FDA Reopens Comments for Phytosterol Claims

WASHINGTONThe U.S. Food and Drug Administration (FDA) reopened its comment period for the proposed rule to amend regulations regarding phytosterols and risk of coronary heart disease (CHD) health claims and labeling.

The proposed rule was published in the Dec. 8, 2010 Federal register, but FDA received a comment on the phytosterols proposed rule by Venable LLP requesting an extension of the comment period until April 23, 2011, because the period of time allowed for comment did not provide enough time for them to collect, assess, and comment on the relevant data regarding the cholesterol-lowering efficacy of non-esterified phytosterols in dietary supplements.

Comments are due Oct. 25, 2011. Electronic comments can be submitted at www.regulations.gov. Written comments can be sent to the Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.