LAKEVILLE, Minn.-- Most who have followed stories about tobacco legislation and regulation in recent years would recognize that the concepts of “relative risk” and “harm reduction” have received considerable attention and been the subject of fierce debate.
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, FDA Center for Tobacco Products Director Mitch Zeller, experts and advocates from public health and tobacco control, businesses and consumers have debated potential benefits (or risks) of applying proven harm-reduction strategies from other health fields toward reducing risks associated with tobacco consumption.
In early 2019, the FDA Tobacco Products Scientific Advisory Committee (TPSAC) will hold a hearing directly related to these concepts and the outcome will provide a clearer picture of where the committee stands on the issue.
The concepts themselves are not particularly complicated. Different tobacco and nicotine products, whether traditional combustible cigarettes, cigars, a wide variety of smokeless tobacco products or electronic vapor products, possess different product attributes, are used differently and pose different risks for consumers.
Long-term scientific data clearly demonstrates that smokeless tobacco poses less health risks. Smokeless tobacco users’ health risks are generally lower than compared to the use of other tobacco products. The questions soon to be considered by TPSAC relate to how this information about lower health risks may, or may not, be provided to the public.
Under current law, tobacco product manufacturers are prohibited from making health claims about their products. One exception provided in the Tobacco Control Act is if the FDA approves claims under what is known as the modified-risk tobacco product (MRTP) pathway. Under this regulatory pathway, the FDA must refer applications submitted by manufacturers to make various health claims to the TPSAC to review MRTP applications concerning scientific issues, including safety, dependence and health issues, and then provide advice, information and recommendations to the FDA to use in its evaluation.
The FDA makes the final determinations about whether to authorize the MRTP to allow specific health-related claims and is under no burden to follow recommendations or votes provided by TPSAC.
Richmond, Va.-based Altria Group Inc., on behalf its subsidiary U.S. Smokeless Tobacco Co., has submitted an MRTP claim for its Copenhagen brand fine-cut moist snuff product. The application asks the TPSAC and FDA to consider allowing the health claim that states, “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”
Years of data and science support this claim. And on Feb. 6-7, 2019, TPSAC will meet at the FDA in Silver Spring, Md., to consider this new MRTP submitted by Altria and amended versions of previously submitted MRTP applications from Swedish Match North America Inc., Richmond, Va., for eight snus smokeless tobacco products sold under the General brand.
Earlier this year, in regard to MRTP applications for Winston-Salem, N.C.-based Reynolds American Inc.’s Camel Snus products, TPSAC recognized that the available science supports that switching completely from cigarettes to Camel Snus can reduce risks of lung cancer and respiratory disease. The TPSAC has not has yet issued an MRTP marketing order on Camel Snus.
CHICAGO -- From the possible buy-in between Big Tobacco and Juul to the U.S. Food and Drug Administration’s (FDA) assault on menthol cigarettes and flavored vaping pods, the past year has been a roller coaster for retailers trying to keep up with a category not typically known for innovation or change.
The FDA played the biggest role in all that commotion, with Commissioner Scott Gottlieb announcing a sweeping range of proposals that will certainly reshape the tobacco category for years to come.
Here’s a countdown of eight of the top tobacco stories of 2018 …
On June 5, a majority of voters in San Francisco approved Proposition E, a measure questioning the Board of Supervisors’ decision in 2017 to ban flavored tobacco products. Those products include menthol cigarettes, candy-flavored tobacco products and flavored vaping liquids. Sixty-eight percent of voters were in favor of the measure and 31% opposed it, reported CNN.
R.J. Reynolds Vapor Co. on April 13 voluntarily initiated a nationwide safety recall of all Vuse Vibe power units after receiving consumer complaints about malfunctioning batteries, which may cause the power unit to overheat and create a fire risk.
The Winston-Salem, N.C.-based company notified the FDA regarding the issue and said it would work directly with the agency on the voluntary recall. Vuse Solo and Vuse Ciro, which use different battery components, were not part of the recall. No similar incidents have been reported to the company about these products.
As medicinal remedies using cannabidiols (CBDs)—or products derived from cannabis or hemp that do not contain the psychoactive chemicals found in marijuana—begin to filter into convenience-store inventories so does concern over product safety. One of the products c-store retailers have been encountering is kratom, a medicinal remedy produced from a Southeast Asian plant.
On April 3, the FDA issued a mandatory recall of all food products containing powdered kratom manufactured, processed, packed or held by Triangle Pharmanaturals LLC after several of the products were found to contain salmonella.
This was the first time the FDA issued a mandatory recall. It took action after Las Vegas-based Triangle Pharmanaturals failed to cooperate with its request to conduct a voluntary recall.
In a sweeping move to reinforce its public statements on preventing underage sales of e-cigarettes—and a move that may potentially affect product flavors—the FDA in September issued 1,300 warning letters and fines to an undisclosed number of retailers as a result of a summer-long undercover operation at the store level, the agency announced.
The majority of the violations were for the illegal sale of five e-cigarette products: Vuse, Blu, Juul, MarkTen XL and Logic, the agency said. These five brands currently make up more than 97% of the U.S. market for e-cigarettes, according to the FDA.
The agency gave each of the five e-cigarette companies 60 days to submit plans describing how they will address youth access and use of their products.
This fall, Richmond, Va.-based Altria Group Inc. and San Francisco-based Juul announced they would stop selling certain vaping products at retail outlets as a result of talks with the FDA. The agency had expressed concerns over minors getting their hands on their vaping devices.
Altria announced plans to remove its MarkTen Elite and Apex by MarkTen pod-based vaping products until they “receive a market order from the FDA or the youth issue is otherwise addressed,” the company said in a press release.
Days later, Juul stopped accepting retail orders for its Mango, Fruit, Creme and Cucumber Juul pods from the more than 90,000 retail stores—including convenience stores, tobacco retailers and vape shops—that sell its products. Juul will make those flavors available only on Juul.com, where it is adding further age-verification measures to an online sales system that is restricted to people 21 years old and uses third-party verification.
While deciding not to follow through on an anticipated ban on flavored electronic cigarettes in c-stores, the FDA did propose bans on menthol in combustible cigarettes and cigars, along with a ban on flavored cigars.
On Nov. 15, Gottlieb said the agency will allow c-stores to sell flavored e-cigarettes, vaping products and other electronic nicotine delivery systems (ENDS) but only in age-restricted areas.
This move does not include tobacco retailers and vape shops that prevent entry of persons under the age of 18.
The FDA will also advance a notice of proposed rulemaking that would seek to ban menthol in combustible tobacco products. The agency’s research suggests “menthol use is likely associated with increased smoking initiation by youth and young adults,” said Gottlieb.
Altria, the maker of the dominant Marlboro cigarette brand, is reportedly vying for a significant minority stake in e-cigarette upstart Juul Labs, according to The Wall Street Journal.
Citing people familiar with the matter, the news source said no deal is imminent—and nothing is certain—but if it were to happen, such a move would come with a hefty price tag. With just a few hundred employees, the three-year-old Juul was valued at $16 billion in a funding round this summer, the Journal reported.
After counting the midterm ballots this past fall, Michigan became the 10th state in the United States to legalize recreational marijuana, while voters in Missouri and Utah passed measures that would legalize marijuana for medicinal use, the Huffington Post reported. The latter moves make those states the 31st and 32nd to approve medical marijuana.
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