American Journal of Law & Medicine

Functional foods: what are they? How are they regulated? What claims can be made?(The Dietary Supplement Health and Education Act: Regulation at a Crossroads)

I. INTRODUCTION

Scientific studies continue to establish a strong relationship between constituents in foods and dietary supplements and certain diseases. (1) The general population is inundated on a seemingly daily basis by media reports of new studies showing that a food or dietary supplement is useful in treating particular diseases or reducing the likelihood that a consumer will develop particular diseases. With increasing frequency, consumers are looking for foods and supplements to help manage and prevent the onset of disease. (2)

Not surprisingly, the food and dietary supplement industries are responding by developing new products and repositioning old products efforts to help consumers manage their health. For example, yogurt used to be positioned only as a delicious component of a meal but now is also promoted for use in weight loss programs after a study showed that the calcium in dairy products is effective in weight loss. (3 Tomato products and ketchup are promoted for their lycopene content, which studies have shown to be effective in treating prostate cancer. (4) Crystalline glucosamine sulfate dietary supplements are used by many people because numerous clinical studies have shown that the supplements are effective in treating the joint pain and reducing the progression of osteoarthritis. (5) These and other products fall into the category of "functional foods." (6)

The "functional food" terminology has been around for many years; (7) however, Congress has never amended the Federal Food, Drug, and Cosmetic Act ("FFDCA") to establish unique requirements for functional foods, and the Food and Drug Administration ("FDA") has never established regulations unique to this product category. Although no statutory or regulatory definitions exist for functional foods, numerous commentators and expert bodies have attempted to define functional foods. The Food and Nutrition Board of the National Academy of Sciences has suggested that a "functional food" is "any modified food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains." (8) Others imply that a functional food is any food promoted or consumed for a specific health effect, regardless of whether the food has been modified in some fashion. (9) A frequent criticism is that all foods are, in some sense, functional. (10)

Because there are no unique statutes and regulations for functional foods, these products fall under the same general requirements that apply to foods, dietary supplements and other products FDA regulates. (11) This means that a functional food product may be regulated as "conventional food," a "dietary supplement," a food for "special dietary use," a "medical food," or a "drug," depending on the claims made for the product and the product's positioning in the marketplace. This article explores how functional foods are regulated under federal laws governing food products. As discussed below, a product's intended use, primarily determined by the claims made on the label and in the labeling and advertising, will have a large impact on how FDA will regulate the product. (12) This article, therefore, first reviews the basic statutory and regulatory framework for products regulated by FDA then reviews the various claims that can be made for foods and dietary supplements, and finally explores the opportunities that exist for marketing functional foods.

II. STATUTORY AND REGULATORY REVIEW OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

FDA has primary regulatory authority over foods pursuant to the FFDCA. (13) While FDA in theory has jurisdiction over all foods, FDA does not regulate meat and poultry products. These products are regulated primarily by the United States Department of Agriculture. (14) This article focuses on the FDA regulatory scheme and does not explore the opportunities that may exist for meat and poultry products.

A. STATUTORY FOUNDATION: "FOOD," "DRUG," AND "SPECIAL DIETARY USE FOODS"

Congress enacted the FFDCA in 1938. (15) Although the statute has been amended numerous times, the basic statutory framework created in 1938 still exists today. When originally enacted, the FFDCA established requirements for only three product categories relevant to functional foods--"foods," "drugs," and foods for "special dietary uses." (16) Different premarket authorization, labeling, manufacturing and other requirements exist for drugs than for foods. Drugs generally are subject to much more onerous requirements than foods and dietary supplements. (17)

A product's intended use will determine whether FDA will regulate the product as a food, a dietary supplement or a drug. (18) Intended use is determined largely by the claims made on labels and in the labeling and advertising for products. (19) A product in conventional food or dietary supplement form, therefore, could be subject to regulation as a drug if marketing claims evidence intent that the product be used in a manner falling within the drug definition. The following FFDCA definitions are most relevant to functional foods.

1. Drugs

The FFDCA defines "drugs" as:

(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified in clause (A), (B), or (C). (20)

"New drugs" are defined as any drugs that are "not generally recognized as safe and effective ... for use under the conditions prescribed, recommended, or suggested in the labeling thereof" and which have not "been used to a material extent or for a material time under such conditions." (21) The "material extent" and "material time" requirements of the new drug definition have the practical effect of subjecting almost all new products to regulation as "new drugs." Even if sufficient data exists to establish the general recognition of safety and efficacy of a product for a drug use, a new product will not have been used to a material extent or for a material time under the conditions of use, thus subjecting it to regulation as a new drug. (22)

"New drugs" must meet extensive premarket approval requirements. A new drug may not be marketed until FDA reviews and approves a new drug application ("NDA") for the product. (23) NDAs must be supported by substantial evidence of safety and efficacy. (24) In almost all instances, clinical studies demonstrating that the new drug is both safe and effective for its intended use are necessary. The process of developing the data needed to support a new drug application can take years and hundreds of millions of dollars in research and study costs. (25) Additional time and resources are then needed to develop the new drug application and shepherd the application through the FDA review process. As part of the review, FDA will review critically the data supporting safety and efficacy and ultimately will determine whether there are sufficient data to support approval for the drug and authorization for the claims the petitioner will make. (26)

2. Foods

The FFDCA defines "food" as "articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." (27) The courts have recognized the circuitous nature of this definition and have offered the following comments on foods:

 
   When the statute defines 'food' as 'articles used for food,' it 
   means that the statutory definition of 'food' includes articles 
   used by people in the ordinary way most people use food--primarily 
   for taste, aroma, or nutritive value. To hold ... that articles used 
   as food are articles used solely for taste, aroma, or nutritive 
   value is unduly restrictive since some products such as coffee or 
   prune juice are undoubtedly food but may be consumed on occasion for 
   reasons other than taste, aroma, or nutritive value. (28) 

The legal challenge presented in Nutrilab resulted after FDA took the position that weight loss products derived from beans and marketed as starch blockers should be regulated as drugs rather than as dietary supplements or foods. (29) The court agreed with FDA's position that the starch blockers, which contained proteins that the manufacturer claimed inhibited an enzyme necessary for starch digestion, were subject to regulation as drugs. (30) The court reasoned that the product was intended to affect digestion, a bodily function, and was not "food" because it was not consumed primarily for taste, aroma, or nutritive value. (31) In other words, the product affected a bodily structure or function, not by way of its consumption as food, but through a pharmaceutical mechanism of action.

While Nutrilab is still valid case law, it may have limited applicability today. FDA has since established a relatively broad definition for "nutritive value." (32) "Nutritive value" is defined as "a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy." (33) While this definition is not necessarily over broad, FDA has taken the position that plant stanol and sterol esters have nutritive value because they have a value in sustaining human existence. (34) FDA concluded that plant sterol esters have nutritive value because they affect the digestive process, which is one of the metabolic processes necessary for the normal maintenance of human existence. (35) This agency position is surprising given stanol and sterol esters' mechanism of action. The substances function by blocking the body's absorption of cholesterol, an effect that is seemingly similar to the effect of starch blockers. (36)

FDA also has indicated that the Nutrilab decision may have limited relevance to dietary supplements. As part of a rulemaking that established the type of structure/function claims that can be made for dietary supplements, FDA rejected a comment that the Nutrilab decision requires the agency to regulate substances as drugs when the products contain "antinutrients" such as the starch blockers. (37) FDA noted that, since the Nutrilab decision, Congress amended the FFDCA to establish requirements for dietary supplements. An amendment to section 403(r)(6) (38) specifically authorizes the use of structure/function claims on dietary supplements without subjecting the supplements to regulation as drugs "even if they could not qualify for the 'food' exception in section 201(g)(1)(C)[(39)]." (40) Importantly, preamble statements are considered advisory opinions that bind the agency. (41) This FDA position seemingly would provide the legal basis for regulating as dietary supplements starch blockers and other products that affect the body by blocking or preventing nutrient absorption.

By expanding the definition of "nutritive value" to include products that block nutrient absorption and by concluding that Nutrilab does not apply to dietary supplements that impact weight loss through the use of "antinutrients," FDA has seemingly limited significantly Nutrilab's applicability.

a. Food Additives

In 1958, Congress amended the FFDCA and established a definition for food additives. (42) The FFDCA defines "food additives" broadly as any substance:

 
   [T]he intended use of which results or may reasonably be expected to 
   result, directly or indirectly, in its becoming a component or 
   otherwise affecting the characteristics of any food (including any 
   substance intended for use in producing, manufacturing, packing, 
   processing, preparing, treating, packaging, transporting, or holding 
   food; and including any source of radiation intended for any such 
   use).... (43) 

A manufacturer cannot market a food additive unless it does so in accordance with a regulation that covers the intended use of the food additive. (44) A food additive regulation can be established by submitting a food additive petition containing extensive data supporting the additive's safety. (45) Animal studies that demonstrate the safety of the food additive for the intended use are required in almost all instances. (46) It can easily cost several million dollars to generate the animal and other studies needed to support a food additive petition. (47)

b. GRAS Ingredients

Congress specifically exempted generally recognized as safe ("GRAS") ingredients from the food additive definition. (48) An ingredient can be GRAS based on two principles: common use in foods or scientific procedures. (49) Common use in foods is established by demonstrating that the ingredient in question has been used for the intended use since before 1958. (50) Given this requirement, newly developed functional ingredients generally cannot be GRAS based on common use in foods.

An ingredient also can be GRAS based on scientific procedures. (51) The data and information needed to support an ingredient's GRAS status based on scientific procedures are generally the same as those needed to support a food additive petition. (52) FDA takes the position that the safety studies must be published so that they are readily available to support general recognition in the scientific community of the substance's safety. (53) The publication requirement prevents many substances from being eligible for GRAS status. While significant data may support the ingredient's safety, that data cannot support the GRAS status unless the data are published. (54)

There are no premarket approval requirements for GRAS ingredients because the ingredients are exempt from the food additive definition and the food additive premarket approval requirements. (55) Marketing a GRAS ingredient without first seeking FDA authorization to do so, however, does present some regulatory risk. There is always a chance that FDA will disagree that the ingredient is GRAS and will subject it to regulation as an unapproved food additive, in which case marketing is prohibited until FDA issues a food additive regulation.

In an attempt to assist the industry in identifying GRAS ingredients, the agency has published a listing of some, albeit not all, GRAS ingredients. (56) For many years manufacturers would amend the list of GRAS ingredients by submitting GRAS petitions that would provide FDA with the information supporting the GRAS status of the ingredient. (57) Because FDA was under no statutory mandate to review these petitions, it took the agency more than twenty years to complete its review of some petitions. (58) FDA has proposed to replace the petition process with a notification system. (59) Although still a proposed rule, the agency has been accepting GRAS notifications and has been able to complete its review of most petitions in six to nine months. (60) The GRAS notifications are publicly available and are easily accessible on the FDA website. (61)

3. Foods for Special Dietary Use

In addition to providing definitions for "food" and "drugs," the 1938 Act introduced the concept of foods for "special dietary uses." (62) While the FFDCA does not contain a definition for "special dietary use foods," it does recognize that there are certain foods that are formulated to meet special dietary uses, and it establishes labeling requirements for such products. (63) A special dietary uses food will be deemed misbranded, and in violation of the law:

 
   [I]f it purports to be or is represented for special dietary uses, 
   unless its label bears such information concerning its vitamin, 
   mineral, and other dietary properties as the Secretary determines 
   to be, and by regulation prescribes as, necessary in order fully to 
   inform purchasers as to its value for such uses. (64) 

A review of the legislative history reveals that Congress considered such special dietary uses, at that time, to include "infant foods, invalid foods, slenderizing foods, and other dietary [products] intended for special nutritional requirements."(65) FDA has since issued regulations that define food for special dietary use. (66)

The term special dietary uses, as applied to a food for man, means particular (as distinguished from general) uses of food, as follows:

(i) Uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, under weight and overweight;

(ii) Uses for supplying particular dietary needs which exists by reason of age, including but not limited to the ages of infancy and childhood;

(iii) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property. Any such particular use of a food is a special dietary use, regardless of whether such food also purports to be or is represented for general use. (67)

The FFDCA and implementing regulations recognize that there are foods that are designed to meet special dietary uses. The regulations implemented by FDA clarify that dietary uses include those special dietary needs that exist by reason of a particular disease. (68) As will be discussed in more detail below, this regulatory definition offers an opportunity to position products as foods for special dietary use when the product is formulated to meet the unique nutritional requirements that may exist in individuals with certain diseases.

4. Medical Foods

While there have been numerous amendments to the FFDCA since 1938 that have an impact on the food and dietary supplement industries, there have been two amendments establishing new definitions that are of most relevance to functional foods: (1) the establishment of the medical food definition in the 1983 Orphan Drug Act, (69) and (2) the establishment of a "dietary supplement" definition in the Dietary Supplement Health and Education Act of 1994 ("DSHEA"). (70)

Although Congress did not establish a definition for medical foods until 1983, the history of medical foods can be traced back to 1972. In 1972, FDA created the first "medical food" by deciding on its own initiative to reclassify the specialty infant formula Lofenalac, which had been regulated as a drug, as a distinct type of food for special dietary use. (71) The manufacturer formulated Lofenalac for infants with phenylketonuria ("PKU"), an inborn error of metabolism. (72) FDA recognized that Lofenalac met the distinctive nutritional requirements of these infants--namely, an impaired ability to metabolize the essential amino acid phenylalanine--and decided to regulate the product as a food. …

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