Vaping FAQs

is vaping industry regulated

by Austen Rohan Published 2 years ago Updated 1 year ago
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Starting in 2016, the agency was able to begin regulating e-cigarettes—this time as tobacco products. Under those regulations, companies must submit an application to FDA to keep selling existing e-cigarette products or to sell new products.Jan 5, 2022

Full Answer

Is FDA banning vaping?

The Food and Drug Administration (FDA) seems intent on banning nearly all of the nicotine vaping products currently available in the United States, even though it acknowledges their harm-reducing...

What does the FDA say about vaping?

The single positive—one in the eye for disgraced researcher Stanton Glantz, billionaire Michael Bloomberg, his proxies at Campaign for Tobacco-Free Kids (CTFK) and Parents Against Vaping E-Cigarettes — is that the FDA finally had to admit that an e-cigarette is “Appropriate for the protection of public health … The toxicological assessment found the authorized products’ aerosols are significantly less toxic than combusted cigarettes.”

Should the federal government regulate vaping?

These federal agencies would also be able to regulate what forms of consumption are allowable. For example, federal law could stamp out vape-based cannabis consumption, both medical and recreational. As a reminder, more than two dozen people have died in recent weeks from mysterious vape-related lung illnesses.

Did the FDA approve vaping?

Vaping: FDA approves e-cigarette in US for first time. The Food and Drug Administration (FDA), which regulates medical products in the US, has approved an e-cigarette for sale for the first time ...

When did CTP start regulating e-cigarettes?

How many people smoke combustible cigarettes?

Why is the warning statement on nicotine important?

Why is the FDA evaluating Ends?

What is FDA's oversight of end products?

When did the FDA issue the first warning letter to a company for selling e-liquids without the required marketing?

Can a product diminish the use of combustible cigarettes?

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Is vaping regulated by the FDA?

FDA PRIORITIZES ENFORCEMENT AGAINST CERTAIN ILLEGALLY MARKETED ENDS. FDA's scientific review of vaping products ensures they are appropriate for the protection of public health. The agency continues to monitor the marketplace to protect youth from certain illegally marketed ENDS products.

Are Vapes regulated by the ATF?

Any person or business that sells, transfers or ships for profit any ENDS in interstate commerce must now register with ATF according to 15 U.S.C. §§ 375 and 376. They must also register with any states that they ship vapes into.

Is vaping regulated in UK?

The TRPR introduced rules which ensure: minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids) that information is provided to consumers so that they can make informed choices. an environment that protects children from starting to use these products.

Are nicotine products regulated?

Yes, FDA regulates NTN products. Since passage of the Family Smoking Prevention and Tobacco Control Act (commonly called the Tobacco Control Act) in 2009, FDA has regulated the manufacturing, distribution, and marketing of tobacco products.

Will the FDA ban vaping?

After a two-year review, the Food and Drug Administration announced Thursday it will ban all vaping and e-cigarette products sold by Juul. It's part of a series of more aggressive moves by the FDA to target vaping and smoking.

Why is the FDA banning Juul?

In 2009, the FDA attempted to stop imports of e-cigarettes on the grounds that they were unapproved drug delivery devices that required pre-approval, registration, and listing with the regulatory agency.

Do you need license to sell vapes UK?

Do you need a license to sell vaping products UK? You don't need a license to sell vaping products.

Are disposable vapes being banned UK?

As a rule of thumb, a disposable vape with 600 puffs or less is likely to be compliant with UK law, as it contains 2ml of vape juice or less, while those with over 600 puffs are likely to be more than 2ml, and so are banned.

Why are Elux bars illegal?

Under UK TPD/TRPR regulations, no vape device can be sold in with capacity of greater than 2ml, which is why most disposables on the market only offer around 600 puffs. The Elux Legend only provides 3500 puffs because the tank is 10ml – which is why it's banned in the UK.

Is Juul regulated?

All electronic nicotine delivery systems, or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed. The stay and the agency's review does not constitute authorization to market, sell, or ship JUUL products.

What vape brands are FDA approved?

Other products authorized by the FDA include the Vuse Solo, Vuse Ciro, Vuse Vibe, Logic Pro, and the Logic Power.

Is vaping worse than smoking?

1: Vaping is less harmful than smoking, but it's still not safe. E-cigarettes heat nicotine (extracted from tobacco), flavorings and other chemicals to create an aerosol that you inhale. Regular tobacco cigarettes contain 7,000 chemicals, many of which are toxic.

What does the ATF regulate?

ATF's responsibilities include the investigation and prevention of federal offenses involving the unlawful use, manufacture, and possession of firearms and explosives; acts of arson and bombings; and illegal trafficking of alcohol and tobacco products.

What happens if you ship a vape?

USPS Officially Prohibits Shippers to Send Vapes and E-Cigarettes through its Network. On October 21, 2021, USPS issued a final ruling that prohibits individuals and small businesses from sending vapes through the mail. This ruling also applies to electronic cigarettes and other battery-powered nicotine products.

What vapes are FDA approved?

Recently, the first disposable vape device passed the PMTA approval process. The NJOY Daily Rich Tobacco and the NJOY Daily Extra Rich Tobacco disposable vapes have now both been approved for sale. A majority of NJOY's other flavors have been given MDOs, or marketing denial orders.

Are vapes considered tobacco products?

E-cigarettes are considered tobacco products because most of them contain nicotine, which comes from tobacco. Besides nicotine, e-cigarettes can contain harmful and potentially harmful ingredients, including: ultrafine particles that can be inhaled deep into the lungs.

FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other ...

Tobacco use is the single largest preventable cause of disease and death in the United States. 1 Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a ...

FDA Oversight of E-Cigarettes Gathers Speed - NCI

Mitch Zeller, director of FDA’s Center for Tobacco Products, provides insights into how e-cigarettes are regulated and recent FDA actions on e-cigarettes.

FDA has authorized e-cigarettes for the first time, citing ... - NPR

FDA says data submitted by R.J. Reynolds showed its Vuse e-cigarettes helped smokers either quit or significantly reduce their use of cigarettes, the leading preventable cause of death in the U.S.

FDA Permits Marketing of E-Cigarette Products, Marking First ...

FDA authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the agency through the Premarket ...

When did CTP start regulating e-cigarettes?

When CTP began regulating ENDS, many of the regulatory and legal requirements that had been in place for manufacturers of cigarettes, smokeless tobacco, and roll-your-own tobacco since 2009 — as well as several new requirements specific to ENDS — became applicable to makers of e-cigarettes and other ENDS products. As of June 2019, the compliance dates to meet many of these requirements have passed, and makers of all ENDS currently on the market should have met certain requirements, including, but not limited to:

How many people smoke combustible cigarettes?

from tobacco-associated cancers, emphysema, heart disease, stroke and the 34.3 million Americans who still smoke combustible cigarettes despite decades of efforts to help them quit. So, any product that can diminish the use of combustible cigarettes substantially has to be considered of enormous potential value. Are e-cigarettes that product? Well, given that most e-cigarette users continue to smoke cigarettes, the answer is not clear. Though there are some data, both epidemiological and from direct clinical trials, that some electronic nicotine delivery systems (ENDS, which includes products known as “e-cigarettes”) can reduce the use of combustible cigarettes and may be less harmful than traditional cigarettes.

Why is the warning statement on nicotine important?

Likewise, the warning statement on nicotine is an important requirement to let the public know that these products contain nicotine, an addictive chemical. FDA has also issued new or revised guidances on these topics.

Why is the FDA evaluating Ends?

Because ENDS products are still relatively new, FDA supports and funds research to evaluate ENDS’ public health impact both at the individual and population levels. For example, in 2018, the agency commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to evaluate the available scientific evidence of the short- and long-term health effects related to the use of ENDS.

What is FDA's oversight of end products?

FDA’s oversight of these products is a top priority for the agency. This ongoing work includes investing in more science to address the unanswered questions about ENDS, developing guidances and regulations, educating industry and the public, and aggressively enforcing the law — all of which have had a wide-ranging impact on the manufacturing, marketing, and selling of ENDS. CTP’s work is constant in its effort to keep these products out of the hands of kids.

When did the FDA issue the first warning letter to a company for selling e-liquids without the required marketing?

In 2018 , as a result of regular inspections that now include e-cigarette manufacturers and retailers, FDA issued the first warning letter to a company for selling e-liquids without the required marketing authorization.

Can a product diminish the use of combustible cigarettes?

So, any product that can diminish the use of combustible cigarettes substantially has to be considered of enormous potential value. Are e-cigarettes that product? Well, given that most e-cigarette users continue to smoke cigarettes, the answer is not clear.

What does the FDA do to regulate tobacco products?

In order to regulate a tobacco product, the F DA had to write a rule that would specify which products it deemed to be subject to the TCA. The law immediately deemed cigarettes, cigarette tobacco, smokeless tobacco, and hand-rolled tobacco as subject to the TCA, and required the FDA to stipulate what other tobacco products it would regulate. Thus, in order to regulate cigars, e-cigarettes, and hookah and vaping products, the FDA had to write a rule that was processed through the formal “notice-and-comment” rule-making process. The shorthand for this effort is “deeming regulation.”

What is the result of this mix of legal and illegal use of addictive substances?

The result of this mix of legal and illegal use of addictive substances is that our jails are full of drug users who have committed nonviolent crimes, significant premature death and disability is tolerated, and there are enormous disparities in enforcement as functions of wealth, race, and power.

Why is tobacco important to the economy?

This person’s conclusions: tobacco produced economic benefit not only because it created jobs , but also because it reduced longevity after retirement. In other words, people who die from tobacco-related diseases often die from sudden cardiac death, myocardial infarction, stroke, or lung cancer — all of which are associated with relatively short intervals of disability.

Is methamphetamine illegal?

Amphetamine derivatives are contained in many over-the-counter and prescription medications, but methamphetamine is illegal and its use is growing rapidly again as opioids become more difficult to obtain. Opioids are prescribed legally, but they are illegal for consumer use.

Is cigarette tobacco a TCA?

The law immediately deemed cigarettes, cigarette tobacco, smokeless tobacco, and hand-rolled tobacco as subject to the TCA, and required the FDA to stipulate what other tobacco products it would regulate.

What is the Big Time Vapes challenge?

The challenge — brought by a Mississippi vape store called Big Time Vapes, Inc., as well as the United States Vaping Association — alleges the 2009 Tobacco Control Act gives an unconstitutional amount of power to the FDA.

Is it illegal to sell vapes to kids?

The agency immediately made it illegal to sell them to children under the age of 18 , started conducting inspections of vape stores to make sure they were complying with regulations, and requiring products to be authorized before going on the market.

Will the court hear a case in which the vaping industry challenged the agency’s broad authority to oversee what goes?

The court will not hear a case in which the vaping industry challenged the agency’s broad authority to oversee what goes into tobacco products, including e-cigarettes

Is vaping harmful?

At the time, e-cigarettes and vaporizers were both exploding in popularity and evidence of how harmful they could be was mounting. “Vaping exposes users to many different substances for which we have little information about related harms — including flavorings, nicotine, cannabinoids, and solvents,” former Centers for Disease Control Director Robert Redfield said in 2019 following the first recorded death of someone who had come down with vaping-induced lung disease.

Is the Tobacco Control Act constitutional?

The Biden administration argued the Tobacco Control Act is constitutional, however, as “Congress laid out intelligible principles with appropriate boundaries for FDA to apply.” Biden’s FDA has also cited the the public health issues posed by vaporizers and e-cigarettes, particularly to children, in defending the its authority to regulate the industry.

Are You a Manufacturer of E-Cigarettes, Vapes, or other ENDS?

FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories.

Are You Looking for General Health and Safety Information Related to E-Cigarettes, Vapes, or Other ENDS?

The longer ENDS and other e-cigarettes are on the market, the more information we know about their impacts on health. This includes data on youth use of these products, which has led to development of several educational programs designed to prevent adolescents and teens from using these products. Through tobacco product problem reports and tobacco product violation reports, the FDA also knows much more about many safety and health hazards they may pose.

How many vapers will be there in 2021?

It’s estimated that the number of adults who vape will reach nearly 55 million by 2021. Meanwhile, the United States is the biggest market, followed by the UK and France.

Do e-cigarettes have societal concerns?

Ultimately, e-cigarette manufacturers that ensure societal concerns are kept in mind as they bring cutting-edge products to market will remain at the forefront in years to come. This will involve a self-regulating “lead-by-example” shift in the way new products are manufactured and marketed.

Is vaping safer than smoking?

In March 2020, England’s leading health agency released its annual report on vaping, which argues that vaping nicotine is indeed a safer alternative to smoking.

Does the FDA have regulatory measures?

FDA regulatory measures have not been applied industry-wide. For example, if “a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.”

Is regulation important in vaping?

On the one hand, regulation can be critically important to our well-being. On the other hand, regulatory actions often come at a cost that exceeds the benefit, and at times can prove counterproductive. The U.S. vaping industry performance will be conservatively optimistic in the short-term.

Is smoking a bad habit?

For decades, it has been widely known that smoking is extremely harmful to our health, and is decidedly a toxic habit that’s hard to break. As a result, smoking treatment products, programs, and alternatives have become a billion-dollar industry that shows no sign of slowing growth.

Is vaping banned in 2020?

In September 2019, the Trump administration said it would ban the sale of most flavored e-cigarettes, amid the continued rise of teenage vaping and alleged vape-related illness concerns. In January 2020, the U.S. has announced a countrywide ban on some e-cigarette flavors –– specifically mint and fruit flavors offered in cartridge-based ...

When did the FDA regulate vaping?

The agency gained the power to regulate tobacco products in 2009, when then-President Obama signed into law the Family Smoking Prevention and Tobacco Control Act. But at that time, e-cigarettes weren’t terribly popular, and they were left out of the FDA’s regulatory rules. The agency didn’t finalize a rule for regulating vaping devices—which heat and aerosolize nicotine e-liquids, hopefully providing a less-dangerous version of a traditional cigarette—until 2016. At that point, the agency informed companies with products already on the market that they would have to retroactively put together premarket tobacco product applications (PMTAs) to ask for permission to keep selling them in the U.S.

When did vaping come out?

E-cigarettes have been sold in the U.S. since 2007. Why is the FDA acting now?

How many high schoolers vape in 2020?

Then there are the impossible-to-ignore youth vaping numbers. As of 2020, about 20% of U.S. high school students said they had vaped in the past month, most often choosing products—like Juul’s—that use pre-filled e-liquid cartridges. That’s actually down from the 27.5% who said so in 2019—perhaps a reflection of pandemic isolation and tighter regulations on e-cigarettes, among other factors. In 2019, the Trump Administration raised the minimum age of tobacco sale to 21, and in 2020, banned the sale of e-liquid cartridges in all flavors except menthol and tobacco, unless and until they receive FDA authorization.

What does the FDA decide about e-cigarettes?

The FDA’s decisions will technically come down to whether each e-cigarette product in consideration is “appropriate for the protection of public health” —the agency’s standard for assessing whether it has a net positive or negative effect on the nation’s public health. Crucially, the agency will assess each product’s potential effect on the entire U.S. population, not just adult smokers.

Is Juul a teenager product?

Juul has repeatedly denied that it purposely targeted teenagers and says its product is meant only for adult smokers. In 2019—apparently anticipating action from the FDA—Juul discontinued the sale of all flavors except menthol and tobacco. That year, it also introduced a new age-verification system in retail stores, and suspended almost all of its U.S. advertising. “While millions of adult smokers have converted to our products from cigarettes, we will only be trusted to provide alternatives to adult smokers if we continue to combat underage use, respect the central role of our regulator and build on our shared commitment to science and evidence,” a Juul spokesperson said in a statement.

Can vaping go back to smoking?

On the other hand, vaping industry representatives and pro-vaping researchers warn that adult smokers may go back to deadly traditional tobacco cigarettes if the FDA clears the market of popular e-cigarettes. “To date, the singular focus of U.S. policies on decreasing youth vaping may well have reduced vaping’s potential contribution to reducing adult smoking,” 15 past presidents of the Society for Research on Nicotine and Tobacco wrote in a recent American Journal of Public Health article.

Is vaping a tobacco product?

(If nicotine is lab-made and not derived from actual tobacco, it is technically not a tobacco product, Vapor Salon and others argue.) “They made it a game of chess with all of our pieces already captured and expected us to play along and be happy about it,” Vapor Salon wrote in the post.

What companies have lobbied for stricter regulation of e-cigarettes?

Pharmaceutical manufacturers GlaxoSmithKline and Johnson & Johnson have lobbied the US government, the Food and Drug Administration (FDA), and the EU parliament for stricter regulation of e-cigarettes which compete with their products Nicorette gum and nicotine patches.

Why are vapes banned in Malaysia?

Malaysia: In 2015, the Malaysian National Fatwa Council issued a fatwa declaring e-cigarettes haram (forbidden) because of their harmful health effects and bad smell. Though the fatwa is not legally binding, it carries weight for religious Muslims and has caused the governments of four majority-Muslim states— Penang, Kedah, Johor, and Kelantan —to ban vaping. As a response to the fatwa, the Malaysian federal government began regulating e-liquid ingredients and vape sales to minors in 2018, marking the first federal regulations of the 2.5 billion ringgit (US$610 million) industry. A petition called "Selamatkan anak-anak Malaysia" was launched by Parent & Teacher Action Group Malaysia to urge government to ban (totally) e-cigarette and vape in Malaysia, which they managed to collect more than 100,000 signatures so far.

How do taxes affect e-cigarettes?

Studies that examine the impact of e-cigarette taxes on use of e-cigarettes and traditional cigarettes have found that e-cigarette taxes increase cigarette use across different populations (adults, children, pregnant), thus providing evidence that the two products are economic substitutes. Along the same line, another study found that e-cigarette minimum legal purchase age laws increase cigarette use among 12 to 17 years old, suggesting that e-cigarettes are displacing youth smoking rather than acting as a gateway to youth smoking. Regarding indoor vaping regulations, one study found that it increased prenatal smoking by about 0.8 percentage points had no significant impact on birth outcomes.

How much nicotine can you buy in Belgium?

Belgium: A royal decree legalized the sale of nicotine containing cartridges outside of pharmacies as long as the cartridge contains not more than 2 ml and a maximum of 20 mg/ml of nicotine. The sale to a minor under the age of 18 years is prohibited.

How many states have e-cigarette laws?

A review of regulations in 40 U.S. states found that how a law defines e-cigarettes is critical, with some definitions allowing e-cigarettes to avoid smoke-free laws, taxation, and restrictions on sales and marketing. Fewer policies have been created to restrict vaping indoors than with cigarette smoking.

How many states have banned e-cigarettes?

As of April 2017. [update] , 12 US states and 615 localities had prohibited the use of e-cigarettes in venues in which traditional cigarette smoking was prohibited. In 2015, at least 48 states and 2 territories had banned e-cigarette sales to minors.

How old do you have to be to smoke an e-cigarette?

The FDA proposed regulation would ban the sale of e-cigarettes with nicotine to any individual under 18 years of age.

When did CTP start regulating e-cigarettes?

When CTP began regulating ENDS, many of the regulatory and legal requirements that had been in place for manufacturers of cigarettes, smokeless tobacco, and roll-your-own tobacco since 2009 — as well as several new requirements specific to ENDS — became applicable to makers of e-cigarettes and other ENDS products. As of June 2019, the compliance dates to meet many of these requirements have passed, and makers of all ENDS currently on the market should have met certain requirements, including, but not limited to:

How many people smoke combustible cigarettes?

from tobacco-associated cancers, emphysema, heart disease, stroke and the 34.3 million Americans who still smoke combustible cigarettes despite decades of efforts to help them quit. So, any product that can diminish the use of combustible cigarettes substantially has to be considered of enormous potential value. Are e-cigarettes that product? Well, given that most e-cigarette users continue to smoke cigarettes, the answer is not clear. Though there are some data, both epidemiological and from direct clinical trials, that some electronic nicotine delivery systems (ENDS, which includes products known as “e-cigarettes”) can reduce the use of combustible cigarettes and may be less harmful than traditional cigarettes.

Why is the warning statement on nicotine important?

Likewise, the warning statement on nicotine is an important requirement to let the public know that these products contain nicotine, an addictive chemical. FDA has also issued new or revised guidances on these topics.

Why is the FDA evaluating Ends?

Because ENDS products are still relatively new, FDA supports and funds research to evaluate ENDS’ public health impact both at the individual and population levels. For example, in 2018, the agency commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to evaluate the available scientific evidence of the short- and long-term health effects related to the use of ENDS.

What is FDA's oversight of end products?

FDA’s oversight of these products is a top priority for the agency. This ongoing work includes investing in more science to address the unanswered questions about ENDS, developing guidances and regulations, educating industry and the public, and aggressively enforcing the law — all of which have had a wide-ranging impact on the manufacturing, marketing, and selling of ENDS. CTP’s work is constant in its effort to keep these products out of the hands of kids.

When did the FDA issue the first warning letter to a company for selling e-liquids without the required marketing?

In 2018 , as a result of regular inspections that now include e-cigarette manufacturers and retailers, FDA issued the first warning letter to a company for selling e-liquids without the required marketing authorization.

Can a product diminish the use of combustible cigarettes?

So, any product that can diminish the use of combustible cigarettes substantially has to be considered of enormous potential value. Are e-cigarettes that product? Well, given that most e-cigarette users continue to smoke cigarettes, the answer is not clear.

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Restricting Youth Access to Ends

Conducting Retailer and Manufacturer Checks

  • FDA also conducts regular inspections of ENDS manufacturing facilities, including vape shops that make or modify ENDS products. Since 2016, CTP has conducted more than 1,200 vape shop inspections to confirm that manufacturers and retailers in these facilities are complying with the Federal Food, Drug, and Cosmetic Act and FDA regulations, as well a...
See more on fda.gov

Increasing Requirements For Ends Manufacturers

  • When CTP began regulating ENDS, many of the regulatory and legal requirements that had been in place for manufacturers of cigarettes, smokeless tobacco, and roll-your-own tobacco since 2009 — as well as several new requirements specific to ENDS — became applicable to makers of e-cigarettes and other ENDS products. As of June 2019, the compliance dates to meet many of th…
See more on fda.gov

Utilizing Premarket Review Requirements

  • All deemed products, including ENDS products, became subject to the premarket authorization requirements in the Tobacco Control Act, effective Aug. 8, 2016. This means that any ENDS product, as well as any other tobacco product, that was not on the market as of Feb. 15, 2007, is a “new” tobacco product that must be authorized by FDA to be on the market. ENDS that were on t…
See more on fda.gov

Providing Data to Inform Premarket Applications

  • To receive marketing authorization of any new tobacco product, manufacturers must follow one of three pathways. FDA anticipates most manufacturers of ENDS are likely to submit their applications through the Premarket Tobacco Product Application (PMTA) pathway. Under the PMTA pathway, FDA evaluates a new tobacco product based on whether it is appropriate for th…
See more on fda.gov

Preventing Youth Tobacco Use Through Enforcement Actions, Policy and Education

  • The U.S. has seen a sharp increase in e-cigarette use among youth, and particularly teens. In response to the concerning prevalence of youth use of these products, FDA created its Youth Tobacco Prevention Plan, which focuses on three crucial areas to prevent youth use of tobacco products — especially e-cigarettes: 1. Preventing youth access to tobacco products 2. Curbing t…
See more on fda.gov

Continuing to Invest in More Science and Research

  • Because ENDS products are still relatively new, FDA supports and funds research to evaluate ENDS’ public health impact both at the individual and population levels. For example, in 2018, the agency commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM)to evaluate the available scientific evidence of the short- and long-term health effects r…
See more on fda.gov

The Link Between Tobacco and Disease

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Lately, I’ve been thinking about these issues every time I walk by the statue of James Buchanan “Buck” Duke in front of the Duke Chapel on the grounds of the university where — barring a handful of years devoted to completing a residency and to serving at the FDA — I’ve spent the last half century. J.B. Duke, the benefac…
See more on aamc.org

How The FDA Came to Regulate Tobacco

  • There is a widespread misconception that the FDA has been regulating tobacco products since the time that a young FDA commissioner, David Kessler, MD, confronted the tobacco industry in the 1990s. Kessler and his colleagues used their authority to uncover documents revealing the tobacco industry’s efforts to obfuscate evidence of harm from their pr...
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A Path to Enforcement

  • However, to fully understand the history of tobacco regulation since the passage of the TCA, one also needs a basic understanding of how federal laws are interpreted and implemented. In essence, once Congress enacts a law, that law must then be interpreted, and federal rules provide binding instructions on how a law is interpreted by the relevant federal agencies. Guidances are …
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The Economic Impact of Tobacco Use

  • An additional key background issue concerns the economics of tobacco and tobacco products. My own introduction to these issues occurred during a clandestine breakfast meeting with a famous demographer and epidemiologist who had conducted a 1990s version of a “big data” analysis. This person’s conclusions: tobacco produced economic benefit not only because it cre…
See more on aamc.org

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