Dietary supplements are used by more than 180 million Americans each day, and it is up to the Food and Drug Administration (FDA) to ensure they do not cause harm. But this can be challenging since the FDA’s authority to regulate dietary supplements is vastly different than the agency’s authority to regulate pharmaceutical agents and medical devices. It is a daunting process with more than 85,000 dietary supplements on the market.
In 1994, the Dietary Supplement Health and Education Act made dietary supplement manufacturers responsible for ensuring that their products were safe. Under this law, manufacturers do not need FDA approval before marketing their dietary supplements. It is the FDA’s job to prove that a supplement is not safe before any action can be taken.
In 2013, the FDA had a case that highlighted the agency’s limited authority to regulate dietary supplements but also illustrated the promise of new enforcement tools provided by the FDA Food Safety Modernization Act (FSMA).
At the time, dozens of people were being diagnosed with acute liver failure or non-viral hepatitis so severe that some needed liver transplants. One person died. Most of those who became ill had been healthy prior to their diagnosis.
The illnesses were linked to certain OxyElite Pro dietary supplements made by Texas-based USPLabs. Certain OxyElite products as well as another product, VERSA-1, were found to contain a new dietary ingredient, aegeline, a synthetic version of an alkaloid that naturally grows in parts of Asia. The ingredient has not been shown to be safe for consumers.
USPLabs had been warned before by the FDA after selling a dietary supplement containing a new dietary ingredient called DMAA (dimethylamylamine). DMAA has been linked to more than 100 reports of illnesses including six deaths.
One exception to the Dietary Supplement Health and Education Act is that supplements that contain new dietary ingredients cannot be sold without prior approval from the FDA based on information that establishes the ingredient’s safety. USLPLabs failed to inform the FDA of its plans to include aegeline to its supplements, thus the agency was able to invoke new enforcement authorities to remove the product from the market. The agency also warned UPSLabs to stop distribution, which the company did, volunteering to destroy all lots of the product in its warehouse, which had an estimated value of $22 million.
The FDA’s battle against UPSLabs is just one in the fight against dangerous dietary supplements. Anyone who has taken a dietary or herbal supplement and suffered side effects should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.