Key changes in regulation of supplements

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1990: The Nutrition Labeling and Education Act amends the Federal Food, Drug and Cosmetic Act to require that most foods, including dietary supplements, bear nutrition labeling.

1994: The Dietary Supplement Health and Education Act creates a new regulatory category, safety standards and other rules for dietary supplements. Under DSHEA, ingredients used before 1994 are presumed to be safe based on past use. If a manufacturer introduces an ingredient not used before 1994, it must file a notice with the FDA.

2002: The Bioterrorism Act requires food facilities, including dietary supplement manufacturers, to register their facilities with the FDA. They do not have to register their products.

2004: After a lengthy legal process, the stimulant and weight loss supplement ephedra is banned after thousands of adverse events, including several deaths.

2006: The Dietary Supplement and Non Prescription Drug Consumer Protection Act requires dietary supplement companies that receive a serious adverse event report to submit the information to the FDA.

2007: Good Manufacturing Practice regulations establish quality-control standards for dietary supplements. Companies had until 2010 to comply.

2009: FDA issues draft guidance to help clarify the difference between liquid dietary supplements and beverages. Historically, supplements could be packaged like conventional beverages as long as the label said "supplement." The new guidelines, not yet finalized, say the package can't resemble a food or be located in a store's food section.

2011: The FDA issues draft guidance on new dietary ingredients. Companies fear that instead of obtaining blanket clearance for a new ingredient they would have to get approval for every new product that contains it. There's also concern that previously grandfathered ingredients might be reclassified as new. The comment period for the guidance ends Oct. 3.

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