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Dietary supplement health claims being reconsidered
The Food and Drug Administration, in accordance with an appeals court ruling, has revoked its regulations in which the agency stated its decision not to authorize health claims for four substance-disease relationships: dietary fiber and cancer, antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart disease, and the claim that 0.8 mg of folate in dietary supplement form is more effective in reducing the risk of neural tube defects than a lower amount in conventional food. The agency is reconsidering these claims and has modified how it will handle these and future health claim petitions for dietary supplements. Details are in the Federal Register of Oct. 3 and 6 (65 FR 58917-58918 and 59855-59857). For more information, contact J.E. Hoadley at FDA, 200 C St., S.W., Washington, DC 20204 (phone 202-205-5372).
Deadline extended for comments on use of “fresh” labeling
FDA has extended until Nov. 20 the deadline for comments regarding use of the term “fresh” for foods processed with alternative nonthermal technologies such as high-pressure processing, pulsed electric field, pulsed light, submerged arc, and filtration. Details are in the Federal Register of Sept. 20 (65 FR 56835-56836). For more information, contact G.A. June at FDA, 200 C St. SW., Washington, DC 20204 (phone 202-205-4168).
FDA’s view on genetically engineered foods upheld by court
On Sept. 29, a District Court dismissed a challenge to FDA’s regulatory policies concerning genetically engineered foods. The Alliance for Bio-Integrity and other public interest and religious groups had made allegations about the legality of FDA’s 1992 policy statement, “Foods Derived from New Plant Varieties.” The court agreed with FDA’s view that genetically engineered foods as a class do not require premarket review and approval of a food additive petition. It also accepted FDA’s view that special labeling for genetically engineered foods as a class is not required solely because of consumer demand or because of the process used to develop them.
Approval of ozone as an antimicrobial agent requested
The Electric Power Research Institute Agriculture and Food Technology Alliance has asked FDA to allow use of ozone in gaseous and aqueous phases as an antimicrobial agent for the treatment, storage, and processing of foods. Details are in the Federal Register of Sept. 13 (65 FR 55264). For more information, contact R.L. Martin at FDA, 200 C St., S.W., Washington, DC 20204 (phone 202-418-3074).
Sharing of proprietary information during recalls proposed
USDA’s Food Safety and Inspection Service is proposing to amend its regulations to share certain proprietary information with state and other federal agencies when a recall of meat, poultry, or egg products is being conducted, without having to disclose the information to the public under the Freedom of Information Act. Agencies receiving the information would agree in writing not to disclose proprietary information without the company’s written permission or written confirmation from FSIS. Deadline for comments is Nov. 20. Details are in the Federal Register of Sept. 19 (65 FR 56503-56505). For more information, contact C. Gioglio at USDA/FSIS, 1400 Independence Ave., S.W., Washington, DC 20250 (phone 202-690-6389).
Part of dimethyl dicarbonate petition withdrawn
FDA has clarified that Bayer Co.’s petition asking FDA to provide for a more descriptive term for dimethyl dicarbonate (DMDC) than “inhibitor of yeast” will also involve adding related limitations. Bayer has withdrawn the part of its petition that asks FDA to allow use of DMDC in noncarbonated juice beverages. Details are in the Federal Register of Sept. 27 (65 FR 58091-58092). For more information, contact M.D. Peiperl at FDA, 200 C St., S.W., Washington, DC 20204 (phone 202-418-3077).
Caprenin petition withdrawn
The Procter & Gamble Co. has withdrawn its petition asking FDA to affirm that caprenin, a triglyceride derived from the esterification of glycerol with capric, caprylic, and behenic acids, is generally recognized as safe for use as a confectionery fat in soft candy and confectionery coatings. Details are in the Federal Register of Sept. 18 (65 FR 56315-56316). For more information, contact P.M. Gaynor at FDA, 200 C St., S.W., Washington, DC 20204 (phone 202-418-3079).
Microbial criteria committee renewed
FSIS has announced that the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is being renewed in cooperation with the U.S. Dept. of Health and Human Services. The committee is charged with advising and providing recommendations on the development of microbiological criteria by which the safety and wholesomeness of food can be assessed, including criteria for microorganisms that indicate whether foods have been adequately and appropriately processed. Details are in the Federal Register of Sept. 15 (65 FR 55936). For more information, contact C. Maczka, at USDA/FSIS, 901 D St., S.W., Washington, DC 20024 (phone 202-690-6540).
by NEIL H. MERMELSTEIN