FDA’s Deeming Rule Takes Effect August 8

Agency is offering information about which provisions take effect immediately or in the near future.

August 01, 2016

WASHINGTON – The FDA’s final rule extending the agency’s regulatory authority to products such as e-cigarettes, cigars, hookah (waterpipe) and pipe tobacco, certain dissolvables, and nicotine gels, goes into effect on August 8, 2016. Some of the rule’s provisions that apply to retailers and manufacturers will take effect immediately on August 8, and others will take effect later.

Some information is particularly important for retailers, manufacturers, importers and distributors to know early on. For example, several provisions take effect on August 8 that restrict the sale of newly regulated tobacco products. Other provisions taking effect on or around that date relate to “modified risk tobacco products,” user fees associated with cigars and pipe tobacco, and the marketing of certain new products. Read more on the FDA’s website about the provisions taking effect in August.

The FDA’s Center for Tobacco Prevention (CTP) created flyers for retailers with information about product-specific regulations relating to the sale of tobacco products. The flyers can be downloaded or ordered through the FDA Center for Tobacco Products Publications Clearinghouse

CTP is offering information on compliance with the deeming rule. As the effective dates approach for various important provisions, CTP will provide information via email.

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