Jack Wenik, Member of the Firm in the Health Care & Life Sciences and Litigation practices, in the firm’s Newark office, was quoted in SupplySide Supplement Journal, in “RFK Jr’s HHS Showing Mixed Signals for Dietary Supplement Sector,” by Josh Long.
Following is an excerpt:
Statements made by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. suggest that he is pro-dietary supplements, harbors a healthy skepticism of the pharmaceutical industry and supports more preventative health care.
However, it’s a mistake to assume that his philosophies on health care will invariably equate to an unregulated and unpoliced free-for-all for the supplement sector.
To wit: RFK Jr’s plan to potentially require that all GRAS (generally recognized as safe) affirmations are reviewed by the U.S. Food and Drug Administration. As New Jersey-based lawyer Jack Wenik said during a March 25 conference hosted by the Food & Drug Law Institute (FDLI), eliminating the self-affirmed GRAS pathway would constitute an “enormous sea change” for the industry.
The identity and safety of relatively few new dietary ingredients (NDIs) are reviewed annually by FDA (we reported in 2022 that about 1,200 ingredient notifications had been submitted to FDA since enactment of the Dietary Supplement Health and Education Act of 1994 [DSHEA]).
What’s more, FDA will not file GRAS notices — or review them — for a substance intended to be used in dietary supplement products.
“The GRAS notification program provides a mechanism whereby a person may inform the FDA of a conclusion that a substance is GRAS for its intended use, and the GRAS standard is specific to the food additive definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” an FDA spokesperson wrote in a March 19 email. “Per section 201(s)(6) of the FD&C Act, dietary ingredients intended for use in dietary supplements are specifically excluded from the definition of the term ‘food additive.’”
FDA’s premarket review of new supplement ingredients is through its NDI notification program, the FDA spokesperson said, adding the agency “also reviews dietary supplement ingredients as part of our post-market surveillance and other regulatory activities to help ensure the safety of dietary supplements on the market.”
Many NDIs — or perhaps even most — are not vetted by FDA. From what lawyers, regulators and business executives have told me over the years, what often happens is an NDI is first added to and sold in a conventional food, then later marketed in dietary supplements in the U.S.
This practice is grounded in a provision in DSHEA (Section 413(a)(1)) that I’d characterize as controversial and murky. Ideally, the safety of the NDI, or food/supplement ingredient, is based on a self-GRAS affirmation free from conflicts of interest and backed by robust science, though again, FDA does not review these conclusions as part of its GRAS notification program.
As Wenik alluded to, supplement companies could face a sea change under the second Trump administration. On March 10, RFK Jr. announced directing FDA’s then-acting commissioner to take steps to explore a potential rulemaking to abolish the self-affirmed GRAS pathway.
HHS claimed the move would improve “FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.” Yet just days earlier, HHS issued a policy statement exempting several matters from notice-and-comment rulemaking.
“So on the one hand, [Kennedy] wants less transparency, and on the other hand, he supposedly wants more transparency,” remarked Wenik, a member of the law firm Epstein, Becker & Green, who has defended makers of dietary supplements against claims of regulatory violations.