Smokeless Tobacco Product Snus Receives FDA Sales Authorization in the USA

The US Food and Drug Administration (FDA) announced that, as of 22 October 2019, it had for the first time authorized marketing of a reduced-risk tobacco product. These authorizations apply to tobacco products sold under the name "General’" by the manufacturer Swedish Match.

These smokeless tobacco products are known as Swedish Snus and have a 200-year history in Sweden. An estimated 10 percent of the world’s population uses smokeless tobacco, including snus.

Swedish Match had previously applied to the FDA in 2015 to market its products. After reviewing the scientific evidence submitted, the FDA announced authorization for their sale. Under this authorization, "General" products may now be marketed as less harmful than cigarettes. The authorization is specific to the designated products and may remain valid for 5 years.

The agency will also impose restrictions on advertising, promotion and marketing to prevent youth access and exposure. As with other tobacco products, required warning statements will appear on packaging and advertisements.

Authorized for Sale, Not "FDA Approved"!

The FDA also stated that permitting sale does not mean these products are safe or "FDA approved"; authorization doesnotmean this. Ultimately, all tobacco products are potentially harmful and addictive. Authorization will be revoked if the products are considered not to benefit public health.

Although all tobacco products pose health risks, under the Family Smoking Prevention and Tobacco Control Act introduced in 2009, the FDA had announced that reduced-risk tobacco products could be evaluated . In this context, the agency examines health effects of products submitted and tries to determine whether they create new addictions in society. Even if safer in risk terms, reaching new users is regarded as a greater public health threat. Based on studies reviewed so far, General products are seen as less harmful to health than other tobacco products.

Current scientific evidence suggests that, compared with smoking, using these specific tobacco products reduces risks of heart disease, lung cancer, stroke, emphysema and chronic bronchitis. However, with snus tobacco products, risks of oral cancer and oral disease are significant, and disruption of the oral flora / beneficial bacterial balance is also known.

In conclusion, we emphasize that all tobacco products harm health and that their addictive effects must be considered. In response to this FDA authorization, "How Much Do We Need a New Tobacco Product?!" is a criticism we cannot help making. The most important point is that people under 25 in particular should not open the door to new addictions by starting this product. It is also important that products promoted as safer alternatives to cigarettes not be used together with cigarettes. We recognize the need for a broader public health perspective and believe further studies will assess overall product safety more objectively.