FDA's Vape fiasco will continue smoking deaths

2021-12-01 08:06:50 By : Mr. Eason Du

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What shouldn't be annoying about the US Food and Drug Administration's non-decision on nicotine e-cigarettes? It is now almost two months before the FDA has passed its pre-market tobacco product application (PMTA) process to determine whether different e-cigarette products are "suitable for protecting public health." So far, the agency has only approved one of the countless submitted e-cigarette products: RJ Reynolds Vapor's Vuse Solo, an outdated tobacco-flavored cigarette device that hardly anyone uses.

After years of ruthless youth e-cigarette panic, smoking cessation mania, insidious haters from tobacco reduction, ever-changing false propaganda campaigns, and the opening of new fronts of the drug war against any nicotine use, it’s not surprising.

This is too fucking crappy.

The FDA is the first to use the PMTA route to approve e-cigarettes. The agency approved a cigarette-like product—or the first e-cigarette...quick question—if this is about protecting public health, will they approve most people? Actual equipment used? ? ?

The only positive factor is that - in the eyes of the humiliated researcher Stanton Glantz, billionaire Michael Bloomberg, his Campaign for Tobacco Free Children (CTFK) and parents against e-cigarettes - is the FDA finally had to Recognizing that e-cigarettes are "suitable for protecting public health... toxicological assessment found that the toxicity of aerosols of authorized products is significantly lower than that of burning cigarettes."

But we knew this many years ago-even before the British Public Health Department's pioneering discovery in 2015 that e-cigarettes are 95% less harmful than cigarettes. Since then, nearly 500,000 people in the United States have continued to die from smoking-related causes each year without adequate harm reduction or information.

But even this most basic recognition is soon qualified to appease the advocates of nicotine-free adolescent brains.

If the FDA does not recognize this, the decision makers of its Center for Tobacco Products (CTP) risk losing all credibility as an insignificant flat earth person. Hundreds of studies on the safety and effectiveness of e-cigarettes--evaluated by the Royal College of Physicians, Cochrane Review, National Academy of Sciences, Academy of Engineering, and School of Medicine--and recently written by 15 former Tobacco Society presidents in support of reducing tobacco harm The research on nicotine and tobacco in the paper is almost impossible to ignore.

But even this most basic recognition is soon qualified to appease the advocates of nicotine-free teenage brains.

Although today's action allows tobacco products to be sold in the United States, it does not mean that these products are safe or "approved by the FDA." All tobacco products are harmful and addictive, and people who do not use tobacco products should not start.

What's more annoying about this tweet is cognitive dissonance and shows that the FDA has not undergone fundamental changes. How many times need to be said that vapes are not tobacco products: they contain zero tobacco! Assert that vapes are unsafe and add that they are "harmful and addictive", which will bring fear and uncertainty to people who currently inhale smoke, which will eventually kill half of the people. Compared with cigarettes, the only measure of these alternative products is the proven, substantial reduction in harm.

How is Vuse Solo “suitable for protecting public health” on the one hand, and “unsafe” or “FDA approved” on the other? Even more confusing is that the authorization does not allow Reynolds to claim the truth: e-cigarettes are safer than smoking.

Negative, false, and contradictory information from the FDA is a failed setting. If the FDA says it is not safe, why would millions of smokers even buy Vuse Solo? If smokers do try outdated cigarettes, many people will find it unsatisfactory and give up switching. This is a self-fulfilling prophecy. Anti-e-cigarette groups will use this to make a more plausible argument that e-cigarettes do not help smokers quit smoking.

CTP will never properly regulate e-cigarette products because it has constructed the whole problem in the wrong way-insisting that e-cigarette programs "have enough benefits for adult smokers to overcome the risks to young people."

Surprisingly, in the controversy surrounding e-cigarettes, the FDA rarely even mentions people who have died of smoking-related diseases.

CTP is obsessed with young people's e-cigarette rate and taste. Both drive each of its decisions. The FDA’s press release on Vuse cited the 2021 National Youth Tobacco Survey and stated: “The agency takes these data very seriously and considers the risks to young people when reviewing these products... These data also show that most use [ vapes] young people and young people begin to have fruit, candy, or mint flavors instead of tobacco flavors. These data reinforce the FDA’s decision to approve tobacco-flavored products because these products are less attractive to young people..."

It doesn't matter, most adults who can save lives by switching also prefer taste. Never mind that the small percentage of young people who smoke e-cigarettes every day used to smoke-and studies have shown that without e-cigarettes, more adolescents would smoke. In addition, the use of e-cigarettes among young people has dropped sharply in the past two years.

Surprisingly, in the controversy surrounding e-cigarettes, the FDA rarely even mentions people who have died of smoking-related diseases. It's as if all these lives are gone, it doesn't matter. Media reports have strengthened the FDA’s blind spot for adult smokers. Reports on this topic presented it as a business story or a political drama, with popular reports on "Big Vape", "Big Vape", and the panic on the "children".

In order to meet the requirements of anti-taste lobby groups, the FDA rejected Vuse's 10 flavored e-cigarette cartridges and is still reviewing its application for menthol flavor. The agency warned that “if any of them are listed, they must be removed or face law enforcement risks.” In order to show who is the real big boss, CTP director Mitch Zeller issued a threat if The availability of Vuse Solo has caused young people to “use a lot” and it will be withdrawn from the market. Anti-e-cigarette groups believe that the use of any nicotine among young people is dangerous, and they will use Zeller's vague terminology a lot.

It is foreseeable that groups that hate e-cigarettes are complaining about the authorization of Vuse Solo. The Truth Initiative and the American Lung Association believe that e-cigarettes contain too much nicotine. An article from the Truth Initiative pointed out, “It’s disappointing that the FDA’s decision on Vuse Solo made the market high in nicotine without addressing the problem of high nicotine content or nicotine delivery... FDA must restrict electronics by restricting nicotine. The intensity and delivery of nicotine in cigarettes is like in other countries."

Incorrect. Heavy smokers need sufficient levels of nicotine to avoid withdrawal and successful conversion. This is why e-liquid and pods have different advantages. The ability to customize the amount of nicotine is one of the most important and innovative features of e-cigarette products.

The PMTA process created by those geniuses of the FDA will go down in history as the most esoteric and stupid way to evaluate and authorize products that have been on the market for many years and have saved countless lives. The illogical and extremely expensive PMTA route requires the submission of a large number of scientific documents, which clearly shows that CTP does not understand the unique pattern of the US e-cigarette market.

From the beginning, the PMTA process was manipulated to fail and bankrupt the couple's e-cigarette business, and to reward the liquidity of the tobacco industry. Sure enough, millions of PMTAs from SMEs were rejected. Strangely, considering that the CTP keeps pace with the organizations that shut down the big tobacco companies, it has established a system to ensure that companies occupy the legal e-cigarette market.

For thousands of small and medium-sized business owners who manufacture, distribute and sell e-cigarette products, the PMTA pathway is the path to destruction.

In addition, it is difficult to believe that CTP staff have been understaffed for a long time during the COVID-19 pandemic and a process of carefully evaluating millions of PMTAs-in fact, they did not. Although the FDA protests that each product has been individually evaluated, at least dozens of companies have received basically the same letter marketing denial order (MDO).

For thousands of small and medium-sized business owners who manufacture, distribute and sell e-cigarette products, the PMTA pathway is the path to destruction. MDO effectively bankrupted them.

It is a crime to destroy this community-based national e-liquid manufacturer and vape store that has helped hundreds of thousands of smokers convert. Many e-cigarette shop owners are former smokers and cannot quit smoking until they try e-cigarettes. To help other smokers, they created a non-existent e-cigarette ecosystem from the ground up. The safety and effectiveness of products and the prevention of sales to minors are at the core of their mission. Why did the FDA shut them down?

However, Vape has not given up the fight, and at least 28 companies have filed lawsuits against the FDA. Amanda Wheeler, president of the American Steam Manufacturers Association, turned anger into actions against CTP. "We will ask for answers at the door of the FDA or force them to pass the Freedom of Information Act laws and courts," she said. "We are not giving up our business or giving up e-cigarettes. As we said in Arizona, this is not just a battle. It will be a liquidation."

The FDA’s fiasco has sounded the alarm and the need to create a new e-cigarette product approval process that is transparent, works with all stakeholders, recognizes the great contribution of the e-cigarette community, and takes quick action to provide smokers with safer Of nicotine products.

The mission of CTP-established by the Family Smoking Prevention and Tobacco Control Act of 2009-is to "make tobacco-related deaths and diseases a part of the United States' past, not its future..." Nearly 40 million adults continue to smoke. The task is not completed, and the future is not optimistic.

CTP was wrong for so long. In its complete dysfunction, it failed to realize that the laser focus on the use of e-cigarettes by young people would prevent the investment of resources in vulnerable groups with the highest smoking rates, morbidity and mortality. Focus on them—not the declining number of wealthy white adolescents who try to use mango-infused nicotine to express rebellion and coolness in high school bathrooms. The "children" will be fine, and most will mature and no longer use them.

To further complicate the issue, CTP has participated in the "Forever War" against nicotine initiated by the Tobacco Free Kids Campaign, the Truth Initiative, and PAVE. They will always use the past of the tobacco industry to destroy the future of the e-cigarette industry.

Kathleen Crosby, director of the CTP Office of Health Communication and Education, initiated a public education campaign against e-cigarettes called "Real Costs." These videos try to intimidate teenagers with threatening worms invading their brains and bodies. Each 30-second advertisement contains exaggerations and omissions. They are the new version of the disgraced American drug-free partnership movement: "This is your drug brain."  

The COVID-19 pandemic has forced society to rethink how it does everything. For 20 years, the number of smokers worldwide has remained the same: 1.1 billion. Obviously, current tobacco control strategies are not working. Now is the time to reformulate a set of policies centered on smoking and e-cigarettes.

For this, you need to turn off CTP. Instead, we should establish a safer nicotine product center based on the principles of harm reduction, the right to health, and social and racial justice.

Today, the harms of smoking in the United States and elsewhere are concentrated in the most oppressed groups: African-Americans, Latinos, and Native Americans who die from smoking-related diseases; LGBTQ communities; people who use illegal drugs; homeless People; and people with a mental health diagnosis. Compared with the general population, the vast majority of smokers are poorer and less educated.

The Safer Nicotine Products Center will focus on efforts to reduce smoking rates among the following populations:

The needs of these groups for safer nicotine products should inform everything. If this country really wants to save the lives of smokers, this is what must be done. Because 500,000 unnecessary deaths every year are unacceptable.

Reynolds American, Inc. provided unlimited funding to The Influence Foundation, which runs Filter. Filter's editorial independence policy applies.

Helen is the senior editor of Filter. She has written articles on nicotine, mental health, and drug policy for publications such as Al Jazeera, AlterNet, Harper's, and The Influence. As an LCSW, she works with drug users in medical and community mental health settings. As an expert on tobacco harm reduction, she provides training and counseling on mental health, nicotine use and THR, and organized the first tobacco harm reduction conference in the United States in 2016. Helen is also a documentary filmmaker.

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