On June 22, 2007, the US Food and Drug Administration (FDA) announced publication of its final rules for Good Manufacturing Practices (GMPs) for dietary supplements (DS). This event originated in 1994 when Congress passed the Dietary Supplement Health and Education Act (DSHEA) which authorized FDA to produce new GMPs for DS. Industry groups offered guidance to FDA in 1997, and much later in 2003, FDA published proposed rules for public comment. The revision then sat at the White House Office of Management and Budget for several years, possibly due to concerns about the impact on small businesses. During this time, industry, Congress, and others pressured for the publication of GMPs.
Mounting public concerns over food safety, evidenced in the recent scandal over melamine-adulterated Chinese wheat gluten discovered in pet foods, probably increased pressure on FDA to release the GMPs, even though the melamine issue pertains to conventional foods and not directly to DS.
The new GMPs cover rules for handling, processing, labeling, and storing ingredients and DS products, which includes quality control, standardized operating procedures, record-keeping, qualifications for technical personnel, handling customer complaints, etc. FDA also published a proposed interim rule on whether companies should be required to test 100% of all ingredients for identity or whether the frequency of such testing can be reduced, depending on whether certain other requirements are met. Public comment on this proposal is due September 24, 2007.
Manufacturers will have 1-3 years to comply with the GMPs: 1 year for companies over 500 employees, 2 years for companies with less than 500 (the size of most), and 3 years for companies with 20 or less. The GMPs will not apply to licensed practitioners who compound and dispense DS preparations within a clinical practice, nor do they pertain to retail establishments.
The new rules will probably have minimal impact on the many responsible and foresighted manufacturers of DS that anticipated the eventual publication of new GMPs. These manufacturers have invested millions of dollars over the past decade creating or expanding in-house laboratories, hiring the qualified technical personnel needed for testing both the ingredients and the final products produced in their facilities, and instituting newly enhanced procedures and record-keeping necessary to ensure product quality. Some companies have contracted with qualified third-party testing laboratories to perform these quality-control functions. Despite these voluntary steps, the new GMPs may require some revisions to record-keeping procedures for these companies.
The new rules do not require compliance by producers of raw materials (including herb extracts) that are sold as dietary ingredients (DI) for finished DS products. This remains potentially problematic. In the past, the herb industry has witnessed numerous cases of misidentified and/or contaminated ingredients. Requiring that the DI processors meet GMP requirements would help reduce quality control problems, although presumably such problems will be detected by the manufacturer of the finished DS products, who will bear the full onus of ensuring the accurate identity and quality of ingredients. FDA may have determined that it simply does not have the resources and ability to inspect facilities in other countries that produce imported DIs.
Another area in which these GMPs are not as stringent as some might prefer is their lack of requirement of the use of validated analytical methods for testing DIs and DS. Instead of requiring consensually validated test methods, which DSHEA does not authorize the FDA to do, each manufacturer and/or laboratory must determine what may be a “scientifically valid” test method. Some experts emphasize that any test method, whether externally validated or not, must still be subjected to in-house validation procedures by each laboratory. While this provides more flexibility, there are concerns that this will perpetuate the use of inappropriate and inadequate test methods, possibly resulting in “laboratory confirmation” of adulterated and/or otherwise poor quality ingredients—a problem that currently exists, and which may continue.
Hopefully, all members of the DS industry will comply with, and the FDA will rigorously enforce, these new GMPs, and quality problems—whether accidental or intentional—will cease. Ultimately, this entire process is designed to help consumers choose DS products with the confidence that packages contain what the labels claim, free of contaminants and adulterated ingredients.
In the long-run, GMP rules may help to “level the playing field” with respect to the manufacture of finished herb products by requiring quality requirements and procedures. Nevertheless, compliance with the new GMP is not a substitute for high quality herbal ingredients. The old Zenith radio and television slogan, “The quality goes in before the name goes on,” still applies to herbal products. -Mark Blumenthal