Until recently, government regulation and consumer protection were quite limited for dietary supplements. However, new rules noted by the Federal Food, Drug, and Cosmetic Act give the Food and Drug Administration (FDA), the federal agency responsible for regulating the safety of food and drug products, the authority to oversee the production of local and imported dietary supplements, including herbal treatments. Dietary supplements don't need to go through the rigorous review process that new drugs must undergo before being "approved" by the FDA. However, the new regulations aim to enhance consumer safety by requiring supplement manufacturers to follow certain manufacturing practices and ensure that supplements contain what their labels claim, and are free of contaminants. The FDA is responsible for monitoring the safety of herbal treatments after they're on the market and enforce punitive action against violators that sell unsafe supplements. These new regulations will be phased in over a three-year period so that by June, 2010, all supplement manufacturers should meet these requirements. "No approved Therapeutic Claims": What It Truly Means
The proliferation of food and herbal supplements, which are being advertised and passed on as effective cure-all products, despite the fact that these have no established therapeutic effects, is a major problem for regulatory health agencies. To the common consumer, the phrase "No Approved Therapeutic Claims", would generally mean that a supplement has not yet been determined by the FDA to be as safe and effective as advertised. It could also mean that no studies and long-term research have yet been done to determine the efficacy of the pill, or herb in actually treating anything. This phrase usually serves as a disclaimer of sorts. The Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed by US Congress to ensure consumers' rights to access safe and effective dietary supplements. This law gave the FDA the mandate to strictly monitor this sector, and ensure the products were safe and made in a consistent manner. The FDA also passed rules to require "Adverse Event Reporting", which requires herbal medicine producers to track safety data, as well as ensure good manufacturing practices. This also means that the herbal products must be made to standardized quality to ensure that consumers are getting good-quality and safe products.
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The Food and Drug Administration (FDA) warns the public to be cautious in taking foods or dietary supplements for curing purposes as it has no approved therapeutic effects. This applies to testimonials given by certain individuals with or without the consent of food manufacturers, importers or distributors promoting or advertising said product. The FDA labeling regulation under Bereau Circular No. 02 s. 1999 requires the declaration of the statement “NO APPROVED THERAPEUTIC CLAIMS” on the label of all food and dietary supplement as a means to inform the consumers that food and dietary supplement has no...