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FDA Clarifies Situations When Tobacco Considered Drug or Device
January 6, 2017 |FDA

The Food and Drug Administration is issuing a final rule (here) to clarify when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said. Under the final rule, 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,” FDA said. “The final rule also clarifies remaining circumstances where a product is subject to regulation as a tobacco product,” it said.

FDA Issues Draft Guidance on Nutrition Facts Label Changes
January 4, 2017 |FDA

The Food and Drug Administration on Jan. 4 issued two draft guidance documents to assist industry in complying with upcoming changes to nutrition facts labels, it said (here). One of the draft guidance documents (here) “answers questions related to compliance, labeling of added sugars, rounding as it relates to the declaration of quantitative amounts of vitamins and minerals, and label format,” FDA said. The other (here) includes examples of food products included in tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established by FDA. Compliance with changes to nutrition facts labeling, set by two final rules issued in May 2016 (see 1605200021), is required by July 2018, except for small businesses, which will have until July 2019 to comply, FDA said. Comments on the two draft guidance are due March 6, the agency said (here) and (here).

FDA Accepting Comments on Prior Notice for Imported Foods
January 4, 2017 |FDA

The Food and Drug Administration will accept comments until March 6 on information collected through its prior notice requirements for imported food, it said (here). Federal agencies are required to allow comments on each new information collection and extension of existing collections, and obtain approval from the Office of Management and Budget. FDA estimates 10 minutes per new prior notice submission through the Automated Broker Interface and 23 minutes for each new submission via the FDA Prior Notice System Interface, 15 minutes for each cancellation of a prior notice in both systems, and one to eight hours for prior notice requests for review and post-hold submissions, for a total of 2,907,576 burden hours. FDA seeks comments on whether the information collection is necessary; the accuracy of the agency’s burden estimate; ways to enhance the quality, utility and clarity of the information collected; and ways to minimize the burden of the information collection.