4. A Lack of Clear Guidance on the Substantial Equivalence Process:
Under the Family Smoking Prevention and Tobacco Control Act, tobacco products (cigarettes, roll your own [RYO] tobacco and smokeless tobacco) that were not grandfathered were required to go through a premarket review process, including the filing of a substantial equivalence report showing that any differences between a covered tobacco product and a grandfathered predicate product did not present “a different question of public health.”
The deeming regulations require all covered tobacco products that are not grandfathered to go through the same premarket review process. Though the FDA released guidance in 2011 on filing a substantial equivalence report relating to cigarettes, RYO tobacco and smokeless tobacco, they have not provided any new or updated information on what is required for substantial equivalence reports for newly covered tobacco products, including cigars, pipe tobacco and e-cigarettes/vapor products. With substantial equivalence reports for each product likely to require numerous hours of work and cost hundreds of thousands of dollars (at least) to prepare, the FDA’s delay in issuing updated guidance of the substantial equivalence process for these newly deemed tobacco products puts manufacturers at a severe handicap in trying to navigate the premarket review process.
5. FDA Field Inspections of Retailers Targeting Minimum Age Requirement to Sell Deemed Tobacco Products:
Ensuring that tobacco products are sold exclusively to those of legal age is one issue the entire industry agrees on. In recent industry presentations, the FDA has informed the industry that it has conducted thousands of field inspections and the target appears to be retailers selling to minors under the legal age for purchasing tobacco.
As with almost every state and local law, the deeming regulations also prohibit retailers from selling deemed tobacco products in any medium (including mail order as well as the internet) to any individuals under 18 years of age. In addition, the FDA mandates that retailers physically check the photo identification of all customers under the age of 27 who attempt to purchase a cigar. All retailers should remember to request the proper age verifying identification prior to selling tobacco products.
– Contributed By Noah Steinsapir, General Counsel, Kretek International
This story first appeared in the July/August 2017 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.
