Global Life Sciences: U.S. FDA Update

Shifting Gears, FDA Seeks Input on Use of the Term “Natural” in Food Labeling

November 12, 2015

On Thursday, November 12, 2015, the Food and Drug Administration (FDA) announced that it was opening a docket to accept public comments on “natural” claims for conventional foods and dietary supplements. In a surprising about-face, FDA appears to be yielding to pressure, most recently from the courts and members of Congress, to provide better guidance on the term. FDA’s notice, on one hand, suggests that the agency may now recognize that adherence to its 20-year-old policy on “natural” fails to reflect current food manufacturing approaches. On the other hand, the type of information sought by FDA signals that the agency believes the development of clear guidelines may be as daunting as it was for the United States Department of Agriculture (USDA) with “organic,” which means this process will take time.

Federal agencies regulating the labeling and advertising of food products have been reluctant to prescribe clear guidelines regarding the meaning and use of the term “natural.” FDA relies on its 1993 “policy” stating that the term “natural” cannot be used in food labeling if anything artificial or synthetic (including all color additives, regardless of source) had been included in or added to a product that would not normally be expected to be in the product. The Federal Trade Commission (FTC), which has jurisdiction over food advertising claims, evaluates “natural” claims on a “case-by-case basis,” and maintains that advertisers must be able to substantiate such claims even in the absence of a clear definition for the term. USDA’s policy states that “natural” claims for meat and poultry are permitted if: (1) the food contains no artificial or synthetic ingredient; (2) the food is minimally processed; and (3) the label explains the meaning of “natural.” While these agencies share authority to regulate “natural” claims and have sought to coordinate their activities to a degree under memoranda of understanding, it is far from clear whether and how the “natural” policy of each agency affects the policies and decisions of the other.

In this notice, FDA acknowledges such shortcomings, among others. The agency recognizes that it will need to coordinate with USDA in considering issues related to “natural” claims in food labeling; however, FDA makes no mention of coordination with FTC. In addition, FDA recognizes that its “natural” policy does not address other critical issues, including food production methods such as genetic engineering, or the use of pesticides, or processing or manufacturing methods such as pasteurization or irradiation. Notably, the agency also indicates that other issues, including consumer expectations and understanding of certain claims, may require further consideration. These and other issues have created uncertainty and confusion for courts, industry, and consumers.

Capitalizing on the absence of a clear “natural” definition, plaintiffs’ attorneys have brought class action lawsuits alleging that foods containing genetically engineered, synthetic and/or chemically-processed ingredients are falsely labeled if advertised as “natural,” even where foods themselves are highly processed and obviously not found in nature. In the past five years, at least three federal district courts have requested that FDA respond to questions related to whether food products containing genetically engineered ingredients may be labeled as “natural.”¹ In addition, another federal district court asked the agency to address whether food products containing high fructose corn syrup may use the claim “natural.”²FDA declined to address the questions posed by the courts; instead the agency stated that, if it decided to define “natural” or amend its existing policy, it would likely engage in a public process, such as issuing a regulation or guidance, and consult with other federal agencies, such as USDA.³

Industry and consumer interest groups have been pushing for clarification on the use of the term “natural” for decades. The Grocery Manufacturers Association (GMA) submitted a citizen petition in March 2014, requesting a regulation authorizing use of the term “natural” in labeling for foods containing ingredients derived from genetic engineering. GMA maintains that, based on FDA’s “in depth analysis and findings concerning plants derived from biotechnology, it follows that a statement of ‘natural’ or a similar statement would be neither false nor misleading on a food derived from such technology solely because of its heritage.”⁴ In contrast, the Consumers Union submitted a citizen petition in October 2014 requesting an outright prohibition on the use of the term “natural” in food labeling on grounds that “there is no formal definition” or “oversight and enforcement,” and, as a result, consumers are being misled.⁵ Unanswered citizen petitions filed by Sara Lee Corporation (2007) and The Sugar Association (2006) point to inconsistencies between FDA and USDA policies regarding the meaning and use of the term “natural” in food labeling and conflicting usage across food products depending on which agency has jurisdiction.⁶

In July 2015 the House of Representatives passed legislation to require FDA to promulgate a regulation defining the term. The legislation would also preempt analogous state and local requirements.⁷ The bill was referred to a Senate committee in July 2015 and has not progressed further.

FDA’s notice identifies a number of unanswered questions for which it seeks public input. While the notice itself does not change the uncertainty and attendant challenges faced by companies making “natural” claims, it does signal to industry more specifically the areas of concern for the agency. Industry may also see a bit of a break in enforcement, while FDA and industry wrestle with the issues. The net result is that industry has an important role to play in submitting meaningful and constructive comments so that FDA receives clear direction on how to move forward.

¹Order Granting Motion to Dismiss in Part (Dkt. No. 37) and For Referral to The United States Food and Drug Administration, Cox v. Gruma Corp., No. 4:12-cv-6502 (N.D. Cal. July 11, 2013), ECF No. 68; Order Granting in Part and Denying in Part Defendant’s Motion to Dismiss Second Amended Class Action Complaint and Staying Matter, Barnes v. Campbell Soup Co., No. 3:12-cv-05185 (N.D. Cal. July 25, 2013), ECF No. 55; Order, In Re General Mills, Inc. Kix Cereal Litig., No. 2:12-cv-00249 (D.N.J. Nov. 1, 2013), ECF No. 92.

²Order for Referral to United States Food and Drug Administration, Coyle v. Hornell Brewing Co., No. 1:08-cv-02797 (D.N.J. June 25, 2010), ECF No. 118.

³Letter from Leslie Kux, FDA, Assistant Commissioner for Policy, to the Honorable Yvonne Gonzales Rogers, U.S. District Court, Northern District of California, the Honorable Jeffrey S. White, U.S. District Court, Northern District of California, and the Honorable Kevin McNulty, U.S. District Court, District of New Jersey (Jan. 6, 2014); Letter from Michael M. Landa, Acting Director, FDA, Center for Food Safety and Applied Nutrition, to the Honorable Jerome B. Simandle, U.S. District Court Judge, District of New Jersey (Sept. 16, 2010).

⁴GMA, Citizen Petition, “Natural” Statements on Foods Derived from Biotechnology, 2 (Mar. 14, 2014) (Docket No. FDA-2014-P-0312).

⁵Consumers Union, Citizen Petition, 1 (June 26, 2014) (Docket No. FDA- 2014-P-1650).

⁶The Sara Lee Corporation, Citizen Petition, Requesting the Food and Drug Administration to Develop Requirements for the Use of the Term “Natural” Consistent with USDA’s Food Safety and Inspection Service (Apr. 9, 2007) (Docket No. FDA-2007-P-0007); The Sugar Association, Citizen Petition, Definition of the Term “Natural” for Making Claims on Foods and Beverages Regulated by the Food and Drug Administration (Feb. 28, 2006) (Docket No. FDA-2006-P-0206).

⁷The Safe and Accurate Food Labeling Act, H.R. 1599, 114th Cong. (July 24, 2015).

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