The Final Deeming Rule: Six Months Later

ORLANDO, Fla. — Much of the latest tobacco legislation has been coming from the state level, but 2016 brought one major change at the federal level: the final deeming rule.

In 2011, the Food and Drug Administration (FDA) announced that it would regulate electronic cigarettes under its authority spelled out in the Family Smoking Prevention and Tobacco Control Act of 2009. The first step was to establish its authority to regulate tobacco products not explicitly noted in the 2009 measure. These newly deemed products include electronic cigarettes, cigars, pipe tobacco, and hookah. Five years later, the final deeming rule went into effect on Aug. 8, 2016. 

One of the sticking points with the deeming rule has been the predicate — or grandfather — date, requiring any tobacco product brought to market after Feb. 15, 2007 to obtain FDA approval to remain on the market. This date was established in the Tobacco Control Act of 2009 and carried over into the deeming rule, which leaves e-cigarettes especially in limbo. Very few, if any, e-cigarette products were on the market 10 years ago, as many in the industry have often pointed out.

Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), outlined several key issues with the deeming rule for attendees of the Convenience Distribution Association's (CDA) 2017 Convenience Distribution Marketplace event, taking place this week in Orlando.

PREMIUM CIGARS

The first key issue is the inclusion of premium cigars in the final deeming rule.

The FDA's proposed rule had offered two options: including all cigars, or giving premium cigars an exemption from the rule. However, after reviewing all comments that came in — more than 135,000 for the overall deeming rule — the agency concluded there was "no appropriate public health justification" to exclude premium cigars, Zeller explained. All cigars, he added, pose a public health threat.

Any efforts to change the rule governing premium cigars will be left up to Congress, according to Zeller.

A bill has been introduced on Capitol Hill to take premium cigars out of the mix. In addition, two lawsuits have been filed over the issue, noted Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO), who was also on hand at CDA's Marketplace event to share news on tobacco legislative efforts across the United States.

VAPE SHOP CLARITY

Another area of concern with the deeming rule is the status of vape shops.

According to Zeller, existing statute — and not the FDA — defines a "tobacco manufacturer," and vape shops that mix their own liquids, for example, fall in line with that definition. As a result, such vape shops "are subject to all of the statutory and regulatory requirements that apply to manufacturers, including the requirements to register their establishments, list their products, and obtain premarket authorization," according to the CTP.

However, as Zeller pointed out, not all vape shops mix e-liquids. Some are traditional retailers that sell finished products to an end user and, therefore, do not meet the statutory definition of a manufacturer.

Last month, the CTP issued a new draft guidance for vape shops that explains certain activities that will make or not make a vape shop subject to the manufacturer requirements.

FDA COMPLIANCE & ENFORCEMENT

Since the Tobacco Control Act was signed into law by President Barack Obama in 2009, there have been more than 714,000 retail inspections, 53,100-plus warning letters issued, and more than 10,180 civil money penalties levied, according to Zeller.

Since the deeming rule went into effect in August, there have been more than 2,500 warning letters issued for newly deemed products.

Most violations stem from the sale of tobacco products to underage consumers. And while underage consumers are getting tobacco products from social sources, the violations indicate they are also obtaining them at retail, the CTP director noted.

"It's a fair point; this is not the only way youth are getting these products. But for whatever reason, there are retailers out there who continue to sell to kids," Zeller said, adding that civil money penalties are not enough of a deterrent for some retailers

The 2017 Convenience Distribution Marketplace began Feb. 13 and wrapped up Feb. 15 at the Hilton Orlando. The annual event is designed uniquely to bring convenience distributors together with their supplier partners in a flexible business and networking environment.

The Convenience Distribution Association, formerly AWMA, is the trade organization working on behalf of convenience products distributors in the United States. Its distributor members represent more than $92 billion in U.S convenience product sales, serving a wide variety of small retail formats. Associate members include leading convenience product manufacturers, brokers, retailers, suppliers and others allied to the industry.