Omega-3 claims petition
This article was originally published in The Tan Sheet
Executive Summary
FDA has filed health claim petition "for conventional foods and dietary supplements relating consumption of omega-3 fatty acids...to reduced risk of coronary heart disease," agency states in Sept. 3 letter to Washington, D.C. law firm Emord & Associates. Emord submitted petition June 23 on behalf of Wellness Lifestyles, Inc., and Life Extension Foundation Buyers Club (1"The Tan Sheet" June 30, 2003, p. 11). Petition is posted on FDA 2website, with open comment period until Nov. 2. Agency will notify petitioners of final decision by April 15, 2004...
You may also be interested in...
Omega-3/Heart Disease Amended Health Claim Without Disclaimer Proposed
FDA should amend the approved health claim linking omega-3 fatty acids to a reduced risk of coronary heart disease by removing the disclaimer and extending the claim to foods, supplement industry members maintain in a June 23 petition
EU’s Unitary SPC System Must Maximize Access To Medicines & Not Block Generic Entry
A European Parliament committee says that some aspects of the EU’s proposed unitary supplementary protection certificate scheme could promote access to cheaper off-patent medicines while others could delay generic competition.
Warning Letters And Close-Outs – September 2023
It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.