- Does not have to prove a supplement is safe (drug manufacturers do).
- Does not have to prove a supplement works (drug manufacturers must prove efficacy).
- Does not have to prove the quality of a supplement (does not have to prove that the content matches that declared on the label).
Echinacea and Truth in Labeling, Archives of Internal Medicine, 2003
In this study, 59 single-herb preparations of Echinacea were analyzed:
- 6 (10%) contained no measurable Echinacea.
- Only 31 (52%) contained what was listed on the label.
- 12 (20%) had no expiration date.
- Only 4 (7%) met all 4 of the FDA's labeling requirements. 1
- And when it came to the word "standardized":
"Claims of standardization by the manufacturer did not indicate that the preparation reliably contained the labeled amount or even the labeled species."
The US Pharmacopeia invites supplement manufacturers to voluntarily comply with testing of samples and to participate in postmarketing product surveillance in return for certification. (See here for some companies that participate.) In the above study, USP weight standards for Echinacea were used by 5 (8%) of the samples. However, "none of those products had content consistent with their labeling."