FDA issues manufacturing standards for dietary supplements
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PRWire – The U.S. Food and Drug Administration (FDA) today released its long-awaited final regulation on good manufacturing practices (GMPs) for dietary supplements.
The rule, according to the FDA, will ensure that “dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.”
“We think the final regulation is strong, but more reasonable than the proposed version. It offers a more flexible framework in meeting standards, such as testing and facility design. This will help smaller companies control costs — costs that would have been be passed along to the consumer — while still maintaining quality standards,” said David Seckman, executive director and CEO of the Natural Products Association.
“At 800-plus pages we’ll need to take a longer, more careful look at this document to fully determine its impact on the industry and consumers, but it appears that FDA took some of our concerns into account.”
The regulations establish controls throughout the manufacturing process, including packaging, labeling, and storing, to ensure quality and purity standards are met. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.
“With heightened consumer concern over the safety of food ingredients, particularly those coming from overseas, this new regulation should help to increase consumer confidence in the dietary supplement products they buy,” said Seckman. “Consumers want to be assured that what’s on the label is in the bottle — nothing more, nothing less — and this regulation aims to make sure that is the case.”
The regulation released today will be officially published in the Federal Register next week. In addition to the final regulation on good manufacturing practices, the agency also issued an “interim final rule” for identity testing that will allow the public and others to comment.
Information about both the final GMP regulation and interim final rule can be found on the FDA Web site.
The Natural Products Association is the industry leader in self-regulation, having established its own GMP certification program for dietary supplements in 1999. This program is based upon third party inspections of manufacturing facilities to determine whether specified performance standards are being met. These standards include many of the same specifications seen in the final regulation.
The Natural Products Association is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. The association represents nearly 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids.