James Giese

FDA to loosen health claim standards
On December 18, recently installed Food and Drug Administration Commissioner Mark McClellan announced a new initiative that will provide consumers with improved nutrition information about foods and dietary supplements. The new initiative will require only that a “weight of the evidence” must exist in the scientific community to allow qualified health claims made on food and dietary supplement labels. FDA currently permits such claims for dietary supplements under certain circumstances but not for conventional foods. FDA has posted its “Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements” online at www.cfsan.fda.gov/~dms/hclmgui2.html. Details are in the Federal Register of December 20 (67 FR 78002-78004). For more information, contact Kathleen Ellwood at FDA, 5100 Paint Branch Pkwy., College Park, MD 20740 (phone 301-436-1450).

FDA releases initial data on acrylamide in foods
On December 4, FDA released some preliminary data on acrylamide levels in a wide variety of food products. On April 24, 2002, researchers at the Swedish National Food Administration and Stockholm University reported finding the chemical acrylamide in a variety of fried and oven-baked foods. The initial Swedish research indicates that acrylamide formation is associated with high-temperature cooking processes for certain carbohydrate-rich foods. In response to concerns about the potential risk of foodborne acrylamide based on known toxicity of acrylamide at much higher doses than those seen in foods, FDA began to analyze a variety of U.S. food products for acrylamide. FDA’s action plan and full research agenda are presented at www.cfsan.fda.gov/~lrd/pestadd.html#acrylamide. This incomplete data set was released by FDA to inform the public of FDA’s progress and to help stimulate research into the formation of acrylamide in foods. For the listing of exploratory data on acrylamide in foods, see www.cfsan.fda.gov/~dms/acrydata.html.

EPA to list requirements for food-contact sanitizers
The Environmental Protection Agency is taking adding a new section to CFR Part 180, which lists the pesticide chemicals that are exempt from the requirement of a tolerance when used in food-contact-surface sanitizing solutions. Until recently, FDA regulated these solutions under Section 409 of the Federal Food, Drug, and Cosmetic Act. EPA will now regulate the pesticide uses of these chemical substances under Section 408 of the act, and FDA will continue to regulate any indirect food additive uses of these chemical substances under Section 409. Details are in the Federal Register of December 3 (67 FR 71847-71861).

FDA issues guide on insect filth in food
FDA announced the availability of a compliance policy guide entitled “Filth from Insects, Rodents, and Other Pests in Food,’’ which revises and clarifies existing guidance on the interpretation of filth in foods within the context of current science. Details are in the Federal Register of December 2 (67 FR 71576-71577). For more information, contact Nina Adler at FDA, 5600 Fishers Ln., Rockville, MD 20857 (phone 301-827-0417).

FDA rules on D-tagatose and dental caries claim
FDA is amending the regulation authorizing a health claim on sugar alcohols and dental caries to include the sugar D-tagatose, a novel food ingredient. Similar to the sugar alcohols currently listed in Section 101.80 (21 CFR 101.80), D-tagatose is a carbohydrate sweetener that is slowly fermented by oral microorganisms, thus producing less acid than more-fermentable carbohydrates. In response to a petition filed by Arla Foods Ingredients amba, FDA has concluded that D-tagatose does not promote dental caries and is amending the health claim to include D-tagatose. Details are in the Federal Register of December 2 (67 FR 71461-71470). For more information, contact James Hoadley at FDA, 5100 Paint Branch Pkwy., College Park, MD 20740-3835 (phone 301-436-1450).

FDA posts pet food manufacture guide
FDA has announced the availability of a draft guidance for industry that provides specific information on the manufacture and labeling of foods that contain raw meat, or other raw animal tissues, for consumption by dogs, cats, other companion or pet animals, and captive noncompanion animal carnivores and omnivores. Details are in the Federal Register of December 18 (67 FR 77500-77501).

by JAMES GIESE
Internet Editor