Trade associations ask FDA for exemptions in 100 percent identity testing
suppliers the possibility of exempting their customers from 100
percent identity testing under what is to be the final rule on Good
Manufacturing Practices.
The FDA (US Food & Drug Administration) published the final rule on Good Manufacturing Practices, known as GMPs, in June. The soon-to-be-implemented GMP legislation forms part of the 1994 Dietary Supplements Health and Education Act (DSHEA) and is set to provide standards specific to the industry for inspectors to check for purity, safety and legality in manufacturing. Both the Natural Products Association (NPA) and the American Herbal Products Association (AHPA) find fault with the fact that under the current GMPs, only supplement manufacturers, but not ingredient suppliers, can submit petitions for exemptions from 100 percent identity testing. The associations say they agree with the stipulation for identity testing, but maintain there are cases in which alternative testing methods should be permitted or where overlapping has occurred. However, they underscore they are not suggesting cutting corners. "We want the testing to be as stringent as 100 percent identity testing," Daniel Fabricant, vice president scientific & regulatory affairs with Natural Products Association, told NutraIngredients-USA. Fabricant addressed a letter on behalf of NPA to Jeffrey Shuren - the assistant commissioner for policy - dated October 24, 2007. In it, Fabricant explains: "We do not believe submitting a petition to request an exemption from 100 percent identity testing of a dietary ingredient is something that should be taken lightly, nor should such exemption be granted without exhaustive demonstration of both the supplier's/vendor's and manufacturer's quality system, specifically that knowledge of a given firm's operating procedures could be used to provide such assurances comparable to 100 percent identity testing." Examples of cases in which exemptions ought to be given, according to NPA and AHPA, are those in which ingredient suppliers or distributors only produce one ingredient, or in which suppliers and distributors occupy the same facility. "Importantly, AHPA supports FDA's position that petitions for exemptions to 100 percent identity testing should only be granted when the described alternative identity testing ensures that there is no reduction in the degree of certainty of an ingredient's identity," said AHPA president Michael McGuffin. The effective date of the interim GMP rule is August 24, 2007. FDA is making allowances for small businesses by giving them extra time to comply. As such, there is a three-year phase-in for small businesses. Those companies with more than 500 employees will have until June 2008 to comply, while those companies with less than 500 employees have until June 2009 to comply. Finally, those with fewer than 20 employees have until June 2010 to comply with the regulations. The trade associations have highlighted cost restrictions as an important factor in identity testing and the implications it could have on smaller businesses.
