FDA issues warning statements for cigars, guidance on warning plans

Although the FDA took five years from the passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Act) (P.L. 111-31) to extend its regulatory authority to cover cigars, it has now issued guidance on required warning statements for cigar products. By May 10, 2018, cigars may not be manufactured, packaged, sold, offered for sale, or imported for sale or distribution without one of several warning statements appearing on product packaging. Manufacturers may not distribute products in non-compliant packaging beginning June 11, 2018.

Final rule and new regulations

The Tobacco Act, enacted June 22, 2009, granted the FDA the authority to deem statutorily defined tobacco products as subject to the agency’s regulation. The FDA did so through a Final rule (81 FR 28974), which established the FDA’s authority over any product made or derived from tobacco and intended for human consumption. These regulations establish responsibilities of manufacturers, distributors, and retailers, which include proper presentation of warning statements and the submission of warning plans (21 C.F.R. parts 1100-1143).

Required statements

As of the effective date, all cigar packages and advertisements must contain one of the following statements:

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

Although retailers are subject to the regulations, they will not be considered in violation of these requirements if the cigars offered for sale contain a health warning, are supplied from a source that has the required licenses or permits, and are not altered by the retailer in a meaningful way. Individually sold cigars without packaging are exempt from packaging requirements, but retailers must post a warning sign with all six warning statements at the point of sale.

Warning plans

The requirement to submit warning plans to the FDA for cigars will take effect May 10, 2017. These plans must provide that all warning statements are displayed in each 12-month period, on each product brand, and are randomly displayed as equally as possible and randomly distributed in all areas of the US.

Generally, for packaged cigars, the FDA believes that the brand manufacturer is best able to ensure that the warning plan contains sufficient information for approval and that the packaging complies with the requirements. If a product is manufactured under contract, the contracting entity is best suited to submit the plan. Importers of finished cigars usually control packaging and distribution, and should submit the plan. Usually, retailers should not submit warning plans, unless they are responsible for the placement of warning statements.

FDA warns 55 retailers about e-cigarette, e-liquid, and cigar sales to minors

Warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids, and cigars, to minors have been issued by the FDA’s Center for Tobacco Products against 55 tobacco retailers. The announcement of these warning letters comes approximately one month after the August 8, 2016 effective date of the Final rule (81 FR 28973, May 10, 2016) extending the FDA’s authority over all tobacco products, and making it illegal to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check the photo ID of anyone under age 27 (see FDA clears the air, ‘deems’ e-cigarettes, hookah tobacco, cigars worthy of regulation, Health Law Daily, May 10, 2016).

Before the Final rule, there were no federal regulations prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under age 18. The Final rule contains the following restrictions:

  • not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • requiring age verification by photo ID;
  • not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
  • not allowing the distribution of free samples.

The warning letters were issued after compliance checks of major retail chains, tobacco specialty stores and online retailers found that minors were able to purchase some of the newly regulated tobacco products in a variety of youth-appealing flavors, including bubble gum, cotton candy, and gummy bear. The results from compliance check inspections of tobacco retailers are available in a searchable retailer inspection database. The database lists which inspected retailers received a warning letter, a civil money penalty, a NTSO, or were found to have no observable violations.

The FDA usually issues warning letters to brick-and-mortar retailers as well as online retailers and manufacturers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws. Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to FDA enforcement actions, including civil money penalties and no-tobacco-sale orders (NTSOs).

Under applicable compliance and enforcement rules, the FDA may pursue a NTSO against retailers that have a total of five or more repeated violations of certain restrictions within 36 months. Retailers are prohibited from selling regulated tobacco products at the specified location during the period of the NTSO. Retailers who receive an NTSO complaint from the FDA may either enter into a settlement agreement with the agency that results in a final order issued by the administrative law judge (ALJ) or choose to go to a full hearing before an ALJ.