During the last weeks of 2020, FDA released a list of nearly 50 tainted dietary supplements, all of them male enhancement or weight loss products. In early 2021, FDA published a voluntary recall regarding two additional tainted sexual enhancement supplements. Only a few days later, FDA published 10 warning letters to supplement companies who market their products with impermissible claims to treat depression and other mental health disorders.
FDA notices such as these will not end any time soon because misbranded and adulterated dietary supplements put patients at risk. One study found that 23,000 emergency department visits and more than 2,000 hospitalizations are attributed to adverse events related to dietary supplements on an annual basis.
As we explain in our latest Rogue Rx Activity Report, dietary supplements are regulated differently than drugs; they are actually considered a subcategory of food under the Dietary Supplement Health and Education Act of 1994. For this reason, manufacturers are supposed to ensure the product’s safety and proper labeling before it goes on sale – and many companies do this. It’s a relatively small number of bad actors that endanger patient safety.
FDA works hard to educate consumers about the need for caution when using dietary supplements, but the agency needs help with this daunting task. That’s why, in recent months, NABP has stepped up our educational efforts to inform pharmacists of this pressing issue, and we encourage you to use these resources so you can pass this knowledge on to your patients:
- Our Rogue Rx Activity Report titled “Risky Dietary Supplements: How Pharmacists Can Help Protect Patients”
- A webinar that we held on the subject that is available for CPE credit.
Additionally, potentially dangerous products can be reported using FDA’s Safety Reporting Portal or by calling FDA’s hotline at (800) FDA-1088. FDA’s tainted products database is another useful tool.
We hope these resources help you in educating your patients, family, and friends. And as always, we appreciate all you do to keep your patients safe.