Courts to the Rescue: FDA Cigar and Pipe Warning Statements

FDA Cigar Warning Requirement Delayed by Courts

On July 5, 2018, a federal judge for the U.S. District Court for the District of Columbia issued an injunction preventing the U.S. Food and Drug Administration (FDA) from enforcing the agency’s six new cigar health warning statements and the new pipe tobacco nicotine health warning statement.

Three cigar trade associations, including the Cigar Association of America, the International Premium Cigar & Pipe Retailers Association and Cigar Rights of America brought a lawsuit against the FDA’s deeming regulations related to premium cigars and pipe tobacco. The initial court ruling on the lawsuit was issued in May of this year, and the judge determined that the new cigar health warning statements and a new pipe tobacco health warning statement were within the FDA’s authority under its deeming regulations.

However, although the federal court’s initial decision in May upheld the new FDA health warning statements for cigars and pipe tobacco, the judge urged the agency not to proceed with implementing the new warnings. Specifically, the judge wrote: “Requiring the premium cigar industry to incur substantial compliance costs while the agency comprehensively reassesses the wisdom of regulation, before the warnings requirements go into effect, smacks of basic unfairness. In the court’s view, the prudent course would be for [the] FDA to stay the warnings requirement as to premium cigars.”

After the May court ruling, the three cigar organizations appealed that initial court decision to the U.S. Circuit Court of Appeals for the District of Columbia while also filing a motion to request an injunction against enforcement of the cigar and pipe tobacco warning statements.

With the injunction being granted on July 5, the cigar and pipe tobacco warning statements that otherwise would have gone into effect on Aug. 10, 2018, will not be enforced for a period of 60 days after a final decision is issued by the U.S. Circuit Court of Appeals. This means that the FDA cannot take any action to require the agency’s new warning statements for cigar and pipe tobacco packaging and advertisements until the pending lawsuit and the appeal are finalized.

Under the FDA’s deeming regulations, the six new cigar health warnings that were to go into effect on Aug. 10, 2018, but are now postponed due to the injunction are as follows:

  1. WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  2. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  3. WARNING: Cigar smoking can cause lung cancer and heart disease.
  4. WARNING: Cigars are not a safe alternative to cigarettes.
  5. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  6. 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.

The same six warning statements would apply to cigars sold individually and not in boxes or product packages.

However, instead of being required to place warnings directly on the cigars sold individually, retailers would have been required to post signage at the point-of-sale listing the six warnings on a sign that measures at least 8.5 inches x 11 inches.

For pipe tobacco, the only new health warning statement that would apply for product packaging or advertising is the nicotine health warning statement that reads: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

Now, with the injunction, cigar manufacturers, pipe tobacco manufacturers and retailers are no longer required to comply with the health warning statement requirements on product packaging, in advertisements or on in-store signage until the appeal of the pending lawsuit is finally resolved.

This story first appeared in the September/October 2018 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.