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FDA Grants First-Ever Modified Risk Orders for Smokeless Tobacco Products

FDA recently granted the first-ever modified risk orders to eight smokeless tobacco products. In a recent press release, FDA announced the authorizations are for Swedish Match USA, Inc. snus smokeless tobacco products, which are marketed and sold under the “General” brand name.

The Products were Previously Authorized Under PMTA

The 8 snus smokeless tobacco products that received modified risk orders were previously authorized for sale in the US without modified risk orders in 2015 by way of Premarket Tobacco Authorization (PMTA).

What the Modified Risk Order Means

Now that 8 products have been granted modified risk orders, the manufacturer can market these specific 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.”

Modified Risk Order Applications Must Include Robust Scientific Data & Evidence

Prior to authorizing modified risk orders, FDA thoroughly reviews modified risk order applications which include scientific evidence to support claims. The Swedish Match USA, Inc. risk application contained available scientific data, including long-term epidemiological studies, which have shown that relative to cigarette smoking, exclusively using these specific smokeless tobacco products pose lower risk of:

  • Mouth cancer
  • Lung disease
  • Lung cancer
  • Stroke
  • Emphysema
  • Chronic bronchitis

The application also incorporated evidence that demonstrated consumers can understand both the claim and relative risk of the products. Additionally, the application provided data that established seeing the modified risk claim influenced the intention to purchase the products among smokers in the target age group. Smokers who are 25 years of age and older stand to benefit the most from modified risk tobacco products.

Warning Statements are Required on Packaging

Despite the modified risk orders, product packaging must still display the required warning statements for all smokeless tobacco products. Strict advertising and promotion restrictions have also been placed on the products in an effort to prevent access and exposure to youth. FDA has also been clear that all advertising for these products must be restricted to adults.

Modified Risk Orders Aren’t the Same as “Safe” or “FDA Approved”

Although FDA has determined that completely switching from cigarettes to these 8 authorized products lowers certain health risks, it doesn’t mean the products are safe or “FDA approved.” The modified risk orders are limited to a term of 5 years, and the time-limited authorization comes with numerous post-market requirements permitting FDA to keep a close watch on the marketplace. Furthermore, FDA reserves the right to contemplate withdrawing the authorization if any information leads them to determine the marketing of the products as posing less risk no longer benefits the health of the population as a whole.

About the Modified Risk Tobacco Product (MRTP) Pathway

The MRTP pathway was outlined in the 2009 Family Smoking Prevention and Tobacco Control Act, and allows companies to submit applications for FDA to assess whether a tobacco product may be sold or distributed to specifically reduce the harm risk of tobacco-related disease which is associated with commercial tobacco products.

Applicants must demonstrate the product, as actually used by consumers, will significantly reduce both harm and risk of tobacco-related diseases. The reduction of harm and risk must apply to individual tobacco users, as well as benefit the health of the population as a whole. When reviewing and assessing applications, FDA takes into account multiple considerations, including whether non-tobacco users would start using the product and whether existing tobacco users would start using the product (rather than having quit if the product had not been marketed with modified risk).

Additional PMTA Resources

Want to know more about the new PMTA guidelines? Check out our blog, What You Need to Know About the FDA’s New PMTA Guidance.

We’ve outlined the major similarities and differences between the 2016 and 2019 PMTA guidance in our blog, Overview of Premarket Tobacco Application (PMTA) FDA Guidance for ENDS.

The 9 most commonly asked questions about PMTA requirements are answered in our blog, 2019 FDA PMTA Guidance FAQs.

Is finding the right lab to partner with stressing you out? Our blog, Choosing the Right Lab for PMTA Compliance, offers some guidance.

Extractables & Leachables (E&L) testing is required in the new PMTA guidance. Our blog, E-Liquids Extractables and Leachables Testing for the PMTA, outlines what you need to know about this integral part of the submission.

Want to know more about bridging studies and how they’re utilized in the PMTA? Check out our blog, The Use of Bridging Studies in the PMTA.

With the court ruling on July 11, 2019, the deadline for submissions has been moved up significantly. For more information, check out our blog, ENDS Industry Faces Tighter PMTA Deadlines with May 2020 Fast Approaching.

FDA is actively enforcing PMTA guidance. Check out our blog, FDA Issues Warning Letters for E-Liquid Products without Marketing Authorization, for more details.

We’ve outlined some common regulatory strategies that have emerged amongst leading ENDS manufacturers in our blog, Will my E-Liquid Product Receive PMTA Authorization?

Concerned about state-led e-liquid bans? Check out our blog, Proposed E-Liquid Bans and the PMTA, for insight into how state-led policies are impacting submission strategies.



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