FDA Issues New Guidance on Deeming Regulations

NATO outlines FDA’s three-month enforcement extension on deeming compliance deadlines.

The U.S. Food and Drug Administration (FDA) has released a guidance document as a follow up to the agency’s announcement last week to further explain the three-month extension of many deeming regulation future compliance deadlines for cigars, pipe tobacco, e-cigarettes, vapor products, hookah tobacco, and nicotine gels, the National Association of Tobacco Outlets (NATO) reported.

This three-month enforcement extension also includes the deadline for the new nicotine-warning requirement for roll-your-own cigarette tobacco. All of the regulation deadlines originally scheduled as of May 10, 2017 or later are extended three months.

The three-month extension does not apply to deadlines under the deeming regulations that have already passed, such as mandatory minimum age to purchase and photo-ID checking requirements to prevent the sale of tobacco to underage persons.

NATO outlined a list of the new deadline compliance dates for the respective FDA deeming regulations:

Deadline of Aug. 10, 2017
The filing of cigar warning plans on how warnings will be randomly displayed and distributed on packages and rotated on advertisements.

Deadline of Sept. 30, 2017
The filing of a registration application by companies engaged in the manufacture, preparation, compounding, of processing of a tobacco product, plus a list of products manufactured. Retailers that blend different pipe tobaccos, roll their own cigars for sale, or mix e-liquids are classified as a manufacturer and need to file a registration application and product list with the FDA by this Sept. 30, 2017 extended deadline.

Deadline of Nov. 8, 2017
The filing of substantial equivalency exemption requests by manufacturers.

Deadline of May 8, 2018
The filing of substantial equivalency applications by manufacturers.

Deadline of Aug. 10, 2018
Manufacturers, importers, and distributors, plus retailers that create their own advertisements for roll-your-own tobacco, must include on packages and in advertisements for roll-your-own tobacco the statement: “Warning: This product contains nicotine. Nicotine is an addictive chemical.”

Deadline of Nov. 8, 2018
The filing of pre-market tobacco applications by manufacturers.




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