Despite complexities, industry committed to FDA compliance

Despite complexities, industry committed to FDA compliance

Jan. 4 USA Today article on the changing regulations for manufacturers of herbal products sparked a letter to the editor from AHPA. 

A Jan. 4 USA Today article on the changing regulations for manufacturers of herbal products ("FDA tells herbal supplement maker to play by new rules"), sparked a letter to the editor from the American Herbal Products Association (AHPA) to emphasize that despite the complexities of current good manufacturing practice (cGMP) regulations, companies that manufacture and market herbal supplements are committed to compliance with all rules.

The letter states that FDA's cGMP rule is a tough regulation and is particularly difficult for small companies to comply. The cGMP requirements also changed the way that herbal experts need to verify the identity of their ingredients and products. 

In spite of these difficulties and changes, all companies that manufacture and market herbal supplements must comply with the rule. In order to do so, the expertise of an herbalist who is responsible for identifying the herbs used in production and the tinctures and extracts made from these herbs must be supported with adequate training records, and the tests used to verify identity must be documented as adequate. 

The letter concludes that the traditional ways in which a trained herbalist identifies a plant are not obsolete. Taste, smell, color, shape and other physical characteristics can still be used to verify an herb's identity. What's changed is that herbalists now need to have documentation to convince an FDA inspector that they know what they are doing.

 

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