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WASHINGTON — Rep. Dan Burton, R-Ind., last week introduced a bill — the Dietary Supplement Protection Act of 2011 — that would reclassify approximately 25,000 supplements launched between Oct. 15, 1994, and Jan. 1, 2007, as "grandfathered" supplements and not subject to proposed new dietary ingredient regulations.
The Food and Drug Administration recently issued draft guidance on NDIs suggesting that manufacturers would need both proof of prior marketing and proof that present-day manufacturing methods mirror those of manufacturing methods employed before Oct. 15, 1994.
"This standard could be difficult to meet for many dietary ingredients due to the lack of information on manufacturing methods used before the grandfather date," suggested a blog posted Wednesday on the FDA Law Blog site. "Moving the date for grandfather status to Jan. 1, 2007, would reduce the number of dietary ingredients for which the manufacturing method may have changed, and reduce the chance that industry no longer possesses information about the manufacturing method for a grandfathered dietary ingredient."
The bill (H.R. 3380) was referred to the House Committee on Energy and Commerce on Nov. 4.