In this issue: SPECIAL FOCUS: FDA Issues Draft Guidance Document on New Dietary Ingredient in Dietary Supplement; NAD Rules on “Fair Trade” Seals, Personal Care Products; $2.5M Settlement in Flash Cookies Lawsuit; Suit Filed Over Organic Personal Care Products; FDA Releases Images for Cigarette Packaging; and U.S. Supreme Court Tackles Use of Prescriber Data.
Excerpt from 'SPECIAL FOCUS:...'
On July 1, 2011, the Food and Drug Administration (FDA) released a highly anticipated draft guidance document on the use of new dietary ingredients in dietary supplements. While the document does not create new requirements, once finalized, it will represent a significant step forward in FDA’s efforts to fully implement the requirements of the 1994 Dietary Supplements Health & Education Act (DSHEA).
Under DSHEA, a new dietary ingredient (NDI) is an ingredient that was not marketed in the U.S. in or as a dietary supplement before October 15, 1994. If a dietary supplement contains an NDI, firms are required to notify FDA within 75 days of marketing it and provide information demonstrating that it is reasonably expected to be safe. The one statutory exception to that rule is a notification is not required if the NDI “is present in the food supply as an article used for food in a form in which the food has not been chemically altered.”
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