September 19, 2016 Practice Points

FDA Issues Revised Draft Guidance for New Dietary Ingredients

By Daniel J. Gerber

On August 12, 2016, the United States Food and Drug Administration (FDA) issued a draft guidance for the dietary supplement industry. 61 Fed. Reg. 53486 (Aug. 12, 2016). The draft guidance follows five years of uncertainty about critical questions facing the dietary supplement industry regarding New Dietary Ingredients (NDI). The draft guidance is intended to clarify issues for the benefit of industry and regulators. Counsel in both the regulatory and litigation fields should pay close attention to the development of this and other guidance provided by FDA.

As part of the Dietary Supplement Health and Education Act (DSHEA), Congress required dietary supplement manufacturers to notify FDA before introducing an NDI into the marketplace. 21 U.S.C. 350b. In 2011, seventeen years after DSHEA’s mandate, FDA issued its original NDI guidance. Over the next five years, FDA recognized that “the 2011 draft guidance contained gaps and unclear statements that were subject to confusion and misinterpretation.” 61 Fed. Reg. at 53487. Because of that confusion, the draft guidance, comments, and ultimate final guidance, likely due in early 2017, are intended to “clarify and better explain” FDA’s position on important issues. Id.

The draft guidance offers FDA’s current thoughts and invites comment on important issues, including: 

• What constitutes “chemical alteration” of a food ingredient already present in the food supply?

• What defines a food ingredient already in the food supply?

• How do manufacturing changes to a food ingredient lead to the creation of a reportable NDI?

• Whether and under what method should FDA develop a list of “grandfathered” dietary ingredients that do not require NDI notice?

• Are there ways to create more efficient NDI filing procedures?

Comments on the issues addressed by the draft guidance are due to FDA by October 11, 2016. The FDA docket, though, includes many requests for 90-day extensions of time to file comments. Any person or entity interested in filing comments should access the draft guidance.

FDA issues draft guidance documents regularly. While some of FDA’s guidance is technical, often FDA’s guidance applies to legal issues that may be important to regulatory attorneys and litigators alike. Current guidance under consideration involves labeling of various foods, including guidance on the use of the term “evaporated cane juice,” labeling of vending machine products, menu labeling, and infant formula disclosures. A current list of guidance drafts is also available.

Litigators should be familiar with FDA guidance. FDA guidance is a useful tool for expert witness reports, cross-examination and motion practice. The First Circuit Court of Appeals referenced the “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act” guidance in Kaufman v. CVS Caremark Corp., No. 16-1199, 2016 WL 4608131, at *4 (1st Cir. Sept. 6, 2016) (citing the guidance for the definition of the term “substantiation”). In Merck Eprova AG, v. Brookstone Pharmaceuticals, LLC, 920 F.Supp.2d 404 (S.D.N.Y. 2013), Judge Sullivan issued an order following a bench trial in a Lanham Act case. The court cited violation of the FDA dietary supplement ingredient guidance as evidence of willfulness and bad faith. Id. at 433.

Judge Curiel cited the NDI guidance in a summary judgment order in a case involving breach of contract and breach of warranty between two business partners in Imagenetix, Inc. v. Frutarom USA, Inc., Case No. 12CV2823-GPC(WMC), 2013 WL 6419674, at *5 (S.D. Cal. Dec. 9, 2013). Fundamental to deciding part of the case was whether Frutarom’s product should have been classified as a drug, grandfathered dietary ingredient, or a new dietary ingredient. The court cited the NDI guidance in granting partial summary judgment under the primary jurisdiction doctrine. Id. at *6. In similar contexts relating to primary jurisdiction, the FDA’s “evaporated cane juice” guidance has been cited by several courts during 2016. See, e.g., George v. Blue Diamond Growers, No. 4:15-CV-962 (CEJ), 2016 WL 1464644, at *3 (E.D. Mo. Apr. 14, 2016) (granting defendant’s motion to dismiss pursuant to primary jurisdiction).

FDA guidance is widespread and persuasive on many issues. The FDA guidance docket should be reviewed by counsel facing any regulatory or litigation issue that may be addressed by FDA.

Daniel J. Gerber is a partner at Rumberger Kirk & Caldwell in Orlando, Florida.

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