FDA Announces Interim Rule to Prevent BSE in Foods, Supplements

WASHINGTON--The Food and Drug Administration (FDA) released an interim final rule prohibiting the use of certain cattle-derived materials in food, dietary supplements and cosmetics in a move to strengthen safeguards against transmission of bovine spongiform encephalopathy (BSE, or "mad cow" disease). The Department of Health and Human Services (HHS) announced in January plans to release an interim rule, as well as take further measures to ensure the protection of the U.S. food supply. (For details on that announcement, visit www.naturalproductsinsider.com/hotnews/41h27161717.html.)

FDA's interim final rule, which is effective immediately, prohibits the use of high-risk materials known to contain infectious prions: the agents responsible for BSE transmission. Among the banned materials are the brain, skull, eyes and spinal cord from all cattle over 30 months of age, and any material from "downer" cattle, material from cattle not approved for human consumption and mechanically separated beef.

Products covered by the interim rule include food ingredients (including GRAS [generally recognized as safe] items), food additives, prepared foods, infant formula, cosmetics and dietary supplements. Regarding dietary supplements, FDA said in a consumer fact sheet, "Most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30 months of age and, because of their age, present little risk of being BSE-positive." FDA also specifically mentioned the broader issue of animal-derived ingredients in dietary supplements, and noted it plans to reply to comments on this topic in its final dietary supplement cGMP (good manufacturing practice) rule.

FDA will take comments on the rule through early October; comments should references Docket No. 2004N-0081 and can be submitted electronically at www.regulations.gov or www.fda.gov/dockets/ecomments.

Additional federal actions were taken on the BSE issue, including a request for public comment on additional preventive actions that may be taken by FDA, HHS and the U.S. Department of Agriculture (USDA); and a proposed FDA rule on recordkeeping requirements for the FDA interim final rule.