The long awaited FDA regulations “deeming” e-cigarettes a tobacco product have, at last been issued and were published in the Federal Register earlier this week. While they may have answered some questions, they also leave many unanswered. With the ink barely dry, the first court challenge has already been filed.
The regulations “deem” e-cigarettes to be like tobacco and, therefore, subject to FDA regulation. Electronic cigarettes are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn nicotine, which is considered to be highly addictive, and other chemicals into a vapor that is inhaled by the user.
In addition to e-cigarettes, the FDA has now extended its regulatory authority to cover all other products “deemed” tobacco, including vaporizers, vape pens, hookah pens, e-pipes, and all other Electronic Nicotine Delivery Systems, or “ENDS.” It will now regulate the manufacture, import, packaging, labeling, sale, distribution, and critical to broadcasters, cable and other advertising platforms, the advertising and promotion, of ENDS.
The new rules prohibit the sale of ENDS to individuals under the age of 18 and require the display of a specific, graphic health warning on product packages and in advertisements. Advertisements will be required to bear a new textual warning statement with specific black and white and border style requirements.
The rule provides that the warnings must accompany all advertising. The report specifically mentions most of the media, new and old, including Internet Web pages, television, electronic mail, messaging by mobile telephone, smartphone, microblog, social media Web site, or other communication tool, including any other programs that allow for the sharing of audio, video, or photography files or promotions. So in addition to traditional media, the rule specifically targets digital media, as well.
Furthermore, the health warnings must occupy 20 percent of the area of any advertisement with a visual component and utilize at least a 12-point font in Helvetica or Arial. It cannot be minimized, and must occupy “the greatest possible portion of the warning area set aside for the required text.” It must be in English, unless it appears in non-English language media, in which case it must appear in the primary language used for the medium’s non-sponsored content.
The FDA noted that it expects the broad range of advertising covered by the new graphic warning rules will create “additional complexities” that will require additional compliance information for a complete understanding. Given the time and resources it will take to achieve compliance, the proposed health warning rules will become effective 24 months after publication, by May 10, 2018.
The FDA devoted a separate section to banning the use of descriptors like Low, Light, and Mild, and Other Unauthorized Modified Risk Claims.
Finally, because the regulations prohibit sales to anyone under the age of 18, for the federal rules, advertising platforms must be careful to screen any otherwise compliant ENDS advertising to be sure it would not appear to be targeting anyone under the age of 18.
More to come as the rules become effective and the FDA issues further guidance.
