FDA Deeming Requirements – New Resources Available

FDA Deeming Requirements - New Resources Available

FDA Deeming Requirements – New Resources Available

FDA Announcement

Dear Tribal Stakeholders,

The U.S. Food and Drug Administration (FDA) is announcing a final rule entitled, “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” (“deeming rule”). The final rule was published in the Federal Register on May 10, 2016, 81 FR 28973. A Dear Tribal Leader Letter (PDF) was also sent on May 10th, notifying Tribes.

The final rule, among other things:

	•		Extends FDA’s “tobacco product” authorities to all other categories of tobacco products meeting the statutory definition of “tobacco product” in the Federal Food, Drug and Cosmetic Act, except accessories of such products;
	•		Prohibits the sale of “covered tobacco products” to individuals under the age of 18;
	•		Prohibits vending machine sales (except in facilities that prohibit individuals under the age of 18 years from entering at any time); and
	•		Requires the display of health warnings on “covered tobacco products,” cigarette tobacco, and roll-your-own tobacco (RYO tobacco) packages and advertisements.

“Covered tobacco products” are all deemed products except components or parts that are not made or derived from tobacco. These newly regulated products include currently marketed products, such as electronic cigarettes, cigars, pipe tobacco, and waterpipe (hookah) tobacco, and future tobacco products.

To assist the newly-regulated tobacco industry in complying with the deeming requirements, FDA has begun posting webinars to the CTP website. You can also view the Notice to Industry letter (PDF) for more detailed information.

A chart of Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products has also been posted. A web version of the chart and downloadable version of the chart are available.

This site will continue to be updated as more webinars are created. Please let us know if you have any questions at ASKCTP@fda.hhs.gov.

Thank you.

Upcoming Events