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FDA Allows More Comments on Proposal to Disallow Soy Protein Health Claims on Food Labeling
January 12, 2018 |FDA

The Food and Drug Administration is extending until March 19 the period for comments on its proposal to revoke a regulation authorizing the use on food labeling of health claims that eating soy protein reduces the risk of heart disease. According to the agency’s proposed rule (see 1710310023), evidence has emerged since the health claim was authorized in 1998 that contradicts the finding that soy protein encourages heart health. If FDA finalizes its rule, it “intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease,” an FDA official said when the agency issued the proposal.

FDA Proposes Delay to Some Provisions of Rule on Regulation of Tobacco as Drug or Device
January 12, 2018 |FDA

The Food and Drug Administration is proposing to delay until further notice certain provisions of its final rule on when products made or derived from tobacco are subject to regulation as a drug, device or combination product. Under the final rule, issued Jan. 9, 2017, a product made or derived from tobacco is regulated as a drug, device or combination product: “(1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000" (see 1701060011). FDA's indefinite delay would apply to provisions describing the types of evidence that may be considered in determining a medical product’s intended uses, it said. The overall effective date of the final rule is already delayed until March 19, 2018 (see 1703170030). Comments are due Feb. 5.

FDA to Delay Enforcement of New UDI Labeling Requirements for Class I and Unclassified Devices
January 12, 2018 |FDA

The Food and Drug Administration is delaying enforcement for two years of unique device identifier (UDI) requirements on class I and unclassified medical devices, it said Jan. 12 in a guidance document. For class I and unclassified devices, FDA will not enforce UDI labeling, data submission and standard date format requirements until Sept. 24, 2020. UDI direct marking requirements for class I and unclassified devices intended to be used more than once and reprocessed between uses won’t be enforced until Sept. 24, 2022, FDA said. Compliance with these requirements had previously been required in 2018 and 2020, respectively, under FDA’s 2013 UDI final rule (see 13092020).