FDA Publishes Final Rule on GMP Requirements for Dietary Supplements

The FDA issued the long-anticipated final rule on current good manufacturing practices (cGMP) for dietary supplements, as well as a companion interim final rule for exemptions to aspects of the new regulation.

Last year Congress revised the Dietary Supplement Health and Education Act, sponsored by Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa). It requires manufacturers of dietary supplements to collect consumer product complaints and submit all serious adverse events in patients taking supplements to the FDA.

The new regulation calls for manufacturers to evaluate the identity, purity, strength and composition of their products and gives the FDA the authority to declare nonconforming supplements as adulterated or misbranded, the agency said.

“The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling,” the FDA said.

In a companion interim final rule, the agency outlines a petition process whereby manufacturers may be exempted from the 100 percent identity testing cGMP requirements for ingredients used in the processing of supplements, the FDA said.

If a manufacturer can demonstrate with sufficient documentation that less frequent testing would still ensure product identity, then an exemption may be obtained.

The final cGMP and interim final rule take effect Aug. 24. The FDA is adopting a three-year phased implementation of the regulation. Manufacturers with more than 500 employees must comply by June 2008 while those with fewer than 500 employees have until June 2009. Companies with fewer than 20 employees have until 2010 to implement the cGMP requirements.