FDA NewsPerspective

FDA extends authority over e-cigarettes, cigars, hookah tobacco

The FDA today extended its regulatory authority over all tobacco products, including e-cigarettes, cigars and hookah tobacco, prohibiting retailers from selling these products to persons aged younger than 18 years, according to a press release.

The regulations, which help implement the Family Smoking Prevention and Tobacco Control Act of 2009, will go into effect in 90 days.

Sylvia Mathews Burwell

Sylvia Mathews Burwell

“Today’s announcement is an important step in the fight for a tobacco-free generation,” Sylvia Mathews Burwell, secretary of the Department of Health and Human Services, said in the release. “It will help us catch up with changes in the marketplace, put into place rules that protect our kids, and give adults information they need to make informed decisions.”

A survey reported by the FDA and CDC showed that e-cigarette use among high school students rose from 1.5% in 2011 to 16% in 2015, the release said. Before today, no federal law prohibited retailers from selling e-cigarettes, hookah tobacco or cigars to children aged younger than 18. Today’s rule will allow the FDA to restrict retailers from selling tobacco products to children by requiring photo ID for age verification. For these new tobacco products, the FDA will require the manufacturer to register their establishment, provide product listings, report ingredients, pass premarket review and authorization, place health warnings on packages and advertisements, and not sell any modified-risk tobacco products unless authorized.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” Burwell said. “All of this is creating a new generation of Americans who are at risk of addiction. We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth.”

The FDA today extended its regulatory authority over all tobacco products, including e-cigarettes, cigars and hookah tobacco, prohibiting retailers from selling these products to persons aged younger than 18 years, according to a press release.

The regulations, which help implement the Family Smoking Prevention and Tobacco Control Act of 2009, will go into effect in 90 days.

Sylvia Mathews Burwell

Sylvia Mathews Burwell

“Today’s announcement is an important step in the fight for a tobacco-free generation,” Sylvia Mathews Burwell, secretary of the Department of Health and Human Services, said in the release. “It will help us catch up with changes in the marketplace, put into place rules that protect our kids, and give adults information they need to make informed decisions.”

A survey reported by the FDA and CDC showed that e-cigarette use among high school students rose from 1.5% in 2011 to 16% in 2015, the release said. Before today, no federal law prohibited retailers from selling e-cigarettes, hookah tobacco or cigars to children aged younger than 18. Today’s rule will allow the FDA to restrict retailers from selling tobacco products to children by requiring photo ID for age verification. For these new tobacco products, the FDA will require the manufacturer to register their establishment, provide product listings, report ingredients, pass premarket review and authorization, place health warnings on packages and advertisements, and not sell any modified-risk tobacco products unless authorized.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” Burwell said. “All of this is creating a new generation of Americans who are at risk of addiction. We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth.”

    Perspective
    Benard P. Dreyer

    Benard P. Dreyer

    The AAP welcomes the long-awaited final rule issued today by the U.S. FDA giving the agency the authority to regulate e-cigarettes, cigars, hookah and other tobacco products.

    As pediatricians, we do everything in our power to ensure that all children have the opportunity to grow up healthy and free from addiction to tobacco and nicotine. Addressing the threat of tobacco, no matter the form it takes, is imperative to meet that goal, which is why the AAP advocated every step of the way for a rule that is strong, effective and most protective of children.

    The rule is a welcomed starting point, but it is only a framework upon which to build meaningful regulation to end the tobacco epidemic in the United States once and for all. Today’s action marks an historic step forward in helping to alleviate the threat of lifelong nicotine addiction for our youth, and should serve as a foundation for further progress when it comes to keeping children safe from dangerous tobacco products.

    More work must be done now as e-cigarettes become more and more common in households and communities across the country. FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape or to prevent marketing tactics that target children. The Academy also looks forward to a law – the Child Nicotine Poisoning Prevention Act – taking effect this summer that will require child-resistant packaging on liquid nicotine containers. The AAP will continue to urge FDA to strengthen its efforts to protect children from tobacco.

    • Benard P. Dreyer, MD
    • President AAP

    Disclosures: Dreyer reports no relevant financial disclosures.

    Perspective

     

    Suchitra Krishnan-Sarin, PhD

    Suchitra Krishnan-Sarin

    Lisa Fucito, PhD

    Lisa Fucito

    The FDA’s recent rule is a significant step in the right direction and could help reduce the significant uptake in the use of newer products like e-cigarettes, especially among youth. E-cigarette use and sales have been rising significantly over the past few years, and there is an ongoing public health debate regarding the therapeutic potential of these products. Despite the burgeoning ease of availability of these products, especially online and in so-called vape shops, there is limited information regarding their safety or efficacy in reducing combustible tobacco use behaviors. The requirement that vape shops will have to comply with all the rules that apply to other manufacturers further enhances the public protections provided by the ruling.

    However, the rule does not address flavors in tobacco products. Flavors are one of the primary reasons that many youth initiate use of tobacco products, and they are believed to help reduce the sensory irritation experienced from nicotine and tobacco smoke. Although we know little about the toxicity of most flavors, many contain chemicals that are known to be toxic. Diacetyl, which can cause “popcorn lung,” is present in many e-liquids. Another key component of many e-liquid flavors are aldehydes, which — along with their oxidation products — are known to react with many biomolecules to produce pulmonary irritants.
    The staggered implementation of these rules for up to a 3-year period could allow many existing and potentially unsafe products to remain on the market for extended periods of time. The rule also does not explicitly address how the marketing and advertising of tobacco products online would be regulated.
    Regardless, the comprehensive regulation of all tobacco products by the FDA has the potential to have significant effects on the use of combustible and noncombustible tobacco products in the United States, and to reduce the burden of cancer and many other tobacco-related diseases. There is a critical need to develop scientific evidence to support these regulatory efforts.

    • Suchitra Krishnan-Sarin and Lisa Fucito, PhD
    • Smilow Cancer Center Yale School of Medicine

    Disclosures: Krishnan-Sarin and Fucito report no relevant financial disclosures.

    Perspective
    Michael B. Steinberg

    Michael B. Steinberg

    E-cigarettes have entered the market over the past decade and have rapidly become a multibillion-dollar industry. In recent weeks, the Royal College of Physicians in the United Kingdom and now the FDA have taken positions regarding the role and regulation that e-cigarettes could play in society. The Royal College of Physicians has advocated that e-cigarettes be viewed as a tool for smoking cessation and that the benefits likely outweigh the risks. The FDA announced it will regulate tobacco products — including hookah, cigars and e-cigarettes — and will require companies to demonstrate that these products do not represent a major risk to the public’s health. Although it is likely that e-cigarettes pose less harm than combusted tobacco products, less harm is not the same as safe. 

    Although controversial in some positions, proposed FDA regulation of tobacco products — including e-cigarettes — has at its core some major components with which most reasonable people would agree. These include:

    1) Tobacco products, including e-cigarettes, should not be sold to those aged younger than 18 years, nor should they be marketed or targeted to children.

    2) Consumers have a right to know what chemicals and potential toxins they are being exposed to from tobacco products. Therefore, these products should undergo testing to document the toxins found in e-cigarette vapor, and what the potential harms could be from these chemicals. Only then can consumers make an informed decision about their use. Consumers who want to get a certain amount of nicotine from their e-cigarettes should be confident that a product is actually delivering that amount. For this to happen, there needs to be some oversight of the manufacturing process.

    3) Once this information is known, it needs to be conveyed to the public in the form of ingredient lists and health warnings. 

    The debated issue comes from the system details as to how regulation of these products will occur. The crux of this has to do with the “grandfathering” of certain products. E-cigarette manufacturers seem to claim that the plan as proposed would give an advantage to cigarette companies over e-cigarette manufacturers due to the timing of when these products came to market. Although the details are not yet clear, common sense would dictate that a system that favors more harmful products — such as combusted tobacco products — over potentially less harmful products, such as e-cigarettes, does not make good public health sense. Thus, the FDA regulatory framework should take into account the relative harm of products in creating its proposed pathway.

    • Michael B. Steinberg, MD, MPH, FACP
    • HemOnc Today Editorial Board member Rutgers Robert Wood Johnson Medical School

    Disclosures: Steinberg reports no relevant financial disclosures.