Dietary Supplement GMPs Finally Released

WASHINGTONThe Food and Drug Administration (FDA) released a final rule on current Good Manufacturing Practices (cGMPs) for dietary supplements, establishing requirements to ensure products are made in a consistent, quality manner and are accurately labeled and free from impurities. This much anticipated ruling applies to companies that manufacture, package or store dietary supplements; FDA management explained, for the most part, retailers are not included in this rule, while health care practitioners will be considered on a case-by-case basis. The final rule is effective August 24, 2007, but there is a 36-month phase-in period for companies to comply, depending on size.

The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling, said Robert E. Brackett, Ph.D., director of FDAs Center for Food Safety and Applied Nutrition.

Among the rules 800-plus pages of requirements, manufacturers will be compelled to evaluate the identity, purity, strength and composition of their dietary supplements. This helps to ensure finished products contain actual labeled contents, but not adulterants such as pesticides, bacteria or heavy metals. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products adulterated or misbranded.

The rule further contains requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product, as well as provisions for handling consumer product complaints and for recordkeepingincluding standard operating procedures (SOPs).

While the final rule specifically mandates 100-percent testing of ingredients, Brackett said those requirements are flexible to allow for ongoing improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements. He further noted the agency published an interim final rule on how manufacturers can petition FDA for an exemption to the cGMP requirement for 100-percent identity testing of specific ingredients used in the processing of dietary supplements. Though, he conceded FDA has no firm sense of what information or documentation will be adequate to qualify for reduced testing.

FDA stated there is an economic analysis section in the lengthy regulation, outlining the estimated costs companies of various sizes might incur in achieving compliance with the GMP rule. While set-up cost for very small (under $1 million annual revenues), small ($5 million to $10 million) and large companies ($10 million to $50 million) range from $20K to $31K, small companies are expected to have a significantly higher annual costs of compliance of $184Kdouble the estimated annual costs of $46K for very small and $69K for large companies.

FDA concedes the rule might raise the price of finished products, but argues the price increase, which will primarily be driven by large companies, may be much smaller than the increase in the average costs of very small producers. The rule further states: Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.

In announcing the publication of the final rule, FDA leaders reported intentions to conduct outreach programs to educate consumers and industry members, as well as FDA staff. The agency also stated enforcement of compliance with these GMPs will fall under the agencys normal program of facilities inspections and rule enforcement.

This rule helps ensure the quality of dietary supplements so that consumers can be confident the products they purchase contain what is on the label, said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.

While welcoming the long-overdue regulations, Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), noted the new rules will probably have minimal impact on many responsible and foresighted manufacturers of herbs and other dietary supplements. These companies, anticipating the eventual publication of these new rules, have invested millions of dollars over the past decade in creating in-house laboratories and hiring the qualified technical personnel needed for testing the ingredients and the final products produced in their facilities,  he said. Many have also instituted newly-enhanced procedures and record-keeping necessary for ensuring product quality the kinds of procedures that are presumably being required or suggested in the FDAs new rules.

For the FDA's Fact Sheet on both the Final GMP rule and the interim rule on testing, visit http://www.cfsan.fda.gov/~dms/dscgmps6.html.