FDA Authorizes Modified Risk Tobacco Products
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On October 22, 2019, FDA granted the first-ever modified risk orders to Swedish Match USA, Inc. for eight snus smokeless tobacco products. This means the eight products may be advertised with specific information about the lower risks of certain health effects using the products compared to smoking cigarettes.
This does not mean that the products are safe or “FDA approved.” All tobacco products are potentially harmful and people who do not use them should not start.
What is a modified risk tobacco product?
When the Tobacco Control Act was signed into law, it became illegal for companies to market their products as being less risky to consumers, except where specifically authorized by FDA. It set the bar very high for good reason. In the past, claims of reduced risk ultimately harmed public health because consumers who might have quit smoking instead switched to cigarettes advertised as “light,” “low” or “mild.”
To market a product as a modified risk tobacco product (MRTP), tobacco companies must now first demonstrate to FDA that a proposed MRTP will, or is expected to, benefit the health of the U.S. population as a whole – including adults and children, tobacco users and nonusers. As a general example, an MRTP can benefit population health when data show consumers who currently use a more harmful product like cigarettes are likely to completely replace their cigarette use with the MRTP, and the marketing of the MRTP would not make non-users of tobacco products more likely to start using them. 1
FDA recognizes that tobacco products exist on a continuum of risk, with combustible cigarettes being the deadliest. The MRTP process provides a mechanism for manufacturers of less harmful tobacco products to provide evidence to FDA demonstrating that a tobacco product poses significantly lower risks to individual users and benefits the population as a whole. To meet the MRTP standard, tobacco companies must show, among other things, that proposed modified risk information about a product—including claims about reduced harm or risk of tobacco-related disease or reduced exposure to a substance—are supported by scientific evidence and that consumers can adequately understand the information.
A modified risk order allows a tobacco company to market the MRTP using specific information about the health risks of using the product, which can include a comparison to other tobacco products. In order to be marketed as an MRTP, the tobacco product must also be able to be legally sold or distributed in the United States.
What is snus?
Smokeless tobacco products include chewing tobacco, snuff, dip, and snus. Snus is used similarly to other chewing tobacco products: it is placed in the mouth, typically between the lip and gums, but users do not need to spit.
What modified risk claims is Swedish Match USA, Inc. allowed to make?
Swedish Match USA, Inc. requested and received FDA authorization to market eight types of General Snus products with the claim:
“Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
This modified risk claim does not apply to all snus products, only to the eight types of General Snus specifically authorized (see below). Swedish Match USA, Inc. may not include new modified risk information in their advertising or refer to statements made by others, including FDA, about the products in advertising without express authorization from FDA.
Are these MRTPs safer than cigarettes? Are they safer than other smokeless tobacco products?
The available scientific evidence shows that exclusive use of these specific General Snus smokeless tobacco products poses lower risks than cigarette smoking for many of the major causes of tobacco-related disease. In addition, FDA previously determined that the levels of N-nitrosonornicotine (NNN) and nicotine-derived nitrosamine ketone (NNK), two potent cancer-causing chemicals, in these General Snus products are lower than those in most smokeless tobacco products sold in the U.S., and when used exclusively instead of other smokeless tobacco products, the General Snus products may pose lower risk of oral cancer.
Regardless, use of these products still poses increased health risks compared to not using tobacco. There are no safe tobacco products.
Is FDA concerned that youth might start using snus because these products are advertised as lower risk?
Swedish Match USA, Inc. submitted scientific evidence showing that non-users of tobacco, including young adults, did not intend to buy any of the eight products. The modified risk claim did not make them more likely to buy the products.
However, research suggests that, in general, youth’s perceptions about the risks or harms of a tobacco product could influence their likelihood of using it. Accordingly, FDA has taken steps to further limit the likelihood that youth will start using General Snus. Following the authorization of these MRTPs, Swedish Match USA, Inc. is required to restrict youth access and exposure to the marketing of General Snus. For example, FDA has placed stringent restrictions on how the products are advertised and promoted, particularly via websites and social media. If Swedish Match USA, Inc., based on any data, is no longer able to show, or FDA is no longer able to find, that continued marketing of these MRTPs would benefit the health of the U.S. population as a whole, including users and non-users of tobacco, then FDA may withdraw the order.
What will consumers now see in stores and online?
In November 2015, FDA issued marketing orders for the eight General Snus. So, adult consumers may have already seen the products, without modified risk information, available for sale. Now, consumers may also see the products advertised with the claim, “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 eight products are:
- General Loose
- General Portion Original Large
- General Dry Mint Portion Original Mini
- General Mint Portion White Large
- General Portion White Large
- General Classic Blend Portion White Large – 12 ct
- General Nordic Mint Portion White Large – 12 ct
- General Wintergreen Portion White Large