LAKEVILLE, Minn. -- Earlier this week, NATO filed two public comments with the U.S. Food and Drug Administration (FDA) regarding modified-risk tobacco product (MRTP) applications the agency is considering related to nine smokeless tobacco products.
Swedish Match North America Inc., Richmond, Va., amended an earlier MRTP application initially submitted in 2014 for eight General snus products; and a subsidiary of Richmond, Va.-based Altria Group Inc., U.S. Smokeless Tobacco Co., filed an MRTP application for its Copenhagen fine-cut moist snuff. NATO filed comments in support of all nine applications and encouraged the FDA to grant modified-risk orders for each.
Under the Family Smoking Prevention and Tobacco Control Act, manufacturers themselves are prohibited from making health claims and are only allowed to do so through modified-risk orders issued by the FDA. Previously, both FDA Commissioner Scott Gottlieb and Center for Tobacco Products (CTP) Director Mitch Zeller have recognized that delivery of nicotine through various means exists on a “continuum of risk.” It is widely accepted within the scientific community that combustible tobacco products are on the higher end of the spectrum of risk while noncombustible nicotine products such as electronic cigarettes or smokeless tobacco fall on the lower end of the spectrum, closer to nicotine-replacement therapies.
While many experts recognize that switching from combustible to noncombustible tobacco and nicotine can provide health benefits, the public, and smokers specifically, are often unaware of potential benefits. In its public comments, NATO urged the FDA to consider that the American public and adult tobacco consumers (who buy products from our member businesses) deserve accurate information upon which to make informed health choices. Making such information accessible not only benefits individuals, but also benefits our population’s health overall.
The MRTP application from U.S. Smokeless Tobacco for its Copenhagen fine-cut moist snuff is receiving its first consideration by the agency. The applications for the eight General snus products from Swedish Match are a continuation of a process begun with the filing of initial MRTP applications in 2014.
In regard to the Swedish Match applications, the CTP previously provided Swedish Match with specific, written recommendations to correct deficiencies it found in the applications and suggested it file amended applications. In response, Swedish Match changed its proposed claims, supplemented the requested evidence and conducted new scientific studies as recommended by the agency.
Swedish Match indicated its willingness to retain a label statement requested by CTP that reads, “WARNING: This product is not a safe alternative to cigarettes.”
Swedish Match requests a modified-risk order to make the following claim about its General snus products: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”
The MRTP application filed by U.S. Smokeless Tobacco’s Copenhagen is seeking approval of the modified-risk claim for Copenhagen Snuff Fine Cut that reads: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”
Reynolds American Inc., Winston-Salem, N.C., is also awaiting approval from the FDA for MRTP applications related to six of its Camel Snus products. Reynolds filed initial MRTP applications in March 2017 and the Tobacco Products Scientific Advisory Committee (TPSAC) considered the applications in September 2018. FDA takes TPSAC recommendations under consideration but makes its determination based on its own review.
RICHMOND, Va.—Close talks with the U.S. Food and Drug Administration (FDA), a minority stake in upstart Juul e-cigarettes and a public step into the marijuana business all happened in a matter of weeks at the tail end of 2018 and into the new year for one of the country’s largest producers of tobacco products, Altria Group Inc.
Faced with the steady decline of cigarette volume across the United States in recent years, tobacco companies like Richmond, Va.-based maker of the popular Marlboro brand of cigarettes have had to scramble to remake their destinies. But none has moved quicker in the past few weeks than Altria.
Here’s a summary of their latest moves …
Following warning letters sent by the FDA last fall to several manufacturers of electronic cigarettes and 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.
The move is the first in what could be many steps by manufacturers as the FDA investigates marketing practices for such devices. The FDA held meetings with top manufacturers late last year and announced its intentions to call for more meetings in 2019.
Announced alongside its quarterly earnings report on Oct. 25, Altria related its actions back to the FDA’s September announcement of steps it is taking to address the problem of minors using vaping products.
On Dec. 7, Altria announcement it would discontinue the production and distribution of all its MarkTen and Green Smoke e-vapor products, as well as Verve oral nicotine-containing products. The company said its decision was based on current and expected financial performance of these products, coupled with regulatory restrictions that burden Altria’s ability to quickly improve these products. The company said it will refocus its resources on “more compelling” reduced-risk tobacco-product opportunities.
Altria signed and closed on a $12.8 billion investment in Juul Labs Inc., a San Francisco-based maker of electronic cigarettes and e-vapor products. Announced in December, the investment represents a 35% economic interest in Juul, valuing the company at $38 billion. Altria will participate in the e-vapor category only through Juul, it said.
Altria’s stated strategic rationale for the investment in Juul is that it:
- Provides a significant stake in the largest and fastest growing e-vapor company with a highly talented management team, successful in-market products and strong innovation pipeline.
- Offers exposure to strong revenue and volume growth opportunity with attractive unit economics and to significant international growth plans and global e-vapor profit pool.
- Better positions Altria with adult smokers interested in alternatives while continuing to compete vigorously in all other tobacco product markets.
Juul will remain fully independent, the companies said, but it will have access to Altria’s infrastructure and services.
In December, Altria also made a significant move in the marijuana business, entering an agreement to acquire newly issued shares in Cronos Group Inc., a Toronto-based cannabinoid company. The transaction represents a 45% equity stake in Cronos Group for an aggregate investment of approximately $1.8 billion.
Regarding its heat-not-burn product, iQOS, Altria officials said they could move the devices to market as quickly as three to four months after the FDA approves the tobacco company’s new-product application.