Pearson
This article was originally published in The Tan Sheet
Executive Summary
FDA postpones ruling on omega-3 fatty acids/coronary heart disease health claim until Oct. 31 and antioxidants/cancer claim until Nov. 30, agency informs Emord & Associates Oct. 24. Although mainly due to lack of resources and staffing, the delay of the omega-3 review also reflects the "new and complex issues raised by the use of a qualifier with a health claim," FDA says. For the antioxidants/cancer claim, the agency says it needs more time because the issue involves relationships between more than one nutrient and several types of cancer. FDA has acted on two Pearson claims, endorsing a qualified folic acid claim but denying the requested folic acid/NTD and fiber/colorectal cancer claims (1"The Tan Sheet" Oct. 16, pp. 3-4)
You may also be interested in...
Folic Acid Qualified Health Claims Based On IoM Findings Allowed By CFSAN
Dietary supplements may carry qualified health claims regarding the amount and sources of folic acid effective in reducing the risk of neural tube defects, FDA announces Oct. 10. The Center for Food Safety & Applied Nutrition's decision is in response to one of the four health claims at issue in the Pearson v. Shalala case.
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands