Posted on 24 May 2022
Unlike regular drugs, dietary supplements don’t require approval from the US Food and Drug Administration (FDA) in order to be sold. However, the FDA is supposed to be informed whenever a new dietary ingredient is introduced into the market, and that hasn’t been happening.
Last week the FDA estimated that since the disclosure law took effect in 1994, supplement makers have told them about 1200 new ingredients, but have failed to disclose another 3400. This means that even the limited (and as many would argue, insufficient) regulations concerning supplements are not being properly enforced. Some supplement manufacturers aren’t complying with the law, and the FDA hasn’t been pursuing them.
Dietary supplements aren’t regulated in the same way as medicines because they are considered as foods. However, there is no scientific basis for drawing a hard line between a supplement and a drug just because one of them derives from something that is edible. After all, digitalis, morphine and a key component of aspirin all come from plants, and have the potential to cause serious harm or death upon overdosing. The natural occurrence of a compound does not magically make it safe to consume, so why shouldn’t it go through the same degree of rigorous testing as any other drug? Yet the FDA is not even allowed to inspect a supplement’s manufacturing process unless it has evidence that the product is harmful, which means that harm has probably already been done.
The FDA has said that it will take action concerning companies failing to submit ingredient notifications, but is giving them a grace period of 180 days. Some supplement makers, meanwhile, have complained that the underlying problem is with the FDA’s rules themselves. According to them, the rules for exactly what needs to be disclosed and in what detail are too vague. If a company is unsure whether a product is subject to regulation or not, they’re more likely to assume that no action is required, especially when they know that there aren’t going to be any repercussions.
The FDA does have a track record of releasing poor guidelines for supplement ingredients. A draft guidance in 2011 was scrapped after widespread criticism. The FDA tried again in 2016, to much the same effect. Rather than rewriting that guidance, they added 14 pages to it and will present it later this year. The FDA claims that most of the confusion over what does and doesn’t need to be submitted has been adressed.
Regardless of who exactly is to blame for what, it’s clear that the situation we are in at the moment is rather silly, and also dangerous. The FDA should know what compounds are being sold in dietary supplements, and there should be actual consequences when supplement companies fail to comply with the law.
The FDA says it’s in the dark about thousands of dietary supplement ingredients: https://www.statnews.com/2022/05/24/fda-in-the-dark-supplement-ingredients/