FDA puts off modified risk decision

The US Food and Drug Administration has deferred a decision on whether to allow Swedish Match North America (SMNA) to claim that use of its General snus brand causes less harm than is caused by smoking combustible cigarettes. It said in a press note issued through PRNewswire that it had ‘issued a response that offers the company an option to amend its applications’.

In January 2011, SMNA started the formal process of making a modified risk tobacco product (MRTP) application and, on August 27, 2014, it became the first company to complete such an application.

The application involved the submission of something of the order of 1,000 pages of evidence with about 120,000 pages of supporting documents, some of which related to studies that pre-dated the start of the application.

On July 31, 2015, at the request of the FDA, SMNA supplied additional information.

SMNA made the application because it wanted to be able to modify, for a number of products within its General snus brand, the health warnings currently applied to all smokeless products sold in the US and to advertising for those products. These warnings declare: this product can cause mouth cancer; this product can cause gum disease and tooth loss; this product is addictive; and this product is not a safe alternative to cigarettes.

The company wanted the first two warnings dropped, the third warning about addictiveness left in place, and the fourth warning replaced with one reading: no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.

SMNA made the warning labels the target of its application because research had indicated that consumers were confused by, on the one hand, seeing dire warnings on snus packs, while, on the other, reading third party reports of studies showing that the consumption of snus was less risky by a factor of 90 percent and upwards than was the consumption of cigarettes.

The US Congress made provision for companies to make MRTP applications to the FDA when it passed the Tobacco Control Act in 2009.

Yesterday, the FDA said it had taken action on the first applications reviewed through the MRTP pathway for eight SMNA snus smokeless tobacco products sold under the General brand name.

‘The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss,’ it said. ‘With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.’

“The lessons learned through these first applications provide key insights moving forward,” said Mitch Zeller, J.D., director for the FDA’s Center for Tobacco Products. “For example, companies should carefully consider how they plan to present and substantiate a modified risk claim. While the FDA is not authorizing modified risk orders for these products at this time, our guidance to the company will enable it to amend its applications if it chooses.”

‘Based on the scientific evidence provided in the applications, as well as other available data, the agency determined that the request to remove the warning related to gum disease and tooth loss should be denied because these products can cause gum disease and tooth loss,’ the FDA said in its note. ‘On the other two requests, for which the FDA has deferred final action, the agency believes that the applications could be amended to support issuance of modified risk orders and has requested that the company amend the applications within two years if it chooses to proceed.

‘In its review, the FDA must 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 making this assessment, the agency must consider whether those who do not use tobacco products would start using the product or whether existing tobacco users who would have otherwise quit would switch to the modified risk product instead.’

In response to the FDA’s announcement Swedish Match (SM), in a note posted on its website, said that the agency had outlined the process forward and encouraged SM to continue its efforts to seek modified risk status for General Snus. ‘Swedish Match interprets their position as wanting to further discuss on how to best communicate a modified risk message to the general public,’ said SM.

‘Although the FDA has not yet approved Swedish Match’s MRTP-application, the Agency had previously determined that the General Snus products are protective of the public health and contain significantly lower levels of harmful constituents compared to over 97 percent of the smokeless products on the US market. These findings are part of the premarket tobacco application (PMTA) decision announced by FDA in November 2015.

‘Swedish Match praises the open, active and constructive dialogue Swedish Match has had with the FDA and the dialogue will now continue.’

“Swedish Match snus products in the US will maintain their current classification, and General Snus will continue to be sold under current regulations,” Fredrik Peyron, senior vice president, regulatory affairs and group communication, SM, was quoted as saying. “Swedish Match is the first and, to date, the only tobacco company ever to have completed and thus [had] accepted [an] MRTP application filed with the FDA. That is a major achievement in itself and has encouraged employees of Swedish Match to work even harder towards Swedish Match’s vision A world without cigarettes.

“Our goal has been to work to communicate truthfully to consumers about our snus products and that snus is a less harmful alternative to cigarette smoking. We took a major step towards our vision A world without cigarettes by having the first MRTP application ever accepted as complete by the FDA, and we believe it’s a sign that we’re moving in the right direction. We will adhere to the invitation by the agency to continue our constructive dialogue in order to understand the next steps necessary for issuance of a modified risk order.”