The FDA regulates dietary supplements, including beauty products, sexual enhancement products, and workout supplements. But, it does not make a determination about the safety or efficacy of these supplements before they become available to the public. Because these supplements can literally kill people, the FDA is supposed to disclose reports of harm from supplements. Why is the FDA hiding information about supplements that are dangerous?
To protect Americans, the FDA has a database, CAERS, that is supposed to include information on supplements that are reported dangerous, including product complaint reports. CAERS is open to public scrutiny because Americans should know when a supplement is dangerous.
But, Consumer Reports has found that the Trump administration is not disclosing information about many supplements that are dangerous; prior administrations have also not done so to the extent required. According to Consumer Reports, the CAERS database does not disclose the names of hundreds of manufacturers of products that have been reported to cause harm. Rather, the FDA is giving many manufacturers an exemption, putting the businesses of manufacturers ahead of the safety of Americans.
The FDA has always exempted a small class of products from being reported for public view (<5 percent) in an effort to encourage manufacturers to report consumer complaints to the FDA. The FDA appears now to be applying this exemption far more broadly, counter to FDA policy.
With products that cause death or hospitalization, a manufacturer must let the FDA know. And, the FDA is supposed to make that information available to the public. Also, when an individual or a physician submits a report about a product, the product’s name is supposed to appear in the CAERS database.
After analyzing documents released because of a Freedom of Information Act request, Consumer Reports found that the FDA exempted more than 400 supplements, even though they were reported to have caused hospitalizations or deaths. The FDA is now saying that these reports were “mislabeled,” acknowledging that the products should have been disclosed.
The CAERS database came into being in 2003 to make consumers aware of safety issues from supplements. But, in 2015, the FDA began exempting 15 percent of product names from public view. During the Trump administration, those exemptions have doubled to more than 30 percent of product names.
Millions of Americans take supplements on a daily basis. And, many swear by them. But, there is little scientific evidence that they provide benefits in most cases. And, lots of evidence that they can cause serious harm.
On top of the failure of the CAERS database to disclose information critical to the health and safety of Americans, the CAERS database is hard to search. The FDA also operates a FAERS database in which adverse events related to drugs are reported. That database is easily searchable.
Here’s more from Just Care:
- Coronavirus: Taking supplements poses risks
- Should you be taking vitamins?
- Herbal supplements may not be what you think they are
- If you take supplements, beware of potentially serious supplement-drug interactions
- Supplements: John Oliver vs. Dr. Oz
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