Functional Foods: Science is Ahead of the Law
By: Daniel J. Gerber
04.08.14Originally published in the ABA Section of Litigation, Products Liability News and Developments, April 7, 2014
Science continues to develop ways to define, refine, improve, and fortify conventional foods with naturally occurring nutrients to occupy niche marketing campaigns, health-based consumption, and individual dietary supplementation efforts. See, e.g., Uros Miljic et. al., Acceptability of Wine Produced with an Increased Content of Grape Seeds and Stems as a Functional Food, J. Inst. Brewing, Jan. 2014 (increases in phenolic and anti-oxidant compounds); Joseph Thomas Ryan, Nutraceutical and Functional Food Bioactive Peptides in Beef (2013) (unpublished Ph.D. thesis, University College Cork) (on file with the University College Cork library) (anti-oxidant, antimicrobial and ACE inhibiting compounds found in beef muscle fibers). The law, though, continues to struggle with the concept that foods can have naturally occurring benefits and the methods used to convey those benefits through advertising and labeling.
All foods provide some functional benefit simply through the delivery of carbohydrates, fats, and proteins. The Federal Food, Drug, and Cosmetic Act does not provide a statutory definition of “functional foods.” However, the Academy of Nutrition and Dietetics defines a “functional food” as “food that provides additional health benefits that may reduce disease risk and/or promote good health.” Sharon Denny, “What are Functional Foods?” Academy of Nutrition and Dietetics website, April 2013. Regulatory proposals have been floated during the past three U.S. administrations, with no crystallization of how marketing and trade regulations address the evolution of new conventional food products. U.S. Gov’t Accountability Office, GAO/RCED-00-156, Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and “Functional Foods” at 18, 20 (2000); Sharon Ross, “Functional foods: The Food and Drug Administration Perspective,” Am. J. Clinical Nutrition 2000; 71(suppl): 1735S–8S; Public Hearing, Conventional Foods Being Marketed as “Functional Foods,” 71 Fed. Reg. 62400-01 (proposed Oct. 25, 2006).
In 2010, FTC Commissioner Brill addressed functional food claims at the Summer NAAG Conference, explaining,
[T]hey are the kind of claims that a manufacturer makes when it wants to say “Do not only eat this food because it provides you with the nutrition that you need to lead a normal life, but because if you eat this product it will actually do something to improve your life—give you better reasoning ability, make you more attentive,” things like that. These are the kinds of claims that we are going to look at very closely and, I would add, that you all should look at very closely.
Julie Brill, Commissioner, Fed. Trade Comm’n, Remarks at the Panel on Consumer Protection: Update On State and Federal Efforts (June 15, 2010).
As late as January 2013, the FDA left open the functional foods questions in its most recent guidance to the food industry for labeling. Fed. Food & Drug Admin., Guidance for the Industry: A Food Labeling Guide. The FDA did not address functional food claims in the guidance, except to reiterate past criteria regarding “structure/function” claims, which many consider more applicable to dietary supplements, rather than to conventional foods. Id. at issue S5.
Recent discussions may focus regulators and clarify existing regulations, if the discussion of functional foods is incorporated into the discussion of new food-labeling regulations. Food Labeling: Revision of the Nutrition and Supplement Facts Labels, 79 Fed. Reg. 11880-01 (proposed Mar. 3, 2014). It is unclear, though, whether these proposed regulations will bring closure to marketing and advertising issues discussed in recent FTC and litigation matters involving beverages, juices, and yogurts, for example.
Scientists will continue to develop more nutritious or more targeted conventional foods using parts of plants or animals not previously used in traditional ways or through extractions or concentrations of naturally occurring compounds. Regulatory and litigation counsel should be aware of past efforts to specifically address functional foods as an area for marketing, advertising, and labeling and prepare for and spur the development of new rules and regulations to clarify the use of these foods.