Founded in 1936, the trade group continues to serve as a watchdog on regulatory and legislative issues, advocating for initiatives to certify the safety and compliance of dietary supplements while preventing government overregulation of an already regulated industry.
“For 90 years, the Natural Products Association has been dedicated to protecting consumer access to safe, trusted natural products while advancing policy allows the industry to innovate and grow,” said Kyle Turk, vice president of government affairs at NPA. “The mission has remained remarkably consistent over nine decades: protect consumers, support responsible businesses and preserve the future of the natural products industry.”
On this year’s agenda: fending off the Mandatory Product Listing bill, modernizing the drug preclusion clause, expanding access to dietary supplements through health savings accounts (HSA) and Flexible Savings Accounts (FSA), and clarifying Food and Drug Administration (FDA) authority in the face of mountain state regulatory action.
Preventing overreach
One of NPA’s biggest battles of the day is urging members of Congress to vote no on the Dietary Supplement Listings Act (S. 3677), reintroduced at the top of the year by outgoing Senator Richard Durbin (D-IL). If passed, the law would require supplement companies to register products, labels, detailed proprietary blends, allergen statements and structure/function claims with the FDA to populate a national database.
“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them,” Senator Durbin shared in a statement issued Jan. 15. “This is FDA’s most basic function, and the first step to protecting consumers. Americans deserve a transparent supplement market, and it’s past time that we deliver it for them.”
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.
“At its core, [mandatory product listing] is not a minor administrative update,” NPA counters. “It 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.”
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.
Protecting innovation
Also top of the agenda is a more technical battle to clarify section 201(ff)(3)(B) of DSHEA, commonly referred to as the “drug preclusion” clause.
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.
NPA has taken the stand that the FDA has expanded its authority far beyond Congress’s 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’s 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.
“The 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,” NPA stated.
The highest-profile example is NMN (nicotinamide mononucleotide), which FDA concluded in 2022 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’s new dietary ingredient status late last year.
Today, NPA is calling for FDA to clarify the ambiguity surrounding what qualifies as a “substantial clinical investigation” or sufficient “public notice” 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.
Promoting access
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.
Under current IRS rules, most supplements are not automatically HSA/FSA eligible unless prescribed for a specific medical condition or accompanied by a doctor’s 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.
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 “high-impact, no-cost solution.”
“Importantly, Section 213 (d) of the IRC defines ‘medical care’ to include amounts paid for ‘the diagnosis, cure, mitigation, treatment or prevention of disease’ as well as ‘the purpose of affecting any structure or function of the body,’ the letter reads. “Nutritional supplements that carry FDA-authorized health claims or lawful structure function statements fall squarely within this definition.”
Ensuring uniformity
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.
This effort is now rallied behind the Dietary Supplement Regulatory Uniformity Act (H.R. 7366), introduced by Congressman Nick Langworthy (R-NY) 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.
“Governor Hochul’s decision to prohibit access to safe and reliable dietary supplements like amino acids, creatine and other essential nutrients is fundamentally flawed and only hurts consumers,” Dan Fabricant, CEO and president of NPA, said at the time. “The FDA data shows there is no connection between the use of dietary supplements, and to ignore the science is a dangerous mistake. NPA will use every lever available including the courts to right this wrong.”
Speaking at the NPA closing reception, Representative Langworthy congratulated NPA members on their important grassroots efforts and spoke to his motivations for protecting consumer access and reducing compliance burdens on businesses caused by state—and particularly New York—restrictions that override FDA authority.
“Now, call me crazy, but shouldn’t government actually be encouraging Americans in businesses who are focused on health and preventative care?” he asked. “Shouldn’t they be focused on helping them succeed, not fail? Instead, businesses are now being forced to comply with costly state-specific requirements while consumers are seeing hyperbolic warnings that often conflict with federal scientific determinations. And once a state starts down that road, others follow. It gets contagious, and we see that.”
Instead, he called for a “common sense” approach to regulation, echoing a refrain heard throughout the day as NPA members sat in House and Senate offices of the Capitol complex, urging Congress to avoid regulation for regulation’s sake.
