Douglas L. Archer

In early June 2001, the Food and Drug Administration announced the issuance of warning letters to a number of food companies selling beverages containing herbal ingredients, a form of functional food. At the IFT Annual Meeting in late June, the halls were abuzz with conversation and speculation about what all this “sudden” FDA activity might mean. What was new about this action? When the history is examined, not too much is really new, but some things are worth noting.

Functional foods provide the basic attributes of traditional or conventional foods, such as nutritive value, aroma, and taste, but also claim to provide an additional health benefit beyond basic nutrition. It is obvious that consumers are interested in achieving nourishment and health and well-being from this type of product. According to the International Food Information Council’s recent survey, 93% of Americans believe that some foods can have health benefits besides nutritive value and can delay the onset, or reduce the risk, of serious and chronic diseases. The popularity of functional foods appears to be fairly evenly distributed across all age groups from 18 to 55 years and older. Sales are expected to reach nearly $50 billion by 2010.

The issuance of warning letters in June 2001 was not really a unique occurrence. Warning letters were sent to a number of companies regarding their functional food products beginning in early 2000. Many of these warning letters cited numerous label violations, including health and drug claims and structure function claims not achieved through nutritive value, and cited companies for marketing a conventional food as a dietary supplement. The questions raised by FDA about the addition of herbal ingredients seemed almost secondary. FDA did, however, question the legality of adding ingredients such as echinacea, ginkgo biloba, St. John’s wort, kava kava, gotu kola, and guarana, because, as stated in the warning letter, “we are not aware of a basis for concluding that their use in conventional foods is GRAS.” FDA also noted that none of the questionable ingredients were approved food additives.

In July 2000, the General Accounting Office issued a report to Congress entitled “Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and ‘Functional Foods.’ ” That report contained far-reaching observations about FDA’s ability to regulate dietary supplements and functional foods, as well as recommendations to Congress and FDA. While the report noted that the addition of certain ingredients to food to create a functional food brings up issues with regard to food additive status, no recommendations were made about that specific issue. The report also noted that some functional foods were being marketed as dietary supplements, probably to use the “new dietary ingredient” provisions permitted for dietary supplements and to avoid the food additive petition or GRAS determination route.

In FDA’s comments on the report, there is the following telling paragraph: “As GAO notes, FDA’s efforts to assure the safety of functional foods and dietary supplements have been limited by its legislative authority. The differing legal requirements for conventional foods and dietary supplements dictate that FDA’s approaches for regulating dietary supplements and functional foods must differ unless the law is changed.” The law has not been changed to date, nor has FDA taken action beyond issuing warning letters.

The Center for Science in the Public Interest focused attention on the safety of functional foods that contain ingredients that, according to FDA, have not been shown to be safe for use in foods. In July 2000, CSPI issued a press release asking FDA to halt the sale of many functional foods being marketed. CSPI also released a list of specific companies and their products that were alleged to contain unapproved ingredients. This focused attention on the safety of added ingredients.

On January 30, 2001, FDA issued an industry-wide letter to manufacturers adding botanicals and other novel ingredients to conventional foods. FDA stated its concerns about the legal status of the added ingredients and reminded manufacturers that food additive status was an issue. FDA also expressed concern about label claims based on the added ingredients. A week later, CSPI issued a press statement supporting FDA’s action, and characterized the action as a “shot-across-the-bow.”

What sets the cluster of warning letters issued in June 2001 apart from earlier letters is not that the food additive status of ingredients was the focus, as it wasn’t. As in past warning letters, labeling issues regarding unauthorized nutrient content claims, misbranding, and the use of a structure-function claim on a conventional food seemed to overshadow the concern about the status of added substance(s). However, in the June warning letters, FDA asked each cited company to “include your basis for concluding that XXXX is the subject of a prior sanction or is GRAS for use in conventional foods.” The inclusion of this request could have considerable regulatory impact, as the industry will be under pressure to submit evidence, and FDA will then need to evaluate that evidence and make a judgment about the status of the added ingredient(s) in question. The impasse may thus be broken. As of this writing, no action beyond a warning letter has been taken, but the industry is aware that FDA can take further action if the requested information is not forthcoming.

Contributing Editor
Professor, Food Science and Human Nutrition Dept.
University of Florida