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  1. FDA In Brief

FDA In Brief: FDA affirms commitment to warning the public about nicotine in tobacco products following court ruling

July 26, 2018


 Michael Felberbaum

“Balancing the complex public health considerations around nicotine is at the center of our comprehensive approach to significantly reducing tobacco-related disease and death. We’re advancing policies that get us closer to the goal of cigarettes that are minimally or non-addictive by lowering nicotine levels in combustible cigarettes, while allowing adults who still seek nicotine to get it from other, potentially less harmful sources. Because nicotine is central to the issue of addiction – with both the potential to lessen or prevent tobacco use and, also, the danger of fueling it – it’s imperative that people are adequately informed of the presence of nicotine in tobacco products and understand the risks – especially kids, who research shows are misinformed,” said FDA Commissioner Scott Gottlieb, M.D. “We know that nicotine addiction can harm brain development, keep people smoking even when they try to quit, and increase the risk of young people becoming lifelong cigarette smokers. That’s why we’re requiring the addition of health warnings about nicotine’s addictive properties on packaging and advertisements for most tobacco products, including e-cigarettes and hookah tobacco, which are commonly used by kids as well as adults. Our efforts to advance policies related to these and other deemed products are a cornerstone of our public health mission. Public health warnings for some tobacco products ‒ cigars and pipe tobacco ‒ are being challenged in court, and even though the court agreed with the FDA that the warnings are lawful, they are unfortunately on a temporary hold while that decision is challenged on appeal. The court’s temporary hold only affects cigars and pipe tobacco, and the FDA is enforcing the requirements on other tobacco products. These are important public health warnings that every tobacco consumer should have access to, especially youth who we know use tobacco products and are even less aware of the risks and the presence of nicotine. I believe consumers who use cigars and pipe tobacco products should be informed about the risks, similar to any consumer who uses a tobacco product. The FDA will continue to defend litigation contesting these warnings and pursue these practical, public health requirements.”

According to the U.S. Centers for Disease Control and Prevention and the National Youth Tobacco Survey, e-cigarettes have been the most commonly used tobacco product among youth since 2014 and many young people do not know that the products they use contain nicotine. Additionally, research shows that nicotine is powerfully addictive and often delivered through tobacco products designed to get and keep people addicted, even when they want to stop.

When the FDA “deeming” regulation went into effect in August 2016, one requirement was the addition of health warnings about the risks of nicotine to “covered” tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco, as well as cigarette tobacco and roll-your-own tobacco. In addition, to assist manufacturers of these products, the preamble to the “deeming” regulation set forth a matching compliance period for other package labeling requirements under sections 903(a)(2) and 920(a)(1) of the Family Smoking Prevention and Tobacco Control Act.

Today, the FDA is reminding companies of the upcoming Aug. 10 compliance date for the health warning and certain other labeling and advertising requirements for these products.  A recent court order, however, enjoins the FDA from enforcing health warning requirements for cigar and pipe tobacco product labeling and advertising set forth in 21 C.F.R. §§ 1143.3 and 1143.5 until 60 days after a final decision on appeal. In addition, to avoid requiring firms to make labeling changes twice for cigars and pipe tobacco products, the FDA intends to issue guidance shortly explaining that it does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a)(1) for cigars and pipe tobacco products while that injunction is in effect. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.




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