Association requests clarification on the Interim Final Rule (IFR) Exemption Petitions for reduced identity testing under the dietary supplement cGMPs
October 25, 2007 (Washington D.C.): The Natural Products Association submitted comments to the U.S. Food and Drug Administration (FDA) surrounding the use of, and forthcoming guidance regarding the Interim Final Rule (IFR) regarding the Interim Final Rule (IFR) as it relates to the ds cGMPs.
“Submitting a petition to request an exemption from 100 percent identity testing of a dietary ingredient is not something that should be taken lightly, nor should such exemption be granted without exhaustive demonstration of both the supplier’s or vendor’s and manufacturer’s quality system. Specifically, knowledge of a given firm’s operating procedures could be used to provide such assurances comparable to 100 percent identity testing.” said Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs at the association. “To that end, we believe that a consistent definition and goal of identity testing is critical to any guidance on the IFR. This will ensure that the burden required to use the petition process is well understood,” said Fabricant.
The Natural Products Association asks that any future guidance regarding the IFR on identity include the minimum ingredient identity characteristics and parameters that the agency believes must be addressed and monitored in the petition process, the degree of variability in these areas the FDA considers acceptable, and which systems used to determine this variability are viable. While the association recognizes that developing such a system would be generally prohibitive for most of the industry to use, the association believes there are favorable models for petitioning for an exemption that warrant the agency’s consideration for any future guidance.
The complete comments submitted by the Natural Products Association to the FDA can be found at www.naturalproductsassoc.org/IFR_Comments. For further clarification on the comments or the new GMP rules, contact Daniel Fabricant, Ph.D. at (202) 223-0101 ext. 102 or [email protected].
About The Natural Products Association
The Natural Products Association (www.NaturalProductsAssoc.org) is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. The association represents more than 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids.