Vaping FAQs

are vaping products regulated in us

by Jessica VonRueden Published 2 years ago Updated 1 year ago
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In the US, the FDA (Food and Drug Administration) regulate vaping products and the regulations are similar to those in the UK:

  • Restricting youth access
  • Conducting retailer and manufacturer checks
  • Increasing requirements for manufacturers
  • Utilizing premarket review requirements
  • Providing data to inform premarket applications
  • Preventing youth tobacco use through enforcement actions, policy and education
  • Continuing to invest in more science and research

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.Jun 29, 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 ...

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

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

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Is vaping regulated in the US?

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.

Are vape products regulated by the FDA?

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.

What kind of 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 disposable vapes FDA approved?

None of the disposable vapes currently popular have received authorization from the FDA, although some disposable manufacturers have submitted premarket tobacco applications (PMTAs), and some have challenged FDA marketing denial orders (MDOs) in court or through FDA administrative appeals.

Why did FDA ban Juul?

Why does the FDA want to stop the sale of Juul products? According to the FDA, the decision was a precautionary response due to a lack of “sufficient evidence regarding the toxicological profile of the products” to ensure protection of public health.

Did the FDA ban flavored vape juice?

Voters largely in favor of vape bans Last week, the FDA banned Juul from selling any of its vaping products in the United States, including tobacco-flavored cartridges, citing insufficient health and safety data.

Are puff bars FDA approved?

Many e-cigarette makers, including Puff Bar, used this loophole to continue selling their nicotine-based products without gaining direct approval from the FDA.

Are e-cigarettes the same as vaping?

Using an e-cigarette is sometimes called “vaping.” E-cigarettes can be used to deliver marijuana and other drugs.

Is synthetic nicotine regulated by FDA?

An important new federal law went into effect in April clarifying FDA's authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine, and the agency continues to implement the law.

Are any disposable vapes made in the USA?

The Vape Pen Max, by Dinner Lady e-Liquids, is the first USA-made disposable featuring e-Liquid from the U.K. Dinner Lady is a very famous brand of e-Liquid that for once is not made in China and is now available in a very convenient disposable format.

Will synthetic nicotine be banned?

Manufacturers of synthetic nicotine products had until May 14, 2022, to submit marketing applications to the FDA; if products did not receive marketing authorization by July 13, 2022, they would be illegal and must be removed from the market.

Is Smok FDA approved?

SMOK has received the acceptance letter for the first round of PMTA applications from the Food and Drug Administration (FDA).

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.

Does the FDA regulate nicotine?

An important new federal law went into effect in April clarifying FDA's authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine, and the agency continues to implement the law.

Are puff bars FDA approved?

Many e-cigarette makers, including Puff Bar, used this loophole to continue selling their nicotine-based products without gaining direct approval from the FDA.

Can the FDA regulate synthetic nicotine?

In March, Congress passed an important new federal law clarifying FDA's authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine.

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 ...

How FDA is Regulating E-Cigarettes | FDA

FDA has made great strides in regulating ENDS as tobacco products over the last three years and remains committed to keeping e-cigarettes out of the hands of minors through enforcement actions ...

US FDA OKs Vuse e-cigarettes, its first vape authorization

The FDA said Tuesday it had authorized e-cigarette products for the first time ever, giving permission to R.J. Reynolds to sell three of its Vuse vape products.

FDA Approves E-Cigarette Products in the U.S. for the First Time

The VUSE Digital Vapor Cigarette packaging is seen during a launch event held by R.J. Reynolds Vapor Company in Philadelphia. On Tuesday, Oct. 12, 2021, heath officials authorized the first ...

Vaping and E-Cigarette Laws by State - Findlaw

Vaping and e-cigarette laws are complex. Vape pens vary and can be adapted to use tobacco, liquid nicotine, marijuana, herbs, and more. Furthermore, while federal law allows 18-year-olds to purchase tobacco products, some states put the minimum age at 21.

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.

How many warning letters did the FDA issue?

In September 2018, in the largest coordinated enforcement effort in the agency’s history, the agency issued more than 1,100 warning letters and initiated 131 civil money ...

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.

Why is it important to stay compliant with vaping laws?

Staying compliant and up-to-date on all vaping laws is essential to avoid trouble with law enforcement. If you are facing charges for vaping underage or trying to buy a product, a lawyer who understands e-cigarette laws and their nuances can help.

What age can you buy a vape?

Furthermore, while federal law allows 18-year-olds to purchase tobacco products, some states put the minimum age at 21. Pay close attention to your state’s evolving laws to avoid conflict while purchasing or using e-cigarettes.

Where is smoking banned?

Use banned at childcare buildings, playgrounds, schools, and everywhere smoking is also banned ( Section 70.345.150 and 110-300-0420 (2) ). Banned at most colleges and universities in their regulations and in state-run veteran’s homes except for designated areas ( Section 484-20-090 (1) (h) ).

Where are tobacco substitutes banned?

Banned at childcare centers, after school activities ( Section 33-3504 (a) ), and on public school grounds or at school events ( Section 16-140 ).

How old do you have to be to buy e-cigarettes?

Must be 19 years old to buy from a store or distributor ( Section 76-10-104 (1)) and must be 18 years old to buy or have e-cigarettes ( Section 76-10-105 (1) ). The exception is active military members over age 18 or anyone accompanied by a parent ( Section 26-62-205 ).

Is vaping banned in Hawaii?

E-cigarettes and vaping banned in the same places as smoking ( Section 328J-1 ). Use banned in all parks and at all University of Hawaii properties ( Section 304A-122 (a) ). Purchase requires an ID even if using a mail order delivery service ( Section 245-17 (b) ).

How do state laws change?

Note: State laws are always subject to change through the passage of new legislation, rulings in the higher courts (including federal decisions), ballot initiatives, and other means. While we strive to provide the most current information available, please consult an attorney or conduct your own legal research to verify the state law (s) you are researching.

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.

How many countries have banned vaping?

There are more than 40 countries that have some type of ban on vaping—either on possession and use, sales, or importation, or a combination. What we have attempted here is to list U.S. state flavor and online sales bans, and the sales and use bans imposed in other countries.

Which countries have no laws on vaping?

Asia. Bangladesh . Bangladesh currently has no laws or regulations specific to vaping. However, in December 2019 a health ministry official told Reuters that the government is “actively working to impose a ban on the production, import and sale of e-cigarettes and all vaping tobaccos to prevent health risks.”. Bhutan.

Where do vaping bans happen?

Most vape bans in the U.S. happen at the state and local levels .And while a few California cities—notably San Francisco—have banned sales of all vaping products, most American vape restrictions involve flavors and online sales. There are only a few of each, despite the large number of vaping bans that have been proposed in state legislatures in recent years—proof that grassroots opposition can stop bad legislation.

Which cities have flavor bans?

Major cities with flavor bans include Chicago, IL; Oakland and San Jose, CA; and Boulder, CO. Hundreds of smaller cities and counties—mostly in California—have flavor bans, as do some larger cities whose bans have since been superseded by state bans (like New York City and Newark, NJ)

Is there a central repository for information on vaping laws?

Our list is extensive, but maybe not definitive. Laws change frequently, and there is no central repository for information on worldwide vaping laws that is updated in real time. While our list includes some original research, these are the primary sources:

Does the FDA regulate vaping?

The FDA has federal authority to regulate vaping products. In September 2020 the agency began reviewing Premarket Tobacco Applications (PMTAs), and has signalled it will not authorize flavored products without extraordinary evidence. Whether the agency will be successful creating an unwritten standard that eliminates legal flavored products (except tobacco and menthol) may be determined by federal courts.

When did e-cigarettes start being banned?

shores in 2007.

What cities have banned vaping?

Localities with vaping bans that include all bars and restaurants (7 total): Abbeville, banned in all enclosed workplaces, including bars and restaurants. Cheneyville, banned in all enclosed workplaces, including bars and restaurants. Hammond, banned in all enclosed workplaces, including bars and restaurants.

When was vaping banned in Madison?

Daphne, August 18, 2014 banned in enclosed facilities owned, operated or leased by the city, including vehicles; vaping can also be prohibited where there is an owner, operator, manager, or other person having control of a place meeting certain criteria. Madison, November 24, 2014, banned in all city buildings.

What is a pictogram for vaping?

A pictogram used to denote a vaping ban. The following is a list of vaping bans in the United States. For federal regulation concerning the legal status of the sale of electronic cigarettes products in and outside the United States, see the worldwide regulation of electronic cigarettes .

Which cities are banned in all enclosed workplaces?

Danville, banned in all enclosed workplaces, including bars and restaurants, as well as within ten feet of the entrance of any such place. Glasgow, banned in bars and restaurants, but not all other workplaces. Lexington, banned in all enclosed workplaces, including bars and restaurants.

Which cities are banned in bars and restaurants?

Lakewood, banned in all enclosed workplaces, including bars and restaurants. Littleton, banned in bars and restaurants, but not other workplaces. Louisville, banned in bars and restaurants, but not other workplaces.

Why are e-cigarettes banned?

This is because of their potential for non-users to be exposed to chemicals and e-cigarette aerosol in indoor areas.

Is vaping legal in Georgia?

No statewide vaping ban. Instead , vaping is prohibited only on all campuses of University System of Georgia, with limited exceptions for educational purposes and research . Municipalities may regulate vaping more stringently than the state. Roswell bans vaping in all city parks

What states have e-cigarette laws?

As of March 31, 2021, 15 states (California, Colorado, Delaware, Hawaii, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Dakota, Oregon, Rhode Island, South Dakota, Utah and Vermont) the District of Columbia and Puerto Rico have passed comprehensive smokefree indoor air laws that include e-cigarettes. These laws prohibit smoking and the use of e-cigarettes in indoor areas of private worksites, restaurants, and bars.#N#Effective October 1, 2018, Alaska implemented new legislation prohibiting smoking and the use of e-cigarettes in indoor areas of private worksites, restaurants, and bars. Also included in the legislation is an option for a municipality to opt out of these provisions through a voter referendum. Because municipalities in Alaska are able to exempt themselves from this legislation, it is not considered to be a comprehensive smokefree indoor air policy that includes e-cigarettes.

How many states will have e-cigarettes in 2021?

As of June 30, 2021, 32 states (Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, Texas, Utah, Vermont and Washington), the District of Columbia, the Northern Mariana Islands, Palau and the U.S. Virgin Islands have passed legislation that requires a retail license to sell e-cigarettes over-the-counter.

How many states are taxing e-cigarettes?

As of June 30, 2021, 29 states (California, Colorado, Connecticut, Delaware, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming), the District of Columbia, Puerto Rico and the U.S. Virgin Islands have passed legislation that requires a tax on e-cigarettes. Twelve states (Connecticut, Delaware, Kansas, Louisiana, New Jersey, North Carolina, Ohio, Utah, Virginia, Washington, West Virginia and Wisconsin) tax e-cigarettes per milliliter of liquid or consumable material. Fourteen states (California, Colorado, Illinois, Maine, Maryland, Massachusetts, Minnesota, Nevada, New York, Oregon, Pennsylvania, Utah, Vermont, and Wyoming), the District of Columbia, and the U.S. Virgin Islands tax e-cigarettes on a percentage of a specified cost. Georgia, Kentucky, New Hampshire and New Mexico tax closed e-cigarette systems (prefilled cartridges) per milliliter of liquid and open e-cigarette systems (refillable cartridges) on a percentage of a specified cost. Puerto Rico taxes the e-cigarette device themselves if disposable, and the nicotine cartridge per milliliter of consumable liquid.

What is e-cigarette tax?

Type of Tax: E-cigarette tax is collected on a percentage on one of three levels—to the manufacturer, to the wholesaler, or to the retailer. Percent Value: E-cigarette tax collected at the manufacturer, retailer, or wholesale level as a percentage of the product price. Top of Page.

What is the legal age to sell e-cigarettes?

A federal law enacted on December 20, 2019, raised the federal minimum legal sales age for all tobacco products, including e-cigarettes, from 18 to 21 across the United States. It does not limit states, territories, localities, or tribes from enforcing their own, additional youth access laws or from setting their own minimum legal sales age higher than age 21.

When will e-cigarettes be legal in Connecticut?

In Connecticut, the comprehensive smokefree indoor air law that includes e-cigarettes becomes effective on October 1, 2021.

Which states are allowing the sale of e-cigarettes to underage people?

As of March 31, 2021, all 50 states, the District of Columbia, Guam, the Northern Mariana Islands, Palau, Puerto Rico, and the U.S. Virgin Islands have passed legislation prohibiting the sale of e-cigarettes to underage persons.

What are the new regulations for e-cigarettes?

The regulations require disclosure of ingredients used in e-cigarette liquids, proof of safety of those ingredients, and regulation of the devices used to vaporize and deliver the liquid. The FDA proposed regulation would ban the sale of e-cigarettes with nicotine to any individual under 18 years of age. In August 2014, attorneys general from over two dozen states advised the FDA to enact restrictions on e-cigarettes, including banning flavors. On 10 May 2016, the FDA published their deeming regulations in the Federal Register, which were to take effect on 8 August 2016. Vendors and companies had until two years afterward to prepare paperwork with the FDA to have their product remain on the market. Currently, there are lawsuits and amendments made in the works in Congress to change that provision. The lack of research on the risks and possible benefits has resulted in precautionary policymaking in the US "which often lacks grounding in empirical evidence and results in spatially uneven diffusion of policy". The time by which applications to market regulated non-combustible tobacco product devices must be submitted for review has been extended to August 8, 2022.

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 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 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.

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.

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.

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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…
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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…
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