Godot Has Arrived: The FDA Tobacco Deeming Rules Update

There has been a tremendous amount of information and opinion lately about teen use of vaping. Broadcasters anxious for new advertisers have looked at vaping as a new source of revenue, but be careful. This is a very dangerous area and one that must be well understood by any broadcaster thinking of accepting vaping advertising. I've written about this before when the regs were first adopted. Here's an update.

The FDA regulations "deeming" e-cigarettes a tobacco product are now final. Any seller of tobacco products, including e-cigarettes, hookah tobacco and cigars must comply with all applicable federal laws and regulations for retailers.

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.

Beginning August 8th, 2016 retailers were required to:

• Check photo ID of everyone under age 27 who attempts to purchase any tobacco product.
• Only sell tobacco products to customers age 18 or older.
• NOT sell tobacco products in a vending machine unless in an adult-only facility.
• NOT give away free samples of tobacco products to consumers, including any of their components or parts.

Beginning August 10th, 2018 retailers were required to:

• NOT sell or distribute cigarette tobacco or roll-your-own tobacco products without a warning statement on the package.
• NOT display advertisements for cigarette tobacco or roll-your-own tobacco products without a warning statement.
• The rules prohibit the sale of ENDS to individuals under the age of 18 and require the display of specific, graphic health warnings on product packages and in advertisements. Advertisement are required to bear one of nine textual warning statements with specific black and white and border style requirements.

The nine graphic warnings are:

WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your health.

See: Retailers: Chart of Required Warning Statements on Tobacco Product Packaging and Advertising for a specific chart of warning statements broken down by type of product.

The warnings must accompany all advertising, including most of the media employed by broadcasters, including Internet web pages, TV, 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 a station's digital sales team. Here's a link to a specific list of all requirements by type of ENDS product: How Do I Comply.

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 and cannot be minimized. It 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.

Since the regulations prohibit sales to anyone under the age of 18, 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.

FDA Priorities

While there is nothing substantively new about the ENDS rules, it should be noted that the FDA is very concerned about the sharp increase in ENDS use by children, and public interest groups are mounting national awareness campaigns. As of July 10th, 2019, FDA Acting Commissioner posted this statement on the FDA website: "What is clear is the explosion of use and nicotine addiction in children driven by the advent of ENDS, especially the pod-based products such as JUUL ... FDA's oversight of these products is a top priority for the agency. This ongoing work includes investing in more science to address the unanswered questions about ENDS, developing guidances and regulations, educating industry and the public, and aggressively enforcing the law - all of which have had a wide-ranging impact on the manufacturing, marketing, and selling of ENDS. CTP's work is constant in its effort to keep these products out of the hands of kids."

Given these priorities, it is not unreasonable to believe that the FDA will examine broadcaster advertising of ENDS for compliance with all advertising regulations. All broadcasters should be careful to assure compliance before accepting any ENDS advertising.

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.