The US Food and Drug Administration (FDA) has issued a draft
guidance document agency officials hope will clear up confusion over
when supplement manufacturers need to notify FDA about new ingredients.
Per a 1994 law, manufacturers must file a safety notification with FDA
before marketing dietary ingredients that were not on the market when
the law passed. However, in the 16 years since the law’s passage, FDA
reports receiving only about 700 such notifications, while agency
officials believe there are more than 55,000 dietary supplement
products. Supplement makers say they have struggled to determine which
products required a notice and what documentation was needed. FDA is
seeking public comment on the draft through 3 October 2011
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