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This is critical to maintaining access to high quality, natural food-supplements. A natural product, by definition, may not be patent-protected. Without the promise of the economic reward that follows successfully patenting a product, it is impossible to weather the new-drug approval process, which can literally cost hundreds of millions of dollars. Thus, if supplements were categorized as drugs and required to go through the new-drug approval process, we would see most of our supplements disappear.
It also outlines safety requirements for new dietary ingredients. Are Dietary Supplements Unregulated? Absolutely not! First, the FDA regulates product labeling. Whenever a marketer wants to make a claim about a supplement, it must submit the proposed claim to the FDA within 30 days after its first use. The FDA may stop the manufacturer from advertising the claim if it is deemed impermissible. In addition, the Federal Trade Commission maintains authority over supplement advertising: Manufacturers must report truthfully what their products contain and must have proof backing up any claims they make.
This is the same system of reporting used for FDA-approved drugs and biologics. This lack of full implementation has led to a perception among the public that dietary supplements are unregulated. First Name.
U.S. Food and Drug Administration
Background[ edit ] In the late s and early s, the American Congress was evaluating several bills which would have increased the powers of the FDA. One of these acts, the Nutrition Advertising Coordination Act of would have tightened the regulations regarding supplement labeling. In response to the proposed bill, many health food companies began lobbying the government to vote down the laws and told the public that the FDA would ban dietary supplements. On October 25, , President Bill Clinton signed the Act into law, saying that "After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.
Dietary Supplement Health and Education Act of 1994
¿Qué es la DSHEA?
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