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  1. Retail Sales of Tobacco Products

Retailers: Chart of Required Warning Statements on Tobacco Product Packaging and Advertising

Are you a tobacco product retailer? If so, did you know that the compliance date for the health warning requirements for “covered tobacco products,”1 roll-your-own tobacco, and cigarette tobacco products is August 10, 2018?2  This means that by August 10, 2018, these products are expected to include any required health warning statements on packages and advertisements (see statement in chart below).3, 4, 5  FDA does not intend to enforce these requirements against retailers for continuing to sell products with non-compliant packages if the products were manufactured before the compliance date of August 10, 2018. All other warning statement requirements on this chart are in effect and failure to comply is subject to enforcement, except as otherwise noted.

Below is a chart to help you better understand what warning statements are required to be on the products you sell and/or advertise. FDA encourages you to contact your distributor/supplier for more information about the tobacco products in your inventory. 

Tobacco Products Warning Statements
Cigarettes6
  • SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.
  • SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
  • SURGEON GENERAL'S WARNING: Smoking By Pregnant Women May Result in Fetal Injury, Premature Birth, And Low Birth Weight.
  • SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.
Smokeless Tobacco
(must display one of the warnings on the two principal display panels)
  • WARNING: This product can cause mouth cancer.
  • WARNING: This product can cause gum disease and tooth loss.
  • WARNING: This product is not a safe alternative to cigarettes.
  • WARNING: Smokeless tobacco is addictive.
Cigarette Tobacco
(must display the warning on the two principal display panels)
  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
Roll-Your-Own Tobacco (RYO)
(must display the warning on the two principal display panels)
  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
Covered Tobacco Products* (except cigars)
(must display the warning on the two principal display panels)
  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
*Note: The 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.
Cigarette Tobacco, RYO, and Covered Tobacco Products* in Small Packaging

Must display applicable warning statements. For more information, see 21 CFR § 1143.3(d), 81 Fed. Reg. 29060, and FDA’s Guidance: Compliance Policy for Required Warning Statements on Small-Packaged Cigars 

*Note: The 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.
Cigars*
(must display one of the warnings on the two principal display panels)
 
  • WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  • WARNING: Cigar smoking can cause lung cancer and heart disease.
  • WARNING: Cigars are not a safe alternative to cigarettes.
  • WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  • WARNING: Cigar use while pregnant can harm you and your baby.; or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.
  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
*Note: The 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.
Cigars Sold Individually without Packaging*

Retailers must display all six of the required warning statements on a sign posted at the point-of-sale that complies with 21 CFR 1143.5(a)(3).  See “Cigars” row above for text of the warning statements.

*Note: The 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.
Tobacco products that do not contain tobacco or nicotine and are not made or derived from tobacco  Required warning statements under the FD&C Act and its implementing regulations are not applicable.

1. The term “covered tobacco product” means any tobacco product deemed to be subject to the Federal Food Drug and Cosmetic Act pursuant to 21 C.F.R. § 1100.2 (including ENDS, cigars, and pipe tobacco), but excludes any component or part that is not made or derived from tobacco.
2. The United States District Court for the District of Columbia recently issued an order in Cigar Association of America v. FDA enjoining FDA from enforcing the health warnings requirements for cigars and pipe tobacco set forth in 21 C.F.R §§ 1143.3 and 1143.5 until 60 days after final disposition of the plaintiffs’ appeal of the court’s order on the health warnings requirements. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. July 5, 2018). FDA intends to comply with the court’s order. However, the court’s order does not enjoin FDA from enforcing the health warning requirements of 21 C.F.R. § 1143.3 for other product categories, including Electronic Nicotine Delivery Systems (ENDS) products, hookah tobacco, and cigarette tobacco and roll-your-own tobacco products.
3. Retailers will not be in violation of the warning requirements for packaging for cigarette tobacco, roll-your-own tobacco, and covered tobacco products that: (i) contains a health warning; (ii) is supplied to the retailer by a manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau issued license or permit, if applicable, and (iii) is not altered by the retailer in a way that is material to the warning statement requirements. A similar exemption applies to smokeless tobacco label statements (see 15 U.S.C. § 4402(a)(5)).
4. Retailers will not be in violation of the warning requirements for advertising of cigarette tobacco, roll-your-own tobacco, and covered tobacco products if the retailer is not responsible for or does not direct the required health warning statements, as long as the advertising of the tobacco product contains a health warning and the advertisement is not altered in a manner that is material to the health warning requirement.  A similar exemption applies to smokeless tobacco label statements (see 15 U.S.C. § 4402(b)(3)(D)).
5. Retailers may continue to sell and distribute tobacco products with packaging that does not bear the required health warning statements after the effective date, but only if the products were manufactured before the effective date of the warning statement requirements.  See 21 CFR1143.13(a).
6. Note: Requirements for cigarette health warnings are contained in the Federal Cigarette Labeling and Advertising Act (FCLAA) and enforced by the FTC – See FTC for more information.

 

 
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