, it makes sense to include information about fat on food labels, assuming, of course, that average consumers understand the information provided and are able to use the information to change their behavior in a way that allows them to reduce disease risk.  Consumer use of information is addressed later.  But for now, the case for fat labeling on food is strong.

III. FAT LABELING BEFORE 1990
	Increasing concerns about providing adequate information for consumers to make healthy food choices brought mandatory labeling requirements to the table in the 1970s.  The FDA mandated disclosure of a few basic food attributes such as calories and fat content, with increased labeling requirements when nutrient claims or health claims were made.  This system came under fire by the late 80s, though, when advocates began pushing for more stringent labeling regulations.

A.  LABELING HISTORY AND PRE-NLEA REQUIREMENTS
	Administrative agencies such as the FDA enforce laws through regulations promulgated under authority granted by Congress.  The FDA, by delegation of authority from the Secretary of Health and Human Services (HHS) has primary responsibility for ensuring food safety and prohibiting misbranding of foods.  For most of the past 70 years, one of the main sources of FDA’s delegated authority comes from the Federal Food Drug, and Cosmetic Act of 1938 (FDCA), covering the standards for adulteration and misbranding of food products, among other things.  
	A push for food labeling regulation started in the late 1960s.  The 1969 White House Conference on Food, Nutrition, and Health (Conference) is described as a watershed in the development of Food and Drug Administration (FDA) food policy.  The Report of the White House Conference highlighted the need for good nutrition, the ability of modern food technology to provide necessary nutrients, and the increased use of nutrition information by the general public, among other things.  Within two years, several individuals who had actively participated in the Conference moved into top positions in the FDA, paving the way for food labeling changes.
The FDA turned to §201(n) of the FDCA to find authority to promulgate labeling regulations.  Section 201(n) stated that in deciding whether a product was misbranded, “the extent to which the labeling or advertising fails to reveal facts material in the light of such representations.”  The FDA deemed nutrient information to be material when manufacturers were making claims about nutrient content on their packaging.
In 1972, the FDA proposed a set of nutrition labeling rules which were implemented as regulations in early 1973.  The mandatory requirements for food labels included the common name of the food (a statement of identity); a list of ingredients in descending order of predominance by weight; and the name and place of business of the manufacturer, packager, or distributor.  
Concerns about broad and sometimes misleading health claims being made about foods led to the requirement of full nutrition labeling when food labels offered claims or information about the nutritional properties of a food in the labeling or advertising.  The full nutrition labeling added several new disclosures to the mandatory requirements:  serving size; servings per container; caloric content; protein content; carbohydrate content; fat content; percentage of U.S. Recommended Daily Allowances (RDA) of protein, vitamins, and minerals; and sodium content.
The fat content portion of the full nutrition label had several parts.  First, it required a statement of the number of grams of fat in a serving, expressed to the nearest gram.  If a serving contained less than one gram of fat, the statement “contains less than one gram” or “less than one gram” could be used.  If the actual fat content of the food exceeded the declared amount on the label by more than twenty percent, the food could be deemed misbranded.  
As an additional voluntary disclosure, the fat content could be further broken down with a listing of the fatty acid composition (polyunsaturated and monounsaturated fat content), which immediately followed the fat content.  Only foods which contained more than 10% fat on a dry weight basis and at least two grams of fat per serving could bear such labeling.  As long as the amount of total fat was listed, along with the total percentage of calories from fat, then food manufacturers were permitted to list the grams per serving of polyunsaturated and monounsaturated fat, rounded to the nearest whole number of grams.
When fatty acid composition information was included, a mandatory statement had to be displayed, which said “Information on fat content is provided for individuals who, on the advice of a physician, are modifying their dietary intake of fat.”  This careful wording reflected the ambivalence felt by the 1970s-era FDA in its recognition that although a significant number of doctors were prescribing diets with reduced fat and cholesterol, there were no definitive studies showing that the general public needed to change its consumption of fat and cholesterol.  In fact, the FDA completely prohibited labeling with claims indicating, suggesting, or implying that the product would prevent, mitigate, or cure heart or artery disease or any attendant condition.
By the late 1980s, about 30% of food package labels were required to list nutrient contents due to claims about health or the nutrients, another third engaged in voluntary nutrient labeling, and the rest bore no nutrient disclosure at all.

B.  PLAYERS – WHO CARED AND PUSHED FOR REGULATION
	By the end of the 1980s, the American public had become more health- and nutrition-savvy and was trying to adjust their diets to the low-fat, low-calorie, and low-cholesterol guidelines recommended by organizations such as the American Heart Association and the American Medical Association.  Needless to say, this was a challenging task when nutrition labels were not universally used and the amount of information provided was not always adequate to make informed choices among food products.  
	In the late 1980s and 1990, a push for revised nutrition labeling was coming both from Congress and from the FDA itself.  In July 1989, Representative Henry Waxman (D-Calif.) introduced a bill in the House proposing an amendment to the FDCA to mandate nutrition labeling for food.  Senator Howard Metzenbaum (D-Ohio) also introduced a nutrition labeling and education bill in the Senate in July 1989.  In August 1989, the FDA published an advance notice of proposed rulemaking, seeking public comments in five areas:  whether to revise the requirements for nutrition labeling; whether to change the nutrition label format on food packages; whether to revise the requirements for ingredient labeling; whether to formally define commonly used food descriptions and/or reconsider the use of standards of identity for foods; and how to reasonably permit the use of messages on food labels that link food components to the prevention of disease.
The congressional interest in pushing legislation through rather than relying on the FDA’s rulemaking authority came partly from a concern that the then-current FDCA did not require the FDA to adopt comprehensive nutrition labeling regulations; some had worries that protracted litigation would result from FDA-promulgated regulations in this area if the FDCA were not amended to give FDA the authority to issue mandatory labeling rules.  Perhaps even a bigger concern, though, was that the FDA simply would not issue the regulations in a timely manner.  The FDA had been trying for many years to establish mandatory nutrition labeling requirements but had not ever issued regulations.  Some say that the dual administrative and legislative race to push the labeling issue through was the result of the popularity of the food labeling issue and the desire by both lawmakers and the FDA to take credit for helping the American consumer.  
Louis Sullivan, Secretary of Health and Human Services, announced at a food policy conference March 1990: “The grocery store has become a Tower of Babel, and consumers need to be linguists, scientists and mind readers to understand the many labels they encounter.”  He promised that the FDA would propose a new food labeling system.  The day after Dr. Sullivan’s “Tower of Babel” comment, Senator Metzenbaum expressed his frustration and impatience with the FDA: “Proposed regulations are nothing more than good intentions.”  While this legislative/administrative give and take might provide fodder for media scrutiny of the power struggles, the message was clear.  In 1989 and 1990, uniform food labeling was on the top of the agenda of the people who had the power to push it forward. 	
	Not everyone wanted increased food labeling requirements.  Changing labels on thousands of food products would be an expensive undertaking, after all.  Food manufacturers were wary of the changes and lobbied heavily to make sure their concerns were heard.  Bruce Silverglade, General Counsel to consumer group Center for Science in the Public Interest (CSPI), pointed the finger at food industry groups such as National Food Processors Association (NFPA) and the Grocery Manufacturers of America (GMA) as impeding Waxman’s and Metzenbaum’s attempts at legislation.  While CSPI supported the initiative to mandate food labeling, the food industry was demanding that any food reform bill must preempt state laws to ensure uniformity.  John Cady, President and CEO of the NFPA, said he believed that voluntary labeling was the best choice, but that his organization would support the bill if it provided for uniform labeling across the United States.    
The food industry’s concerns about uniform labeling were understandable.  The food industry was already troubled by Proposition 65, California’s health warning requirement that foods with even trace amounts of chemicals which California had determined caused cancer or birth defects contain warnings to that effect.  If the federal initiatives did not preempt state law, any national food manufacturer would be put in the position of potentially providing 50 different food labels for a single product if each state had its own labeling requirements in addition to the federal laws and regulations.  Food manufacturers were worried that states may pass a confusing array of food labeling requirements that would increase the cost of production.  These costs would ultimately be passed on to the consumer in the form of higher prices.  As one commentator pointed, out, those trying to protect the consumers via stricter labeling laws would defeat their own pro-consumer purposes by increasing the cost of food for all.
Dr. Sullivan’s “Tower of Babel” comment in March 1990 had been accompanied by a suggestion that some states might want to add to the information required on the food label, which was viewed by the food industry as an open invitation to states to enact their own, stricter food labeling laws.  The comment was seen as evidence of a politically motivated Republican administration trying to bolster states’ rights in an election year.  Just three months later, however, Sullivan reversed his position, announcing that he favored Federal standards that would preempt state and local laws.  
The FDA’s switch in approach towards preemption of state laws appears to a political change rather than simply an administrative one.  FDA officials said that the preemption language was added by the Health and Human Services (HHS) Department, the agency’s overseeing parent organization, before the proposed food labeling regulations were sent to the Budget Office;  HHS spokesperson Campbell Garnett refused to disclose why the change was made.  Perhaps HHS realized the extent of the unpopularity of the non-preemptive stance within the food industry and capitulated its’ pro-states rights position in order to avoid future trouble with powerful food industry lobbyists and lawyers.  Although the FDA’s proposed regulations were ultimately superceded by the legislative efforts in the form of the Nutrition Labeling and Education Act of 1990, the Federal preemption stance was adopted by the Congressional bills as well.

IV.  THE NUTRITION LABELING AND EDUCATION ACT OF 1990 (NLEA)
Although the House, Senate, and the FDA were all committed to moving the nutrition labeling agenda forward, the legislative initiative won the day.  Waxman’s bill was eventually enacted into law by the end of 1990.  A legislative history of the NLEA and subsequent regulatory history follows.
	
A.  LEGISLATIVE HISTORY
A preliminary bill proposing the Nutrition Labeling and Education Act of 1989, which would amend the FDCA to prescribe mandatory nutrition labeling for food, was introduced in July 1989 by Representative Henry Waxman.  The bill was referred to the House Committee on Energy and Commerce (Committee).  A subcommittee on Health and the Environment held a one-day hearing on August 3, 1989, where testimony was heard from 19 witnesses, including representatives from national consumer organizations and industry trade associations.  The Subcommittee met in open session to consider H.R. 3028 on October 25, 1989; the bill was ordered reported by a voice vote, with amendments.
A clean bill (H.R. 3562) reflecting the requested amendments was filed by Representative Waxman on October 31st, 1989.  It first passed through the Committee, where Representatives Terry Bruce (D-Ill.) and Edward Madigan (R-Ill.) proposed amendments authorizing preemption for state safety labeling laws covering areas such as carcinogen labeling and warnings about disease risks.  Waxman objected, saying that they were not germane to his legislation.  An amendment proposed by Thomas Luken (D-Ohio) to exclude fresh seafood, fruits and vegetables was also defeated, 19-24.  The Committee approved the bill by voice vote in May 1990.    The bill was passed in the House by voice vote on July 30th, 1990.  
On August 2, 1990, the House of Representatives requested the concurrence of the Senate.  H.R. 3562 was placed on the Senate calendar on August 8th and passed in the Senate by voice vote on October 24th, 1990.  The Senate requested concurrence for the amended bill on October 25th.  It was signed into law by President George H.W. Bush on November 8th, 1990, with little additional commentary by the President.
	In the end, the push for federal preemption of state labeling laws won the day.  The preemption language was generally seen as a compromise between manufacturers and consumer groups.  Manufacturers, as already noted, desired national uniformity for all labeling requirements in order to avoid having to produce many versions of each food label to meet the state-specific labeling mandates.  Consumer groups, on the other hand, wanted states to have the option to put in strict labeling requirements for maximum consumer protection.  The compromise resulted in Federal preemption of state laws governing nutrient and health claims, while leaving safety claims (such as California’s Proposition 65) in the hands of individual states.

B.  CONTENT OF THE NLEA FAT-RELATED MANDATES
	Sections 403(q) and 403(r) constituted the main additions with fat labeling consequences made to the FDCA by NLEA; they mandated the provision of nutrition information on food labels and established boundaries for nutrient and health/disease related claims on food labels, respectively.  
Section 403(q) requires nutrition labeling on nearly all food which is offered for sale and intended for human consumption, with several considerable exceptions:  food sold in restaurants or other establishments selling food ready for consumption, infant formula, medical food, and food produced by business with less than $500,000 in gross annual sales.  The labels had to disclose the total number of calories derived from total fat, the amount of total fat, and the amount of saturated fat.  The Secretary of Health and Human Services (Secretary) was empowered to add nutrients to the food label (ostensibly via delegation of that authority to the FDA in its rulemaking capacity) if the Secretary determined that information about the nutrient would assist consumers in maintaining healthy dietary practices.  Nutrients could also be removed from the food label if the Secretary deems the nutrient information unnecessary for maintaining healthy diets.
	Section 403(r) covers nutrition levels and health-related claims.  Claims about the levels of nutrients in a food could only be made using terms defined in a regulation.  The absence of a nutrient could not be claimed unless the nutrient was usually present in the food or a close substitute for the food.  For example, a claim for “fat-free carrots” would not be permissible because fat is not normally present in carrots, whereas “fat-free potato chips” would be an acceptable claim because potato chips typically contain some amount of fat.
	Several subsections tie the disclosure of the level of fat with other nutrients, such as cholesterol and fiber.  Claims relating to the level of cholesterol in a food are permitted only when the level of fat or saturated fat in that food does not increase a diet-related risk of disease or health related conditions.  Exceptions to the cholesterol rule may be made by regulation when the food has less cholesterol than usual or when a statement about the usual absence of cholesterol would be helpful to consumers, provided that the level of fat or saturated fat is still disclosed in a reasonable proximity and font size.  If a food package makes claims about the level of saturated fat in a food, disclosure of the amount of cholesterol (if cholesterol is present in the food) must be made in close proximity and with appropriate prominence.  Claims that a food is high in dietary fiber are prohibited unless the food is low in total fat or if the level of total fat is disclosed in appropriate proximity and prominence.
	As mentioned, §403(r) also covers health-related claims, barring any claim linking a nutrient with a disease or other health-related condition not made in compliance with the FDCA.  Food labels could contain regulation-defined health claims as long as the food does not contain any nutrient in a level that increases the risk of a diet-related disease or health condition in the general population.  Accordingly, if a food contains a nutrient that reduces the risk of cancer but also has another nutrient that increases the risk of heart disease, the cancer claim would not be permitted.  Regulations based on the totality of publicly available scientific evidence (gained from valid scientific studies), providing that there is significant scientific agreement among qualified experts.  This means that although new and radical health findings will not make it onto food labels until they are widely confirmed and generally accepted, the public should be able rely with confidence on the health-related claims that do make it onto the foods they consume.  The significant scientific agreement (SSA) standard was later challenged in court on Constitutional grounds, and the FDA eventually backed off the SSA requirement for some health claims by authorizing a new set of qualified health claims, described later.
	Following is a full discussion of the exact regulations promulgated by the FDA in response to the mandates set forth by the NLEA. 

C.  REGULATORY HISTORY  
	NLEA had established a tight timeframe for promulgation of new regulations.  The FDA had 12 months from enactment of the NLEA to issue proposed regulations and 24 months to issue final regulations.  Once final regulations were promulgated, they were to take effect just 6 months later.
The FDA published the proposed set of rules implementing the NLEA approximately one year after its enactment, in late November 1991.  The main sections related to fat content disclosure that were either added or amended to the Code of Federal Regulations were:  §101.9, Nutrition Labeling of Food; §101.13, Nutrient Content Claims; §101.14, Health Claims; §101.36, Nutrition Labeling of Dietary Supplements; §101.56, Nutrient Content Claims for “Light” or “Lite”; §101.62, Nutrient Content Claims for Fat, Fatty Acid, and Cholesterol Content of Foods; §101.73, Health Claims for Dietary Lipids and Cancer; and §101.75, Health Claims for Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease.
Food industry representative lobbied hard to extend the effective date of the final regulations, which was to be May 8, 1993 (6 months after the final regulation deadline of Nov. 8, 1992), estimating that a one year delay would save the industry more than $2 billion in compliance costs.  The NLEA did have a provision allowing for a one year delay in implementation if the compliance would cause undue economic hardship.  In January 1993, the FDA published final regulations implementing the amendments made to the FDCA by the 1990 NLEA.  On the same day, the FDA published its finding that the May 1993 implementation date would indeed pose an undue hardship to the food industry, and granted a one year extension, making the effective date of the final regulations May 8, 1994.

V.  FDA’S FAT CONTENT REGULATIONS POST-NLEA
	As has been noted already, nutrition labeling became mandatory for all foods.  All food labels were required to contain detailed information about calories, fat, cholesterol, sodium, carbohydrates, protein, and vitamins and minerals.  For simplicity’s and clarity’s sake, and because the majority of the regulations’ content has not changed materially since enactment, the current language (circa spring 2006) is described.  Major changes to the language will be noted, but the information provided is generally referenced as it appeared in the 2005 Code of Federal Regulations.

A.  GENERAL DISCLOSURE REQUIREMENTS
Remember that prior to the NLEA and these new regulations, the only mandatory fat content disclosure was the number of grams of fat per serving, and this requirement was only triggered when health claims were made or other nutritional information was provided.  NLEA and the new regulations mandated disclosure of calories from fat, total grams of fat per serving, and grams of saturated fat per serving.  Polyunsaturated fat content in total grams per serving remained a voluntary disclosure, and two more voluntary categories were added:  calories from saturated fat and number of grams per serving of monounsaturated fat.  Each of these disclosure categories will be discussed below.  See TABLE 1 for an explanatory chart of the varying requirements over time.

TABLE 1:  FAT CONTENT DISCLOSURE REQUIREMENTS

	Pre-NLEA	Post-NLEA	After Jan. 1, 2006	
Total Fat (grams per serving)	       X*	X	X	
Percent of Calories from Fat	       X**			
Calories from Fat		X	X	
Calories from Saturated Fat		voluntary	voluntary	
Saturated Fat (grams per serving)	       X**	X	X	
Trans Fat (grams per serving)			X	
Polyunsaturated Fat (grams per serving)	       X**	voluntary	voluntary	
Monounsaturated Fat (grams per serving)		voluntary	voluntary	
* required if any nutritional information is provided, or if health claims are made
** required if any nutritional information is provided, or if health claims are made AND information about fatty acid composition is provided

	Total fat is defined as the total lipid fatty acids per serving, expressed as triglycerides. “Calories from fat” is a required statement of the caloric content derived from total fat per serving; it is expressed to the nearest 5-calorie increment up to 50 calories and to the nearest 10-calorie increment above 50 calories.  “Total fat” or “Fat, total” is simply a statement of the number of grams of total fat in a serving.  
Wherever reference is made to the number of grams of fat in a serving, whether it be “Total fat,” “Saturated fat,” “Polyunsaturated fat,” or “Monounsaturated fat,” the number is expressed to the nearest 0.5 gram below five grams and to the nearest gram above five grams, with anything less than 0.5 grams being expressed as zero.  If the actual total fat or saturated fat content exceeds that stated on the label by 20% or more, the food may be considered misbranded.  Conversely, the food can be considered misbranded if the actual polyunsaturated fat or monounsaturated fat is not at least 80% of that stated on the label.
	Saturated fat is defined as the sum of all fatty acids containing no double bonds.  As mentioned above, “Saturated fat” or “Saturated” is a mandatory statement of the number of grams of saturated fat per serving.  “Calories from saturated fat” or “calories from saturated” is a voluntary declaration which appears below “calories from fat,” if stated.  
	“Polyunsaturated fat” or “Polyunsaturated” is a statement of the number of grams of polyunsaturated fat, defined as cic,cis-methylene-interrupted polyunsaturated fatty acids, in a serving.  Similarly, “Monounsaturated fat” or “Monounsaturated” is a statement of the number of grams of monounsaturated fat, defined as cic-monounsaturated fatty acids, in a serving.  Remember that unsaturated fat in the “cis” formation are different from those in the “trans” formation, so the definitions for polyunsaturated and monounsaturated fat do not cover trans fatty acids.  
Monounsaturated fat and polyunsaturated fat declarations are generally voluntary, but both must be disclosed if either one is stated.  Each must be included on any food package which makes claims about fatty acids or cholesterol where the food does not meet the criteria of a claim of “fat free.”  
	“Total fat” and “saturated fat” must also be expressed as a percentage (to the nearest whole percent) of the Daily Reference Value (DRV) under a column heading titled “% Daily Value”.  The DRV is 65 grams for total fat and 20 grams for saturated fat.  A footnote placed beneath the list of vitamins and minerals states, “Percent Daily Values are based on a 2,000 calorie diet.  Your daily values may be higher or lower depending on your calorie needs”.  The footnote also contains a table listing the DRVs for a 2,000 calorie diet (listed above) and a 2,500 calorie diet, stated as 80 grams of total fat and 20 grams of saturated fat.
	Food for small children presents a notable exception to the fat labeling requirements.  Infant formula must only contain a declaration of total grams of fat.  Foods represented as being specifically for infants and children under four years old must not have the declarations of total fat and saturated fat as a percentage of Daily Value.  In addition, if a food is represented as being specifically for infants and children under two years of age, the label cannot state calories from fat, calories from saturated fat, saturated fat grams, polyunsaturated fat grams, or monounsaturated fat grams.  DRVs had not been established for young children, and the FDA did not wish to establish misleading guidelines for the feeding of young children during periods of major growth, which requires an energy-dense diet with a higher percentage of calories from fat than that required for older children.  
	Restaurants are also exempt from the general nutrient labeling requirements unless they make nutrient or health claims, in which case the labeling requirements do apply.  A number of other exemptions exist, including but not limited to:  food sold by entities with less than $500,000 gross annual sales; medical foods; foods with insignificant amounts of all nutrients and food components required to be disclosed; food in packages too small to bear labeling; food sold in bulk quantities; and food products shipped in bulk that are to be processed, labeled, or repacked at another site.

B.  FAT CONTENT CLAIMS
	Claims about the level of fat or fatty acids in a food may only be made using FDA-defined terms.  No type of nutrient claims may be made if a food qualifies as a “calorie free” or “low calorie” food.  Additionally, if a food contains more than 13 grams of total fat or more than 4 grams of saturated fat per reference amount usually consumed or per labeled serving, any nutrient content claim made on that food must be accompanied by a statement disclosing that the nutrient exceeding the specified level is present in the food.  The required statement must be in the form of “See nutrition information for fat content.”  
In general, the use of a “free” or “low” claim before the name of a food requires that the food has been specially processed, altered, formulated, or reformulated to lower the amount of the nutrient in that food, mainly because the words “free” and “low” imply that the food differs from other foods of the same type by having a lower amount of the nutrient.  Therefore, while a claim for “low fat yogurt” would be proper, since regular yogurt typically contains fat, a claim for “fat free carrots” would be misleading, since carrots do not normally contain fat.  As described below, the carrot description would need to be in the form of “carrots, a fat free food.”  Whether the distinction is actually discernible to consumers is arguable; the language is very similar and the difference in terminology is somewhat subtle.    

i.  TOTAL FAT CLAIMS
	When a food contains less than 0.5 grams of fat per serving and per amount typically consumed (set by a defined reference amount for each type of food), it may be labeled with the following terms:  “fat free,” “no fat,” “zero fat,” “without fat,” “negligible source of fat,” “dietarily insignificant source of fat,” or, in the case of milk products, “skim.”  The food must not have any ingredient added which is a fat or is generally perceived by consumers to contain fat unless the ingredient is labeled with an asterisk and a statement that it “adds a trivial amount of fat,” “adds a negligible amount of fat,” or “adds a dietarily insignificant amount of fat.”  If the particular food (not just the brand being labeled) inherently qualifies as “fat free” without additional processing to lower the fat content, the fat-related claim must clearly indicate that all foods of that type do not usually contain fat (e.g. “broccoli, a fat free food”).  A claim of “100% fat free” may be made on foods that qualify for the above “fat free” designation, contain less than 0.5 grams of fat per 100 grams, and contain no added fat.
	The terms “low fat,” “low in fat,” “low source of fat,” or “little fat” may be used on foods that contain three grams or less of fat per reference amount usually consumed, provided that the reference amount is greater than 30 grams or two tablespoons.  If the food is considered a meal product or a main dish product, a claim of low fat requires fat content of less than three grams of fat per 100 grams and not more than 30% of calories from fat. As with naturally fat free foods, those naturally low in fat without extra processing or alteration must be labeled in a way that indicates that all such food is inherently low in fat (e.g. “frozen perch, a low fat food”).  When a food product qualifies for a “low fat” claim, it may also bear a “percent fat free” claim (e.g. “95% fat free”).
	Food manufacturers are able to make claims that their food has less fat than other foods, within some narrowly drawn categories.  First, the food must be compared against an appropriate reference food, which would be a similar food (e.g. a different brand of cereal for a cereal product claim) or a dissimilar food that can generally be substituted for that food in the diet (e.g. oatmeal, as compared to cereal).  Next, the food being labeled must contain at least 25% less fat than the reference food in a similarly-sized portion.  Then, as long as the food itself does not qualify for a labeling of “low fat,” it may be labeled with the term “less fat,” “lower fat,” or “lower in fat.”  
Food products bearing claims of “reduced fat,” “reduced in fat,” and “fat reduced” must also contain at least 25% less fat than the reference food, but the reference food must be a similar food.  Labels must state the identity of the reference food and how much less fat is in the labeled as compared to the reference food, via a percentage or fraction (e.g. 50% less fat than Lay’s potato chips).  The information about the relative difference in fat content must be in immediate proximity to the most prominent such claim (e.g. reduced fat – 35% less fat than our regular Ritz crackers).  

ii.  SATURATED FAT CLAIMS
When a food label contains a claim related to the level of saturated fat in the food product (e.g. “saturated fat free” or “low in saturated fat”), the level of total fat and cholesterol must also be disclosed in close proximity, in at lettering at least half the size of the saturated fat claim.  Exceptions to this rule exist, however.  The declaration of cholesterol may be omitted when the food contains less than two milligrams of cholesterol per usual amount consumed.  Disclosures of the total fat content may be omitted in several situations.  If the food product qualifies for a “saturated fat free” type of claim and contains less than 0.5 grams of total fat per usual amount consumed, no disclosure of total fat is required.  Similarly, if a food product qualifies for a “low in saturated fat” type of claim or a “reduced/less saturated fat” type of claim, and contains three grams or less of total fat per reference amount usually consumed, no declaration of total fat is required, either.
Aside from the types of adjacent total fat and cholesterol disclosures just listed, claims related to saturated fat are very similar to those related to total fat content in food products.  When a food contains less than 0.5 grams of saturated fat and less than 0.5 grams of trans fatty acid, both per reference amount and per labeled serving, the following terms may be used:  “saturated fat free,” “free of saturated fat,” “no saturated fat,” “zero saturated fat,” “without saturated fat,” “trivial source of saturated fat,” “negligible source of saturated fat,” or “dietarily insignificant source of saturated fat.”  For a “saturated fat free” type of claim, the food must also contain no ingredient that is generally understood by consumers to contain saturated fat unless the ingredient listing contains an asterisk with one of the following statements:  “adds a trivial amount of saturated fat,” “adds a negligible amount of saturated fat,” or “adds a dietarily insignificant amount of saturated fat.”  As with total fat, if a food is naturally saturated fat free without further processing to reduce saturated fat, the claim should reflect that saturated fat is not usually present in the food (e.g. “romaine lettuce, a saturated fat free food”).
When a food contains one gram or less of saturated fat per usually-consumed amount and obtains no more than 15% of its calories from saturated fat, the following claims may be used for that product:  “low in saturated fat,” “low saturated fat,” “contains a small amount of saturated fat,” “low source of saturated fat,” or “a little saturated fat.”  A food that meets the above condition without extra processing or alteration to lower the saturated fat content should be labeled clearly to refer to all foods of that type (e.g. asparagus, a saturated fat free food).
Claims for lower and reduced saturated fat follow the same protocol as claims for lower and reduced fat overall.  The food must contain at least 25% less saturated fat than the appropriate reference food.  For claims of “less saturated fat,” “lower saturated fat,” or “lower in saturated fat,” the reference food may be a similar food or a dissimilar food commonly substituted for the labeled food, while claims of “reduced saturated fat,” “reduced in saturated fat,” and “saturated fat reduced” require a similar reference food.  Claims must contain a percentage or fractional difference in saturated fat between the labeled food and the reference food, and the identity of the reference food must be in close proximity to the most prominent claim (e.g. “Reduced saturated fat.  Contains 35% less saturated fat than Kellogg’s Pop Tarts”).  Neither the “less saturated fat” type of claim nor the “reduced saturated fat” type of claim may be made if the food meets the definition for “low saturated fat.”

iii.  LIGHT CLAIMS
	The term “light” or “lite” may be used on a food label with reference to reduced fat content, provided that the food does not already qualify for a nutrient claim of “low fat.”  In general, to qualify for a fat-related “light” claim, a food must have at least 50% less fat per amount usually consumed as compared to a similar reference food.  The identity of the reference food and the percent or fraction of fat reduction must be declared in appropriate proximity and font size (e.g. “50% less fat than our regular eclairs”).  Information comparing the level of calories and fat content in the food and the appropriate reference food must also be displayed next to the most prominent “light” claim or the nutrition label (e.g. “lite éclair – 250 calories, 5 grams of fat per serving; regular éclair – 350 calories, 10 grams of fat per serving).
	Meal products and main dish products may bear “light” claims, but the criteria are different than other foods.  The meal or main dish must qualify for a “low calorie” or “low fat” claim and a statement must explain whether “light” means “low calories,” “low fat,” or both. 

iv.  LEAN CLAIMS
The FDA used the same criteria as the U.S. Department of Agriculture (USDA) did in its post-NLEA final regulation which defined the term “lean.”  “Lean” may be used to describe seafood or game meat if it contains less than 10 grams total fat, 4.5 grams or less of saturated fat, and less than 95 milligrams of cholesterol per amount usually consumed and per 100 grams.  The same reference amounts apply for meal products and main dish products, except that the measurements are per labeled serving.  The term “extra lean” may be used for seafood or game meat products if they contain less than 5 grams total fat, less than 2 grams saturated fat, and less than 95 milligrams of cholesterol per amount usually consumed and per 100 grams; again, the reference amounts are the same for extra lean claims on main dish products and meal products, but the amounts are per labeled serving.  

v.  RELATED CLAIMS (CHOLESTEROL AND FIBER)
If a claim is made about the level of fiber, such as “high fiber” or “good source of fiber,” then unless the product also qualifies for a claim of “low fat,” the label must also disclose the level of total fat per serving.  The disclosure must be in close proximity to the fiber claim and accompanied by the statement “See nutrition information for fat content.”
	Cholesterol claims are dependent on the fat content of the food.  If a food contains less than 2 milligrams of cholesterol per reference amount usually consumed, and has 2 grams or less of saturated fatty acids per reference amount, it may qualify for a claim of “cholesterol free,” “free of cholesterol,” “zero cholesterol,” “without cholesterol,” “no cholesterol,” “trivial source of cholesterol,” “negligible source of cholesterol,” or “dietarily insignificant source of cholesterol.”  If the food contains more than 13 grams of total fat per amount usually consumed or per serving, the label must also disclose the level of total fat in the serving.
	If a food product contains 20 milligrams or less of cholesterol and 2 grams or less of saturated fatty acids per reference amount, it may qualify for a claim of “low in cholesterol,” “contains a small amount of cholesterol,” “low source of cholesterol,” or “little cholesterol.”  As with cholesterol free claims, when the food contains more than 13 grams of total fat per serving or reference amount, it must also bear disclosure of the level of total fat per serving. 
	Claims of “reduced cholesterol,” “reduced in cholesterol,” “cholesterol reduced,” “less cholesterol,” “lower cholesterol,” or “lower in cholesterol” also are limited to foods with less than 2 grams of saturated fat per reference amount.  These claims may apply when a food has reduced its cholesterol by 25% or more from a reference food.  As with the other types of cholesterol claims, a reduced cholesterol claim for a food containing more than 13 grams of total fat must bear a disclosure of the number of grams of fat per serving.   

C.  HEALTH CLAIMS
	A health claim is any claim made on the label of a food that expressly or by implication characterizes the relationship of any dietary substance to a disease or health-related condition for which the general public of the U.S. or a particular sub-population, such as the elderly, of the U.S. is at risk.  According to the NLEA, the FDA may only promulgate regulations authorizing a type of health claim when it determines, on the basis of the totality of publicly available scientific evidence, that there is significant scientific agreement on the validity of that claim.  
The approach used to decide whether the “significant scientific agreement” requirement was met for dietary supplement health claims was overturned in a D.C. appeals court on First Amendment grounds in 1999.  The court disagreed with the FDA that claims unsupported by significant scientific agreement are inherently misleading.  The FDA authorized a new type of health claim for both dietary supplements and conventional foods with a lower standard of scientific credibility.  The new claims are referred to as qualified health claims and will be discussed in the next subsection.  
Currently, two fat-related health claim types are covered in the regulations – the connection between dietary lipids and cancer, found in 21 C.F.R. §101.73, and the link between saturated fat and cholesterol and the risk of coronary heart disease, found in 21 C.F.R. §101.75.  
Foods are completely disqualified from bearing health claims on their labels if they contain more than 13.0 grams of total fat, 4.0 grams of saturated fat, 60 milligrams of cholesterol, or 480 grams of sodium per reference amount or labeled serving size.  Claims must be complete, truthful, and not misleading; additionally, the claim must be clear enough for the public to understand the information and its significance.  In order to bear a health claim, prior to any nutrient addition, foods must contain 10% or more of the Reference Daily Intake or  DRV for vitamin A, vitamin C, iron, calcium, protein, or fiber per amount usually consumed.  As with nutrient claims, restaurants must provide full nutrition labeling information upon request if a health claim is made about that food.
	Health claims linking dietary lipids and cancer are based on the scientifically observed correlation between total fat intake and risk of some types of cancer.  Based on the totality of studies available, the FDA concluded that total fat intake alone, regardless of number of calories consumed, is associated with cancer risk.  The fact that cancer is ranked as a leading cause of death in the United States and that the average U.S. diet contains more calories from fat than is dietarily recommended provided justification for the importance of allowing fat/cancer link health claims.
	Any food bearing a fat/cancer health claim must qualify for the nutrient claim of “low fat.”  A health claim linking diets low in fat with a reduced risk of cancer must meet the following conditions:  states that diets low in “fat” or “total fat” “may” or “might” reduce the risk of “some cancers” or “some types of cancer;” does not make claims about specific types of fat or fatty acid; does not specify a level of reduction in cancer risk; and indicates that cancer development is dependent on many factors.  An example of a permissible claim provided by the FDA: “Development of cancer depends on many factors.  A diet low in total fat may reduce the risk of some cancers.”  The claim may also disclose additional optional information about the relationship between dietary fat and cancer; other risk factors for the development of cancer such as cigarette smoking, alcohol consumption, overweight and obesity, etc.; or current information taken from designated sources about the number of people in the U.S. who have cancer.
	The FDA has also approved claims based on the connection between dietary saturated fat and cholesterol and the risk of coronary heart disease.  The FDA acknowledges that coronary heart disease is a major public health concern in the U.S. because it accounts for more deaths than any other disease or group of diseases.  Scientific studies have shown that high levels of both total cholesterol and low density lipoprotein (LDL) cholesterol in the blood are risk factors for coronary heart disease.  Those increased cholesterol levels in turn are positively associated with diets high in saturated fat and cholesterol.
	Claims linking fat and cholesterol consumption with coronary heart disease must meet the following conditions:  states that diets low in saturated fat and cholesterol “may” or “might” reduce the risk of “heart disease” or “coronary heart disease;” does not specify an amount of the heart disease risk reduction due to diets low in saturated fat and cholesterol; and states that coronary heart disease depends on many factors.  A model claim offered by the FDA: “While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.”  Additional optional information may also be provided, including but not limited to:  disclosure of additional risk factors for coronary heart disease such as a family history of the disease, excess body weight, high blood pressure, cigarette smoking, etc.; statistics about the number of people in the US with coronary heart disease; information about the intermediate link between high blood cholesterol and heart disease; and advice stating that individuals with elevated total- or LDL-cholesterol should consult their physicians for medical advice and treatment.

D.  QUALIFIED HEALTH CLAIMS
	As mentioned earlier, Pearson v. Shalala questioned the “significant scientific agreement” standard for dietary supplement health claims under First Amendment grounds, which created an opening for those who hoped to loosen the scientific requirements for general food health claims.  In October 2000, the FDA published notice of its intention to exercise enforcement discretion with regard to certain dietary supplement claims that did not meet the significant scientific agreement standard.  A subsequent D.C. district court case established “credible evidence” as the appropriate standard for reviewing qualified health claims.  
Near the end of 2002, the FDA announced the availability of a guidance document titled “Guidance for Industry:  Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements.”  This announcement explicitly expanded the field of qualified health claims to cover conventional foods.  To meet the criteria for a qualified health claim, a petitioner would need to provide a credible body of scientific evidence supporting the claim, as well as demonstrating that the “weight of the evidence” supports the qualified claim.  The agency also announced that a “reasonable consumer” standard would be used in evaluating whether the claim is misleading.  The guidance was implemented immediately without public comment to ensure that the FDA was complying with the governing First Amendment case law.
In November 2003, the FDA published an advanced notice of proposed rulemaking requesting comments on alternatives for regulating qualified health claims, those that do not meet the significant scientific agreement standard.  In Fall 2004, FDA issued letters of enforcement discretion for two qualified health claims related to the reduction of risk of coronary heart disease from the consumption of monounsaturated fatty acids from olive oil and omega-3 fatty acids.  The claims are listed below:
1.  Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil.  To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day.  One serving of this product [Name of food] contains [x] grams of olive oil.
2.  Supportive but not conclusive evidence shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.  One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids.  [See nutrition information for total fat, saturated fat, and cholesterol content.]
	Some consumer groups feel that allowing consumer health claims is misleading to the general public.  Carol Tucker Foreman, director of the Food Policy Institute at the Consumer Federation of America questioned the messages being sent by qualified health claims, mentioning that the FDA did no research to establish that consumers would know that qualified health claims provide less information and assurance of validity.  CSPI has called for complete revocation of all qualified health claims, arguing that they are not understood by the consumer and lead to in accurate and misleading science being passed off as fact.

VI.  TRANS FAT REGULATION
	The rise of trans fats in the American diet was helped by a 1980s move to get rid of heart-unhealthy tropical oils used in many foods.  The FDA declined to include trans fat disclosure in the NLEA implementation regulations due to lack of conclusive scientific evidence of its link to heart disease.  By the time studies verified the negative effects that trans fat has on blood cholesterol and  the risk of coronary heart disease in the early 1990s, trans fat was firmly established within the U.S. food supply.  Over the next decade, trans fat was researched and described in the media continuously.  The 1995 Dietary Guidelines disclosed that partially hydrogenated oil containing trans fat may raise blood cholesterol, but did not make a recommendation to reduce intake.  
Pundits had widely varying opinions.  On one extreme was Walter Willett, chairman of the nutrition department of Harvard School of Public Health and prolific trans fat researcher saying that “introducing trans fat into the American diet is the single most harmful thing the food industry has done in the last 100 years.”  Edward Emken, a labeling opponent and researcher at the U.S. Department of Agriculture said that “the amount of trans fat in the typical American diet doesn’t pose much risk of heart disease for the average person.”

A.  MEDIA ATTENTION
Consumer advocates such as CSPI had been pushing for trans fat labeling regulations since the early 1990s.  And the FDA was pursuing a trans fat labeling rule as of 1999 (described below).  But it was a lawsuit that catapulted the term trans fat into living rooms across the country.
On May 5, 2003, San Francisco attorney Stephen Joseph filed suit against Kraft Foods in California’s Marin County Superior Court, asking for an injunction ordering Kraft to desist from selling its Nabisco brand Oreo cookies to children in California because the cookies were made with partially hydrogenated oil, which contains trans fat.  Joseph’s suit relied on a California product liability law which exempts companies from product liability actions if the product consumed is inherently unsafe and known to be unsafe by the ordinary consumer.  Therefore, if Joseph could prove that trans fat is inherently unsafe but that the ordinary consumer was unaware of its danger, Kraft would theoretically not be exempt from a products liability judgment in court.  The unsafe nature of trans fat stems from its link to high cholesterol and heart disease.  Joseph decried a “widespread ignorance about trans fats” and admitted that the intended effect of the lawsuit was to educate people.
The Oreo lawsuit certainly brought trans fat to the general consumer’s attention.  Online and word-of-mouth discussions about trans fat increased more than eightfold during the month the lawsuit was filed.  One analyst described the Oreo lawsuit as a tipping point, noting, “All of the energy created by nutritionists, dietitians and nutrition thought leaders suddenly exploded with the lawsuit and subsequent media coverage....It turned into a long-term deep and complex interest in the trans fats issue among mainstream consumers.”  
Just nine days after filing suit, Stephen Joseph announced plans to drop the action because he had achieved the goal of the lawsuit, which was raising awareness about trans fat.  Even if the lawsuit had only been a publicity stunt, it had probably lost its legal standing from all the attention and hype.  The Oreo lawsuit is described by its proponents as a victim of its own success – the amount of media attention and publicity the suit received left the plaintiffs in a situation where they could no longer tell a judge that trans fats were not known to be unsafe by the ordinary consumer.
Clearly, Kraft felt the heat from the media onslaught.  The company began a nutrition and public relations campaign to remove itself from the eyes of the public as the poster child for trans fat in packaged food.  On July 2, 2003, Kraft Foods announced that it was working on developing Oreo cookies without trans fats as a part of a general plan to rethink product lines and fight obesity.  

B.  REGULATORY HISTORY
In July 2003, the FDA announced a final rule mandating the disclosure of trans fat levels in food products.  While it may have appeared to be a quick reaction to sudden public awareness of trans fatty acids, the FDA had been aware of trans fatty acids and their potential significance in the diet for quite a while.  The final rule was the end result of a lengthy administrative procedure lasting many years. 
	In its July 1990 proposal for mandatory nutrition labeling, the agency made a preliminary conclusion that disclosure of trans isomers of fatty acids was not needed because then-current scientific research had failed to establish a connection between trans fat and blood cholesterol increases.  In 1991, when proposing the nutrient labeling rules, the scientific knowledge about trans fat was progressing, but was not extensive enough for the FDA to propose that it should be listed on the food label.  The agency requested comments on whether trans fat listing should be voluntary, though, in recognition that newer studies could yield further information on the topic.  When the final post-NLEA regulations were published, trans fat was not included, but the FDA acknowledged that it would likely have to revisit the issue in the future.  
The Center for Science in the Public Interest (CSPI) filed a citizen petition with the FDA in February 1994, arguing that mounting evidence shows that dietary trans fatty acids do raise blood cholesterol and therefore contribute to the development of coronary heart disease.  CSPI insisted that the new regulations covering saturated fat disclosure underestimated the total amount of “heart-unhealthy” fats because trans fat was not included, and requested that the regulations related to saturated fat be amended to account for trans fatty acids.  In 1998, CSPI amended its petition, suggesting that the FDA either (1) require the saturated fat disclosure to include trans fat in the measurement with an asterisk at the bottom stating “contains x grams of trans fat, or (2) require trans fats to be added into the measurement of saturated fat with a notation of “saturated + trans fat” when trans fat was present.
The FDA responded to CSPI’s proposal with a proposed trans fat labeling rule in November 1999.  The proposed rule would have added a symbol next to the saturated fat declaration when trans fatty acids were present in a food, with a footnote listing the number of grams of trans fatty acids present in a serving of the food.  The comment period was originally open until February 15, 2000, but was extended until April 17, 2000 to accommodate requests for more time to comment.
The FDA announced another reopening of the comment period in November 2002 in order to allow for response to a report by the Institute of Medicine of the National Academy of Sciences (IOM/NAS) entitled “Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids” which declined to designate a dietary reference intake value for trans fatty acids.  The report noted a positive linear trend between trans fatty acid intake and both total- and LDL-cholesterol levels (and hence risk of coronary heart disease), which led IOM/NAS to make a recommendation “that trans fat consumption be as low as possible while consuming a nutritionally adequate diet,” in lieu of establishing an unrealistically low daily upper limit of zero grams of trans fat.  The agency requested comments on its proposed use of a footnote statement “Intake of trans fat should be as low as possible.”
The FDA published the final rule relating to trans fat disclosure on food labels in July 2003, announcing that the effective date for the rule’s mandates would be January 1, 2006.  The agency withdrew a number of portions of the proposed rules, including definitions of nutrient content claims for “free” and “reduced” levels of trans fatty acids, limits on the amounts of trans fatty acids when saturated fat nutrient content claims or health claims are made, and the footnote requirement.  Only the bare declaration of the number of grams of trans fat was added to food labels.

C.  CONTENT OF THE REGULATION
	As of January 1, 2006, a declaration of the number of grams of trans fat now appears directly below the declaration of saturated fat on a standard food label.  Trans fat is defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e. non-conjugated) double bonds in a trans configuration.  
A declaration of trans fat content is mandatory unless a product contains less than 0.5 grams of total fat in a serving and makes no claims about fat, fatty acid, or cholesterol content; in this situation, the statement “Not a significant source of trans fat” must be placed at the bottom of the table of nutrient values.  As with total fat and saturated fat, the trans fat content is expressed in 0.5 gram increments below five grams and to the nearest gram above five grams, with levels of less than 0.5 grams of trans fat being expressed as zero.  A product is considered misbranded under the FDCA if the actual trans fat content of the food is more than 20% in excess of the stated amount.

D.  IMPLEMENTATION OF THE REGULATION
	Food manufacturers responded to the call for trans fat labeling not by simply adding the disclosure to their labels, but in many cases by reformulating their products to lower or eliminate trans fat content.  As Stephanie Childs of GMA, a major food manufacturers’ group, noted, “I don’t know of a company that didn’t look at reformulation.”
Recall that Kraft had planned to take a hard look at the trans fat content in its products both in response to Stephen Joseph’s lawsuit and also in a general effort to make its products more healthy.  After the July 2003 announcement of the trans fat labeling requirements, it was clear that unless Kraft wanted every package of Oreos to proclaim its trans fat content, it needed to work quickly to remove the trans fat before 2006.  In April 2004, a Reduced Fat Oreo which contained zero grams of trans fat per serving was introduced.  By December 2005, Kraft had reformulated around 650 products to reduce their trans fat content and announced that less than 2.5% of their products would be required to disclose trans fat content (i.e. had 0.5 grams or more of trans fat) when the trans fat regulations became effective in January 2006.  Regular Oreos which qualify for the “zero grams trans fat” labeling have finally made it to grocery shelves (circa May 2006), at least in the greater Boston area.  It may take time for the existing stock manufactured before 2006 to move off the shelves in some stores, however.
Frito Lay, manufacturer of Doritos, Lays Potato Chips, and other snack foods, replaced trans-fatty oils in their products with corn and cottonseed oils.  It took a year to accomplish this feat, in part because of the technological efforts of reformulating the products, but also because farmers had not grown enough corn for Frito Lay to make the massive replacement efforts in its many products.  In a press release, Frito Lay touted its own success as the first major company to eliminate trans fat from its entire line of snack chips, totaling more than 35 brands and over 150 products.
Kraft and Frito Lay are just two prominent examples of the food industry’s efforts at reducing the trans fat content in their products prior to the labeling implementation deadline.  Obviously there are some products which were not changed to eliminate trans fat, but generally it appears that food manufacturers successfully met the labeling deadline and often tried to rework their products to eliminate trans fat without sacrificing taste and texture. 
The FDA recognized that most, but not all, food manufacturers would be able to meet the January 2006 compliance date.  In December 2005, the FDA announced the availability of a guidance document titled “Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of Jan. 1, 2006,” which advised businesses who were unable to implement the labeling requirements on time on how to request agency enforcement discretion on the use of existing stock on hand.  The FDA has received more requests for extensions than it originally expected; the agency currently anticipates receiving around 600 requests in 2006 and 300 requests in 2007.  No requests for extensions are expected past 2007 because all existing labeled stock should have been sold by that time.
A recent trip to a local grocery store yielded some interesting observations.  Many products in snack food aisles now proclaim  “0 grams trans fat” on their labels, including the majority of potato chips and other similar snacks.  Products where trans fat could still be found were some cookies, frozen fried foods such as fish sticks, and some crackers, among other things.  
Two things were interesting about the grocery store visit:  1) so few foods contain 0.5 grams or more of trans fat per serving (amounts below 0.5 grams may be stated as zero), and 2) many labels bear the “zero grams trans fat” statement on package fronts.  Apparently the reformulation efforts were quite successful in some food types (potato chips), but not in all (fish sticks).  The fact that many companies are choosing to put the “0 grams trans fat” label on their products is not terribly surprising.  After all, companies spent a lot of time and effort removing the trans fat from their food.  Additionally, the general public probably does not know that much about trans fat, except that it is “bad” and should be avoided.  If consumers are unaware of which foods contain trans fat, it is in the manufacturers’ best interests to be proactive and volunteer the “zero grams trans fat” information in order to lessen confusion and to encourage people to buy their products.  A valid question, however, is whether these proclamations related to trans fat numb consumers into a false sense of security, by making them think that because there is little or no trans fat in the product, the food is therefore healthy.  Calories, fat, and saturated fat should be examined by consumers worried about fat intake, in addition to verifying the amount of trans fat.

VII.  THE FUTURE OF FAT CONTENT DISCLOSURE
	Fat content disclosure requirements will continue to be a hot topic in the near future.  Consumer protection lawsuits, calls for differing trans fat labeling requirements, and questions about whether consumers effectively use label information to make informed choices all remain on the table for discussion.  Perhaps the loudest drumbeat of all is the one asking for restaurant nutrition labeling.

A.  CURRENT REGULATORY ENVIRONMENT
The FDA still has some work to do with trans fatty acids.  Trans fat is an tricky target for regulation, because unless the FDA wants to revisit the entire food labeling structure, trans fat must find its place within it.  Currently, the agency is wrestling with issues like determining whether there should be a maximum DRV for trans fatty acids such as those for total fat (65 grams) and saturated fat (20 grams), or whether it should be combined with the DRV for saturated fat.  As of yet, no definitions exist for nutrient claims such as “low trans fat” or “reduced trans fat,” and none will be forthcoming until the FDA determines what level of trans fat in the diet (if any) is safe and/or recommended.
Other fat-related areas being dealt with by the FDA are “lean” claims and qualified health claims, each of which are discussed below.

i.  TRANS FATTY ACID NUTRIENT CONTENT CLAIMS
	While the disclosure of the amount of trans fatty acids has been successfully added to food labels, the FDA still has not settled the issue of trans fatty acid nutrient content claims.  On July 11, 2003, the same day the trans fat disclosure requirement was announced as a final rule, the FDA issued an Advanced Notice of Proposed Rulemaking (ANPRM) soliciting information and data to be used to establish trans fat nutrient content claims.  
The comment period ended on October 9, 2003, and was reopened for 45 days on March 1, 2004 to allow response to a study published by IOM/NAS titled “Dietary Reference Intakes:  Guiding Principles for Nutrition Labeling and Fortification.”  The report suggested that although trans fat and saturated fat were structurally different, their similar effects in raising total- and LDL-cholesterol levels and in potentially contributing to coronary heart disease might justify listing saturated fat and trans fat together for the “percentage of daily value” column.  The FDA requested comments on whether establishment of a Daily Value (DV) reference level for trans fat intake alone or saturated fat plus trans fat intake combined would be more appropriate in light of the IOM/NAS study results.  Comments were also solicited for the issue of whether a DV for trans fat or joint DV for trans fat and saturated fat would obviate the need for a disclosure statement about the role of cholesterol-raising lipids in the development of coronary heart disease and/or a footnote about trans fat, either alone or in combination with saturated fat and cholesterol.
On April 19, 2004, the comment period was extended for another 60 days to allow incorporation of information gathered from a Food Advisory Committee Nutrition Subcommittee meeting scheduled for the end of April.  The meeting was called to discuss both the then-current scientific evidence for the purpose of determining a potential maximum limit of trans fat intake for setting RDAs and the nature of trans fat as compared to saturated fat in its effect on coronary heart disease.  As of October 2005, the timeline for the Notice of Proposed Rulemaking was still listed on the FDA’s Semiannual Regulatory Agenda as “to be determined.”

ii.  LEAN CLAIMS
	In late 2005, the FDA published a proposed rule which would expand the claim of “lean” to cover foods categorized as “mixed dishes not measurable with a cup,” covering foods like Hot Pockets, Lean Pockets, similar ready-made sandwiches and other foods.  This initiative was in response to a petition from Nestle, who suggested that manufacturers are hindered by not being able to use the lean claim on foods which are similar to main dish and meal products but have smaller portion sizes and are not measurable with a cup.  The agency proposed that to bear a “lean” claim, foods falling within this category must have less than 8 grams total fat, 3.5 grams or less of saturated fat, and less than 80 milligrams of cholesterol per amount customarily consumed.  The FDA considered including a requirement for trans fat, but declined to do so in absence of a DRV for trans fatty acids.  Comments on the “lean” claim proposed rule were due by February 8, 2006.  As of early May 2006, no further action has been taken.

B.  CONTINUED CALLS FOR CHANGE
Lawsuits related to fat, obesity, and advertising are not likely to go away.  Some expect future suits against food companies based on consumer protection laws, attacking food manufacturers for doing things like advertising products as low-fat without mention of high calorie and sugar content, or saying that a food is “lower” in fat even when it is not actually low in fat.  Currently, those claims are perfectly valid under the FDA’s regulations.  One could ask whether it is the FDA’s responsibility to promulgate stiffer regulations to avoid consumer confusion and food industry liability, or if manufacturers should accept sole responsibility for any claims they make.  It will be interesting to see what happens if and when these types of lawsuits appear.
A combination of public shaming and attention and the desire to avoid disclosing positive levels of trans fat in its products made Kraft reformulate hundreds of its packaged foods.  Kraft was certainly not the only company to do so.  Now that trans fat is on the food label, it’s safe to assume that companies will stay with the newly reformulated products and continue to create new products that do not contain trans fat.  One might ask – if no products contain trans fat any more, is the labeling mandate necessary?  The answer is yes.  If the FDA were to remove the trans fat labeling requirement, nothing would prevent companies from returning to their original pre-2006 trans fat-laden recipes.  But the fact that less products contain trans fat now might mean that its disclosure could someday be moved to a less prominent position.  Some people support requiring an asterisk next to total fat or saturated fat when a product contains trans fat (with an attending footnote explaining the level of trans fat found in the food).  Those who argue that trans fat is taking away the focus on total fat and saturated fat might support such a plan.
CSPI and other consumer groups are asking for changes in the definition of zero in trans fat disclosures, pushing for a number much lower than 0.5 grams.  CSPI tested several margarines and found that spreads like Shedd’s Country Crock and I Can’t Believe It’s Not Butter had 0.4 and 0.3 grams of trans fat per serving.  Although the amounts of trans fat are small and qualify the products for labeling of zero grams trans fat, some believe this can be misleading to consumers because the small amounts do add up.  Dr. Carlos Camargo of Harvard Medical School says that zero grams should really mean zero, or at least something a lot closer to zero.
Some people claim that the trans fat issue has been blown out of proportion, and that focusing only on trans fat takes important attention away from other nutrition aims, such as eating a balanced diet, reducing calories and reducing total fat and saturated fat in order to maintain a healthy lifestyle.  As one commentator says, media outlets and researchers often focus too much on singular breakthrough findings and advice, focusing on one aspect of nutrition at the expense of the constant, dull message of eating a balanced and healthy diet.  People love to hear about how intake of calcium, omega-3 fatty acids, folic acid, etc. might be a major catalyst toward better health.  It’s easy to imagine a consumer who, having heard and seen all the recent media coverage on avoiding trans fat at all costs, goes to the grocery store and checks the label of the food she is buying…but only for trans fat content.  The products she chooses may have been reformulated to remove trans fat, which gives her a misguided belief in their healthfulness.  After all, if trans fat is so bad for one’s health and she is buying products with zero grams trans fat, they must be healthy, right?  
The problem remains that when trans fat is removed from food, the resulting product does not necessarily have lower fat, and perhaps even has a higher total fat or saturated fat content.  If a manufacturer removes the partially hydrogenated oil from a product, the oil must be replaced with a similar product.  Recall from the earlier fat and disease link discussion that trans fat has a more negative effect on LDL- and HDL- cholesterol levels in the blood than saturated fat.  So as long as the trans fat is being replaced by saturated fat (or even better, a monounsaturated or polyunsaturated fat) on a gram-for-gram basis, the net health effect for the consumer is positive.  But if more saturated fat is used to replace the trans fat, that effect could be minimized or disappear.  It’s nearly impossible to know how these reformulations are actually being carried out.
Regardless, it’s valid to question whether the consumer is much better off if she chooses products based solely on their trans fat content.  If her health goal for choosing food products is the prevention of heart disease alone, then focusing on fats (and trans fat in particular) would be a good strategy.  But the American public has more to think about than just disease prevention.  Strategies for overall health also involve things like following the food pyramid recommendations, eating adequate amounts of fruits and vegetables, and managing weight by controlling caloric intake.  A singular focus on trans fat arguably takes away from these overarching goals. 

C.  EFFECTIVENESS – CONSUMER USE OF INFORMATION
	The NLEA declared that the Secretary of Health and Human Services shall carry out activities which educate consumers about the availability of nutrition information in the label or labeling of food, and the importance of that information in maintaining healthy dietary practices. Although not much has been done on this front due to budgetary constraints, the FDA is making strides in the area of consumer use of information.
The FDA admits that it often lacks empirical data about how consumers understand and respond to statements made in product labeling.  The agency recently announced that it wants to work on this information deficit, though, announcing its plans to do an experimental study evaluating how consumers comprehend and react to possible disclosure requirements for trans fat content claims.  The information gathered from internet panel surveys will be used to evaluate the possible options for future regulatory policies.  Assuming the FDA follows through on its plans, valuable information could be gathered on the public’s understanding of trans fatty acid nutrient content claims and possibly other types of nutrition labeling.  The cost to surveying consumers via the internet is low, which suggests that future use of these types of panels could be an affordable option for information gathering in the future, provided that the data collected is actually useful.  
Another initiative underway at the FDA is a project assessing consumer perceptions of health claims.  Because health claims and qualified health claims have been such a controversial area of labeling, this research can be very valuable.  Understanding what the average consumer perceives from food labels can help the FDA meet its goals of identifying what type of information would be misleading (and hence not allowable under the FDCA).
	According to the Food Marketing Institute’s 2005 U.S. Grocery Shopper Trends Report, 95% of consumers are at least somewhat concerned about their food’s nutritional content.  The Natural Marketing Institute, an industry research firm, reports that product packaging is the second most common place where people get their nutrition advice, after doctors.  
Those who study the consumer use of information have been able to apply economic analysis to the labeling issue.  Studies of advertising show that consumers use product claims as a signal for quality; in a competitive environment, when one product says “low fat and low sodium” and a competing product does not, the consumer uses that information to infer that the latter product is inferior.  Mandatory labeling requirements may even improve food products when food manufacturers reformulate their products to avoid making unfavorable disclosures.  When food products are improved, the benefit passes to all consumers, whether or not they seek out nutritional information.

D.  THE BIG QUESTION:  SHOULD RESTAURANTS HAVE TO PROVIDE NUTRITION INFORMATION FOR THEIR FOOD PRODUCTS?
	Eating away from home is associated with increased energy intake, overweight, and obesity; additionally, the increased portion sizes of restaurant meals influence consumers into eating more when they do eat out.  Eating snacks and meals away from home increased by more than 2/3 between 1977 and 1995, with Americans eating out 27% of the time by 1995.  On these occasions, people consume 34% of their total calories and 38% of their total fat.  With much of their energy and fat coming from restaurant and fast food, it is important for consumers to understand the nutrition content of what they are eating.
	As mentioned earlier, restaurants and other types of food producers selling ready-to-eat food are exempt from affirmative food labeling unless they choose to make nutrient claims or health claims.  This allows restaurants to make changes in their menus based on what ingredients are on hand from day to day; it allows top chefs to be creative in their daily menus and bakers to work with the baking materials available on that given day.  For these reasons, it’s unsurprising that restaurant owners would resist the addition of labeling requirements.  
Clearly fast food restaurants and some chain restaurants are able to provide stable nutrition statements about their menus because some of them have already been assembled and published, either online or in the restaurant.  Perhaps fast food restaurants would be the best initial targets for labeling efforts.  This type of initiative would have to come from Congress in the form of an amendment to the FDCA, however, since restaurant labeling exemptions were codified by NLEA.  Currently, versions of the Menu Education and Labeling Act (MEAL) are before both the House and Senate but have not moved forward quickly.  The Act would amend FDCA § 343(q) to mandate a simplified label for foods sold by restaurant chains with more than 20 restaurants; calories, grams of saturated plus trans fat, and milligrams of sodium per item would have to be disclosed on menus, menu boards and other signs in a clear and conspicuous manner.  In 2004, the FDA encouraged restaurants to engage in a national voluntary effort to provide nutritional information to consumers as a part of the FDA’s strategy to reduce obesity.
The recent addition of trans fat to packaged food labels has helped to light the fire under an initiative urging restaurants to either ban the use of partially hydrogenated oil in their cooking or to provide nutrition information on their menus.  Michael Jacobsen, Executive Director of CSPI, says that restaurants which choose cooking oils with trans fat in them rather than healthier alternatives need to be pressured to add health information to their menus so that customers can make informed health choices.  Jacobsen likens selling food cooked in partially hydrogenated oil to selling a car without seatbelts:  “Partially hydrogenated oil causes thousands of avoidable premature deaths, and the restaurant industry’s reluctance to change is absolutely reckless.”
Other countries have managed to limit the trans fat amounts in their foods.  A recent study published in the New England Journal of Medicine found that while 10 McDonald’s McNuggets and a large order of french fries in the United States contains nearly 10 grams of trans fat, the same meal at McDonald’s in Denmark has less than one gram of trans fat, due in large part to Danish limitations on the amount of trans fat that is allowed in food.
	Let’s take a look at some of the offerings from fast food and popular chain restaurants in the United States.  Many such restaurants provide menu information online, and some offer it in their stores, although not necessarily on menus or places easily visible or accessible when customers are placing food orders.  See Table 2 for a sampling of restaurant foods’ caloric and fat content levels.  Although burgers were often available as “doubles” or “triples” (e.g. the Triple Whopper), only the original sizes are included so as not to overstate the intake of a regular restaurant customer.

TABLE 2:  FAT CONTENT OF POPULAR RESTAURANT FOODS
Restaurant/Item	Calories	Total Fat (g)	Saturated Fat (g)	Trans fat (g)	
      McDonalds					
Large French Fries	570	30	6	6	
Quarter Pounder with Cheese	510	25	12	1.5	
Chicken Selects Premium Breast Strips (5)	630	33	6	4.5	
      Burger King					
Large French Fries	500	28	6	6	
Whopper with Cheese	760	47	16	1.5	
Tendercrisp Chicken Sandwich	780	43	8	4	
      Dunkin’ Donuts					
Chocolate Chip Muffin	630	26	8	0	
Sausage Egg Cheese Croissant Sandwich	690	51	17	7	
Chocolate Frosted Cake Donut	360	20	5	5	
      KFC					
Extra Crispy Breast	460	28	8	4.5	
Chicken Pot Pie	770	40	15	14	
Crispy Strips (3)	400	24	5	4.5	
      Pizza Hut					
Cheese Personal Pan Pizza	630	27	12	1	
Pepperoni Lover’s Personal Pan Pizza	800	42	17	1	
      Taco Bell					
Grilled Stuft Burrito – Beef	720	32	11	3	
Fiesta Taco Salad	860	46	14	5	
Nachos BellGrande	750	36	10	5	
      Chilis					
Chicken Crispers	1870	129	25	n/a	
Grilled Baby Back Ribs	1370	82	24	n/a	
Fajita Steak Quesadillas w/ Guacamole	2020	111	54	n/a	
      Romano’s Macaroni Grill					
Spaghetti & Meatballs w/Meat Sauce, Dinner	2270	115	56	n/a	
Chicken Caesar Salad	840	64	15	n/a	
Fettucini Alfredo w/Chicken	1370	97	56	n/a	
New York Cheesecake w/Caramel Fudge Sauce	1760	113	66	n/a	
      On the Border Mexican Grill & Cantina					
Fajita Beef Quesadilla	1530	107	52	n/a	
Tres Enchiladas, Chicken	1010	68	19	n/a	
Border Chimichanga, Ground Beef	1310	98	31	n/a	

	Some of the caloric and fat content numbers in Table 2 are simply astonishing.  It’s not difficult to see why a restaurant serving of fettucine alfredo is sometimes referred to as a “heart attack on a plate.”  In consuming 1,370 calories, 97 grams of fat, and 56 grams of saturated fat in Macaroni Grill’s Fettucine Alfredo with Chicken, a person takes in 69% of his daily calories, 149% of  his total fat DRV, and 280% of his saturated fat DRVs.  Also quite troubling are the high amounts of trans fat found in fast food french fries and other fried food, the whopping 14 grams of fat in a KFC Chicken Pot Pie, and the generally high levels of total fat and saturated fat in all the offerings.  Nearly every food listed contained at least half of the daily value of total fat in just one serving.  
	Brandeis’ famous saying that “sunlight is the best disinfectant” comes to mind.  To order at a restaurant with a vague awareness that your slice of cheesecake is “sort of unhealthy” is a very different situation from seeing that it has over 1700 calories and 66 grams of saturated fat and deciding to order it anyway.  If restaurants were made to disclose the calorie and fat content (as well as other nutritional information) to customers along with their menus as they are ordering, what sort of changes would they make?  Portion sizes would likely shrink to begin with, as that is an easy change that requires no re-working of recipes and ingredients.  But then what might happen?  Restaurants would take the same steps that Kraft and Frito Lay did when forced to disclose trans fat content – they would find ways to make their offerings look more appealing on a nutrition label.
	Restaurant nutrition labeling would not be a cure-all, of course.  Remember that the trans fat reformulations did result in the adding back of saturated fat to some foods.  It would be nearly impossible to maintain portion size, flavor, texture, and consumer appeal while also drastically cutting calories and fat.  But at least restaurants would be given a reason to try to provide more healthy alternatives if they had to give customers a nutrition snapshot of what they were about to eat.  The more information consumers have about the food they eat, the better decisions they will be able to make regarding their health.
	
VIII.  CONCLUSION
Fat content disclosure requirements have changed dramatically over the past 35 years, moving from a system of almost entirely voluntary disclosure to a complex set of requirements covering fat content (total fat, saturated fat, trans fat, unsaturated fats), nutrient content claims such as “fat free” and “reduced fat,” and health content claims, both unqualified and qualified.  Trans fat and qualified health claims remain at the forefront of current discussion, as does the possibility of mandating restaurant nutrition information disclosure.  
The trend toward providing increasing amounts of information brings issues related to complexity.  Ordinary consumers can benefit from nutritional information by using it to inform their food choices in the pursuit of better health.  But issues arise when debate over scientific standards muddles the clarity of health claims.  When consumers do not understand what a health claim means or whether it is supported by scientific evidence, the information provided to them is less useful.  Another problem arises if a focus on singular nutrients such as trans fat overshadows basic good nutrition advice in consumers’ minds, driving them to choose food products based on one attribute rather than overall nutrition.
Restaurant food labeling will be an interesting topic to follow in the near future.  If Congress does follow through on the pending MEAL bills, restaurants would be expected to make some menu, portion size, and ingredient changes in response to labeling requirements.  These changes are likely to benefit consumers overall by providing more healthy (at least slightly more healthy) options at fast food and chain restaurants.  
The FDA’s challenge in upcoming years will be to provide information via food labeling that is beneficial to food consumers in a way that they understand and can use it, while also supporting general nutrition, anti-obesity, and disease prevention efforts.