DSHEA Sheds Little Light On Distinguishing Old From New Ingredients
This article was originally published in The Tan Sheet
Former Senate staffer Patricia Knight, who helped write DSHEA, says her “one regret” about the act passed in 1994 is “something we left out, how to prove, how to lock in what was on the market.” There is just no way for the FDA to figure out what was on the market then,” she says.
You may also be interested in...
On behalf of the FTC, DoJ alleges Bayer violated a 2007 settlement to substantiate supplement claims and asks a court to require the firm to provide two RCTs for dietary supplement claims for Phillips’ Colon Health. Trade groups rally behind the firm, arguing the requirement is unfair and illegal.
Pharma firms’ introduction and wide promotion of Rx drugs containing EPA or DHA acids and aimed at improving cardiovascular health were expected to boost omega-3 supplement sales, but negative research results reported over the past year could diminish consumers’ regard for the nutrients’ benefits.
Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.