Tobacco Packaging Warnings

Tobacco packaging warning labels have been put in place by various government agencies worldwide as a means to communicate the risks of health effects to consumers. Generally speaking, warnings on cigarettes (or the lack of strong warnings as is the case in the U.S.) is the most discussed, but smokeless tobacco products also have warnings.

## U.S. History

Prior to the 1980s in the United States, no warnings were present on smokeless tobacco products, and such products were a small and declining percentage of tobacco consumers. In fact, the 1964 and 1979 Surgeon General Reports did not find increases in mortality due to smokeless tobacco use, but did disclose that Asian nations had increases in leukoplakia and oral cancer, but it may have been due to differences in the products consumed. Meanwhile, smokeless tobacco was still permitted to be advertised on television and radio, while cigarettes had been banned from ads since 1971.

Following strengthened cigarette warnings in 1985, beginning in 1986, warning statements have been required on smokeless tobacco products. One of the statements in particular, "This product is not a safe alternative to cigarettes", which still is in place today, has come under scrutiny from harm reduction advocates. The main argument is that in stating it is not a safe alternative, one is led to believe it is more harmful than continuing to smoke cigarettes. Further reading in the article *Origins in the USA in the 1980s of the warning that smokeless tobacco is not a safe alternative to cigarettes: a historical, documents-based assessment with implications for comparative warnings on less harmful tobacco/nicotine products* by Lynn T. Kozlowski points to studies used to arrive at the conclusions for stronger warning labels. One was a March 1981 study involving female users in the Southern United States, however, the users were dipping dry snuff, not moist snuff (dipping tobacco). Later, the introduction of Skoal Bandits in 1983 had a significant impact on the market and was promoted as a smoking alternative. Sales of moist snuff began to grow and it became the only segment of the tobacco market with a growing user base. Its popularity and advertising by UST triggered a response from various organizations and, beginning with Massachusetts in 1985, prompted 26 states to require warning labels. Then, federal legislation was enacted the following year, as well as an advertising ban on electronic media.

As of July 22, 2010, the FDA has required bolder warning labels on smokeless tobacco products per the Tobacco Control Act. They are as follows:

* 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.

The FDA requires the warnings to be alternated "as randomly as possible" and advertisements must have their warning labels rotated quarterly. Warning labels must appear on the two "principal display panels" of the packaging and comprise 30% of the display panels. It must be printed in 17-point type, either in black text on a white background, or in white text with a black background.

### Other Labeling Requirements

The FDA also requires the name and location of the manufacturer or distributor, an accurate statement of quantity or weight of the contents, an accurate statement of the percentage of foreign and domestically-grown tobacco, and the statement "Sale only allowed in the United States" to appear on the package.

### Modified Risk Products

The FDA has allowed a process in which manufacturers can apply for a modified risk order. The applicant must demonstrate the positive benefits to the current tobacco consumer that will be obtained by switching, among other requirements. On October 22, 2019, the first ever modified risk orders were granted to General Snus products made by Swedish Match. The designation allows Swedish Match to market the product as a less harmful alternative to cigarettes.

### Other FDA Regulations

Introducing new products has been tightly controlled by the FDA since 2007. Any "new tobacco product" is considered new if it was not commercially available as of February 15, 2007. Products on the market before that date are considered grandfathered in. Three methods are available to introduce a new product:

* Premarket tobacco product applications
* Substantial equivalence
* Requesting exemption from substantial equivalence

A premarket tobacco product application (PMTA) must show scientific evidence that demonstrates the product is appropriate for the protection of public health. So far, General Snus has successfully used this method and is the only smokeless brand to do so. Other PMTA orders have been issued for Philip Morris' iQOS (heat-not-burn cigarettes) and 22nd Century Group's cigarettes containing tobacco genetically-engineered to contain less nicotine than standard cigarettes.

The substantial equivalence method must demonstrate that a "new product" has the same or similar characteristics to a predicate product already on the market. Many recent smokeless tobacco products have come on the market using this method.

The exemption method is used when an additive is added or removed to a currently legal tobacco product and the change is minor.

## Canada Warnings

Disclosure of toxic constituents in tobacco products was first required under the Tobacco Act of 2000's Tobacco Product Information Regulations (TPIR).  These coincided with graphic warning labels mandated on cigarette packs. These regulations were amended in 2011 for cigarettes, which then required 75% of the package to be warning labels among other changes. Four alternating warnings must be displayed in both English and French:

* "This Product Is Highly Addictive"
* "This Product Causes Mouth Diseases"
* "This Product Is Not a Safe Alternative to Cigarettes"
* "Use of this Product Can Cause Cancer"

The toxic constituents must be displayed on no less than 50% of the side of the packaging and no less than 60% of the surface.

As announced in 2019, Canada will begin to require plain packaging on all products starting November 9, 2019 at the manufacturing level and February 7, 2020 at retail.

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References ==

1. ↑ https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-018-0228-8#ref-CR2
2. ↑ http://www.buffalo.edu/news/releases/2018/07/021.html
3. ↑ https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/smokeless-tobacco-labeling-and-warning-statement-requirements
4. ↑ https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-tobacco-products
5. ↑ https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-orders
6. ↑ https://www.fda.gov/tobacco-products/products-guidance-regulations/market-and-distribute-tobacco-product
7. ↑ https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications
8. ↑ https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/substantial-equivalence
9. ↑ https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence
10. ↑ https://www.canada.ca/en/health-canada/services/health-concerns/tobacco/legislation/federal-regulations/tobacco-products-information-regulations.html
11. ↑ https://www.canada.ca/en/health-canada/services/health-concerns/tobacco/legislation/federal-regulations/tobacco-products-labelling-regulations-cigarettes-little-cigar.html
12. ↑ https://laws-lois.justice.gc.ca/eng/regulations/sor-2000-272/FullText.html
13. ↑ http://www.cancer.ca/en/about-us/for-media/media-releases/national/2019/plain-packaging-regulations/?region=qc