FDA Cracks Down on Dietary Supplements

Yesterday, Dr. Scott Gottlieb, the Food and Drug Administration’s Commissioner, announced a new plan to crack down on dietary supplement makers who claim their products can prevent, treat or cure certain diseases. Gottlieb revealed the FDA sent twelve warning letters and five advisory letters to companies whose products are being illegally marketed as unapproved new drugs and claiming they prevent, cure or treat Alzheimers, diabetes, cancer and other diseases.

In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), which gave the Food and Drug Administration (FDA) the power to regulate dietary supplements, the dietary supplement market has grown from a $4 billion industry to a $40 billion industry with as many as 50-80,000 different products. It’s estimated that nearly 75-80% of adult Americans take dietary supplements.

A large part of the DSHEA is to regulate the manufacturing and labeling of dietary supplements. However, as the warning and advisory letters point out, some companies market, distribute and sell potentially dangerous drugs or make unproven or misleading claims about the health benefits of their products.

Ultimately the FDA’s wants to ensure (1) consumers have continued ‘access to safe, well-manufactured and appropriately labeled products’ and (2) crack down on adulterated and misbranded products, especially those with drug ingredients not listed on their labels and misleading claims.