United States—
A Good System Gone Bad

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

Many companies, both large and small, are selling or developing products that could be considered to be functional foods. Some of the biggest names in the industry are involved, including Kellogg, Campbell Soup, Con Agra, Quaker Oats, and Mars.(92)

Some companies sell such products with FDA-approved health claims. For example, in 1996, Kellogg petitioned the FDA for a health claim that soluble fiber from psyllium may reduce the risk of heart disease when eaten as part of a diet low in saturated fat and cholesterol. The company also demonstrated to the FDA that psyllium, which it adds to its Bran Buds cereal, is GRAS. Recently, however, companies have begun to market functional foods on the basis of structure/function claims which do not require FDA approval. For example, Kellogg has decided to make structure/function claims in cases where FDA regulations prohibit health claims. Other companies are marketing functional foods as dietary supplements or medical foods to avoid FDA pre-market approval requirements. These practices raise a number of troubling questions and serious legal issues.

A.  Some Foods and Supplements are Sold with FDA-Approved Health Claims.

The FDA has approved 10 health claims for foods and two health claims for both foods and supplements (Table 9). The approved claims are estimated to appear on several hundred products found in a typical supermarket.(93) These include claims linking folic acid with a reduction in neural tube birth defects, psyllium with a reduced risk of heart disease, and sugar alcohols and dental caries. Some companies have used such FDA-approved claims to re-position conventional food products as functional foods. For example, Kellogg markets Product 19 cereal with the approved FDA claim linking insufficient consumption of folic acid in women of child-bearing age to neural tube birth defects.

Initially, FDA-approved health claims encompassed general diet/disease relationships, e.g. diets low in saturated fat and cholesterol could reduce the risk of heart disease.(94) These claims were utilized by major food companies. For example, Campbell’s Pork and Beans uses an FDA-approved health claim regarding diets low in saturated fat and cholesterol and the risk of heart disease (the product contains minimal amounts of fat),(95) and Pillsbury Green Giant brand frozen broccoli spears uses an FDA-approved claim that links diets low in fat and high in vegetables containing certain nutrients to a reduced risk of cancer.

More recently, in response to a petition from the Quaker Oats Company, the FDA approved a new health claim linking soluble fiber specifically from oatmeal and oat bran to a reduction in the risk of heart disease. Product labels may state: "Diets low in saturated fat and cholesterol that include soluble fiber from whole oats may reduce the risk of heart disease." The new claim will allow Quaker, which dominates the oatmeal market, to specifically highlight the benefits of eating oatmeal, even though certain fruits, vegetables and other grain products can provide the same benefit. Kellogg followed suit with a petition — approved by the FDA in 1997 — to make a claim linking soluble fiber from psyllium to a reduced risk of heart disease. At the time of Kellogg’s petition, only one nationally distributed brand-name cereal contained psyllium — Kellogg’s Bran Buds. The FDA’s authority to approve health claims concerning the relationship of a nutrient to a disease has thus been used by some companies as a mechanism to gain approval for what could be characterized as claims for functional foods.

B. Functional Foods are Often Sold on the Basis of Structure/Function Claims in order to Avoid FDA Approval Requirements that Apply to Health Claims.

Although companies use the health claims originally approved by the FDA, and have persuaded the agency to approve new claims, the industry generally remains dissatisfied with the length of the FDA approval process which can often take several years. To avoid FDA approval requirements, some companies have begun making structure/function claims in lieu of health claims.

For example, Kellogg has recently launched a new line of functional foods (called "Ensemble") that contain psyllium. The product line consists of 22 items including breads, pasta, frozen entrees such as lasagna, snack chips, cakes and cookies.(96) While all of the products contain either psyllium or oat bran, which have been recognized by the FDA as being useful in reducing cholesterol and lowering the risk of heart disease,(97) some items contain too much fat to qualify for the FDA-approved health claim concerning psyllium; others provide inadequate nutritional value and under FDA’s "Jelly Bean Rule" are not entitled to make any health claims at all. To get around these restrictions, Kellogg makes structure/function claims on products not meeting the criteria for health claims. For example, the Kellogg’s Ensemble carrot cake label states: "made with a natural soluble fiber [psyllium] that actively works to promote heart health." This statement most certainly implies that the product can help reduce the risk of heart disease, and should be considered by the agency as an implied health claim requiring pre-market approval even though the claim does not specifically mention heart disease. It is possible that the FDA would consider the statement to be a structure/function claim. In that case, the statement should nonetheless be prohibited under the agency’s general authority to stop misleading labeling claims because the carrot cake contains too much fat to be considered healthy for the heart.

Similarly, the Campbell Soup Company, which produces V8 Juice, makes a structure/function claim on the label that "Research . . . suggests that antioxidants [in V8 juice] may play an important role in slowing changes that occur with normal aging." The product contains too much sodium to make an FDA-approved health claim concerning benefits from consuming fruits and vegetables. The company, however, can evade FDA pre-market approval requirements by making a structure/function claim instead of a health claim. In this case the structure/function claim on the label is especially misleading because diets high in sodium are linked to high blood pressure, a condition that is associated with aging. Moreover, the evidence linking the consumption of anti-oxidants to aging is preliminary. Nonetheless, the company continues to market V8 as a functional food that may slow changes that occur with aging.

C.  Some Companies are Selling Functional Foods as Dietary Supplements to Avoid FDA Regulation.

Other companies are attempting to avoid FDA regulation by positioning functional food products as dietary supplements. Since 1994, food and drug companies have increasingly envied the rights of dietary supplement manufacturers to market products with ingredients that have not been approved by the FDA. As sales of dietary supplements grew after the passage of DSHEA, more and more companies began to consider how they could avoid complying with FDA approval processes by marketing functional foods as dietary supplements.

In the most heavily publicized case, McNeil Consumer Health Care, a subsidiary of Johnson & Johnson, attempted to market Benecol — a margarine promoted on the basis of a cholesterol-lowering functional ingredient — as a dietary supplement. Had the company been permitted to do so, it could have avoided compliance with the U.S. law that requires that ingredients be approved as food additives or recognized as GRAS.

The product has been sold in Finland since 1995. However, in a precedent-setting action, the FDA told the company that it would be illegal to sell the product in the U.S. The FDA stated that Benecol could not legitimately be marketed as a dietary supplement and that the plant stanol esters that it contains would be considered unapproved food additives or perhaps even drugs, both of which require FDA pre-market approval. In response to FDA pressure, the company has decided to market the product as a food, but must first demonstrate to the agency that plant stanols are GRAS.(98)

What claims will or will not appear on the label, however, remains undecided. Normally, the company would be free to petition the FDA under the NLEA to approve a health claim for plant stanols or use a structure/function claim without FDA approval. However, in both cases, the FDA requires that the substance that is the subject of a health claim(99) or a structure/function claim(100) must provide taste, aroma, or nutritive value, or have a technological effect on the food itself (e.g. preserve, color, flavor, etc.). In other words, the substance must be one that is normally found or used in foods. Plant stanols do not provide taste, aroma, or nutritive value and do not have a technological effect on margarine. Thus, if the FDA maintained its current policy, Benecol would not be able to make any label claims at all.(101)

Dietary supplements can make structure/function claims without meeting the requirement that the substance which is the subject of a health claim provide taste, aroma, or nutritive value,(102) and, as previously mentioned, their ingredients do not have to be approved by the FDA or be recognized as GRAS. It is thus not surprising that food companies are increasingly trying to market functional foods as dietary supplements. This trend is opposed by dietary supplement manufacturers who fear competition from the food industry.(103)

In another such development, The Hain Food Group, Inc. is selling a line of canned soups containing medicinal herbs. The products are labeled as supplements and are sold as a part of a new product line that is boldly called "Kitchen Prescription."(104) The labels of those products contain structure/function claims normally found on dietary-supplement labels. Hain’s "chicken broth and noodles with Echinacea" makes the structure/function claim for "support of the immune system." The label of Hain’s split pea soup containing St. John’s Wort claims to "give your mood a natural lift."(105) By labeling the canned soups as a "supplement," the company apparently hopes to escape its obligation to obtain an FDA food additive approval or demonstrate to the FDA that Echinacea and St. John’s Wort are GRAS when used as food ingredients. Also, by labeling the soups as a "supplement," the company apparently hopes to be able to make structure/function claims even though these herbs do not provide taste, aroma, or nutritive value. That requirement applies to foods, but not to dietary supplements, that make structure/function claims.

Another example of this trend is illustrated by Amurol Confections’ marketing of Stay Alert Caffeine Supplement Gum. The company is labeling the product as a dietary supplement, even though the name of the product includes the name of a conventional food — "gum" — and the product looks like and is marketed in stores next to other chewing gums. Significantly, caffeine is only approved for food use in non-alcoholic carbonated beverages,(106) and is otherwise considered a drug covered by FDA regulations for non-prescription stimulants.

It is not known the extent to which the FDA will enforce the law and prevent food companies from marketing functional foods as dietary supplements in order to avoid FDA requirements intended to insure the safety of food ingredients and the validity of claims on food labels. While the FDA has taken action in the case of Benecol margarine, there is no indication that the agency is willing to devote the resources necessary to take enforcement action in cases that raise similar issues. Consumer groups, however, are urging the agency to act.

D.  Some Functional Foods are Sold as Medical Foods to Avoid FDA Regulation.

Medical foods are intended for consumption under the supervision of a physician. However, the failure of the FDA to complete its rulemaking on medical foods and establish requirements for approval of medical food claims has inspired some manufacturers to market functional foods (which are not consumed under the supervision of a physician) as medical foods. These manufacturers pay "lip service" to the requirement that the products be used under medical supervision by simply stating on the product label "use under the supervision of a physician." But, given the fact that these products are marketed directly to consumers, the products may be used without a physician’s knowledge.

One industry observer predicts that medical foods are positioned for rapid growth in the next five years and "will be the biggest branch of the developing food market."(107) A brochure advertising a March 1997 conference sponsored by the Pharmaceutical Division of the Institute for International Research boasts that "[m]edical food regulations provide a pathway for health claims for products as aids in the dietary management of diseases or conditions." During one discussion session, a product called Cardia Salt (a salt alternative)(108) was to be featured as a case study of how functional foods can escape FDA approval requirements for health claims by being positioned as medical foods.(109)

Other prominent examples of functional foods being marketed as medical foods include: NiteBite(110) and Zbars,(111) snack bars designed to reduce diabetics’ risk of developing hypoglycemia. They bear little resemblance to bona fide medical foods, like TraumaCal Liquid or Travasorb Hepatic Powder, and often are not consumed under the supervision of a physician. Rather these products appear to be more akin to "foods for special dietary use." However, health claims for those products must be pre-approved by the FDA. Not surprisingly, the manufacturers are attempting to market the products in a manner that does not require FDA approval of label claims.

A similar example involves a product called HeartBar that is being promoted as the first medical food developed for the management of coronary artery and vascular disease. The product contains arginine, a crystalline basic amino acid that its manufacturer claims will enhance the body’s production of nitric oxide. The manufacturer states that raising the levels of nitric oxide will increase blood flow and pain free-exercise.(112) Like NiteBite and Zbars, however, HeartBar is sold directly to consumers and appears to be labeled as a medical food in order to avoid FDA approval requirements that might apply if the product were labeled correctly.

The potential for harm to consumers is readily apparent. Contrary to FDA intentions, the latest medical foods to enter the marketplace are not used by consumers under the supervision of a physician. They are sold with health claims that are neither evaluated by a physician nor approved by the FDA. Thus, there is no assurance that such claims are valid.(113)

FDA is slowly reevaluating its approach to regulating medical foods; it issued an advance notice of proposed rulemaking on Nov. 29, 1996. In the notice, the agency recognized the need to require pre-market approval of health claims for medical foods. However, no further action has been taken by the FDA.

E.  Companies Limit Health Claims to Advertising to Avoid FDA Scrutiny.

In the United States, responsibility for stopping deceptive claims in food advertising is shared by the FDA and the Federal Trade Commission (FTC). During the last several decades, the FTC has eschewed industry-wide regulation in favor of case-by-case enforcement and employed enforcement standards that were often more lenient than the FDA’s. In some situations, the FTC has permitted companies to make health claims in advertising that are not permitted on labeling. Not surprisingly, the food industry has favored FTC enforcement policies over those of the FDA. Since 1954, the FTC and the FDA have operated under a Memorandum of Understanding under which the FTC has assumed primary responsibility for food advertising, and the FDA has assumed primary responsibility for product labeling.(114) At the time of the agreement, the FDA’s reliance on the FTC to regulate food advertising may have made sense. However, now that many food ads are filled with claims involving complex scientific matters, the FDA’s reliance on the FTC (an agency with no scientific expertise) to police deceptive claims may no longer be appropriate.

In an attempt to harmonize its enforcement policies with those of the FDA, the FTC issued an Enforcement Policy Statement on Food Advertising following the implementation of the NLEA.(115) Although the FTC enforcement policy states that the agency will defer to the FDA’s scientific expertise, the FTC, as a matter of practice, fails to take enforcement action against claims in advertising even though such claims have not been approved by the FDA for labeling.

This inconsistency in the U.S. regulatory scheme is sometimes exploited by food and dietary supplement companies. For example, Welch’s Foods, Inc. advertised that "[g]rowing evidence suggests that diets rich in antioxidants may reduce the risk of some cancers . . ." and noted that ". . .Welch’s purple grape juice has more than three times the naturally-occurring antioxidants of other popular juices." The FDA, however, rejected a health claim that diets rich in antioxidants may reduce the risk of some cancers because there was not "significant scientific agreement" to support the claim.(116) Nonetheless, the FTC took no action to stop the claim in ads. Heinz advertised that lycopene in its Ketchup "may help reduce the risk of prostate and cervical cancer." Heinz has not petitioned the FDA for permission to make such a claim on labels, and unapproved health claims on labeling are expressly prohibited by law. The case for advertising is much different. The company does not need the permission of the FTC to make such claims in ads. Indeed, the company has run such claims in major U.S. publications since January 1999. The FTC can order the company to cease and desist after the fact if it determines that the cancer prevention claims are not supported by competent and reliable scientific evidence or are otherwise false or misleading. That process, however, can take years. The FTC is investigating the advertising claims, but to date, has taken no enforcement action.

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