FDA issues manufacturing standards for dietary supplements
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.
It’s official: Tea recognized as health product in Canada
Tea Assn press release - Health Canada’s Natural Health Products Directorate (NHPD) has deemed tea to be a natural health product and has officially recognized tea for its role in maintaining good health.
After a period of extensive review, the NHPD has approved three health claims for tea. All types of tea infusions (black, green and oolong) are recognized as a source of antioxidants for the maintenance of good health. tea is approved for increasing alertness. And tea is further accredited as helping to maintain and/or support cardiovascular health. Read more
FDA plans stricter regulations for alternative medicines
Insight Journal - The FDA is proposing stricter regulations for herbs, vitamins, vegetable juices and even “devices” such as massage oils, massage rocks, and acupuncture needles under a new guidance document up for review.
Complementary and Alternative Medicines are defined by NCCAM (the National Center for Complimentary and Alternative Medicine, a branch of the National Institutes of Health) as any medical practices that are distinctly different from those used in “conventional” or “allopathic” medicine generally practiced in the United States. It’s a very broad definition, encompassing such practices as acupuncture, massage therapy, herbal supplementation, and aromatherapy.
According to the document produced by the FDA, use of CAM therapies has risen substantially over the last few years, with one third of adults reporting using some form of CAM in the last year. Interestingly, the docket also reports that visits to CAM practitioners outnumber visits to primary care physicians each year.
The FDA claims that their regulations are simply a “guidance” as to what constitutes regulated CAM items. The CAM community disagrees. They see the defining of regulated items as an attempt to control the use of CAM within the United States—and possibly incorporate CAM devices and medicines into what some refer to as “Big Pharma,” the pharmaceutical industry.
The guidance document essentially defines any item used to treat, mitigate, cure or prevent a disease as regulated by the FDA. This means that if someone claims their vegetable juice helps cure cancer, the FDA then has the right to regulate that vegetable juice as a drug. It also means that if someone is using massage rocks as part of their therapy for a disease or disorder, those massage rocks are regulated as medical devices.
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