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FDA Seeks New Authority to Restrict Supplement Access

FDA Seeks New Authority to Restrict Supplement Access
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The FDA has asked for the authority to implement an anti-supplement policy—we can’t let it happen. Action Alert!

The agency wants to institute “mandatory product listing” for dietary supplements. This policy sounds innocuous but creates a slippery slope towards regulations that would restrict your supplement choices. This is the same policy championed by Senator Dick Durbin (D-IL) that, with your help, we defeated last year. We need to keep up the pressure to make sure it doesn’t make a comeback this year.

The agency included mandatory product listing for supplements in its wish-list of legislative proposals for Congress to pass in FY 2024. Remember, too, that after we defeated Sen. Durbin’s efforts last year, he vowed to continue pushing for his anti-supplement policy this year. 

Mandatory product listing for supplements sounds simple enough. It would allow the FDA to build a registry of the entire supplement industry. Companies would need to submit detailed information on every product they sell to the FDA. But don’t let this fool you—such a registry would be used by the FDA to target and eliminate products that the agency believes do not comply with its ridiculous regulations.

Consider the example of NMN, the longevity supplement we’ve been writing about for some time. The FDA has said that NMN does not fit the definition of a supplement because it was studied as a drug before being sold as a supplement—a similar position the agency adopted on NAC. With a registry of the entire supplement industry, the agency could have eliminated all NMN and NAC supplements right away; once eliminated, it would be almost impossible to bring these supplements back. Without the supplement hit list in place, consumers and stakeholders have a chance to mount a defense of supplements like NMN and NAC—in the case of NAC, the agency is now contemplating an exception to the law to allow continued sale of NAC supplements. This was only possible because consumers and industry stakeholders had time to mount a defense against the FDA’s position on NAC—it was this pushback that ultimately led the FDA to pause its attack. If mandatory product listing was in place, the FDA could have swept the market of NAC directly after it determined it wasn’t a supplement, making the job of defending access extremely difficult if not impossible.

This policy is also dangerous because of how it interplays with the agency’s “new dietary ingredient” (NDI) guidance we’ve written so much about over the years. According to the law, companies bringing “new” (ie post-1994) supplements to the market must notify the FDA in advance of doing so with a NDI notification. The problem is that the FDA’s implementation of the NDI notification system is a wild overreach, creating a drug-like pre-approval system for supplements. One of the biggest problems with the FDA’s guidance is that it contains an expansive definition for what constitutes a “new” supplement, such that tweaks to a formula of a vitamin D supplement could, in theory, trigger NDI notification rules, even though vitamin D is far from a “new” supplement. Analysts have estimated that the FDA’s guidance threatens to eliminate as many as 41,700 supplements from the market.

Mandatory product listing creates a lose-lose situation for consumers and supplement companies: if companies don’t comply, they face fines and jail time; if they do comply, companies are orchestrating their own demise by giving the FDA the list it needs to sweep the market of as many as 41,700 supplements that do not comply with the agency’s overreaching NDI guidance. Supplement companies lose, the economy suffers, and consumers lose access to critical health products.

There are more reasons to oppose this bill. It moves us closer to restrictions on high-dose supplements similar to those being pursued in the European Union. It threatens to restrict consumer choice by restricting or eliminating access to innovative products, leaving only basic, cookie cutter supplements on the market.

In a recent survey, 61 percent of supplement companies said they supported mandatory product listing for supplements. How could that be? We touched on this issue last year in an article on mergers in the supplement industry. More and more supplement companies are being bought up by multinational corporations like Nestle, Unilever, Clorox, Pfizer, and others. Mandatory product listing is in their interest because it paves the way towards standardized supplement dosages, which is what the EU is in the process of doing. Mega-corporations doing business across the world would welcome harmonized levels of supplements so they can sell their products on the world market without having to change formulations or labels. It’s bad for consumer choice, but good for profits.

To recap: Durbin’s mandatory listing legislation would add regulations to supplements that would increase prices for consumers and decrease available options, making it easy for the FDA to eliminate supplements that compete with the drugs that provide significant funding for the Agency. We’ve argued that mandatory product registration is a prelude to eliminating high-dose dietary supplements, as the EU is in the process of doing, and throttling innovation in the supplement sector that delivers American consumers a diverse array of cutting-edge products that support health.

Action Alert! Write to Congress and tell them to oppose mandatory product registration for supplements. Please send your message immediately.

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