Seals of Approval: Part II
(6/30/03)- In a previous article, we described in detail the meaning of the USP "seal of approval" found on many products in the dietary-supplement industry. This approximately $20 billion industry is viewed by many consumer groups as an unregulated Wild West territory. A groundswell of investigative reporting coupled with the need to legitimize itself has resulted in the creation of certain industry standards by these manufacturers. To further compliment these standards, they have reached out to independent organizations for their seals of approval or certifications. Presently, we are aware of three other organizations, besides USP, competing to attest their "official" seals of approval. These are NSF International, ConsumerLab.com, and Good Housekeeping.
Basically these organizations are certifiers of "truth in labeling" standards. Most require the companies to pay for the stamp of approval. They determine that the ingredients listed on the label accurately reflect the contents of the pills in the bottle. This seal does not mean that the pill or supplement works or for that matter is safe. This means that the approval organizations do not test for any possible tainting effects or, for that matter, side effects of the pill. Nor do they check for dangerous contraindications with other products. Recently, ephedra was pulled from the market because of its side effects. Kava has had the same problem. St. John's wort efficacy has been challenged in many recent studies.
Research has indicated that U. S. Pharmacopeia (USP) has the most rigorous testing of the four. The USP seal tells the consumer that the product was manufactured in a clean, professional facility; the contents are accurately stated on the label; that it is free of common contaminants; and that it dissolves quickly enough in the stomach for the active ingredients to be absorbed by the body.
NSF International was started in 1944 by a group of University of Michigan professors concerned about standards in the food service industry. It certifies a wide range of products including bottled water, chicken-processing machinery and now dietary supplements. The chicken-processing industry has been under fire because of unclean conditions found in many plants. The Dept. of Agriculture does inspections of these plants, but the numbers of inspectors to carry out the surveys of these processing plants has decreased, in synch with federal policy (less federal governmental control) to rely on industry self regulation. NSF does follow-up on the products bearing its seal twice a year and looks at the manufacturing process annually. Manufacturers are given a year to clean up any deficiencies noted. Manufacturers of products approved by NSF pay for this privilege, suggestive that only the larger manufacturers could afford to seek this seal.
ConsumerLab.com was founded in 1999 by a former FDA chemist and a doctor. Since then, they have tested the most products and do independent testing of supplements without charging the manufacturers. If a company wants its product included in the testing, they can pay ConsumerLabs.com a sum of money ranging from $2500 to $4000. A company also pays to have the seal of approval of ConsumerLab.com placed on its product or to be mentioned in its advertising.
Good Housekeeping Institute, a research arm of Good Housekeeping magazine, requires companies to agree to buy advertising in their magazine to be considered for a seal of approval. They do ask for clinical trail studies that appeared in a peer-reviewed scientific journal as a back up for the claims the manufacturer makes about the product. This is their attempt to verify health claims made by the manufacturer of the product.
The question still remains whether, even with a seal of approval, the products efficacy and safety are warranted. Should they be subjected to the same rigorous clinical trails that prescription drugs must undertake before approval? This is a more complicated issue than it seems on the surface. Safety and efficacy as well as truth in advertising are of prime concern. Prescription drug manufacturers want a level playing field. They also want to protect their own products, maintain exclusive control over the drugs patents, thus discouraging competition. Who is willing to invest money in the rigorous testing process to prove the efficacy and safety of these supplements?
"Seals of approval" are a beginning if the testing is properly done and not linked to the deep pockets of the manufacturer. The four organizations mentioned above represent a start in achieving consumer protection.
Please see our earlier article on this topic:
The U.S. Pharmacopia (USP) and Medication Errors-Part I
Medication Errors: a Growing Problem
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Harold Rubin, MS, ABD, CRC, Guest Lecturer
posted June 30, 2003
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