FDA Continues Fight for Supplement “Hit List”

This time, the agency is trying to use the Government Accountability Office (GAO) to do its dirty work. We can’t let them get away with it. Action Alert!

THE TOPLINE

• A GAO report on 12 prenatal vitamins is being used as a justification for more supplement restrictions.
• The GAO’s findings hardly support the case for more supplement regulations; for example, the report looked at less than 2 percent of the prenatal vitamins on the market.
• This is all about the FDA getting what it has been trying to achieve for years now: the passage of “mandatory product listing” or “mandatory filing” for supplements that sounds innocuous but is a prelude to much wider supplement restrictions. We must continue to oppose these efforts.

The FDA is starting to get creative in its quest to obtain the supplement “hit list” it wants so it can start eliminating access to supplements you care about. We beat back these efforts over the last few years, but we need to stay vigilant and make sure the latest attempt fails.

Last week, the GAO released a report testing nutrient levels in twelve prenatal supplements and comparing them to what is claimed on their labels. The authors conclude, “Our testing showed that 11 of 12 prenatal supplements had at least one nutrient above or below the levels noted on labels. This could result in a person consuming too much or too little of some nutrients. We recommended that Congress consider giving FDA more authority to oversee dietary supplements.”

If you don’t do any further digging, you might be inclined to agree with the GAO’s conclusion, but even a cursory review of their findings shows that this is much ado about nothing. It is, to us, a bald attempt to gain power over supplements that, so far, the FDA has failed to achieve.

First, a bit of context. The GAO tested 12 prenatal supplements. A search of the FDA’s online supplement database shows there are 842 prenatal vitamins on the market. The GAO report captures less than 2 percent of the prenatal market, but wants to use this data as a rallying cry to give the FDA more power over our supplements. Huh?

There’s no question that there are bad actors and cowboy operators out there. We’ve reported on quality testing performed by NOW Foods showing potency and other issues with certain supplement products. But this is more of a “buyer beware” issue, hardly amounting to a public health problem requiring more FDA oversight over supplements. The GAO report’s results actually support this view: most of the nutrients in the 12 supplements fell between the upper and lower thresholds set by the US Pharmacopeia. We’ve written previously about why the upper levels for nutrients devised by governmental bodies are incredibly flawed, so nutrients being above the pitifully low “upper limit” levels is hardly a cause for concern. The European Union (EU) has been moving slowly but surely over the last 15 years to use these guidance levels as the basis to set maximum levels for supplements, and we cannot allow such madness to land on US shores.  

The 12 supplements were also tested for heavy metals, but none contained levels that concerned the FDA.

This all smacks of the classic “solution in search of a problem.” The FDA wants its “hit list,” and it’s doing anything it can to get it—even enlisting the help of the GAO to do a bogus report on 12 supplements to try to support the agency’s case.

The FDA’s “hit list”—often referred to as “mandatory product listing” or “mandatory filing”— 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.

With your help, we were able to stop it, and it looks like we’ll need to do so again. You can read our previous coverage to remind yourself why this is such a terrible policy. The main threat is the way that “mandatory filing” requirements would interplay with other FDA regulations, particularly the “new supplement” regulations that have not yet been completed. The “hit list” would give the agency an easy way to seek out supplements that are not in compliance with the very problematic “new supplement” guidance and remove those products from the market. 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 “new supplement” guidance. Supplement companies lose, the economy suffers, and consumers lose access to critical health products.

Put simply, 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 attempting and that our colleagues at ANH International have been in the frontline fighting for over 15 years. Mandatory registration would also throttle innovation in the supplement sector that delivers American consumers the most diverse array of cutting-edge products that support health, anywhere in the world.

Action Alert! Write to Congress and tell them to oppose mandatory product registration for supplements to avoid dumbing down America’s world-leading dietary supplement sector that is critical to our long-term health. Please send your message immediately.