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  Title	Regulatory roundup: HHS GRAS attack, Makary's confirmation to lead FDA and NMN wars
  ID	7682781
  External ID	7623881788
  Author	Unknown
  Published Date	March 13, 2025, 12:28 p.m.
  Summary	Washington, D.C., is buzzing with activity directly affecting industry. Below, we review an announcement by Robert F. Kennedy Jr., a key vote by a congressional health committee, and developments in a
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  URL	https://www.supplysidesj.com/supplement-regulations/regulatory-roundup-hhs-gras-attack-makary-s-confirmation-to-lead-fda-and-nmn-wars
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  Content ID	4988027
  Key	d3766b53-8f3e-49f0-86de-490cdc3a969f
  Content	Washington, D.C., is buzzing with activity directly affecting industry. Below, we review an announcement by Robert F. Kennedy Jr., a key vote by a congressional health committee, and developments in an administrative proceeding involving a healthy aging ingredient. At a Glance HHS Secretary Robert F. Kennedy Jr. made a big announcement this week regarding food ingredient safety. With a key vote today, Johns Hopkins University's Marty Makary, M.D., is on a path to become the next commissioner of FDA. Pharma is in a squabble with a trade association in an effort to control the market for a healthy aging ingredient (NMN). From ingredient regulation and legal battles to new leadership at FDA, there's a lot going on in and around the nation's capital impacting the dietary supplement industry. Below are some developments on our radar. RFK Jr. and the GRAS loophole On Monday, March 10, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced he was directing FDA's acting commissioner to explore a rulemaking to revise a final rule and related guidance “to eliminate the self-affirmed GRAS (generally recognized as safe) pathway,” or what Kennedy characterized as a “loophole.” “Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply,” HHS announced in a Although FDA strongly recommends that manufacturers submit GRAS notices through its , companies can self-affirm that the use of a substance is generally recognized as safe without notifying the agency, according to HHS. “HHS also is committed to working with Congress to explore ways legislation can completely close the GRAS loophole,” the agency added. “Such legislation, in tandem with potential future rulemaking, are crucial steps necessary to Make America Healthy Again.” Over the coming weeks, we'll be covering this development in greater depth to examine the potential implications for the dietary supplement industry. This topic is complex, to say the least, but it's worth exploring since FDA and industry for years have commiserated over the relatively with the agency — which an (in 2019) is FDA's only chance to evaluate the safety of a new dietary ingredient (NDI) before it is marketed to consumers. Presumably, many or most of the NDIs sold in dietary supplements have been unfiled, so hopefully — this is where the picture gets murky and controversy brews — many or most of these ingredients first marketed in the conventional food supply have been subject to self-GRAS affirmations. The Dietary Supplement Health and Education Act of 1994 (DSHEA) says squat about GRAS, although an exemption to the premarket notification for NDIs has been characterized from time to time as the GRAS loophole. (See published in 2021 regarding FDA and beta-alanine). The relevant provision excludes an NDI from notification if it's “been present in the food supply as an article used for food in a form in which the food has not been chemically altered.” Much more is to come on this developing story, with expert commentary from supplement insiders, but don't hold your breath on a rulemaking anytime soon from RFK Jr.'s agency. “Given the personnel cuts and budget shortages being faced by FDA, it remains to be seen whether FDA will have the resources to effectively undertake the regulatory review in any timely way,” the law firm Keller and Heckman LLP wrote in a client alert. The firm also questioned whether FDA has authority “to eliminate the self-affirmed GRAS pathway,” as described by HHS. “Right now, the law provides FDA with jurisdiction to authorize only food additives, as defined in the [Federal Food, Drug & Cosmetic Act, or FDCA], to be used in food,” Keller & Heckman noted. “Since the definition of food additive excludes, among other things, GRAS substances, FDA does not have much room, if any, to regulate these substances beyond the way they already have.” FDA nominee Marty Makary Today, March 13, the Senate Committee on Health, Education, Labor and Pensions voted affirmatively for Marty Makary, M.D., to lead FDA. The vote was 14 to 9, with the nomination moving to the Senate floor for a final vote at a later date. “If confirmed as FDA Commissioner, Dr. Makary committed to promoting medical innovation while upholding FDA's gold standard of review, so Americans can benefit from the latest lifesaving medicines and devices,” Senate HELP Committee Chairman Bill Cassidy, M.D., (R-La.), said in remarks in support of Makary's nomination. “He emphasized the need to address obesity and chronic disease, in collaboration with other administration officials.” Makary, a surgeon and health care public policy researcher at Johns Hopkins University, , at which time he outlined his goals for FDA if he is confirmed by the U.S. Senate: “More cures and meaningful treatments for Americans, including diagnostics, healthy food for children and rebuilding the public trust.” I'm not sure at this time how he views dietary supplement products. Based on his , the last FDA commissioner, Robert Califf, M.D., didn't appear to industry to be particularly knowledgeable of, or overly impressed with, the commodity. Califf's predecessor, Scott Gottlieb, M.D., As we , Sen. Dick Durbin (D-Ill.) has already met with Makary and discussed his legislative proposal to require that dietary supplement products are listed with FDA. So perhaps the physician is starting to form a view of the industry — and whether that's good, bad or ugly remains to be seen. Pharma's fight to monopolize NMN In mid-February, Metro International Biotech in response to an amended citizen petition filed by an industry trade association. The clinical-stage pharma company reported it has invested millions of dollars and several years developing a proprietary form of NMN called MIB-626 as an investigational new drug. In January, the Natural Products Association , elaborating on arguments that the healthy aging ingredient β-NMN (beta-nicotinamide mononucleotide, or NMN) should not be excluded from the definition of a dietary supplement. FDA is expected to respond to the petition by July 31, 2025. The agency is facing a that a in October. NPA requested in the amended petition that FDA's commissioner determine NMN is not excluded from the definition of a dietary supplement — or commit to exercising “enforcement discretion in connection with the marketing and selling of NMN in or as a dietary supplement.” Alternatively, NPA requested FDA recommend that the secretary of HHS (now RFK Jr., also now a defendant in NPA's lawsuit) decide NMN is lawful in supplements through a notice-and-comment rulemaking. In its January filing, however, Metro concurred with FDA's conclusion that the FDCA prohibits the marketing of NMN as a dietary supplement, and the company maintained the agency should not allow NMN-containing products to be sold as a supplement. Metro made various legal arguments to support FDA's position that NMN cannot be marketed in dietary supplements. What I found most noteworthy was its policy arguments for why FDA should not undertake a rulemaking or exercise enforcement discretion. In August 2022, FDA issued an enforcement discretion policy regarding NAC (N-acetyl-cysteine) in a . FDA concluded that NAC was excluded from the definition of a dietary supplement because it was first approved as a new drug in 1963. However, industry had provided FDA evidence that NAC had been marketed in dietary supplement products for decades. The agency said it was considering rulemaking to allow NAC to be lawfully marketed in supplements, and it cited a lack of safety-related concerns with the ingredient. FDA said it intended to exercise enforcement discretion until denying or completing a notice-and-comment rulemaking requested by NPA. But in its recent filing with FDA, Metro argued the circumstances surrounding NAC are distinguishable from NMN. The pharma company noted, for instance, that the manufacturer of NAC later discontinued distribution of the drug, and a new drug application was withdrawn in 2009. “FDA also had a ‘longstanding policy' of permitting the marketing of NAC as a dietary supplement,” Metro wrote to the agency. “FDA's recent decision to exercise enforcement discretion with respect to dietary supplements containing NAC must be understood within this unique situation. There is no legal or policy basis for applying similar enforcement discretion in the NMN-context, where Metro is actively pursuing clinical investigations into NMN as a new drug.” For now, though, pending the outcome of the lawsuit, FDA is, in essence, exercising enforcement discretion regarding NMN-containing supplements. The government last year to not target NMN dietary supplements for enforcement actions under certain conditions. “FDA has further represented to NPA that, while it considers the arguments raised in the citizen petition, the agency does not intend to prioritize enforcement action related to the sale and distribution of NMN-containing products that are labeled as dietary supplements, provided that they would be lawfully marketed dietary supplements if NMN is not excluded from the definition of a ‘dietary supplement,'” attorneys for NPA and the U.S. government asserted in a joint motion to the court. However, they added, “If FDA becomes aware of new safety concerns, the agency would need to reevaluate its enforcement priorities.” Metro has filed a motion to intervene in NPA's lawsuit against FDA and HHS, so it can can the join the litigation and presumably side with the U.S. government. If the judge grants the request, prepare to see the pharmaceutical and supplement industries bash skulls both in federal court and through an administrative proceeding. Stay tuned. There's lots happening on the policy front that could shape the industry's future — for good or ill — and we'll do our best to keep you current with the news. About the Author
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