In the National Association of Boards of Pharmacy® (NABP®) January 2021 Rogue Rx Activity Report, the association focuses on the risk of tainted dietary supplements to consumers. The report, titled Risky Dietary Supplements: How Pharmacists Can Help Protect Patients, explores adulterated dietary supplements that enter the marketplace and how pharmacists are well-positioned to provide consumers with information regarding the risks associated with these supplements.
Since the mid-1990s, the United States dietary supplement market has grown tenfold to a $40 billion industry with at least 50,000 products available for sale. The report explains that many consumers believe Food and Drug Administration (FDA) verifies the safety of supplements prior to sale, but that is not the case. Because supplements fall under the subcategory of food, FDA regulates these products after they enter the marketplace and have been sold to consumers. Unfortunately, this gap provides an opportunity for actors to illegally sell misbranded and adulterated dietary supplements.
Illegal dietary supplements can be:
- contaminated with undeclared active pharmaceutical ingredients,
- loaded with declared adulterants, such as amphetamine derivatives, steroids, or untested new drugs, and/or
- falsely marketed with claims to treat diseases.
The report references one US study that estimates 23,000 emergency department visits and 2,000 hospitalizations per year are due to adverse events related to misbranded dietary supplements. According to a 2019 study by The Pew Charitable Trusts, 70% of Americans have used dietary supplements in the past two years. Therefore, the need to provide resources to patients continues to grow.
According to the report, to keep consumers apprised of safety issues regarding adulterated and misbranded supplements, FDA publishes important alerts, issues warning letters, and oversees recalls. They also maintain an online tainted dietary supplements database for consumers’ reference. In some cases, FDA collaborates with the Department of Justice and other federal agencies to pursue criminal penalties. Although rarely used, FDA can also issue a regulatory ban on an ingredient.
Pharmacists play a critical role in protecting consumers from dangerous supplements. NABP supports increased education for pharmacists about misbranded and adulterated dietary supplements in addition to counseling for patients regarding the safety concerns associated with these products. To hear from regulatory experts about the dietary supplement landscape, register for NABP’s webinar, Dietary Supplement Regulation: Separating Fact From Fiction, hosted on January 20. Read the full report and learn more about rogue dietary supplements and how pharmacists can protect public health by visiting the Reports section of www.nabp.pharmacy.