Are dietary supplements regulated by the FDA?
Despite the media's perception of our industry, dietary supplements are regulated by the FDA. In fact, there are extensive FDA, FTC, and state regulations covering almost every aspect of the dietary vitamin and supplement manufacturing process – from the sourcing and composition of ingredients to the final packaging and other post-production finishing touches!
How does the FDA regulate dietary supplements?
Just like the "conventional" foods and the pharmaceutical industry, dietary supplements are regulated by broader, cross-industry regulations and a series of industry-specific regulations. Among those industry-specific regulations are:
- Dietary Supplement Health and Education Act (DSHEA)
- Several sections of Foods and Drugs Title 21
DSHEA is primarily responsible for establishing a specific definition for the term “dietary supplement," establishing dietary supplements as a food category, granting the FDA the authority to recognize new dietary ingredients (NDIs), removing products that have been deemed "unsafe" from the market, and taking action against misbranded or adulterated products.
Title 21, on the other hand, outlines the current good manufacturing practices (cGMPs) that dietary supplement companies and manufacturers must abide by.
Granted, as the regulations currently stand, it's not possible for a company or manufacturer to be "FDA approved" or "FDA certified."
Instead, several key components of a dietary supplement manufacturer's operation, including (but not limited to) the production facilities, machinery, standards of production, and storage spaces, must be recognized as FDA Dietary Supplement (DS) cGMP-certified by a reputable third-party (such as NSF).
