The U.S. Food and Drug Administration (FDA) is moving forward with requirements for warning labels on cigars in spite of multiple lawsuits surrounding labeling on tobacco products.

Beginning on May 10, 2018, all cigar packages from the United States must have one of six specific warning statements randomly displayed on the packaging. Manufacturers are required to submit a proposal to the FDA on how they will comply with the new packaging 12 months before marketing a cigar or no later than May 10, 2017.

The statements not only have to be rotated randomly over a 12-month period but they have to be displayed in very specific ways. For example, they must be in a prominent location and appear in Helvetica bold or Arial bold font against a solid white background.

According to the FDA, the exact phrasing, capitalization, and punctuation of the warning labels must be as follows:

  • 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.
  • SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight.*
  • WARNING: This product contains nicotine. Nicotine is an addictive chemical.

In 2016, the FDA finalized a rule extending its regulatory authority to cover all tobacco products, including cigars. Before the FDA’s decision, the agency only regulated cigarettes and related products. The new rule allows the agency to regulate how all tobacco products can be advertised and promoted.

Critics Question Cigar Label Requirements

Criticism on how the FDA is handling warning labels for tobacco products has come from both sides.

Dr. Brad Rodu, professor of medicine and a first holder of the endowed chair in Tobacco Harm Reduction Research at the University of Louisville, has been a vocal critic of the FDA’s campaign against tobacco products. He recently took issue with the research the FDA presented to justify the labels on cigars.

In a review carried out by FDA staff, it was concluded that smoking cigars is just as dangerous as cigarettes.

“In summary, cigar smoking carries many of the same health risks as cigarette smoking,” the authors of the study wrote. “Mortality risks from cigar smoking vary by level of exposure as measured by cigars per day and inhalation level and can be as high as or exceed those of cigarette smoking.”

But Rodu found that “consumption of up to two cigars per day, while not completely safe, is neither associated with significantly increased risks for death from all causes, nor smoking-related cancers” once he delved into the data.

This decision also comes in light of a study published Dec. 12 in the Journal of Adolescent Health suggesting that teens may not heed health warnings on cigars. More than 1,100 U.S. teens between 13 and 17 years old were surveyed on how much they believed cigar warnings.

Only about half thought the warnings that cigar smoking can cause cancers of the mouth and throat even without inhaling and that cigars are not safe alternatives to cigarettes were believable.

Cigar Warning Labels Come Amid Lawsuits

The FDA has come under fire in the past for its attempt to regulate warning labels on cigarettes similar to what it’s now doing with cigars. After the Tobacco Control Act was signed in 2009, the FDA was able to select nine label warnings that would be required on cigarette packs.

The graphic warnings, which came with stringent requirements, were scheduled to be on cigarette packaging in September 2012 but were halted after a group of tobacco companies filed a lawsuit against the FDA for exceeding authority and violating free speech. The labels were struck down in court based on First Amendment grounds.

At the other end of the spectrum, a group of antitobacco organizations filed a lawsuit in October 2016 to force the FDA to abide by the Tobacco Control Act and impose the extremely delayed graphic labels. The FDA has yet to create new label warnings and is therefore in violation of the law, the lawsuit states according to the Wall Street Journal.

While the antitobacco groups behind the lawsuit insist that warning labels are effective tools at stopping people from taking up smoking, 2007 research from the American Journal of Preventive Medicine suggests that it’s one of the least effective measures in raising awareness of the dangers.