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FDA Rule Regulates Quality of Dietary Supplements

Healthnotes Newswire (July 5, 2007)—The US Food and Drug Administration (FDA) has announced that, rather than being regulated by the standards used in the food industry, manufacturers of vitamins, minerals, and herbs will now be held to standards more in step with the pharmaceutical industry. Many supplement manufacturers have created and kept high standards for their products and welcome the new FDA regulations, since they ensure that other companies that have been slow to adopt such practices will be held to equal standards.

Despite efforts by more responsible manufacturers, occasional findings of contaminated products, inaccurate labeling, improper packaging, and other irregularities have been reported, shaking consumer confidence. With the new ruling, the FDA will be able to routinely inspect the quality-control practices of supplement manufacturers, hold them to the new standards, and cite them if mislabeling or contamination is discovered.

Manufacturers will be required to routinely test their products’ identity, purity, strength, and ingredient content, and to follow up on consumer complaints. Many companies have and will continue to look for guidance on quality standards in manufacturing from the United States Pharmacopeia (USP), an independent nonprofit organization that sets standards for prescription medicines, over-the-counter medicines, dietary supplements, and other medical products.

“This regulation essentially raises the bar industry-wide for dietary supplement manufacturing standards,” said David Seckman, executive director and CEO of the Natural Products Association. “Although many manufacturers are already meeting these standards, they will now apply across the board. The good news for consumers is that they can have increased confidence in the quality and purity of the dietary supplements they buy.”

Seckman continued, “Consumers can have increased confidence that what’s on the label of a dietary supplement is in the product—nothing more, nothing less. With the recent heightened concerns about food safety, particularly those products made from ingredients from overseas, this regulation is very timely.”

Jane Hart, MD, board-certified in internal medicine, serves in a variety of professional roles including consultant, journalist, and educator. Dr. Hart, a Clinical Instructor at Case Medical School in Cleveland, Ohio, writes extensively about health and wellness and a variety of other topics for nationally recognized organizations, Web sites, and print publications. Sought out for her expertise in the areas of integrative and preventive medicine, she is frequently quoted by national and local media. Dr. Hart is a professional lecturer for healthcare professionals, consumers, and youth and is a regular corporate speaker.

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