FDA Issues Warning Letters to Manufacturers of Misrepresented Conventional Foods and Dietary Supplements
As we have previously reported here and here, manufacturers of conventional food products and dietary supplements have often been the target of U.S. Food and Drug Administration (“FDA“) Warning Letters for allegedly misrepresenting their products. Pursuant to Section 201(ff)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(ff)(2)(B)], if a product is represented as a conventional food, the product cannot also be marketed as a dietary supplement. However, categorizing conventional foods and dietary supplements can be complicated.
The FDA defines conventional foods as “foods that are not dietary supplements.” All ingredients in conventional foods must be pre-approved by the FDA as a food additive or meet the requirements of the “Generally Recognized as Safe” (“GRAS“) provisions. Dietary supplements are defined as products “intended for ingestion that contain a Ëœdietary ingredient intended to add further nutritional value to (supplement) the diet,” dietary supplements may be in forms such as tablets, capsules, softgels, gelcaps, liquids, or powder, and may be one, or a combination, of the following substances: vitamins, minerals, herbs or botanicals, amino acids, concentrates, metabolites, constituents, or extracts.
Prior to 2009, the FDA determined if a product was a conventional food or dietary supplement based on the labeling pursuant to the Dietary Supplements Health & Education Act (“DSHEA“). For example, conventional foods were required to have a “Nutrition Facts” panel on their labels, and dietary supplements were required to have a “Supplement Facts” panel. However in 2009, the FDA issued the draft guidance document “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods” that changed the factors that the FDA relies on to determine a products category. The 2009 draft guidance states that the FDA considers a products name, packaging, serving size, and recommended conditions of use, as well as other representations about the product, to be important determinants of whether the product is a conventional food or dietary supplement. If the product is a conventional food or dietary supplement but marketed as the other, the product could be deemed by the FDA to be misbranded or adulterated in violation of 21 U.S.C. § 331(a) and 21 U.S.C. 342(a)(2)(C).
The FDA issued 13 Warning Letters to companies that misrepresented their products as either conventional foods or dietary supplements prior to the issuance of the 2009 draft guidance and has issued 7 Warning Letters subsequently. In 2011, an FDA spokesman reportedly stated that the FDA had not been more aggressive with enforcement actions due to competing priorities and limited resources available to the FDA. The 2 most recently issued Warning Letters were made public on May 23, 2012 and July 20, 2012, and can be found here and here.
FDA Warning Letters notify recipients and the public that the FDA believes that a particular firm has violated federal law. Thus, given the bad publicity that these letters generate, it is advantageous for firms to correct possible violations as quickly as possible. The recipients of Warning Letters have 15 days to address the issues presented by the Warning Letter and to develop specific corrective actions. Failure to do so may put the recipient in jeopardy of facing product seizures or formal legal action by the FDA. Please see our previous reports here and here, discussing whether, and if so how, the recipients of these Warning Letters may respond or challenge the Warning Letters in court in light of the United States Supreme Courts recent ruling in Sackett v. EPA.
Fuerst Ittleman David & Joseph, PL will continue to monitor the regulation of conventional foods and dietary supplements. The attorneys in the Food, Drug, and Life Sciences practice group are well-versed in the complex FDA regulatory framework. For more information, please email us at firstname.lastname@example.org or call us at (305) 350-5690.