- The Food and Drug Administration has permitted the marketing of Swedish Match USA snus tobacco pouches.
- The American Lung Association criticizes the decision, saying not enough review has been done on the product.
- Experts disagree on how much safer snus tobacco pouches are than cigarettes.
Over the objections of the American Lung Association, the Food and Drug Administration (FDA) has
It’s the first time the agency has given the green light to a company to advertise through its modified risk tobacco product (MRTP) pathway.
Swedish Match USA will market snus — teabag-like pouches containing tobacco that the user holds in their mouth.
The packages will contain warnings that the product can cause cancer and other diseases but at a lower risk than if you use cigarettes.
Snus has been compared to dipping tobacco. It has been legally used in some areas of Europe since the 1500s, according to Swedish Match’s website.
It’s been marketed in the United States since 2015 but without the modified risk status on the label.
The products will be released under the “General” brand name.
The FDA said in its press release that the new status “does not mean these products are safe or ‘FDA approved.’ All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use.”
The new authorization is product-specific and good for 5 years.
The MRTP pathway became available in the
This is the first time in a decade the FDA has determined a product meets those guidelines.
The American Lung Association doesn’t agree with the FDA decision, saying Swedish Match USA didn’t submit enough evidence to justify the move.
“We’re disappointed,” Erika Sward, the Association’s national assistant vice president for advocacy, told Healthline. “The Lung Association and its partners urged the FDA not to grant this petition. We’re particularly disappointed that the FDA granted this for flavored products… We know enough about kids and about flavored tobacco to know who it’s aimed at.”
Sward stressed marketing authorization isn’t FDA approval, which the Lung Association is concerned will be the perception among young people and those who don’t already use tobacco.
“One major question is, if the youth use, will the FDA know about it before it’s too late, and will they do something about it?” she said.
Sward said the Association would want to see third-party surveys done to find out who is using snus — and have those surveys done in accurately.
“For example, if you asked kids if they use e-cigarettes, and don’t say ‘vape’ or “Juuls,’ they may not realize what you mean,” she explained. “This is the first reduced risk product that’s even been authorized in the United States. A lot of people are trying to figure it out right now.”
Gerry J. Roerty, the vice president and general counsel of Swedish Match North America, told Healthline in a statement: “Through the MRTP process, Swedish Match was required to conduct research approved by the FDA as sufficient to determine if making a claim to consumers would result in nonconsumers using General snus.
“The research results, shared and evaluated by the FDA, were that nonconsumers are not interested. Swedish Match provided the results for its research on whether the claim would positively influence consumers of cigarettes to use General snus and the research supported this.”
The statement added: “The FDA has itself conducted research (a PATH study) among young people to determine their use of tobacco products, including snus. Every use was reported at less than 2 percent and past 30-day use was reported at 0.7-0.8 percent.
“Finally, as a condition of keeping its MRTP status, Swedish Match must conduct post-market surveillance in a manner approved by the FDA and must submit its marketing plans to the FDA in advance of beginning to market the product with the modified risk claim.”
Dr. Harshal Kirane, the medical director of New York-based Wellbridge Addiction Treatment and Research, said snus is less harmful than cigarettes for two reasons.
“Combustion of tobacco, from lighting up a cigarette, creates numerous carcinogens, which directly impact many areas of the body. Snus does not involve combustion,” Kirane told Healthline. “Additionally, snus (are) prepared by way of pasteurization of tobacco, which lowers the content of toxic chemicals such as nitrosamines, compared with other forms of smokeless tobacco.”
“It appears there is a two- to threefold decrease in the risk of cancer, heart disease, and stroke,” Kirane said. “While those results are striking, it must be mentioned that most available data involved adult men and was obtained outside the U.S.”
Dr. Brad Rodu has published research on the health implications of smokeless tobacco — including snus — for 25 years. He holds an endowed chair in tobacco harm reduction at the University of Louisville in Kentucky and believes the FDA will be strict with snus.
As far as the evidence presented, Rodu said, “it was a huge application.”
“Smoke delivers nicotine, along with 7,000 other chemicals — many of which are toxic,” Rodu told Healthline. “Smokeless products deliver nicotine and other contaminants at trace levels that don’t cause disease. Epidemiological studies of smokeless users in Sweden and the U.S. indicate little or no risk of cancer.”
“American government officials (and) policymakers have repeatedly claimed that no tobacco product is safe, so they have never acknowledged that smokeless tobacco is vastly safer than smoking,” he added. “Just considering cancer, one study estimated that smokeless use among men would be associated with only 1.1 percent of the deaths now seen from smoking.”
The FDA said Swedish Match’s claim “is supported by scientific evidence, that consumers understand the claim and appropriately perceive the relative risk of these products, compared to cigarettes, and that the modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.”
Documentarian and founder of anti-drug advocacy group Steered Straight, Michael DeLeon, said the risk is still too great.
“It’s still carcinogenic to humans,” DeLeon told Healthline. “The (World Health Organization) concluded this in 1992, and every study done since then buttresses those conclusions.”
“The nicotine content has varied widely, and the addictive nature of nicotine causes massive problems to most people who use it, especially kids,” he added. “To say that people can quit smoking cigarettes by turning to snus, a completely different product and ingestion method, was ignoring the obvious. The more we paint a reduced perception of harm, ignoring proof of harm, the more we increase adolescent use of these products.”
The FDA authorization was also opposed by a group of five organizations, including the American Cancer Society, that sent a May 13 letter to the FDA voicing their concerns.
To market General snus beyond the current 5-year limit, Swedish Match must submit a renewal request before the current orders expire.
The FDA can pull the authorization at any time if it determines the company’s marketing “no longer benefits the health of the population as a whole.”
Kirane said to expect to see a “strong push” of new tobacco products in the United States.
“In the age of new options, it is essential that consumers of these products understand the potential harms and benefits,” he said. “New products may potentially offer decreased risk compared to smoking, but for those who have never used tobacco, the healthiest choice is never to start.”