Collagen supplements are classified as dietary supplements by the U.S. Food and Drug Administration (FDA). The FDA does not approve dietary supplements for safety and effectiveness as they do with pharmaceutical drugs. Instead, manufacturers are responsible for ensuring that their products are safe and that claims about them are truthful and not misleading.

However, collagen and its preparations, such as hydrolyzed collagen, are generally recognized as safe by the FDA and can be sold as dietary supplements without pre-market approval¹². The FDA can take action against any dietary supplement that is unsafe or if the labeling is false and misleading.

For further details:

• The FDA's regulatory framework for dietary supplements is outlined under the Dietary Supplement Health and Education Act (DSHEA) of 1994³.
• A variety of collagen types, including Type II collagen commonly used in joint health supplements, have also been explored and recognized for their safe use⁴.

Footnotes

1. FDA collagen classification ↩

2. Safety evaluation of hydrolyzed collagen ↩

3. FDA regulations on dietary supplements ↩

4. Collagen in dietary supplements ↩