FDA Issues Final Rule and Two Guidances


Important news released on December 28 by the FDA regarding their oversight of premium cigars below.

FDA Issues Final Rule on Criteria for Refusing to Accept a Tobacco Product Submission or Application

The US Food and Drug Administration (FDA) recently issued a final rule regarding the refuse to accept procedures for premarket tobacco submissions. Under this rule, the agency 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.

On Aug. 8, 2016, the refuse to accept proposed rule was published along with the refuse to accept direct final rule. Consistent with the FDA’s direct final rule procedures, the agency withdrew the direct final rule on Nov. 16, 2016, due to comments received. This rule finalizes the proposed rule and responds to the comments received during the comment period.

For more information, please see the final rule here.

FDA Issues Guidance on Submitting Warning Plans for Cigars

The FDA recently issued Submission of Warning Plans for Cigars, a guidance to assist industry who are required to submit warning plans related to required warning statements on cigar packaging and advertising. Those to whom this applies 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).

Among other things, the guidance specifies the information that should be submitted in a warning plan; when, where, and how to submit plans; and an example of a cigar warning plan.

Starting on May 10, 2018, in accordance with the FDA’s final “deeming” rule, cigars will be required to randomly display and distribute warning statements on their packaging and quarterly rotate the warning statements in advertisements. Once this requirement goes into effect, cigar packages must bear one of the following six warning statements:

  1. WARNING: This product contains nicotine. Nicotine is an addictive chemical.

  2. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.

  3. WARNING: Cigar smoking can cause lung cancer and heart disease.

  4. WARNING: Cigars are not a safe alternative to cigarettes.

  5. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.

  6. WARNING: Cigar use while pregnant can harm you and your baby.

Alternative to #6: SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.

In order to comply with these provisions, industry is also required to submit a proposed warning plan to the FDA. These warning plans are subject to FDA review and approval. This guidance is intended to assist those who will need to submit these plans.

For more information on this topic, please read the guidance here.

FDA Extends Compliance Date for Ingredient Submissions

The FDA recently published the final guidance titled 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. 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.

Read the guidance here for more information.

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