The FDA Tobacco Deeming Rules Are Here
May 10, 2016
The long-awaited FDA regulations "deeming" e-cigarettes a tobacco product have, at last been issued and are to be published in the Federal Register today. While they may have answered some questions, they also leave many unanswered.
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, 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. Advertisement will be required to bear a new textual warning statements 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, employed by broadcasters, including Internet Web pages, television, electronic mail, messaging by mobile telephone, smartphone, microblog, social media website 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 sales, the rule specifically targets your digital sales team as well.
Furthermore, the health warnings must occupy 20% 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. The regulations are supposed to be published in the Federal Register May 10th that would make them effective May 10th, 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, broadcasters must be careful to screen any otherwise complaint ENDS advertising to be sure it would not be deemed to target anyone under the age of 18.
More to come as the rules become effective and the FDA issues further guidance.
This column is provided for general information purposes only and should not be relied upon as legal advice pertaining to any specific factual situation. Legal decisions should be made only after proper consultation with a legal professional of your choosing.