Supplements Derived From Elk, Deer Exposed To CWD Due For Rulemaking
This article was originally published in The Tan Sheet
Executive Summary
FDA will issue a proposed rule prohibiting use of dietary supplements and cosmetics derived from animals exposed to chronic wasting disease on a date "to be determined," according to the agency's "unified agenda" published in the May 14 Federal Register.
|
FDA will issue a proposed rule prohibiting use of dietary supplements and cosmetics derived from animals exposed to chronic wasting disease on a date "to be determined," according to the agency's "unified agenda" published in the May 14 Federal Register. The proposal will require products derived from any part of cervids, such as deer and elk, not enter into commerce until scientific evidence indicates they do not present a public health threat. A proposed reg restricting the use of materials derived from ruminant animals born, raised or slaughtered in countries where bovine spongiform encephalopathy exists is tentatively slated for October release. FDA already has recommended supplement firms not use such materials. BSE is one of the agency's top priorities; FDA is making available research funds for detection of BSE in end products (1 (Also see "Dietary Supplement, Foods BSE Detection Research Funds Announced By FDA" - Pink Sheet, 28 May, 2001.)). The "unified agenda" also lists a June publication of the long-awaited proposed rule on dietary supplement good manufacturing practices, which was delayed earlier this year due to the Bush administration transition. A final rule amending regulations governing 180-day generic drug exclusivity for ANDA sponsors is scheduled for November; the rule will clarify existing eligibility requirements and conditions. The Aug. 6, 1999 proposed rule suggested a 180-day "triggering period" during which an applicant's marketing exclusivity must be started by one of two events: the commercial marketing of the product or a favorable court decision regarding the applicable patent (2 (Also see "180-Day Exclusivity Must Begin Within 180-Day "Triggering Period" - FDA" - Pink Sheet, 9 Aug, 1999.)). FDA additionally plans to amend its administrative regulations to state that written information being considered at an advisory committee meeting be made available for public disclosure before or at the time of the meeting. The agency originally published a proposed rule and direct final rule Jan. 8, but withdrew the direct final rule after Public Citizen objected, requesting instead that materials be made available more than 24 hours before a meeting. The agency noted it will consider Public Citizen's comments before issuing a final rule, which is slated for September release. Upcoming regulatory actions for various OTC monographs include an advance notice of proposed rulemaking for sunscreen products containing insect repellant, slated for August, and a proposed rule for sunscreen products with UVA/UVB protection, planned for September. A proposed rule amending the topical antifungals monograph to include clotrimazole 1% will publish in the Federal Register May 29 (3 (Also see "Schering-Plough Lotrimin AF Ingredient Monograph Status Granted" - Pink Sheet, 28 May, 2001.)). Another proposal, for ingrown toenail relief products, is targeted for December, as is final action on an amendment to the warning section of the cough/cold antitussive monograph. |