CONCERNED BY WEAKNESSES IN FDA'S NEW RULES FOR DIETARY SUPPLEMENTS, CONSUMERLAB.COM ACTS TO "RAISE THE BAR ON QUALITY"
WHITE PLAINS, NEW YORK — July 17, 2007 — Disappointed by the lack of quality standards within the FDA's newly released Good Manufacturing Practices (GMPs) for dietary supplements, ConsumerLab.com has announced two initiatives today intended to "raise the bar on quality." The first is the publication of a free online index to ConsumerLab.com's highly regarded testing methods and standards covering the top categories of supplements. The second is a new testing program designed to help companies more economically meet new GMP testing requirements while applying CL's rigorous methods and standards.
"Unfortunately, it is possible for a company to manufacture a 'bad' supplement under the new 'good' manufacturing practices," said Tod Cooperman, MD, President of ConsumerLab.com. "The GMPs require manufacturers to test all ingredients going into supplements, but fail to specify the methods and standards by which ingredients are to be judged," he added. He noted, for example, that the GMPs do not set limits on the amounts of lead or other contaminants that can occur in supplements. Contamination is a well-known problem with some herbal and mineral supplements. The GMPs permit these limits to be determined by individual manufacturers. Similarly, manufacturers are left to choose the appropriate methods and standards for judging the identity of ingredients. Unfortunately, ConsumerLab.com has seen many instances in which manufacturers choose non-specific testing methods that are easily tricked and allow the production of supplements of low quality or with very little real ingredient.
Access to ConsumerLab.com's Methods and Standards
Since ConsumerLab.com's founding in 1999, Dr. William Obermeyer, ConsumerLab.com's Vice President for Research and a former FDA natural products chemist, has established rigorous testing methods and standards for each of more than 50 popular categories of dietary supplements that ConsumerLab.com evaluates. Meeting these standards earns a product a place on ConsumerLab.com's Approved Quality product listings. With the GMPs devoid of such standards, ConsumerLab.com today published an index to its methods and standards free to the industry, academia, and the public at www.consumerlab.com/methods_index.asp. ConsumerLab.com hopes that the index will guide manufacturers interested in producing high quality supplements. This information also continues to be available within each Product Review.
Affordable GMP Testing for Top Quality Manufacturers: The CL-cGMP Verified Ingredient Testing Program
Under the GMPs each manufacturer must demonstrate that 100% of its ingredients are tested. However, rather than multiple manufacturers each testing the same ingredient lot from a supplier, it is more economical and efficient for an expert, third party organization to work with the ingredient supplier and oversee the proper testing of each lot once, eliminating the burden on the individual manufacturer. With this in mind, CL has created the new "CL-cGMP Verified Ingredient Testing Program," designed to ensure the highest quality ingredients at an affordable price. The following are attributes of the new program:
- Certifies that each lot of an ingredient meets the cGMP testing requirement with ConsumerLab.com's scientifically valid testing methods and high standards.
- Provides finished product manufacturers with FDA-ready documentation of meeting cGMP testing requirements.
- Provides ingredient suppliers marketing advantage by offering "added value" ingredients that:
- Save customers time and money by relieving them of the cGMP testing and documentation burden.
- Meet ConsumerLab.com's high standards.
- Offers 24-hour online look up of verification certificates directly from the ConsumerLab.com website — giving manufactures the confidence of "true" verification while reducing paperwork.
- Extends a discount to manufacturers using CL-cGMP verified ingredients when participating in CL's finished product testing programs.
Companies interested in testing programs should contact Lisa Sabin, Vice President, for more information at firstname.lastname@example.org.
ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. The company is privately held and based in Westchester, New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.
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