New FDA GMP Guidance Offers Clarity to Small Firms

December 18, 2010

FDA yesterday issued a guidance aimed at helping small businesses understand the dietary supplements Current Good Manufacturing Practices (GMP).

FDA yesterday issued guidance geared at helping small businesses understand the dietary supplements Current Good Manufacturing Practices (GMP) regulations.

Notably, it addresses an interim provision FDA had included in the final dietary supplements GMPs that outlined procedures for small firms to request an exemption from conducting “at least one appropriate test or examination to verify the identity of any dietary ingredient that is a component of a dietary supplement.”

In compliance with section 212 of the Small Business Regulatory Enforcement Act, the new guidance, partially titled the Small Entity Compliance Guide (SEGC), outlines GMP regulations for small companies, including the interim testing-exemption provision. FDA is now accepting guidance comments and petitions.

Small companies, considered those with fewer than 20 full-time employees, have been required to comply with the dietary supplement GMPs as of June 25 of this year.

FDA also noted that the guidance does not reflect a petition submitted by the American Herbal Products Association (AHPA) when the dietary supplements GMP final rule was issued. AHPA’s petition requests that certain provisions of the final rule be reconsidered. FDA says it is still considering the petition and that the new SEGC guidance does not represent a response to AHPA’s petition.