Wednesday, March 31, 2010

FDA and Dietary Supplements

I have received a few questions on the difference between "food grade" and "Pharmaceutical grade" supplements, and the FDA's role in regulating these. Pharmaceutical grade products are drug products, manufactured under Good Manufacturing Practices (GMP) and tested for purity, potency and dissolution among other factors.  Pharmaceutical grade products will received a USP certification.   

USP Verified pharmaceutical ingredients are also issued a USP Certificate of Standards Compliance–currently the highest quality and most comprehensive verification on the market.  USP certifications have the assurance that the ingredients are consistent in quality from batch to batch; meet label claims for strength, purity and quality; and are manufactured under the important GMP for Drug substances and excipients.   

FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter).  Note:  Conventional Foods are also referred to as "food grade" in the industry. 

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Note: This say’s “SAFE” as opposed to ensuring that “Potency, Purity and Bioavailability“ is achieved.

FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Note: After it reaches the market or after the consumer has taken it.

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading. Note: No assurance that label claims are correct.

FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising. Note: “Voluntary Reporting”.

*Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA.

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