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FDA Extends Period for Comments on Limit for Carcinogen in Smokeless Tobacco
March 21, 2017 |FDA

The Food and Drug Administration is extending until July 10 the period for comments on its proposal to establish a limit on N-nitrosonornicotine (NNN) in finished smokeless tobacco products, it said (here). The proposed limit would apply to smokeless tobacco products manufactured, imported, distributed or sold beginning three years after the publication date of the final rule (see 1701200031). Comments were originally due April 10.

FDA Adds Functionality in ACE ABI for Product Code Builder
March 21, 2017 |FDA

The Food and Drug Administration recently deployed a web service that will allow importers and customs brokers to access FDA’s product code builder database through the ACE Automated Broker Interface (ABI), CBP said in a CSMS message (here). The product code builder application program interface released March 20 will allow software developers to build a user interface for the product code builder in ABI, FDA said (here). “This does not replace the current online Product Code Builder but compliments it by providing trade a method to program existing software to query and verify FDA Product Codes,” it said.

FDA Delays Effective Date of Final Rule on When Tobacco Considered Drug or Device
March 17, 2017 |FDA

The Food and Drug Administration is delaying the effective date of a final rule that clarified when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said (here). Under the final rule, issued Jan. 9, 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). Originally effective March 21, 2017, the final rule will now take effect March 19, 2018, FDA said. The agency will take the extra time to consider a petition from industry, including by seeking more comments on the final rule, it said.

FDA Issues Draft List of Class II Devices Exempt From Premarket Notification Requirements
March 17, 2017 |FDA

The Food and Drug Administration recently asked for comments on a proposed list (here) of class II medical devices that will be exempt from premarket notification requirements once the list is finalized. The 21st Century Cures Act, enacted in December, requires FDA to publish the final list by 210 days after enactment and then every five years. Comments on the draft list are due May 15.