Dec. 14 2016
WASHINGTON, D.C. – The Food and Drug Administration today denied an application by the Swedish Match tobacco company to eliminate or weaken required health warnings for eight of its snus smokeless tobacco products and allow these products to be marketed as “modified risk tobacco products” that are less harmful than other tobacco products. Swedish Match had asked the FDA to completely eliminate the congressionally-mandated warnings that smokeless tobacco products can cause mouth cancer and gum disease and to revise the warning that smokeless tobacco products are “not a safe alternative to cigarettes.”
The FDA had no choice but to reject this application based on the current record because Swedish Match failed to provide sufficient scientific evidence to support its claims and failed to meet the standard set by law for allowing modified risk claims. As the FDA accurately concluded, the evidence does not support claims that Swedish Match’s products cannot cause mouth cancer, tooth loss or gum disease. Swedish Match also failed to provide evidence that if its requests were granted, current tobacco users would change their behavior and would switch to one of its snus products.
Before allowing modified risk claims, a 2009 federal law – the Family Smoking Prevention and Tobacco Control Act – requires the FDA to look at whether a product, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual users and benefit the health of the population as a whole. In other words, the FDA must consider whether allowing the claim would increase the number of people, including kids, who start using tobacco products or reduce the number of current tobacco users who quit.
This was not a case of the FDA setting the bar too high or requiring too much scientific evidence. It was a situation in which a company failed to meet the most basic criteria required by the Tobacco Control Act. Indeed, while rejecting outright Swedish Match’s request regarding tooth loss and gum disease, the FDA deferred final action on Swedish Match’s two other requests to enable the company to revise its application, supplement the supporting evidence and conduct new studies within two years if it chooses to proceed.
In rejecting this proposal, the FDA made clear that it is prepared to grant a properly prepared modified risk application that seeks to make clear, understandable and scientifically accurate statements about the health risks of particularly products. A properly prepared application could well have received a different result, but the flaws in this application made it impossible for the FDA to approve it.
The Campaign for Tobacco-Free Kids, along with the Tobacco Control Legal Consortium, had filed extensive comments with the FDA opposing the Swedish Match application, raising many of the deficiencies cited by the agency.
Under the 2009 law that authorized the FDA to regulate tobacco products, tobacco companies can apply to the FDA to make a “modified risk” claim that a specific tobacco product is less harmful than other tobacco products, but they must meet criteria set by the law before they can do so.
Specifically, the law requires a company to demonstrate that the product “as it is actually used by consumers, will (A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole,” taking into account both users and non-users of tobacco products. In other words, the FDA must ensure that any reduction in harm to individual tobacco users is not offset by increasing the number of people, including kids, who start using tobacco products or reducing the number of current tobacco users who quit.
The modified risk process is intended for companies seeking to make a specific claim that a designated tobacco product is less harmful than other products. However, instead of asking permission to make such a claim, Swedish Match sought to use its modified risk application to change the statutory warning labels as they apply to eight of its snus smokeless tobacco products.
Under current law, all smokeless tobacco products are required to bear one of the following warning labels:
WARNING: This product can cause mouth cancer.
WARNING: This product can cause gum disease and tooth loss
WARNING: This product is not a safe alternative to cigarettes
WARNING: Smokeless tobacco is addictive.
Swedish Match proposed to eliminate the first two warnings altogether and to change the text of the third to read, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” The net result would have been that the proposed warnings for these products would not mention any specific disease or disease risk and the only health harm mentioned would be that the products are “addictive.” The FDA properly found that such a result would not be sufficient to warn the public against the dangers posed by these products and would not benefit public health.