New FDA Documents on Cough/Cold Products and Annual Reporting

The Food and Drug Administration recently released two documents of interest to manufacturers and distributors of homeopathic drugs. The first is a “consumer update” concerning the use of cough/cold products in young children. It specifically calls attention to the fact that homeopathic products have never been reviewed by the agency for safety and efficacy. The second document discussed a new requirement for reporting annual manufacturing data by all drug manufacturers.

Association Counsel, Al Lorman, provides background information on the documents as well as the context of how they can impact your product marketing and labeling. Read the member’s only memo here. The AAHP Board is planning two informational sessions to help members further delve into the ramifications (and implementation of the Annual Reporting requirement) in the coming weeks. Details of these two sessions are being finalized; watch your email for notice of the day and time of each, and be sure to sign up to get the most complete information available to AAHP.