FDA Issues Final Ruling on New Regulations for E-Cigarettes

On May 5, 2016, the U.S. Food and Drug Administration issued a long-awaited final ruling regarding the regulation of electronic cigarettes (“e-cigarettes”) and other tobacco products, including hookah and pipe tobacco, and cigars. See Press Release, U.S. Food and Drug Administration, FDA takes significant steps to protect Americans from dangers of tobacco through new regulation (May 5, 2016), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm (hereinafter “FDA Press Release”). Most notably, as part of these far-reaching regulations, the FDA announced that it would now ban the sale of e-cigarettes to anyone under the age of 18.  The new measures go into effect in ninety days. Id. at ¶4.

As reported on this blog, the FDA previously announced in April 2011 that it would regulate e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009. The FDA, however, had not released any regulations until now. In fact, prior to the issuance of this rule, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under the age of 18. See FDA Press Release at ¶4. In the absence of such federal laws, many states have already imposed a variety of measures to regulate the sale of e-cigarettes.

The FDA’s final rule is “aimed at restricting youth access” and imposes sweeping regulations, including:

  • 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 sale of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

Id. at ¶4. Of note, at this time the rule does not prohibit the use of flavors in e-cigarettes. Sylvia Burwell, secretary of Health and Human Services said in a press conference that, while the FDA is interested in the issue of flavoring in e-cigarettes, further study was needed before imposing relevant regulations.

The rule also subjects “all manufacturers, importers, and/or retailers of newly-regulated tobacco products to any applicable provisions,” including registering with the FDA, listing all ingredients, and putting health warnings on all packaging and advertisements. FDA Press Release at ¶11. Specifically, the requirements include:

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

Id. at ¶12. Further, manufacturers of all newly-regulated products that were put on the market after February 15, 2007 must now get FDA approval by showing “the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA.” Id. at ¶6.

The FDA notes that these requirements bring the e-cigarette industry in line with other tobacco products that the FDA has regulated since 2009 under the Tobacco Control Act. Id. at ¶11. Nonetheless, further developments in and challenges to the implementation of these newly-issued regulations will be of considerable interest to those in the tobacco industry, as well as those companies that produce products that are regulated by the FDA.

We will continue to monitor the developments and challenges in this area.