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June 2019

Are dietary supplements regulated?

June 12, 2019 is Dietary Supplement Day on the Hill. This will be an opportunity for industry trade organizations to meet with Congress to advocate for reasonable regulations related to supplements and to honor DSHEA, the act that currently defines regulations for dietary supplements. Despite the fact that DSHEA was enacted 25 years ago, there’s a lot of confusion among consumers about what authority the act gives the FDA to monitor supplements.

Contrary to what some may think, dietary supplements are in fact regulated by the FDA, but these regulations are very different from those imposed on prescription drugs. One of the biggest differences between drug regulations and dietary supplement regulations is the approval process. There is NO approval process for dietary supplements. As long as supplements contain dietary ingredients that were either already used in supplements before DSHEA (1994), or established as reasonably safe since then, they can be sold to consumers lawfully. This is very different from drugs, which must go through an extensive approval process BEFORE entering the market. Basically, drugs are assumed unsafe until proven safe, whereas supplements are assumed safe until proven otherwise. The FDA can step in and ban supplement ingredients once safety is proven to be a concern. Ephedra is one good example of this. But the burden of proving that a supplement is unsafe rests with the FDA, not the manufacturer.

If a dietary supplement includes an ingredient that has never been used in a supplement before, it must be submitted to the FDA as a New Dietary Ingredient with information showing that the ingredient is “reasonably expected to be safe.” Unfortunately, some manufacturers ignore these guidelines and sell potentially unsafe products to consumers without any consideration for DSHEA or the FDA. Unlabeled ingredients are also a concern. Many dietary supplements have been shown to contain undeclared drugs like sildenafil and sibutramine, increasing the risk for side effects and interactions. Some supplements even contain banned ingredients such as ephedra. The FDA can remove these products from the market, but only after it’s confirmed that they are mislabeled. Because these products do not need to be reviewed or approved BEFORE they hit the market, this means that the public is exposed to safety risks before the FDA can identify or act on problematic products.

For now, your best bet is to use Natural Medicines to make sure supplement ingredients are safe. And always pick supplements that have been verified by a third-party to ensure what is on a product label is actually in the bottle. To do this, you can look for USP or NSF stamps on the product websites or labels. Also, as of May 2019, CVS Pharmacy is now requiring third-party testing of all vitamins and supplements sold at their stores and online. If you want to learn more about available supplements, check out our Commercial Products Database with over 185,000 listings.

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2019 Natural Medicines Inc. Commercial distribution or reproduction prohibited. Natural Medicines is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.