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medpundit |
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Saturday, August 24, 2002Your recent quote crystallized the response that was needed on this issue. The quote claims: "... food supplements are unregulated ... " Bzzt. False. Bald faced lie. The actual law that applies to food supplements requires: 1.) Supplements must be safe, according to the same standards as are used for food. 2.) Claims for supplements must be accurate, e.g. "truth in advertising" 3.) Supplement packaging must be clearly different from drug packaging. The FDA is required to issue and enforce the regulations to make this law take effect. They have done issued regulations. Food supplements are regulated. Those who claim otherwise are using the big lie technique. Tell your lie loud enough and often enough and people will think it is true. I do not lie - not even under a mistake. My accuser is parsing terms. Herbal medicines are drugs. They aren’t food. They aren’t even vitamins. Yet, they aren’t subjected to the same regulatory standards that other drugs are. They aren’t even subjected to the same regulatory standards as other over the counter drugs. I stand by my statement that they aren’t regulated, although to be accurate I should have said "aren't regulated like the drugs they are". Here’s how the FDA describes their oversight duties when it comes to herbal medicines: FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising. In contrast, other drugs have to prove their safety and their efficacy before being brought to market. Even when problems come to light, the FDA has trouble tracking down the reports,as in the recent ephedra case: The FDA has long sought the records as part of its probe of ephedra, which has been linked to dozens of deaths. Three weeks ago, the FDA asked the Justice Department to pursue a criminal investigation - one Justice lawyers themselves had been urging. "Metabolife has refused and resisted us at every step of the way," Crawford said. "News that so many reports exist greatly heightens our concern." Allowing drugs to come to market without scrutinizing them or even inspecting them for safety, and reserving the prerogative of inspection only after damage has been done is hardly “regulation”. posted by Sydney on 8/24/2002 07:20:00 AM 0 comments 0 Comments: |
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