Opinion: A Look at 2015 FDA Regulatory Actions

By 
Thomas A. Briant, NATO Executive Director

Tom Briant

This year has been marked by both anticipation of the FDA’s deeming tobacco regulations and other actions by the agency as it moves forward with regulating tobacco products. Most of the attention has been focused on finalizing the extension of the agency’s authority to cigars, pipe tobacco, e-cigarettes, hookah tobacco, dissolvables and nicotine gels. However, the other actions pursued by the FDA in 2015 are just as important.

Deeming Regulations

On Oct. 19, the FDA’s Center for Tobacco Products submitted to the White House Office of Management and Budget (OMB) the final deeming regulations on cigars, pipe tobacco, e-cigarettes, hookah tobacco, nicotine gels and dissolvable products. Generally, the OMB has a period of 90 days to review final federal regulations. If approved, the regulations will be published in the Federal Register and take effect in 30 days.

The final version of the deeming regulations submitted to the OMB was not made public. The deeming regulations were first proposed by the FDA in April 2014 and had two options: Option one regulated all cigars, pipe tobacco, e-cigarettes, nicotine gels, hookah tobacco and dissolvables; option two exempted premium cigars from regulations.

Under the deeming regulations as originally proposed, manufacturers would be required to register each tobacco manufacturing facility, submit tobacco product lists and fi le ingredient disclosures. Also, modified-risk descriptors such as “light,” “low” and “mild” could not be used to describe a regulated tobacco product. Free samples of the products also would not be allowed.

For e-cigarettes and other tobacco products that were not on the market as of Feb. 15, 2007 (which includes most cigars and pipe tobacco products), manufacturers would need to submit a premarket tobacco application (PMTA) to the FDA within 24 months after the effective date of the final deeming regulations. The PMTA process allows the FDA to authorize or prevent the introduction of products into the market.

The minimum age to purchase deemed tobacco products would be 18, and retailers would be required to verify via photo ID the legal minimum age of a customer younger than 27. Finally, a new health warning would be required on all deemed tobacco products, all cigarette tobacco and roll-your-own tobacco, and in all ads for these products.

FDA Research

The FDA has funded almost $500,000 in research studies on tobacco products. The results of these studies will form the basis for new regulations to be proposed by the agency. A sampling of the research topics:

  • What impact does the use of menthol and other flavors in tobacco products have on experimentation with tobacco products, initiation of tobacco use, cessation of tobacco use, switching tobacco products and use of more than one kind of tobacco product?
  • What metals are contained in e-cigarette aerosol?
  • Do e-cigarettes reduce harm, and do e-cigarettes affect human health?
  • Besides nicotine, what other ingredients, components and design features of tobacco products enhance or increase their addictive properties?
  • What role do tobacco product advertising displays at retail point-of-sale have on youth initiation of tobacco use and cessation?

Menthol, Ages and More

In response to a request by the FDA, the public submitted more than 225,000 comments on the question of whether additional regulations should be considered for menthol cigarettes. The FDA is still reviewing these comments. Moreover, the FDA has funded three ongoing studies to obtain more scientific data on menthol cigarettes.

An FDA-funded study through the Institute of Medicine determined that raising the legal age to purchase tobacco products to 21 would reduce the number of youth who begin to use the products. On the federal level, only Congress can consider legislation to increase the legal age to purchase tobacco products.

In October, the FDA announced it had filed complaints against eight retail stores to initiate No-Tobacco-Sales Order actions because the stores violated federal regulations on the sale of tobacco products, including sale to minors. The FDA may pursue a No-Tobacco-Sales Order against retailers that have five or more repeated violations of these restrictions during inspections in a 36-month period. The agency is seeking to prohibit the sale of all tobacco products at these stores for 30 days.

Also, the FDA produced a second set of four TV ads under its “The Real Cost” campaign, which is targeted at 12- to 17-year-olds, to educate them about the health consequences of tobacco use.