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.