FDA expands oversight of dietary supplements

Created date

March 25th, 2019
Senior Scams Prevention Act has been introduced in the Senate. If passed, the bill would create a federal advisory council to develop educational materials for retailers, financial institutions, and wire transfer companies.

Have you noticed how crowded the supplement aisle is at your local pharmacy? In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), which gave the Food and Drug Administration (FDA) the authority to regulate dietary supplements, the industry has seen tremendous growth. 

What was once a $4 billion a year industry is now a $40 billion industry comprised of over 50,000 different products.

While most supplements for sale are safe, not all of them are. FDA Commissioner Scott Gottlieb, M.D., thinks the time has come for the FDA to do more. “As the popularity of supplements has grown,” says Gottlieb, “so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”

Earlier this year, the FDA sent out 12 warning letters to companies accused of illegally selling unapproved and/or misbranded drugs that claim to prevent, treat, or cure Alzheimer’s disease and other serious diseases and health conditions.

Misleading, potentially dangerous

“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like Alzheimer’s,” says Gottlieb. “Alzheimer’s is a challenging disease that, unfortunately, has no cure. Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease or worse, as some fraudulent treatments can cause serious or even fatal injuries. Simply put, health fraud scams prey on vulnerable populations, waste money, and often delay proper medical care—and we will continue to take action to protect patients and caregivers from misleading, unproven products.”

Sadly, scammers aren’t just targeting Alzheimer’s patients. In the past five years, the FDA has sent similar letters to over 40 companies fraudulently marketing supplements purported to cure or treat cancer, opioid addiction, dementia, schizophrenia, and Parkinson’s disease.

While the FDA goes to work strengthening its oversight of health supplements, consumers are advised to stay vigilant. Before you pull a container of supplements from a store shelf or place an order on an e-commerce site, do some research. Ask your doctor if the supplement is safe and effective and make sure you are aware of any potential interactions that supplement may have with medications you already take.

If you do use a supplement and suffer an adverse reaction, the FDA wants to know about it. They ask consumers to report any adverse events including serious drug side effects and product quality problems. You can file a report by visiting www.accessdata.fda.gov/scripts/medwatch/.