May 2016

This week, the Food and Drug Administration issued final rules to establish regulatory authority over all tobacco products, including cigars, e-cigarettes, hookahs and dissolvable tobacco products.  Prior to this week's action, the FDA already had authority to regulate cigarettes, but had not yet exerted its authority to regulate other tobacco products.

The rule takes many immediate steps to protect the public from the harmful effects of tobacco, including:

• Banning the sales of all tobacco products to minors (some states still allow e-cigs sales to minors)
• Requiring age verification by photo ID
• Not allowing the sale of covered tobacco products in vending machines (unless in an adult-only facility)
• Not allowing the distribution of free samples.

The rule also applies the following actions to newly-covered tobacco products, namely cigars and e-cigarettes:

• Registering manufacturing establishments and providing product listings to the FDA
• Reporting ingredients and harmful and potentially harmful constituents
• Requiring pre-market review and authorization of new tobacco products by the FDA
• Placing health warnings on product packages and advertisements
• Not selling modified risk tobacco products (including those described as "light," "low," or "mild") unless authorized by the FDA.

While not directly covered in the FDA's final rule, the agency said that it intends to issue future rule-making to ban "characterizing" flavored cigars and cigarillos in the near future.  Characterizing flavor means adding enough of a flavoring to a cigar or cigarillo that it tastes and smells like that flavor – for example, adding enough grape flavoring to  cigar that it tastes and smells like "grape."  Many tobacco products include flavor additives that change the flavor of the product, but do not rise to the level of a characterizing flavor.  Presumably, non-characterizing flavorings would still be permitted.

The final rule does not address flavorings in e-cigarettes, but instead requires all products not on the U.S. market prior to February 15, 2007 (which includes the vast majority of e-cigarette products) to submit pre-market tobacco product applications for review by the FDA.  Under the review process, as set out by the law passed by Congress and further explained in the FDA final rule,  the FDA will only grant permission to market these products if they meet several thresholds, including a "public health standard" requirement.  Because of the significant volume of these products and the large body of work required in submitting the FDA application and FDA's time in reviewing these applications, industry will have up to two years to submit the appropriate application and the FDA will have up to one year to review the application before any final determinations will be made.

The final FDA rule is strongly supported by the medical, public health and tobacco control community.  Attention now turns to Congress to see if they will pass legislation to significantly weaken, delay or stop the FDA from exercising its authority to regulate tobacco products.  The House Appropriations Committee has already passed a provision that would effectively gut most of the FDA's enforcement authority over e-cigarettes and "premium cigars."  The Senate has not yet considered similar provisions.  The ATS will continue to work with our sister organizations to oppose any effort to weaken or delay the FDA's authority to regulate all tobacco products.