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FDA Authorizes the Marketing of “Modified-Risk” Tobacco Products

“Would you like smoking, or non-smoking?” The historic phrase, could soon be back, as the The U.S. Food and Drug Administration (FDA) begins normalizing sympathy for tobacco use throughout modern America. While previously banned, the U.S. will begin to see a resurgence of tobacco related propaganda, “targeting current smokers”, offering a “safer”, “healthier” alternative. In sight of the loosening of restrictions from the FDA, could the invasion of propaganda for public acceptance of tobacco use, have begun to seep its way back into everyday society?

On December 23rd, 2021 The U.S. Food and Drug Administration authorized1 the marketing of modified-risk tobacco products, stating they posed low risk to non-smokers, and youth.

“Modified-Risk Tobacco Products2” (MRTP) is the name given by the U.S. Food and Drug Administration’s depiction of “low-risk” tobacco products which discourage use among non-users and youth. Companies’ products can gain access to this loophole terminology, Modified-Risk Tobacco Products (MRTP), through online submission. As for regular tobacco, Modified-Risk Tobacco is a financial opportunity, which a simple altering of the name, and classification, of the product allows.


FDA Press Release

The FDA rejoiced on December 23rd, announcing, 

“Today, the U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s ‘VLN King’ and ‘VLN Menthol King’ combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them. These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive ‘ exposure modification’ orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.”

The FDA’s director at the FDA’s Center for Tobacco Products proclaimed in the FDA press release that,

“Our mission is to find ways to stop tobacco-related disease and death.”stated Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers.”


Tobacco Usage

The Center for Disease Control and Prevention (CDC) states that tobacco use is responsible for 7 million deaths throughout the world. The CDC states,

“If the pattern of smoking all over the globe doesn’t change, more than 8 million people a year will die from diseases related to tobacco use by 2030.” reported3 the Center for Disease Control and Prevention (CDC), adding “If smoking continues at the current rate among U.S. youth, 5.6 million of today’s Americans younger than 18 years of age are expected to die prematurely from a smoking-related illness. This represents about one in every 13 Americans aged 17 years or younger who are alive today.”

The FDA also recognizes tobacco as a toxic substance, yet they have authorized the marketing of the substance under the guise that it is safer without nicotine. Adding a chemical to tobacco and reducing that chemical in the tobacco, still means that the product contains the original levels of tobacco. Is now modified-risk tobacco healthier, even almost harmless? Should tobacco be marketed as a helpful alternative for individuals who smoke cigarettes?


“Tobacco use is considered the single most important man-made cause of cancer that can be avoided.4” – National Institutes of Health


“Helps You Smoke Less”

The FDA states that in order to be marketed as a “Modified Risk Tobacco Product” (MRTP), it must include the words “Helps you smoke less”.

The FDA states, “When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, ‘Helps you smoke less.’”

Modified-Risk Tobacco is stated by the FDA to contain 95% less nicotine than normal tobacco products. However, just because a cigarette or tobacco contains less nicotine, does not guarantee that an individual will smoke less. In regular users, the reduction in nicotine may encourage them to smoke more. Using words like “Modified-Risk” and “Helps you smoke less” give the impression that these products are healthier than other tobacco alternatives. Is nicotine the only ingredient responsible for a user’s habit of smoking? Is the act of smoking addictive in and of itself?

The FDA also “recommends” that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”

The carefully selected word, “recommends”, ensures that companies can omit the very important effects related to the user’s health. In the context of “Helps you smoke less” the FDA guidelines state that companies “must” use deceptive wording, while giving opportunity to leave nicotine’s carcinogenic health effects off the label of the product.


“Modified-Risk” Substances

The notion is similar to removing the flavor from alcohol, stating it is “Modified-Risk Alcohol”, and that people would to drink less because it does not have an addictive taste. Modified-Risk Alcohol could be manipulated using marketing to state it “Helps you drink less”. Additionally, Modified-Risk Alcohol would be safer, as it wouldn’t have harmful chemical flavoring. Although these arguments could be seen as true, this wouldn’t make sense, from a legal perspective. Often times, users of the substance use them for effects of the substance, meaning marijuana with lower THC would most likely mean users would consume more of that product, as a result boosting sales. At the end of the day, increased advertising will increase consumers attraction, leading to increased revenue. Is tobacco simply being re-weaponized on the youth of modern America, in an attempt to boost sales?


Tobacco Advertising in America

On April 1st, 1970, former President Richard Nixon signed legislation5banning all cigarette advertising in media throughout the United States.

In 1998, the Tobacco Master Settlement Agreement was passed, which prevented public display of tobacco advertising. This move represented the final nail in the coffin for Cigarette Advertising. Now, there was no way to publicly promote their products, beyond word of mouth.

On November 8, 2017 the FDA ordered a compliance for companies to “Stop manufacturing tobacco products, the label, labeling, or advertising of which uses the descriptors ‘light,’ ‘mild,’ ‘low’ or similar descriptors unless you have a Modified Risk Tobacco Product order in effect. (Stop distributing these modified risk tobacco products in interstate commerce by December 8, 2017.)”

This move allowed FDA regulators to create a loophole which would be used by tobacco companies at the end of 2021 to begin allow the re-introduction and re-marketing of tobacco products in a positive light, provided they would be labeled as a “Modified Risk Tobacco Product”. After decades of restrictions, cigarette companies can thrive again, targeting new customers with the “Modified-Risk” allure.


Section 911: Customer Surveillance

The FDA notes that Section 9116requires companies which implement these tobacco marketing tactics with their products, must also conduct “postmarket surveillance” to determine whether or not the criteria to access these products continues to be met, stating,

The FDA stated, “The authorization for these products requires the company to conduct postmarket surveillance and studies to determine whether the authorization criteria for these exposure modification orders continue to be met, including assessing use among youth.”

All Modified-Risk Tobacco Productsare required to conduct postmarket surveillance. Under section 911, (or 911), applicants are required to conduct invasive surveillance including consumer perception, behavior, and health.

The official FDA submission form states,

“Postmarket Reporting: Requires under section 911(g)(2)(C) or 911(i) (as applicable), among other things, applicants to conduct surveillance and postmarket studies to determine the impact of the modified risk order on consumer perception, behavior, and health, to allow FDA to review the accuracy of the determinations upon which the modified risk order was based.”


Menthol

The FDA concluding assuring the public that despite their allowance of heightened marketing for big tobacco manufacturers, they will work to ban menthol from being used as a future ingredient.

“The FDA is committed to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to issue proposed rules in the spring of 2022.”


The National Institutes of Health

The National Institutes of Healthclassifies menthol as an irritant, though states that burning methol creates bitter toxic fumes which contain carbon monoxide, and carbon doxide.

“This compound may be harmful by inhalation, ingestion or skin absorption. It is an irritant of the skin and eyes. It is also irritating to the mucous membranes and upper respiratory tract. When heated to decomposition it emits acrid smoke and toxic fumes of carbon monoxideand carbon dioxide.”

Which FDA decision will cause more damage to society? Is allowing companies to market reduced nicotine products to the public as “alternatives” to smoking worse than menthol? Is menthol worse than other flavor ingredients and chemicals used in these products? Is tobacco healthier than menthol?


Conclusion

The FDA continues to coordinate efforts to allow organizations to bypass existing decisions by changing the levels of a specific additive. Marketing tactics like this are used in many health products, often causing consumers to fall victim to a product’s effects decades after the standards are reformed. Yet the war against tobacco wages on.

Was the FDA’s 2017 decision to create a loophole in the marketing of “safer” cigarettes, financially motivated? Did the FDA intend for companies to create minor adjustments to the to the original design allowing it to be considered “healthier”? Is the FDA encouraging sympathy for cigarette smokers, offering companies a new deadly product, purely designed for profit? While ‘lower risk’ tobacco may be cigarette companies’ next ‘big marketing tactic’, how long will Modified-Risk Tobacco Products’ last before the term “Makes you smoke less” is extinguished?

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