Guest guest Posted April 19, 2004 Report Share Posted April 19, 2004 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Honso USA, Inc. News Alert FDA News April 19 2004 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ -- " FDA is absolutely committed to protecting consumers " -- FDA expects to evaluate the available pharmacology, published literature... Acting FDA Commissioner Dr. Lester M. Crawford Outlines Science-Based Plan for Dietary Supplement Enforcement Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), today outlined the agency's science-based approach to protecting American consumers from unsafe dietary supplements. " FDA is absolutely committed to protecting consumers " ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Dr. Crawford said the agency would soon provide further details about its plan to ensure that the consumer protection provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) are used effectively and appropriately. Through DSHEA, which sets up a distinct regulatory framework for dietary supplement products, Congress attempted to strike a balance between providing consumers access to dietary supplements and giving FDA regulatory authority to act against supplements or supplement ingredients that present safety problems, are marketed with false or misleading claims, or are otherwise adulterated or misbranded. " FDA is absolutely committed to protecting consumers from misleading claims and unsafe products, " said Dr. Crawford. " Unlike most foods, some dietary supplements are pharmacologically active. And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose. " Read on... FDA expects to evaluate the available pharmacology, published literature... ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ To support its consumer protection actions, the agency is developing approaches to systematically review the evidence about the safety of individual dietary supplements. FDA expects to evaluate the available pharmacology, published literature (including animal, in vitro, epidemiological and clinical trial data) evidence- based reviews, and adverse event information -- the approach that formed the scientific foundation for FDA's recent rulemaking on ephedra. Supplement labels can make claims about the impact of a supplement on the structure or function of the body, but the claims must be truthful and not misleading. Two weeks ago, FDA sent warning letters to 16 firms to stop making false claims for weight loss. The FDA plans, in addition, to issue guidance on what data would substantiate such claims. Read on... Contact Information ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ email: info voice: 480-377-8787 web: http://www.honsousa.com ~~~~~~~~~~~~~~~~~~~~~~~~~~ Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.