Jun
15
Dietary Supplement Verification Programs
Filed Under Dietary Supplements | Comments Off
Three organizations analyze dietary supplements to ensure safety, the U.S. Pharmacopeia (USP), ConsumerLab.com, and the Natural Products Association (NPA).
The USP is an independent, nonprofit organization that establishes standards for all prescription and over-the-counter drugs, dietary supplements, and other healthcare products manufactured in the United States, such as medical devices. Founded in 1820, the USP is recognized by federal law as the official body that sets standards for drugs and dietary supplements. The USP aims to improve public health by ensuring the high quality of drugs and dietary supplements by setting high standards and working with various entities, including manufacturers and healthcare providers, to meet those standards.
While drug manufacturers must comply with USP standards, manufacturers of dietary supplements voluntarily participate in the relatively new USP verification program (launched in October 2001), which consists of independent, third-party testing and evaluation of ingredients used in dietary supplements and the finished products. The USP verification program for dietary supplements is based on the use of current good manufacturing practices.
The USP also created a mark that can be placed on packaging of products that meet their specific standards. The USP mark tells you that the product contains tested and verified ingredients and final product and that manufacturing processes meet established standards. Dietary supplements bearing the USP mark contain the ingredients stated on the label; contain the ingredients in the amounts stated on the label; will be metabolized to release the nutrients for absorption in the body; have been screened for harmful levels of contaminants, including pesticides, bacteria, and heavy metals; and have been manufactured using safe, sanitary, and controlled procedures.
The USP currently verifies vitamin and mineral supplements and is in the process of continually adding similar information for herbal, botanical, and other dietary supplements. The USP web site (http://www.usp.org) provides detailed information regarding the exact brands and specific types of dietary supplements that have been evaluated and meet USP standards for purity, dissolution, and manufacturing. There is also a directory of where such dietary supplements can be purchased. For a list of current USP-verified dietary supplement manufacturers and brands.
ConsumerLab.com conducts independent product reviews of multiple brands of dietary supplements claiming to contain the same key ingredient (such as Gingko biloba). These product reviews are conducted every 24 to 36 months for each product category and include the results of blinded tests performed by academic and commercial labs that Consumer-Lab.com selects. Results are posted on their web site (http://www.ConsumerLab.com) for online subscribers, and free general information is also available. By paying a testing fee, dietary supplement manufacturers and distributors may choose to participate in the Voluntary Certification Program of ConsumerLab.com. Brands that meet the standards for identity, strength, purity, and pill disintegration are posted on the ConsumerLab.com web site and may be licensed to carry the Approved Quality Products Seal. In order to continue to carry the seal, those products must be retested every 12 months to ensure consistency. The seal indicates that a product meets recognized standards of quality, contains the quantity of ingredients stated on the label, is free of contaminants, and breaks apart properly so that it can be absorbed.
The NPA (www.naturalproductassoc.org), formerly known as the National Nutritional Foods Association, is a nonprofit organization that protects consumers and manufacturers by ensuring product quality and label integrity in the dietary supplement industry. The NPA modeled its own Good Manufacturing Practices Certification Program after the GMPs recommended by members of the dietary supplement industry in 1997. This program consists of random third-party inspections of members’ manufacturing facilities to determine whether they meet specifications for staff training, cleanliness, equipment maintenance, record keeping, and handling of raw materials. The NPA’s TruLabel Program randomly tests members’ products for “label integrity” to ensure that the product contents are as listed. Members of the NPA that manufacture dietary supplements under their own label have been required to participate in this program since 1990.
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