Heart disease health claim for omega-3 fatty acids allowed
In response to a court decision, the Food and Drug Administration on Oct. 31 allowed a qualified health claim for EPA and DHA omega-3 fatty acids in dietary supplements, even though it did not meet the “significant scientific agreement” standard previously established for such claims. The claim states, “The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids may or may not have on risk of CHD in the general population.” The claim may be used in labeling dietary supplements, provided that they do not recommend daily intakes exceeding 2 g of EPA and DHA omega-3 fatty acids.
Dietary supplement disclaimer exemption requested
Hyman Phelps & McNamara, the American Herbal Products Association, the Council for Responsible Nutrition, and the Consumer Healthcare Products Association have asked FDA to allow dietary supplements to make claims about effects on the structure or function of the body that are derived from nutritive value, without being subject to the disclaimer and notification requirements of the Federal Food, Drug, and Cosmetic Act. Deadline for comments is Dec. 22. Details are in the Federal Register of Oct. 23 (65 FR 63256–63257). For more information, contact R.R. Kane at FDA, 200 C St., S.W.,Washington, DC 20204 (phone 202-205-4168).
Data on potential allergenicity of StarLink corn submitted
The Environmental Protection Agency has announced that Aventis CropScience has submitted new information in support of its petition for an exemption from the requirement of a tolerance for the genetically engineered “plant-pesticide’’ materials in StarLink genetically modified corn. These materials are the Bacillus thuringiensis subsp. tolworthi Cry9C protein and the DNA necessary for its production. While the original petition requested an exemption covering both the Cry9C DNA and Cry9C protein in all food commodities, this submission limits the request only to foods made from StarLink corn, specifically addressing the potential allergenicity of the Cry9C protein that may be present in food made from the corn. Details are in the Federal Register of Oct. 31 (65 FR 65245–65251). For more information, contact P. Lewis at EPA, 1200 Pennsylvania Ave., N.W., Washington, DC 20460 (phone 703-305-5369).
Irradiation of seeds for sprouting approved
FDA is allowing use of ionizing radiation at levels up to 8 kGy to control microbial pathogens in seeds for sprouting, in response to a petition filed by Caudill Seed Co., Inc. Sprouts grown from seeds that have been irradiated need not be labeled as treated by irradiation, if the sprouts themselves have not been irradiated. Details are in the Federal Register of Oct. 30 (65 FR 64605–64607). For more information, contact L.A. Highbarger at FDA, 200 C St., S.W., Washington, DC 20204 (phone 202-418-3032).
Emulsifier okayed for use in cream liqueurs
FDA is allowing use of sodium stearoyl lactylate as an emulsifier, stabilizer, and texturizer in cream liqueur drinks at no more than 0.5% by weight, in response to a petition filed by the American Ingredients Co. Details are in the Federal Register of Oct. 13 (65 FR 60858–60859). For more information, contact M.E. LaVecchia at FDA, 200 C St., S.W., Washington, DC 20204 (phone 202-418-3047).
Polydextrose okayed for use in tablespreads
FDA is allowing use of 5–12% polydextrose as a bulking agent and/or texturizer in tablespreads, in response to a petition filed by Pfizer, Inc. (now Danisco Cultor America, Inc.). Polydextrose is intended to replace fully caloric ingredients and to produce reducedor lower-calorie and/or lower-fat tablespreads. Details are in the Federal Register of Oct. 30 (65 FR 64604–64605). For more information, contact R.M. Angeles at 200 C St., S.W., Washington, DC 20204 (phone 202-418-3107).
Performance standards for slaughter plants published
USDA’s Food Safety and Inspection Service has published the performance standards for food safety and non-food safety conditions that it will apply in a limited number of young turkey and market hog slaughter plants that participate in the HACCP-based Inspection Models Project (HIMP). Under HIMP, FSIS has developed new inspection models for pilot testing in a limited number of plants slaughtering young, healthy, and uniform animals. With these models, FSIS designs HACCP-based slaughter inspection procedures, and plants develop appropriate controls for meeting FSIS requirements. Details are in the Federal Register of Nov. 2 (65 FR 65828–65829). For more information, contact M. Grasso at FSIS, Washington, DC 20250 (phone 202 205-0025).
Chocolate additive petition withdrawn
Fuji Oil Co., Ltd., has withdrawn its petition asking FDA to affirm that use of a triglyceride containing behenic and oleic acids is generally recognized as safe as a tempering aid and as an antibloom agent in chocolate and chocolate coatings. Details are in the Federal Register of October 13 (65 FR 60968–60969). For more information, contact P.M. Yasaei at FDA, 200 C St., S.W., Washington, DC 20204 (phone 202-418-3023).
by NEIL H. MERMELSTEIN