Established in 1936, this trade association remains a critical advocate for regulatory and legislative matters concerning dietary supplements. Its mission is to ensure the safety and compliance of these products while opposing unnecessary government overreach in an already heavily regulated sector.
“For 90 years, the Natural Products Association has been committed to safeguarding consumer access to safe and reliable natural products while fostering policies that allow the industry to innovate and expand,” explained Kyle Turk, the NPA’s vice president for government affairs. “Our core mission has remained remarkably consistent over nearly a century: to protect consumers, support responsible businesses, and secure the future of the natural products industry.”
This year, the agenda includes efforts to combat the Mandatory Product Listing bill, modernize the drug preclusion clause, expand access to dietary supplements via Health Savings Accounts (HSAs) and Flexible Spending Accounts (FSAs), and clarify the FDA’s authority amid increasing regulatory activity at the state level.
Preventing Overreach
A primary focus for the NPA is lobbying Congress to oppose the Dietary Supplement Listings Act (S. 3677), recently reintroduced by Senator Richard Durbin (D-IL). If enacted, this law would mandate supplement companies to register their products, labels, proprietary blends, allergen information, and structure/function claims with the FDA, creating a national database.
“It’s essential for the FDA—and consumers—to know which dietary supplements are available and what ingredients they contain,” Senator Durbin stated in a release dated January 15. “This is a fundamental FDA responsibility and the first step toward ensuring consumer protection. Americans deserve a transparent supplement market, and it’s time we deliver that.”
While supporters argue that such a database would help identify problematic products more quickly, the NPA firmly believes it would impose legal burdens, increase compliance costs detrimental to smaller businesses, and hinder innovation. Recently, Congresswoman Maxine Dexter, M.D. (D-OR) introduced a corresponding act in the House (H.R. 8370), reflecting a bipartisan interest in advancing this legislation.
“At its core, [the mandatory product listing] is not just a minor administrative adjustment,” the NPA asserts. “It serves as a gateway policy allowing the FDA to regulate which supplements can enter or remain in the market without scientific support, due process, or congressional oversight.”
NPA members conveyed to Congress that they believe the solution lies in bolstering FDA enforcement, enhancing collaboration against illegal activities, and targeting genuine safety issues rather than penalizing compliant businesses operating under current regulations.
Protecting Innovation
Another significant area of focus is amending section 201(ff)(3)(B) of the Dietary Supplement Health and Education Act (DSHEA), known as the “drug preclusion” clause.
Originally intended to prevent supplement companies from circumventing the drug-approval process, this provision prohibits the sale of an ingredient as a dietary supplement if it has been authorized or substantially investigated as a pharmaceutical drug unless that ingredient was already available as a supplement prior to an investigation.
NPA argues that the FDA has overstepped its bounds, employing this clause to remove long-available supplement ingredients from the market as soon as drug companies initiate clinical research on them. The organization contends that such interpretations create market uncertainty, stifling innovation as companies risk hefty investments in ingredient development if pharmaceutical investigations later invoke this clause.
“The dietary supplement industry is committed to innovation, safety, and public health, but without reform to section 201(ff)(3)(B), companies are placed at a disadvantage that prioritizes pharmaceutical interests over consumer options and wellness,” the NPA stated.
A notable case is NMN (nicotinamide mononucleotide), which the FDA determined in 2022 could no longer qualify as a dietary supplement due to its previous authorization for drug investigation. The NPA responded with litigation, citizen petitions, and lobbying efforts, eventually proclaiming victory when the FDA reinstated NMN’s status as a new dietary ingredient late last year.
Currently, the NPA is advocating for the FDA to clarify what constitutes a “substantial clinical investigation” or sufficient “public notice” to avoid arbitrary enforcement. Proposed reforms would also include establishing a public registry for investigational new drug (IND) filings, helping dietary supplement companies evaluate compliance risks when launching new products, and creating exemptions for naturally occurring ingredients with a history of safe use prior to any IND submission.
Promoting Access
An enduring goal for the NPA is to broaden the coverage of Health Savings Accounts (HSAs), Flexible Spending Accounts (FSAs), and Health Reimbursement Arrangements (HRAs) to include dietary supplements.
Under existing IRS regulations, most supplements are not automatically eligible for HSAs or FSAs unless prescribed for a specific medical condition or accompanied by a doctor’s letter of necessity. Advocates believe that updating the Internal Revenue Code (IRC) to allow access to a greater variety of wellness and nutrition products would promote preventive healthcare and help lower long-term medical expenses.
While visiting lawmakers, NPA members urged their representatives to endorse a Dear Colleague letter from Senator Kevin Cramer (R-ND) and Representative Darin LaHood (R-IL) directed to the Treasury and Health and Human Services Secretaries, suggesting updates to IRS publication 502 as a “high-impact, no-cost solution.”
“Crucially, Section 213(d) of the IRC defines ‘medical care’ to encompass expenses for ‘the diagnosis, cure, mitigation, treatment, or prevention of disease,’ as well as encompassing ‘the purpose of affecting any structure or function of the body,’” the letter states. “Nutritional supplements that carry FDA-authorized health claims or lawful structure/function statements clearly fit into this definition.”
Ensuring Uniformity
Another priority for the NPA is combating an influx of state-level initiatives aimed at regulating supplements, such as restricting sales to minors or imposing warning labels.
This initiative aligns with the Dietary Supplement Regulatory Uniformity Act (H.R. 7366), introduced by Congressman Nick Langworthy (R-NY) in February, which aims to designate the FDA as the exclusive regulatory authority for dietary supplements, thus preventing states from enacting fragmented, conflicting, or additional regulations. In 2023, New York Governor Kathy Hochul became the first to sign legislation prohibiting the sale of over-the-counter diet pills and muscle-building supplements to individuals under 18.
“Governor Hochul’s decision to restrict access to safe and effective dietary supplements like amino acids and creatine is fundamentally misguided and only harms consumers,” remarked Dan Fabricant, CEO and President of the NPA, at the time. “Data from the FDA reveals no connection between the use of dietary supplements and harm; disregarding this science is a perilous error. The NPA intends to explore all legal avenues, including the courts, to rectify this issue.”
While addressing attendees at the NPA closing reception, Representative Langworthy praised NPA members for their grassroots efforts and expressed his commitment to maintaining consumer access while minimizing compliance burdens imposed on businesses due to state—and particularly New York—restrictions that conflict with FDA jurisdiction.
“Now, call me crazy, but shouldn’t the government be encouraging Americans and businesses focused on health and preventive care?” he questioned. “Shouldn’t they be working to help them succeed, rather than fail? Instead, businesses are burdened with costly state-specific requirements, and consumers are confronted with misleading warnings that often contradict federal scientific determinations. Once a state starts down that path, others tend to follow, creating a domino effect.”
He emphasized the need for a “common-sense” approach to regulation, echoing sentiments heard throughout the day as NPA members lobbied in the House and Senate offices on Capitol Hill, urging Congress to avoid unnecessary regulations.
