Editor's Note: As noted above, these restrictions will not be required. I have decided to leave the text below published so that you can see what might have happened. — CM.
Like cigar boxes, FDA's deeming regulations will require warning labels to be placed on advertising.
FDA has declined to explicitly define "advertising," but has stated that it believes advertising may appear in the following:
Promotional materials (point-of-sale or non-point-of-sale), billboards, posters, placards, published journals, newspapers, magazines, other periodicals, catalogues, leaflets, brochures, direct mail, shelf-talkers, display racks, Internet Web pages, television, electronic mail correspondence, and also include those communicated via mobile telephone, smartphone, microblog, social media Web site, or other communication tool; Web sites, applications, or other programs that allow for the sharing of audio, video, or photography files; video and audio promotions; and items not subject to the sale or distribution ban in § 1140.34. (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 334-335)
There are a variety of requirements for advertising warning labels:
- The warning notice must cover at least 20 percent of the total area of the advertisement
- The warning notice must be placed in the upper portion
- The warning nootice must be printed in at least 12-point font in either Helvetica bold, Arial bold or similar sans serif font. The warning must be black text on a white background
Companies—both manufacturers and retailers—will be required to rotate between one of the five warnings:
- 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.
In addition, companies will be required to submit the warning labels to FDA as part of a warning label plan that is provided to the agency 12 months prior to the advertisement being displayed. This means companies will not only need to state which warning label they intend on using 12-months prior, but also the ad itself.
Questions
In 2000, a variety of companies including Altadis U.S.A., General Cigar Co., Swisher International and Altria voluntarily agreed to place warning labels—smaller than those which are to be required under FDA's deeming regulations—on their products as part of an agreement with the Federal Trade Commission (FTC). Because Swisher owns Drew Estate and Altria owns Nat Sherman, it means a variety of brands are already federally required to have warning labels on their boxes and advertisements.
These warning labels are smaller and carry less restrictions than the planned FDA warning notices.
Yes.
- There's not a ton of precedent with the cigarette/smokeless tobacco because those companies are prohibited from even having social media accounts. E-cigarette companies are already required to comply with the warning label requirements.
What is unclear is whether FDA would attempt to regulate personal accounts of employees who work for a cigar company or retail store.
Last edited: April 29, 2020.