Monday, April 30, 2012

FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers

FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers | Eye on FDA:

"10 Count ‘em 10.

That is how many Warning Letters the agency sent out last Friday to manufacturers and distributors of dietary supplements.  The specific focus of the letters was products that were being marketed containing dimethylamylamine, also known as DMAA, sold as a “natural stimulant”.

The list contains 10 different manufacturers covering 15 separate products.

The specific violation cited in the letters was that current law states that when supplements contain dietary ingredients not marketed before October 15, 1994, manufacturers must submit the new ingredient for use as a New Dietary Ingredient, notifying FDA of evidence that supports a conclusion that use is safe.  The agency said in the letters that this requirement had not been met."

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1 comment:

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