FDA Expands Its Regulatory Reach on Tobacco Products

Regulations keep 2007 grandfather date, no exemption for premium cigars

WASHINGTON – The U.S. Food and Drug Administration (FDA) has issued its final “deeming” regulations, extending the agency’s regulatory authority over all tobacco products, including electronic cigarettes, cigars, hookah tobacco and pipe tobacco.    

During an FDA media briefing, FDA commissioner Robert Califf described the regulations, which were announced May 5, as “a critically important foundational rule [and] a milestone in consumer protection.”

  • Join CSP's Tobacco Update webinar on May 24 to hear industry experts' input on how the new regulatory landscape could affect tobacco retailing.

Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), said the FDA considered all of the more than 135,000 comments received during the public comment period.

“We believe our approach in this final rule is both reasonable and balanced,” Zeller said. “This historic rule allows the FDA to use a variety of regulatory tools to improve public health and protect future generations from the dangers of tobacco use.

Among other things, the regulations—which go into effect in 90 days (Aug. 8, 2016)—will restrict the sale of these newly deemed products to anyone under 18. Specific provisions aimed at restricting youth access include:

  • 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).
  • Not allowing the distribution of free samples.

Beyond restricting sales to minors, the final deeming rule did not differ greatly from the proposed deeming regulations the FDA issued in April 2014. Once the rule goes into effect, manufacturers of newly regulated products will be required to submit a premarket tobacco application (PMTA) to the FDA unless the product (or a substantially equivalent product) was on the market as of Feb. 15, 2007.

In the initial proposed deeming rule, the FDA estimated the PMTA process would take approximately 500 hours per application. The figure has now tripled, to 1,700 hours per application.

The February 2007 date (known as the predicate, or “grandfather,” date) was something many electronic-cigarette and vaping advocates had hoped would be pushed back to the date deeming goes into effect, which would allow electronic cigarettes and other newer products to qualify for the less costly substantial equivalence (SE) pathway.

Instead, the FDA addressed concerns by establishing a “staggered timeline” that would give nongrandfathered products more time to submit a PMTA than products that qualify for the SE pathway. Under the final rule, such manufacturers would be allowed to keep products on the market during the two years they have to submit a PMTA, as well as up to one additional year as the FDA reviews said applications.

“The product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as appeal to youth and non-users,” Zeller said.

Another issue in question was how the FDA would treat premium cigars. In the proposed rule, there was an option to exempt premium cigars from FDA regulation all-together.

“The FDA has concluded there is no appropriate public health justification for excluding premium cigars," Zeller said. “All cigars pose serious health risks. To exclude such a product from FDA regulation would be neglecting our duty to protect public health.”

Zeller and others at the FDA were quick to point out that the 499-page final deeming rule is just the start of regulatory actions to come. The final rule included a guidance suggesting that the agency will soon look to extend the ban on flavored cigarettes to also include the use of characterizing flavors in cigars.

“This is just a foundational rule,” said David Ashley, director of the CTP’s Office of Science. “The vast majority of actions are still down the road.”

Join CSP's Tobacco Update webinar on May 24 to hear industry experts' input on how the new regulatory landscape could affect tobacco retailing.

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