Under the 2007 supplement Good Manufacturing Practices (“GMP”) final rule, as well as the pending Food Safety Modernization Act regulations, supplement companies must set out specifications to identify an ingredient’s source and lifecycle.  Industry has struggled to comply with the GMPs in this area.  Since April 15, 2013, FDA has issued at least six Warning Letters to companies for failing to establish and test product and ingredient specifications.  These firms either failed to implement any procedures to identify the ingredients in their products, or FDA found that their specifications were wanting.

Daniel Fabricant, the director of FDA’s Division of Dietary Supplement Programs, has asserted that GMP compliance remains FDA’s top priority in the supplement realm.  FDA is sure to continue to hammer home GMP compliance during its inspections, and companies with inadequate specifications in place should expect to be cited.

If you have any questions about FDA’s GMPs, or any concerns about complying with federal and state supplement regulations, feel free to call us any time at 516-294-0300.

We extend our thanks to “The Tan Sheet” (September 23, 2013) for contributing to the content for this post.