As noted in previous articles (see May 2008 issue of GXP LifeLine for example), the primary purpose of the final FDA Rule on Dietary Supplements (21 CFR Part 111) is to assure that current good manufacturing practices (cGMP) are followed and documented. The final FDA Rule on Dietary Supplements does not require manufacturers of dietary supplements to test their products before they are marketed.
Some manufacturers of dietary supplements, however, choose to test their products, or to contract out this function to an independent laboratory. Among the benefits of taking this extra step to assure quality are that it safeguards a manufacturer's reputation and brand, and raises consumer confidence. In particular, a company that contracts out its testing to an independent laboratory is allowed to display the lab's seal of approval or "verified" mark on the labels of products that pass the lab’s testing procedures.
U.S. Pharmacopeia (USP)
The U.S. Pharmacopeia's "USP verified" mark is probably the most familiar laboratory cachet. U.S. Pharmacopeia verifies the identity, strength, purity, and quality of dietary supplement finished products, dietary supplement ingredients, and pharmaceutical ingredients. Products and ingredients that pass all U.S. Pharmacopeia verification requirements--which, in addition to product and ingredient testing, include a GMP audit and a manufacturing documentation review--are awarded use of the distinctive "USP Verified" mark. Participation is voluntary and available to manufacturers worldwide.
In addition, the U.S. Pharmacopeia Web site (usp.org) sells the USP Dietary Supplements Compendium (DSC), currently in its sixth edition, which is specifically developed for manufacturers, contract laboratories, and distributors of dietary supplements. According to the Web site, the USP DSC contains "the DSHEA standards and authoritative information needed to develop, manufacture, and test quality dietary supplement products". The compendium is available in English only and gets updated and published every two years.
The usp.org Web site also lists the manufacturers and brands of dietary supplements that are participating in the USP verified program. These include: Your Life® brand supplements (manufactured by Inverness Medical Innovations), Nature Made® brand supplements and Nature's Resource® brand herbal supplements (manufactured by Pharmavite LLC), Q-Gel® brand supplements (manufactured by Tishcon Corporation), Schiff® brand supplements (manufactured by Schiff Nutrition), and selected private-label brand supplements manufactured by various dietary supplement manufacturers. It is important to note that only the products that have actually been tested are awarded the USP verified mark, and that not necessarily every product from the manufacturers listed on the usp.org Web site has been tested. Interestingly, the U.S. Pharmacopeia has been in existence for close to 200 years.
Although relatively a newcomer to the realm of dietary supplement testing (ConsumerLab.com has been in existence only since 1999), the Internet company is fast becoming well known among consumers, largely through integrative and holistic, as well as alternative, healthcare practitioners. The reason is because ConsumerLab.com does not accept products directly from manufacturers, but instead buys them from retail stores, catalogs, online retailers, or multilevel marketing companies. ConsumerLab.com then contracts with independent laboratories to have the supplements tested by category, and makes the results of the tests available on their Web site to consumers. Consumers who don't wish to pay the fee of $29.95 per year to see full test results can get a truncated version. The criteria ConsumerLab.com uses to test products include identity, potency, purity, bioavailability, and consistency.
Manufacturers of products that pass ConsumerLab.com's testing can enroll in ConsumerLab.com's "CL Approved Quality Product Seal" licensing program, which allows them to add ConsumerLab.com's approval symbol (CL) to their product's label. ConsumerLab.com has all products retested every few years. For more information, see the review published in the Journal of the Medical Library Association.
Sharon Phillips is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).