Four FDA officials along with a high-ranking Federal Trade Commission (FTC) expert spoke to nearly 150 attendees at CRN’s first ever Regulatory Summit on May 5 in Bethesda, Maryland, just outside Washington, D.C.  Steven Tave, acting director, of the newly-designated FDA Office of Dietary Supplement Programs (ODSP) underscored the importance of the elevation of dietary supplements from the “division” level to the “office” level at the agency, giving dietary supplements a higher profile not only with regulators, but beyond.

CRN’s Steve Mister offered industry’s expectations for FDA’s ODSP, noting that the office’s first priority should be to address tainted products. Staffing priorities should include individuals with expertise in technology and probiotics, he added, and advised that FDA should leverage the resources and contacts it has in Washington to advance its priorities. Michael McGuffin, president of the American Herbal Products Association, advised that release of the long-awaited update draft guidance on New Dietary Ingredient (NDI) Notification should be a top priority for FDA. He recommended ODSP consider botanical experts, nutritionists and other experts with industry experience to round out its staff. In addition, he noted that FDA records, such as NDI notifications, can be very instructive to industry stakeholders and requested that the agency make these documents more accessible.

Cara Welch, Ph.D., senior advisor in the ODSP, discussed the intersection of science and regulation with regard to whether an ingredient meets the legal requirements for a “dietary ingredient under the law, including such factors as: concentration, chemical alteration, and ingredient combination. Dr. Welch noted that ingredient combinations take different forms, such as mixtures or molecules held together by ionic or covalent bonds. FDA examine how the body responds to the combination (e.g., whether it breaks combination ingredients back into their original components) when determining the status of an ingredient, she explained.

Richard Cleland, FTC’s assistant director of the Division of Advertising Practices at its Bureau of Consumer Protection, provided updates on the Commission’s guidelines for native advertising and social media. Mr. Cleland emphasized transparency and disclosure to avoid making misleading or deceptive claims. If a material connection exists between the advertiser and an endorser, disclose it, he advised, noting that companies must also train their affiliates and monitor what they’re doing on the company’s behalf. Because advertisers are responsible for substantiating all objective product claims, you need to explain to your network the claims you can support, he explained.

The Summit agenda also included industry experts such as Ricardo Carvajal of Hyman, Phelps & McNamara who observed that the Dietary Supplement Health and Education Act of 1994 (DSHEA) must be fully implemented before we can truly asses whether it works or not, even in the midst of all the change the industry currently faces. Greer Lautrup of Sidley Austin LLP gave a bit of practical advice regarding good manufacturing practices (GMP) inspections, encouraging company representatives to build a strong relationship with their FDA district office because they will be forever linked—unless the company moves or FDA re-districts.

“The Tan Sheet” andNutraIngredients.com covered the summit and offer additional recap details. Presentations from FDA and FTC officials are available on CRN’s website. Additional presentations are available to attendees only. For more information, contact Desiree Lewis (202-204-7687).

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