Nicotine: The deeming regulations promulgated by the Food and Drug Administration contain new warning requirements for certain tobacco products, including cigars, pipe tobacco, e-cigarettes, vapor products, hookah tobacco, dissolvables, and nicotine gel.  Effective August 8, 2018, a nicotine health warning is required on packaging and advertisements.  The language is:

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

This warning must be in 12 point type and cover 30% of the two principal display panels of the product (most likely to be displayed, shown or examined by consumer), and 20% of the area of advertisements.

If the product is too small to allow this, the warning may be placed on the outer wrapper, carton or tag.  If there is a tag used, then the warning must be on both sides of the tag.

A manufacturer may notify FDA that its product contains no nicotine and may use the alternate warning:

“This product is derived from tobacco.”

A distributor or retailer may not sell, offer, distribute or import the products after August 8, 2018 without the new warning.  This does not apply if the product is manufactured before August 8, 2018.  Retailers can sell tobacco products manufactured before August 8, 2018 that do not contain the warning.

Cigar Health Warnings:The deeming regulations have added two additional health warnings (total 6) for cigars.  The additional warning is:

“WARNING: Cigar use while pregnant can harm you and your baby.”

Optional alternate:

“SURGEON GENERAL’S WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth, and Low Birth Weight.”

Cigar health warning plans will be approved by FDA beginning August 8, 2017. Similar to the nicotine warning, these must also be in 12 point type, and cover 30% of the two principal display panels of the packaging.  For advertising, the warnings must cover 20% of the print advertising for cigars. Warnings on cigar advertising must be in quarterly alternating rotation.  The 12 point type may be too small for the advertising size, and this warning must occupy the greatest possible portion of the warning area set aside for required text.   Retailers will be required to submit a plan for advertising they create.

The six warnings must be randomly displayed on packages in each of the 12 month period in as equal a number of times as possible for each brand.

The same warnings will apply to cigars sold individually, but instead the six warnings will be posted at point of sale on a 8.5 x 11 sheet.

There are language requirements for advertising tobacco products in publications in other languages.  Normally, all warnings would be in English.  However, if advertising is placed in a publication of another predominant language, then the warnings should appear in the language of the publication.  If the advertisement is placed in an English publication but the advertisement is in another language, then the warning should be in the same foreign language as is the advertisement.

Warnings must be permanently affixed to packages and advertisements. The warnings are not applicable to manufacturers or distributors that are not manufacturing, packaging or distributing the product for sale or distribution in the United States.

The effective date is 24 months after the Final Rule published in the Federal Register.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.