Health Highlight: Thu. 16, Mar.
Today’s highlights: Today’s highlight is entirely dedicated to the FDA’s Modified Risk Tobacco Product (MRTP) authorization of Copenhagen’s Classic Snuff.
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Did the FDA just endorse smokeless tobacco?
✍🏼 Carlos Franco | @Itstechnical_cf • 🗣️ @US_FDA, @FDATobacco
Wait, What?
Today, the US Food and Drug Administration approved the marketing of Copenhagen Classic Snuff, as a modified risk tobacco product (MRTP). This means that the product can now be advertised with the following statement on its marketing and labeling materials:
This change only applies to Copenhagen’s moist snuff smokeless tobacco product; it does not apply to all smokeless tobacco products. While the process of this modified risk decision is similar to the over a dozen similar requests listed on the FDA’s Modified Risk Granted Orders page the message is different.
Using the 2019 Modified Risk Tobacco Product Application (MRTPA) for Swedish Match USA, Inc. smokeless tobacco products as an example, the FDA permitted the following changes to their product packaging:
Removal of the phrases:
“WARNING: This product can cause gum disease and tooth loss.”
“WARNING: This product can cause mouth cancer.”
Changing of the phrase:
“WARNING: This product is not a safe alternative to cigarettes.”
TO: “WARNING: No tobacco product is safe but this product presents substantially lower risks to health than cigarettes.”
The Copenhagen MRTPA phrasing omits the “No tobacco product is safe” language but includes the reduced risk messaging, allowing for the interpretation that smokeless tobacco is an effective method for quitting smoking—which it is not.
Why did the FDA agree to this change?
According to the MRTPA submitted to the FDA by Altria Client Services LLC, the parent company of U.S. Smokeless Tobacco Company LLC and Copenhagen brand, the scientific evidence supports that their smokeless tobacco is significantly less harmful than cigarettes; the modified risk claim is accurate and not misleading; and a net benefit to the health of the population as a whole is expected by allowing this change. 1 To which the FDA agreed.
Added context
The Director of the FDA’s Center for Tobacco Products, Brian King, Ph.D., M.P.H., added some context and clarity to this decision by stating the following:
“No tobacco product is safe or ‘FDA approved, so those who do not use tobacco products shouldn’t start…But tobacco products do exist on a spectrum of risk, with those that are smoked having the greatest risk. In this case, the FDA’s scientific review found that if an adult smoker completely switched from cigarettes to this smokeless product, it would reduce their risk of getting lung cancer.” 2
Despite this evidence that smokeless tobacco can be safer than smoking, the FDA continues to discourage the use of all tobacco products and recognizes the health risks associated with smokeless tobacco, “There is no safe level of smokeless tobacco use. And smokeless users can experience health consequences at any age, even as teenagers.” 3
The National Cancer Institute (NCI), the largest branch of the National Institutes of Health (NIH), also maintains that there is no safe form of tobacco and that smokeless tobacco causes oral, esophageal, and pancreatic cancer, as well as heart disease, gum disease, oral lesions, and precancerous growths in the mouth (leukoplakia). 4
So what’s different? Did the Product change?
No, in fact, it’s the opposite. Copenhagen’s moist snuff smokeless tobacco product is classified as a pre-existing tobacco product, which means that because it has been commercially available in the United States since 2007, it does not require “premarket [tobacco product application (PTMA)] authorization to be legally marketed” unless the product is changed or modified. 5
This is significant because the PTMA application has much more comprehensive requirements, implying that U.S. Smokeless Tobacco Company LLC (Copenhagen) will most likely keep this product as-is to capitalize on this new 5-year marketing opportunity.
Bottom-line
The fact that Copenhagen’s packaging and advertising have been permitted to change does not change the fact that its smokeless tobacco products are not safe to use and are not an effective way to quit smoking. Period.
If you use any tobacco products, you should strongly consider quitting. If you need more information or help quitting tobacco, please see the following resources:
Where To Get Help When You Decide To Quit Smoking (Cancer.gov)
Handling Nicotine Withdrawal and Triggers When You Decide To Quit Tobacco (Cancer.gov)
Further reading
🏷️ Tags: #FDA #BigTobacco #Copenhagen #SmokelessTobacco #PublicHealth
Sources +5
Accessed on March 16, 2023.(https://digitalmedia.hhs.gov/tobacco/static/mrtpa/Copenhagen/2.3-executive%20summary%20_Redacted.pdf) ↩︎
Accessed on March 16, 2023. (https://www.fda.gov/news-events/press-announcements/fda-authorizes-copenhagen-classic-snuff-be-marketed-modified-risk-tobacco-product) ↩︎
Accessed on March 16, 2023. (https://www.fda.gov/tobacco-products/products-ingredients-components/smokeless-tobacco-products-including-dip-snuff-snus-and-chewing-tobacco) ↩︎
Accessed on March 16, 2023. (https://www.cancer.gov/about-cancer/causes-prevention/risk/tobacco/smokeless-fact-sheet#r7) ↩︎
Accessed on March 16, 2023. (https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/pre-existing-tobacco-products) ↩︎