FDA issues further guides

The US Food and Drug Administration has issued a final rule regarding the refuse-to-accept procedures for premarket tobacco submissions.

Under this rule, the agency says, it will refuse to accept tobacco product submissions or applications that are not in English, do not pertain to a tobacco product, do not include contact information, or do not meet other requirements as listed in the rule.

At the same time, the FDA has issued its Submission of Warning Plans for Cigars, a guide to assist industry players that are required to submit warning plans related to statements on cigar packaging and advertising.

Those concerned are required to submit a proposed warning plan to the FDA no later than May 10, 2017, or 12 months prior to advertising or commercially marketing the cigar, whichever is later.

Meanwhile, the FDA has published its final guidance entitled Listing of Ingredients in Tobacco Products.

‘This guidance is intended to assist manufacturers and importers making tobacco product ingredient submissions to the FDA, as required by the Tobacco Control Act,’ said the FDA. ‘Revisions to this guidance include minor clarifying and editorial changes to promote consistency throughout the FDA’s guidances and updated submission compliance dates.

‘The guidance also explains the statutory requirement to submit a list of all ingredients in tobacco products, who submits ingredient information, what information is included in the submissions, how and when to submit the information, the FDA’s compliance policies, and definitions.

‘Under the policies outlined in the guidance, the FDA does not intend to enforce the submission requirement for newly deemed tobacco products that were on the market as of August 8, 2016, until August 8, 2017, or February 8, 2018 for small-scale manufacturers. Tobacco products entering the market after August 8, 2016, must submit the ingredient information at least 90 days before the product is introduced into interstate commerce.

‘FDA is currently accepting ingredient listings for tobacco products and encourages manufacturers to start the processes as early as possible.’