Michael McGuffin, the president of the American Herbal Products Association (AHPA), tells Shane Starling why recently implemented adverse event reporting (AER) is delivering on its promise some three years down the line.
A new guidance manual targeting the US dietary supplement industry aims to help firms document their manufacturing processes to ensure they meet Food and Drug Administration requirements.
The adverse event reporting system for dietary supplements is an association system, not a cause and effect system, says trade group AHPA, stressing that high numbers of AERs linked to multivitamins does not mean the products are dangerous.
FDA has issued another draft guidance document on the labeling of dietary supplements to facilitate adverse event reporting, despite earlier calls from industry that the guidance should be withdrawn.