Legal Hotline: FDA Tobacco Advertising Rules

Legal Hotline: FDA Tobacco Advertising Rules

PNA Legal Hotline

Q:  What products are covered by the FDA’s tobacco advertising rules, and do they cover e-cigarettes and vaping liquids?

 A:  FDA regulations governing tobacco advertising cover an expanded class of products and require specific warning language and layout criteria for each. However, tobacco regulation is frequently the subject of legislation and lawsuits, thus it is impossible for PNA to provide comprehensive guidance on all aspects of this topic.

The general rules governing tobacco advertising do not impose liability on publishers for compliance with tobacco advertising laws, and liability typically rests with the retailers and manufacturers (advertisers). However, publishers can be held liable for false, deceptive and misleading advertising under state and federal consumer protection laws, thus they should ensure that tobacco ads do not contain false, misleading or deceptive content.

As an initial matter, it is important to remember that under Pennsylvania law, tobacco products cannot be sold to anyone under the age of 21. Similarly, federal law was amended in 2019 to increase the minimum age to purchase e-cigarettes and vaping materials to 21. Tobacco ads are not required to include minimum-age-to-purchase information, but if they do, the information must accurately reflect the minimum age to purchase.

The Food and Drug Administration (FDA) is empowered by federal law to oversee tobacco products in the marketplace. FDA regulations and guidance cover “tobacco products,” which is defined to include hookah, e-cigarettes, dissolvables (e-liquids), cigarettes, smokeless tobacco, cigars, roll-your-own tobacco and pipe tobacco. The warning label requirements for each are similar, but not the same.

 

The FDA rules for e-cigarette and e-liquid (vaping) require retailers to:

  • Check photo ID of everyone under age 27 who attempts to purchase any tobacco product.
  • Only sell products to customers age 21 or older.
  • NOT sell products in a vending machine or self-service display unless in an adult-only facility.
  • NOT give away free samples of tobacco products, including any of their components or parts.
  • NOT sell or advertise flavored vaping liquids (menthol and tobacco flavors are acceptable).

 

For vaping, hookah, roll-your-own and loose tobacco products that include nicotine, product packages and advertisements must bear the following warning statement:

“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

If the product contains tobacco, but does not include nicotine (and the manufacturer has data to support this assertion), product packages and advertisements must include:

“This product is made from tobacco.”

These warnings must comprise at least 20% of the ad space, appear in black and white text, inside a border and be at least 12-point font size.

Moreover, as part of ongoing enforcement actions related to vaping products, the FDA sent warning letters to e-cigarette manufacturers and retailers warning about smoking cessation and health claims, identifying them as potentially false, misleading or deceptive. Additionally, the FDA also sent warning that certain ad content that targets youth like cartoons and candy runs afoul of federal law. E-cigarette/vaping ads should not claim the product is healthier than traditional cigarettes or that the products can aid in smoking cessation as those claims may be considered false, misleading or deceptive and publishers could be held liable for such ad under various state and federal consumer protection laws. Likewise, e-cigarette/vaping ads should not contain content that targets youth such as cartoons or candy. Similarly, and as noted above, flavored vaping liquids, except menthol and tobacco, are prohibited and thus should not be advertised.

 

The FDA has proposed new regulations for cigarettes that include graphic warnings (photographs) as well as new warning texts, which can be reviewed here. The proposed regulations must complete the formal regulatory process, which is not scheduled to take place until January 14, 2022. Until such time as new regulations are approved and finalized, cigarette ads must contain one of the following four (4) Surgeon General’s warnings:

SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.
SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
SURGEON GENERAL’S WARNING: Smoking By Pregnant Women May Result in Fetal Injury, Premature Birth, And Low Birth Weight.
SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon Monoxide.

The warning must be black and white text, capitalized as written above, and located inside a border. The warning must be “conspicuous and legible.”

 

Smokeless tobacco advertisements have larger and more visible warnings. Smokeless tobacco includes tobacco products such as moist snuff, chewing tobacco, and snus. Every smokeless tobacco package and advertisement must include one of the following warning label statements:

WARNING: This product can cause mouth cancer.
WARNING: This product can cause gum disease and tooth loss.
WARNING: This product is not a safe alternative to cigarettes.
WARNING: Smokeless tobacco is addictive.

For advertisements, the warning label statements must appear at the top of the ad, cover at least 20% of ad space, be printed in black and white, inside a border and be at least 12-point font size.

 

Cigars are governed separately, with one of 6 approved warnings required to appear in advertisements. Note: the federal regulations governing cigars are the subject to federal litigation and have been put on hold as part of the lawsuit. The FDA is encouraging cigar retailers and manufacturers to comply voluntarily until the lawsuit is resolved.

WARNING: This product contains nicotine. Nicotine is an addictive chemical.
WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
WARNING: Cigar smoking can cause lung cancer and heart disease.
WARNING: Cigars are not a safe alternative to cigarettes.
WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
WARNING: Cigar use while pregnant can harm you and your baby. (Or, as an optional alternative statement:
SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.)

Again, the warning must appear at the top of the ad, comprise at least 20% of the ad space, be printed in black and white and inside a border and be at least 12-point font size. For ads scheduled to run more than once, the warning must rotate between the approved warnings.

You can learn more about tobacco regulations from the FDA’s Small Entity Compliance Guide and in the FDA’s materials on the Family Smoking Prevention and Tobacco Control Act available here.

As always, this is not intended to be, nor should it be construed as, legal advice. Please consult a private attorney or contact the PNA Legal Hotline at (717) 703-3080 with questions or for pre-publication review.