Date: Sep 01, 2007
The Food and Drug Administration (FDA) has published its long-awaited final regulation describing the current good manufacturing practice (cGMP) requirements for the manufacture, packaging, labeling or holding of dietary supplements. The final rule largely tracks the proposal the FDA issued in 2003 (68 Federal Register, 12158, Mar. 13, 2003), although the requirements have been modified in several respects.
Once implemented, the cGMP requirements are intended to address improper packaging and the use of incorrect labeling, in addition to product quality issues such as subpotency; superpotency; contamination with filth, bacteria, microorganisms or drug ingredients; variation in tablet size or color; and mis-filled containers.
One important change is that the final cGMP regulations apply only to domestic and foreign parties that manufacture, package, label or hold finished dietary supplements. Producers of dietary ingredients are not subject to these requirements (unlike in the FDA's 2003 proposal), although the agency states that they are still subject to general "food" GMP requirements. However, since supplement manufacturers will be required to maintain more detailed information establishing the quality of the component material they use, suppliers of components to finished dietary supplement manufacturers may face additional demands from their customers with respect to quality control information, recordkeeping and the like.
For purposes of the final rule, a "component" means "any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement." (New 21 CFR part 111.3; 72 Federal Register 34944). This term includes dietary ingredients and other ingredients intended to be present in the finished dietary supplement. The FDA did not intend for the term "component" to include things like packaging materials, although the agency recognized that the term may be confusing, noting in response to one comment, that "[t]here may be differences in how components are referred to by certain manufacturers and how we refer to it in this final rule," (72 Federal Register, 34795).
In the packaging area, the cGMPs require firms to establish and follow written procedures with respect to packaging and labeling operations. They must also take the steps necessary to determine whether the packaging to be used for dietary supplements meets specifications to ensure continuing quality and potency of the dietary supplement.
Although the final regulation officially took effect on Aug. 24, 2007, the FDA established a phase-in schedule for compliance with the new provisions, based on the size of the dietary supplement company. Companies with 500 or more full-time employees must comply by June 25, 2008, companies with 20 to 499 employees by June 25, 2009, and companies with fewer than 20 employees have until June 25, 2010 to comply.
Overall, the dietary supplement cGMPs are expected to be viewed as a positive development for the industry, leading to greater consumer confidence in the quality of these products.
George Misko, partner at respected law firm Keller & Heckman, has been a featured columnist in FOOD&DRUG packaging since January 1994. Address comments or questions to him at 202-434-4170 or email@example.com
Used with permission. Copyright FOOD & DRUG PACKAGING, September, 2007.