United States—
A Good System Gone Bad

Regulatory Requirements
    
Introduction
Japan—The Inventor of Functional Foods
United States—A Good System Gone Bad
        Background
        Regulatory Requirements
        Marketplace Implications and Consumer Impact
        Recommendations
United Kingdom—Chaos Reigns Supreme
Conclusion
Endnotes

In the U.S., functional foods are not defined by law, and currently there are no proposals for new legislation. The FDA, however, does have a myriad of related but widely varying regulations and policies governing health claims and structure/function claims for foods and dietary supplements, as well as regulations for medical foods, foods for special dietary use, and drugs. The agency says it will apply those existing rules to functional foods on a case-by-case basis. However, some FDA officials concede that the agency lacks a coherent policy. As one recently retired FDA official stated, "The market is moving faster than we can sit down and think things through."(50)

Whether a manufacturer positions a particular functional food as a conventional food, a dietary supplement, or a product fitting into another regulatory category is central to determining how the FDA will regulate both the use of a functional ingredient and any accompanying labeling claims.(51)

A.  Regulation of Ingredient Safety

Under the Federal Food, Drug and Cosmetic Act,(52) manufacturers must obtain pre-market approval for food additives or demonstrate that such ingredients are "Generally Recognized As Safe" (GRAS).(53) If a manufacturer does not consider the ingredient to be GRAS(54), or its GRAS determination is challenged by the FDA, the company must submit a food additive petition establishing the safety of the ingredient under the conditions of its expected use before the FDA will grant approval.(55) Because the filing of a food additive petition can be costly and take several years, both the food and dietary supplement industries have pressed Congress to deregulate the process.

The supplement industry has been more successful in that effort than the food industry. After a grass-roots consumer letter-writing campaign largely organized by the industry, Congress enacted the Dietary Supplement Health and Education Act of 1994 (DSHEA).(56) That law prevents dietary supplements from being subjected to the approval requirements applied to food additives. New dietary ingredients may be marketed 75 days after the manufacturer provides notice and substantiation to the FDA that the ingredient can "reasonably be expected to be safe."(57) FDA approval, however, is not required. Ingredients marketed prior to Oct. 15, 1994 are exempt from even this minimal requirement.

The new law also makes it more difficult for the FDA to remove an unsafe, or potentially unsafe product from the market. Prior to DSHEA, the FDA used its authority to regulate food additives as an expedient means of declaring a supplement ingredient unsafe or inadequately tested. If the FDA charged that the dietary ingredient was unsafe under the food additive provisions of the FDCA, a manufacturer had the burden of proving that the affected ingredient was exempt from such requirements. By eliminating the FDA’s authority to regulate dietary supplements as food additives, DSHEA shifted the burden of proof to the FDA.(58) To take a product off the market, DSHEA requires the FDA to establish that the product "presents a significant or unreasonable risk of illness or injury"(59) or poses an "imminent hazard to public health or safety."(60) As a practical matter, this means that FDA must first build a convincing case of substantial harm to the public health and prevail in court before it can act. This process often takes years. As a result, the agency has resorted in most cases to merely issuing public warnings about hazardous supplements.

In order to escape strict FDA regulation of the safety of functional substances, it is thus in a manufacturer’s interest to try to market a functional food as a dietary supplement rather than as a conventional food with added ingredients. By marketing functional foods as dietary supplements, companies can escape their obligation under the law to prove that added ingredients are GRAS and when questions arise, such products can stay on the market until the FDA proves in court that they may be harmful.

B.  Regulation of Product Claims

Claims for functional foods are subject to a variety of regulations depending on the regulatory category into which the product is placed, e.g. food, dietary supplement, medical food or drug.

1.  Health Claims for Foods and Dietary Supplements Positioned as Functional Foods
(Table 6)

Health claims for foods and dietary supplements are both subject to the NLEA, which requires FDA pre-market approval or authorization. Under the NLEA, the FDA must determine, based on "the totality of publicly available scientific evidence" that the claim is supported by "significant scientific agreement, among experts qualified by scientific training and experience."(61) If FDA determines that such a claim may be made, it issues a regulation that allows any qualifying product to bear the claim.(62) For example, all manufacturers of low-saturated fat products that also have low levels of total fat and cholesterol and that are not high in sodium may state: "Diets low in saturated fat and cholesterol may help reduce the risk of heart disease."

Under amendments to the law resulting from passage of the FDA Modernization Act of 1997 (FDAMA),(63) manufacturers may also use health claims for foods and dietary supplements based on authoritative statements published by a scientific body of the U.S. government about "the relationship between a nutrient and a disease or health-related condition to which the claim refers."(64)

Such claims do not require approval by FDA, but must still be authorized by the agency. Manufacturers must: (l) notify the FDA at least 120 days in advance of marketing a product with the prospective health claim;(65) (2) demonstrate that the claim is based on an "authoritative statement" of a scientific body "with official responsibility for public health protection or research directly relating to human nutrition;"(66) and (3) submit a balanced representation of the scientific literature on which the claim is based.(67) Once a manufacturer takes those steps, the claim can be made unless the FDA, within the 120-day period, issues an interim final regulation prohibiting the claim or successfully brings a lawsuit against the company in court.

Public health groups have voiced considerable anxiety over the effect that FDAMA would have on the FDA’s ability to prohibit poorly substantiated and misleading claims before they appear on labels. Recent actions by the FDA, however, have allayed some of those fears. First, the FDA announced that the 1997 amendments to the law did not change the "significant scientific agreement" standard, and health claims based on authoritative statements still have to meet that requirement, based on the totality of publicly available scientific evidence.(68)

Second, the FDA denied the first series of attempts to make health claims based on authoritative statements. Within days of the effective date of FDAMA, Weider Nutrition International, Inc., a dietary-supplement marketer, submitted nine prospective health claims to the FDA based on what it considered "authoritative statements." FDA rejected all nine of the claims within the 120-day period established by law by issuing interim final regulations prohibiting their use.(69)

Whether a manufacturer submits a petition for a new health claim under the NLEA or a notification of a new health claim based on an "authoritative statement" of another government agency pursuant to FDAMA, health claims for functional foods may not be used on products that the FDA has determined contain excessive levels of fat, saturated fat, cholesterol, sodium, or other substances specified in FDA regulations.(70) Similarly, health claims are not permitted for products that do not contain — prior to any nutrient addition — at least 10 percent of the Reference Daily Intake or Reference Daily Value of vitamin A, vitamin C, calcium, protein or fiber per reference amount customarily consumed.(71) Thus, health claims for functional soda pops, chewing gum, bottled waters and other foods of low nutritional value would not be permitted under what has been nicknamed the "Jelly Bean Rule."

FDA’s refusal to allow health claims based on nutrient fortification of the products is rooted in a fortification policy that it has followed for many years.(72) The policy, however, is not legally binding and thus may have limited effect on the development of functional foods.(73)

2.  Health Claims for Foods for Special Dietary Use and Medical Foods
(Table 7)

U.S. law also recognizes two other categories of foods that are often thought to have a bearing on how the FDA can regulate health claims for functional foods. They are "foods for special dietary use" and "medical foods."

"Foods for special dietary use" encompasses certain products that are: 1) used for supplying particular dietary needs which exist by reason of age, including but not limited to infancy and childhood; 2) used for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property; 3) contain artificial sweeteners.(75) Those products include hypoallergenic foods, certain infant foods and products useful in reducing or maintaining weight.(76)

Health claims for foods for special dietary use are specifically covered by the NLEA’s pre-market approval requirements. However, if the FDA has already issued a food for special dietary use regulation that authorizes a particular health claim, a manufacturer need not reapply under the NLEA for approval.

Companies seeking to market functional foods could, theoretically, petition the FDA to issue a regulation for a food for special dietary use instead of petitioning the agency to permit a health claim under the NLEA. However, the FDA has not recently made use of this authority and has instead withdrawn regulations for some foods for special dietary use.(77)

Some companies have relied on another provision of the FDCA concerning the regulation of "medical foods" as a mechanism for marketing functional foods without FDA approval. The FDCA defines medical foods as:
food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."(78)

Many medical foods are intended for institutional use in hospitals and nursing homes. Examples include TraumaCal Liquid used to feed burn patients and Travasorb Hepatic Powder for patients suffering from liver failure. As a matter of practice, traditional medical food suppliers generally require written orders from a physician before filling orders.(79) Neither label claims nor formulations have to be approved by the FDA prior to marketing. The FDA has instead depended on the judgement of individual physicians who traditionally authorize the use of such foods for patients.

Increasingly, however, manufacturers have begun to call foods sold to the general public and used by consumers without the supervision of a physician "medical foods" in order to escape FDA-approval requirements for health claims. The FDA has recognized the irony of permitting medical foods — which are intended for consumption by individuals with serious health conditions — to receive less regulatory scrutiny than conventional foods marketed with health claims to the average consumer. It is attempting to close the gap by issuing new regulations.(80) The regulatory process, however, is moving slowly and some companies, in the interim, are using this regulatory loophole to make health claims for functional foods without FDA approval.

3.  Structure/Function Claims for Foods and Dietary Supplements
(Table 8)

Perhaps the biggest loophole in the U.S. regulatory scheme utilized by marketers of functional foods is a series of statutory provisions and regulatory policies permitting food and supplement companies to make structure/function claims.(81) Such statements explain how a substance affects the structure of the human body or the normal functioning of a body organ or system. An example is "Vitamin A is essential for normal vision."(82) Some companies are deciding to forgo attempts to gain FDA approval for health claims and instead are marketing functional foods on the basis of structure/function claims, which can be made without approval. Supplement manufacturers that wish to make structure/function claims must only notify FDA 30 days after initial marketing. While they must have substantiation for their claims, they need not show such information to the FDA.(83) Instead, supplement labels must include the following disclaimer:

"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."(84)

Food products that bear structure/function claims do not have to meet such requirements. Much controversy has arisen over the fine line separating structure/function claims, which do not require FDA pre-market approval, from health claims, which do require such approval. A structure/function claim ". . . describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function . . .(85) A health claim "characterizes the relationship of any nutrient to a disease or health related-condition."(86) In its implementing regulations, however, FDA substituted the word "substance" for the word "nutrient,"(87) and defined "substance" as any food or food component, including "vitamins, minerals, herbs, or other similar nutritional substances."(88)

Those ambiguous definitions have triggered a game of statutory semantics with regard to the labeling of foods and supplements that contain functional ingredients. If a body organ is mentioned, a permissible structure/function claim can be made without FDA pre-market approval. If, however, a disease is mentioned, the claim must be approved by the FDA. For example, cranberry juice may be legally marketed without prior approval if the label states that it "helps maintain urinary tract health" but cannot be sold if the label states that it "prevents the recurrence of urinary tract infections." The former claim is considered to be a structure/function claim; the latter claim is considered to be a health or drug claim requiring FDA pre-market approval.(89)

In an attempt to provide direction to the dietary supplement industry, FDA issued a proposed rule on structure/function claims.(90) Unfortunately, the proposed rule draws hairline distinctions that will, no doubt, be lost on most consumers. For example, FDA states that a manufacturer can claim that a supplement "maintains healthy cholesterol," but is prohibited from claiming that a supplement "lowers cholesterol." The agency said it will prohibit the use of brand names such as "Carpaltum" that make an implied health claim (that the product will help treat carpal-tunnel syndrome), but will permit brand names like Cardiohealth (because, according to the agency, that claim does not imply that the product will help treat heart disease).

Furthermore, the FDA has failed to propose how much scientific evidence a company must have to make a permissible structure/function claim. Traditionally, structure/function claims were considered to be statements of undisputed fact such as "calcium is necessary for bone growth and development." Recently, however, some companies have been making structure/function claims based on preliminary scientific studies. The failure of the FDA to articulate a substantiation standard for structure/function claims has contributed to the prevalence of misleading claims.

The food industry submitted comments urging the FDA to weaken certain limitations on structure/function claims in the proposal, and then expand the proposed rule to cover structure/function claims for foods as well.(91) The food industry objected to differentiating between structure/function claims for foods — which FDA says must relate to the nutritive value of the component which is subject of a claim — and structure/function claims for supplements which FDA policy allows whether or not the relevant component has nutritive value. Thus, under current FDA policy, the scope of structure/function claims for foods is more limited than that for supplements. Not surprisingly, the supplement industry wants to maintain the nutritive value distinction which currently provides supplement manufacturers with a competitive advantage over the food companies.

The root of the problem is that the FDA has been forced by Congress to make sense out of a series of inconsistent and overlapping statutory amendments that reflect political pressures instead of sound public policy. Unfortunately, until the law is further amended, it will be nearly impossible for the FDA to develop sensible regulatory policies.

 
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Copyright 1998 by the Center for Science in the Public Interest. References available by request.