\u201cFDA\u2014and consumers\u2014should know what dietary supplements are on the market and what ingredients are included in them,\u201d Senator Durbin shared in a statement issued Jan. 15. \u201cThis is FDA\u2019s most basic function, and the first step to protecting consumers. Americans deserve a transparent supplement market, and it\u2019s past time that we deliver it for them.\u201d<\/p>\n
While proponents of the law argue that the listing would help identify bad actors more expeditiously, NPA categorically states that it would create legal burdens and lawsuits, introduce compliance costs that would hurt smaller businesses and slow innovation. Last month, Congresswoman Maxine Dexter, M.D. (D-OR) introduced the act in the House (H.R. 8370), signaling bicameral interest in pushing the legislation through.<\/p>\n
\u201cAt its core, [mandatory product listing] is not a minor administrative update,\u201d NPA counters. \u201cIt is a gateway policy that enables the FDA to control which supplements can enter or remain on the market, without scientific evidence, due process or congressional accountability.\u201d<\/p>\n
NPA members explained to their members of Congress that in their view the solution lies in increasing FDA enforcement, enhancing coordination against illegal actors and focusing on real safety risks, not compliant businesses under the existing regulatory structure.<\/p>\n
Protecting innovation<\/p>\n
Also top of the agenda is a more technical battle to clarify section 201(ff)(3)(B) of DSHEA, commonly referred to as the \u201cdrug preclusion\u201d clause. <\/p>\n
Originally designed to prevent supplement companies from bypassing the drug-approval system, the provision prevents an ingredient from being sold as a dietary supplement if first authorized or substantially investigated as a pharmaceutical drug unless that substance was already on the market as a supplement or food prior to the initiation of a a drug investigation.<\/p>\n
NPA has taken the stand that the FDA has expanded its authority far beyond Congress\u2019s original intent, using the clause to remove already-marketed supplement ingredients from the shelves after drug companies begin clinical research on them. It also puts forth that the government\u2019s interpretation creates market uncertainty and discourages innovation as companies risk losing significant resources and time to develop an ingredient should pharmaceutical research later trigger the clause.<\/p>\n
\u201cThe dietary supplement industry is committed to innovation, safety and advancing public health, but without reform to section 201 (ff)(3)(B), companies face an uneven playing field that prioritizes pharmaceutical interests over consumer choice and wellness,\u201d NPA stated.<\/p>\n
The highest-profile example is NMN (nicotinamide mononucleotide), which FDA concluded in 2022<\/a> could no longer legally qualify as a dietary supplement because it had previously been authorized for investigation as a drug. NPA responded with lawsuits, citizen petitions and lobbying campaigns accusing the FDA of retroactive enforcement and regulatory overreach, declaring victory when the agency reinstated NMN\u2019s new dietary ingredient status<\/a> late last year.<\/p>\n Today, NPA is calling for FDA to clarify the ambiguity surrounding what qualifies as a \u201csubstantial clinical investigation\u201d or sufficient \u201cpublic notice\u201d under the statute to avoid what it views as arbitrary enforcement. Revisions would also include creating a public registry of investigational new drug (IND) filings to help dietary supplement companies assess compliance risk when developing new products and create a carve out for naturally occurring ingredients with a history of safe use prior to any IND submission.<\/p>\n Promoting access<\/p>\n Expanding Health Savings Accounts (HSAs), Flexible Spending Accounts (FSAs) and Health Reimbursement Arrangements (HRAs) to cover supplements has been a long-time objective of the organization.<\/p>\n Under current IRS rules, most supplements are not automatically HSA\/FSA eligible unless prescribed for a specific medical condition or accompanied by a doctor\u2019s letter of medical necessity. Expanding the Internal Revenue Code (IRC) to provide access to a wider range of wellness and nutrition products, supporters argue, would encourage preventive care and reduce long-term healthcare costs.<\/p>\n While on the Hill, NPA members urged their representatives to sign onto a Dear Colleague letter from Senator Kevin Cramer (R-ND) and Representative Darin LaHood (R-IL) addressed to the Secretaries of the Treasury and of Health and Human Services to update IRS publication 502 as a \u201chigh-impact, no-cost solution.\u201d<\/p>\n \u201cImportantly, Section 213 (d) of the IRC defines \u2018medical care\u2019 to include amounts paid for \u2018the diagnosis, cure, mitigation, treatment or prevention of disease\u2019 as well as \u2018the purpose of affecting any structure or function of the body,\u2019 the letter reads. \u201cNutritional supplements that carry FDA-authorized health claims or lawful structure function statements fall squarely within this definition.\u201d<\/p>\n Ensuring uniformity<\/p>\n Another priority on the current NPA agenda is fighting off the steady stream of state-level supplement initiatives like restricting supplement sales to minors or requiring warning labels. <\/p>\n This effort is now rallied behind the Dietary Supplement Regulatory Uniformity Act (H.R. 7366), introduced by Congressman Nick Langworthy (R-NY)<\/a> in February to establish the FDA as the sole regulator of dietary supplements and preventing states from creating patchwork, conflicting or additional requirements. In 2023, New York Governor Kathy Hochul was the first to sign legislation into law banning the sale of over-the-counter diet pills and muscle-building dietary supplements to minors under the age of 18. <\/p>\n![\"Representative](\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2026\/05\/VRMXRYF5LBCHJGGN2IUV746YOU.jpg\")
Representative Nick Langworthy (R-NY) speaking the NPA reception on May 12. (NutraIngredients)<\/p>\n