Injunction Prohibits FDA Enforcement of Only Cigar and Pipe Tobacco Warning Requirements; August Compliance Date Remains in Effect for All Other Covered Tobacco Products

RJO Update:
Retail Industry Trade Regulation and Environmental Law
August 2018

Injunction Prohibits FDA Enforcement of Only Cigar and Pipe Tobacco Warning Requirements; August Compliance Date Remains in Effect for All Other Covered Tobacco Products

By Suhani Kamdar

In May 2016, the Food and Drug Administration (“FDA”) promulgated the “Deeming Rule,” which subjected cigars (including little cigars and cigarillos), pipe tobacco, e-cigarettes and other covered tobacco products to warning requirements.  In enacting the Deeming Rule, the agency appeared primed for a legal battle, and three non-profit associations representing cigar industry members brought suit in July 2016.  In May of this year, the D.C. Circuit court granted the FDA a sizeable—but pyrrhic—victory in defense of cigar warning requirements.  Plaintiffs appealed and successfully sought injunctive relief.  Last month, the D.C. Circuit court entered an order enjoining the FDA from enforcing health warning requirements for cigar and pipe tobacco product labeling and advertising set forth at 21 CFR §§1143.3 and 1143.5 until 60 days after the final disposition of the appeal.

Although the FDA may not enforce the Deeming Rule’s warning requirements for cigars or pipe tobacco, it retains free rein to enforce warning requirements for other product categories.  Therefore, as of August 10, 2018, no entity may manufacture, sell or offer to sell nicotine-containing cigarette tobacco, roll-your-own tobacco, hookah tobacco, e-cigarettes, e-liquids or liquid nicotine (for the sake of simplicity, referred to herein as “subject tobacco products”) unless the product package bears the following addictiveness warning:

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

The addictiveness warning must appear directly on the package, either indelibly printed or permanently affixed, and it must be clearly visible underneath any wrapping.  The warning statement must also meet a host of requirements relating to size, appearance and location.  For example, the warning area must comprise at least 30% of each of the principal display panels, and the statement must be printed in at least 12-point font size.

Retailers who sell subject tobacco products with a deficient warning label are afforded a “safe harbor.”  Retailers will not be considered in violation of the warning requirements if the packaging meets the following three requirements:  (1) it contains a health warning; (2) it is supplied to the retailer by the tobacco product manufacturer, importer or distributor who has the required state, local or federal license or permit; and (3) it is not altered by the retailer in any material way. Note, however, that subject tobacco products with non-compliant packaging may not be distributed as of September 11, 2018.

The addictiveness warning statement must also appear on advertisements.  Any manufacturer, distributor or retailer who advertises or causes to be advertised subject tobacco products must include the required warning statement on any advertisement with a visual component, including advertisements on Internet web pages.  Again, the addictiveness warning statement must meet several requirements relating to size, appearance and location.  For example, the warning statement must occupy at least 20% of the area of the advertisement and must be surrounded by a rectangular border.  Internet advertising on non-static pages, which “scroll,” raises questions regarding the method for determining the area over which a statement must appear; the FDA has not provided written guidance on this issue.

Advertising-related requirements for subject tobacco products only apply to retailers who are responsible for or who direct the required health warning.  Nonetheless, retailers will face liability if they display, in a location open to the public, an advertisement that does not contain a health warning or that contains a health warning materially altered by the retailer.

The advertising-related warning requirements under the Deeming Rule also become effective on August 10, 2018. As of that date, all entities that manufacture, distribute, sell or offer for sale cigarette tobacco, roll-your-own tobacco, e-cigarettes, hookah tobacco, liquid nicotine and other covered tobacco products-except for cigars and pipe tobacco-must ensure compliance with all warning requirements specified in the Rule, unless listed exemptions or “safe harbor” provisions apply.

• Note: Businesses that manufacture, distribute, sell or offer for sale tobacco products in California must also comply with Proposition 65 warnings requirements. See new regulations at 27 Cal. Code Regs. §§ 25600 et seq., effective August 30, 2018.

How We Can Help Your Company

Rogers Joseph O’Donnell specializes in helping its clients comply with laws impacting the sale of consumer products as well as alcohol and tobacco.  If you have any questions related to compliance with Federal or California statutory requirements, Renee D. Wasserman (rwasserman@rjo.com), Alexis J. Morris (amorris@rjo.com), Suhani Kamdar (skamdar@rjo.com) and Alecia Cotton (acotton@rjo.com) are available to assist.  Biographies and other contact information are available at: https://www.rjo.com.