Stop Sneak Attack on Supplements: 41,700 Supplements at Risk

Members of Congress are working to include an amendment to a must-pass appropriations bill that would give the FDA enormous power to eliminate food supplements we need to stay healthy, especially during the pandemic. 

Their goal is to create mandatory supplement product listing with the FDA, which seems innocuous but is far from it. The problem is that FDA is separately completing a process to eliminate every supplement from the market that doesn't meet "new supplement" notification requirements, which are akin to new drug requirements, and the FDA needs this list to locate and pull an estimated 41,700 supplements from the market.

Such notification requirements may seem reasonable, even laudable, but they will restrict consumer access to supplements. Drugs can afford these types of requirements because they are patentable in a way natural food supplements are not, which means that supplements do not have the ability to recoup the costs of complying with additional regulations. This will either force companies to go out of business or it will make supplements so expensive that they are priced out of the market.

This is also a solution in search of a problem since supplements have a consistently sterling record of safety.

It's particularly sneaky to pass legislation this way. The funding bill as a whole has to pass for the government to continue operations, and any ancillary provisions buried within it must pass too, even if they couldn't stand on their own. 

We cannot allow this sneak attack to succeed. Tell lawmakers to oppose this move!

Subject: Please oppose a mandatory list for supplements

 Dear [Congress person],

Please oppose any legislation to institute a mandatory FDA listing and fees requirement for dietary supplements, especially backdoor approaches to create this new FDA authority through the appropriations process rather than following the proper legislative process. This dangerous policy sounds innocuous but threatens consumer access to important dietary supplements.

 Such notification requirements may seem reasonable, even laudable, but they will restrict consumer access to supplements. The stated purpose for mandatory listing is to improve the FDA's ability to root out bad actors who sell dangerous products. It is a laudable goal, but the FDA already has the authority to go after companies that break the law and use illegal ingredients, including those referenced in news articles this week. The agency can, and has, enforced this law, as it should.

Using safety as a justification to give the FDA more power over supplements is a smokescreen because data shows that supplements are overwhelmingly safe. Some on the Hill have referred to 23,000 hospitalizations annually from supplements. To put this in perspective, acetaminophen alone causes 50,000 emergency room visits and 25,000 hospitalizations every year. So, all dietary supplements combined cause as many hospitalizations as a single drug. Properly prescribed drugs are estimated to cause 1.9 million hospitalizations a year.

Do supplements really cause 23,000 hospitalizations per year? This number comes from a 2015 Department of Health and Human Services-funded study, but 20% of the cases analyzed were the result of unsupervised children swallowing pills and 40% of cases among those 65 and older were caused by choking.

So why does the FDA want more power to go after supplements which are overwhelmingly safe, during a pandemic in which the evidence shows supplements can help support health?

A mandatory list could be used by the FDA to target and eliminate supplements that have not yet complied with the agency's over-reaching "new supplement" policy. The FDA's "new supplement" (NDI) guidance seeks to impose drug-like pre-approval requirements on all "new supplements" that came to the market after 1994. The "new supplement" policy has not been completed yet, having languished in draft form since 2011. But the FDA just indicated that its goal is to complete this policy by the end of June 2022.

A mandatory list of all supplements and a completed "new supplement guidance" would be potent tools for the FDA to efficiently remove thousands of supplements from the market. With a comprehensive list of products, the agency could very easily create a supplement "hit list" and remove supplements that it believes have not complied with the guidance, which is already expected to eliminate as many as 41,700 products from the market.

Furthermore, the additional costs and regulatory compliance will be no problem for enormous multinational pharmaceutical corporations with supplement branches; but small, new, innovative supplement companies will have an even harder time joining and staying on the market. 

Ultimately, this will hurt small businesses, eliminate competition and increase costs for American supplement users. This is an unneeded additional regulatory burden on an overwhelmingly safe industry that would eliminate the food supplements we need to stay healthy, especially during the pandemic. For these reasons, please do not support a mandatory list for dietary supplements.

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