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Required Warning StatementsThe United States District Court for the District of Columbia recently issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk tobacco products without an FDA order. The deeming regulation requires that all cigar packages that are manufactured, packaged, sold, offered for sale, distributed, or imported for sale or distribution within the United States must bear one of the following required warning statements, per 21 CFR § 1143.5(a)(1), on the package label:
50-Count Cigar Box 5-Count Cigar Box These images are intended to serve as examples and alternative approaches may suffice. *You may choose to display either one of the warning statements regarding reproductive health. FDA expects that providing this optional alternative will benefit entities bound by the Federal Trade Commission (FTC) consent decrees, and this requirement is appropriate for the protection of public health. Each required warning statement must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping as follows, per 21 CFR § 1143.5(a):
A cigar retailer will not be in violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) Is not altered by the retailer in a way that is material to the requirements of this section. Cigars in Small PackagesThe FDA issued Guidance: Compliance Policy for Required Warning Statements on Small-Packaged Cigars. This guidance document is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in 21 CFR § 1143 for product packaging. These images are intended to serve as examples and alternative approaches may suffice. Cigar Warning Plans for PackagingYou must submit a proposed warning plan to FDA no later than August 10, 2017, or 12 months before advertising or commercially marketing a cigar product, whichever is later (21 CFR § 1143.5(c)(3)). Except for cigars sold individually and not in a product package, the six required warning statements must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigar sold in product packaging, in accordance with an FDA approved warning plan, per 21 CFR § 1143.5(c)(1). The six warning statements must also be randomly distributed in all areas of the United States where the product is marketed, in accordance with the aforementioned plan submitted by the responsible cigar manufacturer, importer, distributor, or retailer to, and approved by, FDA. Cigars Sold Individually without PackagingFor cigars that are sold individually, and not in a product package, the retailer must display all six of the required warning statements on a sign posted at the point-of-sale, per 21 CFR § 1143.5(a)(3). The sign at point-of-sale must be:
Other Cigar Labeling RequirementsThere are other labeling requirements. For example, tobacco products deemed under the deeming final rule to be subject to FDA’s authority, if in package form, must bear a label containing—
Section 920(a) of the FD&C Act provides that the label, packaging, and shipping containers of tobacco products shall bear the statement “Sale only allowed in the United States”. In the guidance entitled “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops” FDA indicated that it does not intend to enforce section 903(a)(2)(C) of the FD&C Act for those products that are made or derived from tobacco. Additional Resources
Which of the following statements is true of the Family Smoking Prevention and Tobacco Control Act?Which of the following statements is true of the Family Smoking Prevention and Tobacco Control Act signed by President Barack Obama in 2009? It authorizes the Food and Drug Administration (FDA) to regulate tobacco products themselves in specific ways.
What messages are currently included on cigarette packaging or anti smoking advertisements?cover most of the packaging.. statements – such as 'Smoking harms unborn babies'. graphics – photos that are related to the warning statements.. explanatory messages – more detail about the warning statements.. information messages – a fact about the harmful effects of smoking.. Can smoking be prevented by raising the price of cigarettes claim?Tobacco use kills eight million people every year and is the leading cause of preventable deaths globally. Evidence shows that significantly increasing tobacco excise taxes and prices is the single most effective and cost-effective measure for reducing tobacco use.
Which of the following was the first disease clearly linked to cigarette smoking?The relationship between tobacco use and health stems initially from clinical observations about lung cancer, the first disease definitively linked to tobacco use.
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