Repugnance as paternalism: bans on flavored tobacco products

 The NY Times has the story on the recent FDA policy:

Biden Administration Plans to Propose Banning Menthol Cigarettes. The move has been long sought by public health and civil rights groups, after decades of marketing aimed at Black smokers.  By Sheila Kaplan

"The Biden administration is planning to propose a ban on menthol cigarettes, a long-sought public health goal of civil rights and anti-tobacco groups that has been beaten back by the tobacco industry for years, according to a federal health official.

"For decades, menthol cigarettes have been marketed aggressively to Black people in the United States. About 85 percent of Black smokers use menthol brands, including Newport and Kool, according to the Food and Drug Administration. Research shows menthol cigarettes are easier to become addicted to and harder to quit than plain tobacco products.

"The F.D.A. is being forced to act by a court deadline — a federal district judge in Northern California had ordered the agency to respond by April 29 to a citizens’ petition to ban menthol. But the odds are unlikely that a ban would take effect anytime soon, because any proposal is likely to wind up in a protracted court battle. The proposal would also include a ban on all mass-produced flavored cigars, including cigarillos, which have become popular with teenagers.

...

"Delmonte Jefferson, executive director of the Center for Black Health and Equity, one of the organizations behind the petition, called the decision a victory for African Americans and all people of color.

“This has been a long time coming,” said Mr. Jefferson. “We’ve been fighting this fight, since back in the 1980s. We told the industry then, we didn’t want those cigarettes in our communities.”

...

"Menthol is a substance found in mint plants, and it can also be synthesized in a lab. It creates a cooling sensation in tobacco products and masks the harshness of the smoke, making it more tolerable." 

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Here's the announcement from the Food and Drug Administration:

FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers  Efforts to ban menthol cigarettes, ban flavored cigars build on previous flavor ban and mark significant steps to reduce addiction and youth experimentation, improve quitting, and address health disparities

"April 29, 2021: Today, the U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of preventable death in the U.S. The FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars; the authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency. This decision is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.

“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products. With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products,” said Acting FDA Commissioner Janet Woodcock, M.D. “Together, these actions represent powerful, science-based approaches that will have an extraordinary public health impact. Armed with strong scientific evidence, and with full support from the Administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.

...

"If implemented, the FDA’s enforcement of any ban on menthol cigarettes and all flavored cigars will only address manufacturers, distributors, wholesalers, importers and retailers. The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product. The FDA will work to make sure that any unlawful tobacco products do not make their way onto the market.

"These actions are an important opportunity to achieve significant, meaningful public health gains and advance health equity. The FDA is working expeditiously on the two issues, and the next step will be for the agency to publish proposed rules in the Federal Register allowing an opportunity for public comment. "

New York doesn't ban Menthol cigarettes, amid controversy

 The NYT has the stories, first about the proposed ban, and then about the budget compromise that defeated it:

Black Smokers at Center of New York Fight to Ban Menthol Cigarettes. A proposal to make New York the third state to ban menthol cigarettes has created a furious and expensive lobbying war, and has divided Black leaders. By Luis Ferré-Sadurní

"A push by Gov. Kathy Hochul to ban menthol-flavored cigarettes in New York has become the focal point of a fierce and expensive lobbying fight, pitting Big Tobacco against the medical community.

"Caught in the middle are Black smokers, who smoke menthol cigarettes at higher rates than white smokers, and are the main group the ban is meant to help. Decades of aggressive marketing by tobacco companies have caused Black smokers to consume menthol cigarettes, whose cooling sensation on the throat makes them more appealing and addictive.

...

 "Well intentioned as the ban may be, it has angered some Black leaders, including a group of ministers who have rallied against Ms. Hochul’s proposal because they worry it could increase encounters between Black people and the police if menthol cigarettes were to go underground and authorities crack down on sellers.

"Other Black opponents of the ban suggest it may be discriminatory, a heavy-handed crackdown on the preferred nicotine fix of Black smokers, even if African American men have the highest rates of lung cancer, according to the Centers for Disease Control and Prevention. 

...

"Although lawmakers have signaled their support for the tax increase, the menthol ban’s prospects are far less certain, according to four officials familiar with the negotiations.

The issue has divided Black lawmakers, leaving the measure hanging by a thread in the State Capitol "and potentially forcing Ms. Hochul to weigh how much political capital she should expend on the ban, as opposed to other policy priorities."

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And here's a story saying that the governor abandoned the proposed ban in a set of budget compromises:

New York Would Change Minimum Wage and Bail in $229 Billion Budget Deal. After weeks of dissension, leaders in Albany reached a handshake agreement on a budget that saw Gov. Kathy Hochul fall short on some of her key objectives. By Luis Ferré-Sadurní and Grace Ashford

"Lawmakers managed to knock down other divisive ideas, including ... a ban on the sale of menthol cigarettes that was opposed by Big Tobacco and had divided Black leaders. Lawmakers did agree, however, to raise taxes on cigarettes to $5.35 a pack, up from $4.35."

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All posts so far on menthol

Selling flavored cigarettes after California's ban

 It's hard to regulate tobacco. The NY Times brings us up to date on California's ban on flavored tobacco products.

R.J. Reynolds Pivots to New Cigarette Pitches as Flavor Ban Takes Effect. Now that California’s tobacco prohibitions are in place, some Camel and Newport items are billed as newly “fresh” or “crisp” non-menthol versions. By Christina Jewett and Emily Baumgaertner

"R.J. Reynolds has wasted no time since California’s ban on flavored tobacco went into effect in late December. “California, We’ve Got You Covered,” the company declared in bold letters on a flier mailed to its cigarette customers.

"The law prohibits flavors, odors or “tastes” in tobacco products, including menthol cigarettes. But antismoking experts argue that R.J. Reynolds, the maker of Camel and Newport brands, is trying to circumvent the ban by luring smokers with a suite of what it says are new non-menthol versions offering “a taste that satisfies the senses” and “a new fresh twist.”

"The campaign is viewed by critics as a provocation of California authorities who are supposed to enforce the ban, which includes a provision outlawing packaging or claims that suggest a product has a flavor. The Food and Drug Administration also is moving forward with a national plan to take menthol cigarettes off the market.

...

"Dr. Robert Jackler, a professor at Stanford Medicine who provided the ads to The New York Times, called the new marketing “outrageous.”

“The thing that surprises me is there’s no camouflage,” said Dr. Jackler, who received the mailers along with staff members of Stanford’s program on tobacco advertising. “They’re saying, ‘This is our menthol replacement. And by the way — wink, wink — it is not really menthol.’”

...

"Worldwide, tobacco companies have discovered loopholes to bans on menthol or flavored tobacco, studies show. In Canada, flavor cards and additive drops have been used to supplement unflavored products. In Denmark, smokers now have access to menthol sprays, capsules and tubes."

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Earlier:

Tuesday, December 27, 2022

Suppressing vaping is hard

Drugs, drug regulation, and chemistry: the case of nicotine (following Rob Jackler)

 My Stanford colleague Dr. Rob Jackler has a longstanding interest in nicotine as an addictive drug that continues to be effectively marketed and ineffectively regulated.

Lately he's been concerned with novel delivery systems, such as the non-combustion vaping devices offered by sellers like Juul (which  has recently been on a regulatory roller coaster.)

You can find many of his papers at the Stanford Research into the Impact of Tobacco Advertising (SRITA) site.  The most recent of these papers concerns the fact that a lot of regulation is focused on "tobacco products," but that nicotine itself--the addictive chemical in tobacco--has been successfully synthesized in the lab, and so can be marketed as a "tobacco free" product.

Here's a recent NY Times article on his work:

The Loophole That’s Fueling a Return to Teenage Vaping. Sales are rising of flavored e-cigarettes using synthetic nicotine that evades regulatory oversight, a gap that lawmakers are now trying to close.  By Christina Jewett

And here's the paper:

Marketing of “Tobacco-Free” and “Synthetic Nicotine” Products. Ramamurthi D, Chau C, Lu Z, Rughoobur I, Sanaie K, Krishna P, Jackler RK. SRITA White Paper. March 8, 2022.

"Executive Summary:

• A 2009 US law assigned tobacco regulation to the FDA, created its Center for Tobacco Products, and defined a tobacco product as derived from any component of the tobacco plant.

• As the September 2020 deadline for submission of application to the for FDA authorization of novel tobacco products (PMTA) approached, major tobacco companies submitted application for their brands, but innumerable smaller companies lacked the resources needed to undertake the extensive studies required.

• In an effort to circumvent FDA tobacco regulations, and thus exempt their products from the PMTA process, numerous brands claimed to be formulated with tobacco-free and/or synthetic nicotine.

• Following the late 2021denial of their PMTA applications, some brands which were ordered off the market promptly relaunched claiming that they had been reformulated with tobacco-free or synthetic nicotine.

• Brands claiming to use non-tobacco derived nicotine are offered in a wide array of youth-appealing sweet & fruity flavors – which have been systematically denied market authorization during the ongoing FDA PMTA process.

• Synthetic nicotine is currently expensive, costing approximately 4x tobacco derived nicotine. 

• While residuals from tobacco leaf derived nicotine are well known, byproducts of the chemical synthesis of nicotine have not been characterized for potential human toxicity and carcinogenicity.

• Justified by concerns for unknown safety risk, the FDA should insist upon toxicity/carcinogenicity studies of synthetic nicotine products before they are marketed.

• The FDA should also consider systematic testing of products claiming to be tobacco-free as at least a portion of them may prove to have chemical signatures indicative of tobacco origin.

• Some brands marketed as “tobacco-free” or “tobacco leaf-free” use a purified form of tobacco derived nicotine and thus are legally tobacco products under US law and thus subject to the PMTA requirements.

• Terms describing nicotine products as “tobacco-free,” “non-tobacco,” and “zero tobacco” need regulation as consumers may perceive such products as having reduced addictive potential.

• Marketing claims such as “clean,” “pure,” and “free of carcinogens” should be disallowed absent modified risk designation by the FDA.

• “Tobacco-free” nicotine brands have been allowed to post paid advertisements, and are widely sold on major online stores (e.g., Amazon, eBay, Google Shopping), which prohibit sale of all tobacco products.

• Underage sales of “tobacco-free” nicotine products are common via major online stores.

• As it is a potently addictive substance, and harmful to the developing adolescent brain, there is no justification for nicotine, regardless of its source, to be exempt from regulation.

• The synthetic nicotine regulatory loophole should be closed by designating such products as unauthorized drugs requiring pre-market authorization. "

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Congress closed the synthetic nicotine loophole in March, and since July 2022 synthetic nicotine products can only be on the market if they have been authorized by the FDA – none have been so yet.   Here's the story from the Washington Post:

Congress moves to give FDA new powers over synthetic nicotine products including a youth favorite — Puff Bar e-cigarettes By Laurie McGinley, March 8, 2022

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There have also been bans on flavored nicotine, aimed at children as well as adults. These may be doomed to be at least partly ineffective. Menthol flavored cigarettes are likely to be banned in the U.S., and have already been banned in Britain and elsewhere. But just as cocktail mixes can be sold separately from alcohol (but ready to mix), so apparently can flavorings for cigarettes and e-cigarettes... e.g. search for "menthol flavour cards for cigarettes" or "menthol crush balls" to see how to add menthol back into your smokes in England.

Here's a recent NBER working paper comparing menthol smokers to non-menthol smokers:

Are Menthol Smokers Different? An Economic Perspective, by Yu-Chun Cheng, Donald S. Kenkel, Alan D. Mathios & Hua Wang, WORKING PAPER 30286, DOI 10.3386/w30286, July 2022

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And here's an old NYT story in which Rob describes himself as “an accidental tourist in the world of advertising.”

When Doctors, and Even Santa, Endorsed Tobacco, By Stuart Elliott, Oct. 6, 2008

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earlier: 

Sunday, January 30, 2022

Chemistry is replacing agriculture in the supply of black market drugs

Sunday, May 2, 2021

Repugnance as paternalism: bans on flavored tobacco products

Tuesday, February 12, 2019

The new market for (and marketing of) nicotine--Robert Jackler (followed by the CDC)

Menthol cigarettes get a reprieve

 The WSJ has the story:

Biden Administration Shelves Plan to Ban Menthol Cigarettes. White House had been weighing health benefit of ban against angering some Black voters   By Jennifer Maloney, Liz Essley Whyte, and Andrew Restuccia

"The Biden administration is reversing course on its plan to ban menthol cigarettes, after the White House weighed the potential public-health benefits of banning minty smokes against the political risk of angering some Black voters in an election year. 

...

Menthols account for more than a third of all cigarettes sold in the U.S. each year and are predominantly used by Black and Hispanic smokers. Some 81% of Black smokers used menthols in 2020, compared with 30% of white smokers and 51% of Hispanic smokers, according to a Wall Street Journal analysis of data from the National Survey on Drug Use and Health.

Some Black community leaders had fought the measure, saying a ban would expand the illicit market for cigarettes and lead police to racially profile Black smokers. The American Civil Liberties Union and some members of the Congressional Black Caucus expressed similar concerns.

...

"By contrast, Rep. Robin Kelly (D., Ill.), chair of the Congressional Black Caucus Health Braintrust, said she was “deeply disappointed that the FDA has chosen to abandon its established plan to ban menthol cigarettes… This is a common-sense plan which could have saved hundreds of thousands of lives.”

"Political considerations have swayed the Biden administration’s thinking on this public-health issue, said Mitch Zeller, who served as director of the FDA’s Center for Tobacco Products until 2022. “The science is clear that there will be a massive health benefit from removing menthol cigarettes,” he said."

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All my posts on menthol here.

California referendum bans flavored tobacco

More midterm election news on controversial markets and repugnant transactions:

California bans flavored tobacco products, including vapes, by Nicholas Florko at Statnews

 "On Tuesday, Californians overwhelmingly voted to ban all flavored tobacco products in the state.

"The move makes California by far the largest state to ban such products, which are already illegal in a smattering of smaller states, including Rhode Island, New Jersey, and Massachusetts.

"Regulators have targeted flavored products in particular because they are overwhelmingly preferred by young people. More than 84% of young people who vape reported using flavored products, according to recently released survey data by the Centers for Disease Control and Prevention.

"California’s ban would also outlaw menthol cigarettes, which federal regulators have proposed banning nationwide because they argue such products are easier to start and harder to quit. Survey data also show that menthol cigarettes are overwhelmingly preferred by Black smokers."

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Here's a recent (massive) report on the marketing efforts that went into making menthol flavoring popular (suggesting that we can soon expect to see menthol substitutes):

Advertising Created & Continues to Drive the Menthol Tobacco Market: Methods Used by the Industry to Target Youth, Women, & Black Americans. Jackler RK, Ramamurthi D, Willett J, Chau C, Muoneke M, Zeng A, Chang M, Chang E, Bahk JR, Ramakrishnan A. SRITA Research Paper 

Full Report: high-resolution PDF link (1.62Gb) / low-resolution PDF link (46.4Mb)
Executive Summary: high-resolution PDF link (6.2Mb)