A regulation that threatens supplement access is gaining traction. Action Alert!
A well-organized, coordinated campaign from the FDA and Big Pharma is threatening access to the supplements you depend on. Using the false premise that supplements are unsafe, the FDA is working to gain more power over the regulation of supplements in order to further solidify Big Pharma’s monopoly over medicine. These efforts must be opposed.
The House Appropriations Committee report for the FDA’s 2022 funding contains concerning language regarding the development of “mandatory product listing and registration” for dietary supplements. The Committee report states that members are concerned with the “lack of robust regulation of dietary supplements, some of which cause an estimated 23,000 emergency room visits per year.” The Committee encourages the FDA to “issue regulations requiring mandatory product listing and registration to create transparency in the supply chain.”
This language isn’t enough to give the FDA the power to create a mandatory list; Congress would need to pass legislation giving the FDA this power. What is concerning, though, is that this issue is on Congress’s radar, so we may see such proposals in the not-too-distant future. We also know that the authority to create a mandatory list of supplements is something that the FDA has asked for a number of times.
Simultaneously, news articles appeared this week describing how some bad actors in the industry use illegal ingredients in predominantly weight loss, sexual enhancement, and body building supplements, seeking to justify a push for more regulation. This can’t be a coincidence.
The stated purpose for mandatory listing is to improve the FDA’s ability to root out these kinds of bad actors who sell dangerous products, since the agency claims it has little information about the thousands of products on the market. 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 the 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 we know that supplements are overwhelmingly safe. The report language refers to 23,000 hospitalizations from supplements. To put this in perspective, acetaminophen alone causes 50,000 emergency room visits and 25,000 hospitalizations every year. So, even if we accept the government’s figure, all dietary supplements 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, and we issued a critique when it was released. More details are provided in that coverage, but we’ll briefly note here that over 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.
The idea that supplements are unsafe and more regulation is needed doesn’t pass the laugh test. So why would 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?
We believe this is about extending Big Pharma’s monopoly power over medicine. 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. Recall that the FDA’s “new supplement” 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. A mandatory list makes the FDA’s job that much easier.
A mandatory list is also a concern because of its likely use to create a list of supplements, potentially including high-dose supplements, that might lead to “adverse events,” similar to a legislative effort by Sen. Dick Durbin (D-IL) we defeated a number of years ago. A mandatory list could be used to target supplements and to remove “dangerous” high-dose supplements that don’t gel with the government’s pitifully low recommended dosages.
We must oppose these efforts. The FDA, in conjunction with Big Pharma, is working methodically to eliminate all healthcare options outside of drugs. We see similar dynamics playing out with NAC. NAC is a critical supplement that has been available for decades, but all the sudden the FDA has issued warning letters stating it isn’t a legal supplement, saving this essential compound for the drug industry. We must fight for our right to choose the healthcare options that best fit our needs.
Action Alert! Write to Congress and tell them to oppose any effort to establish a mandatory list for supplements. Please send your message immediately.