FDA's Plan for Tobacco and Nicotine Regulation (2022)

FDA's Plan for Tobacco and Nicotine Regulation (1)

Text of milestones graphic

FDA's comprehensive plan places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan serves as a multi-year roadmap to better protect youth and help addicted adult smokers quit, significantly reducing tobacco-related disease and death in the U.S. in the years to come.

Key Features of the Comprehensive Plan for Tobacco and Nicotine Regulation

  • Regulatory Policies on Addiction, Appeal, and Cessation
    • Seeking evidence and public comment on potential FDA regulation
    • Increasing access to, and use of, medicinal nicotine products to help people quit
    • Educating the public and correcting misperceptions about nicotine
  • Science-Based Review of Tobacco Products
    • Extending certain compliance dates
    • Seeking industry feedback on application processes
    • Implementing product standards for safety
  • Youth Tobacco Prevention Plan

Regulatory Policies on Addiction, Appeal, and Cessation

Seeking evidence and public input on potential FDA regulation:

  • Tobacco Product Standard for Nicotine Level of Combustible Cigarettes
    • Lowering nicotine in cigarettes to a minimally or non-addictive level through the creation of a potential nicotine product standard could decrease the chances that future generations become addicted to cigarettes, and could make it easier for more currently addicted smokers to quit.
    • The advanced notice of proposed rulemaking sought public comment on these topics and offered newly published estimates of one possible policy scenario for a nicotine product standard.
    • FDA also issued a draft concept paper, Illicit Trade in Tobacco Products After Implementation of an FDA Product Standard, which discussed potential illicit trade implications of product standards more generally.
  • Regulation of Flavors in Tobacco Products
    • FDA has issued an advance notice of proposed rulemaking to help determine how best to regulate flavors in tobacco products, including menthol.
    • FDA plans to expedite the review and analysis of comments on this notice
  • Regulation of Premium Cigars
    • An advance notice of proposed rulemaking about regulation of “premium” cigars sought input on the appropriate definition of “premium" cigars, use patterns, and public health considerations.

FDA Issues Draft Guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products

(Video) FDA Announces Regulatory Plan to Shift Trajectory of Tobacco-related Disease and Death

The guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products, including flavored e-cigarettes and cigars, and describes how FDA intend to prioritize its enforcement of products that do not have premarket authorization.

  • Read statement from FDA Commissioner Dr. Scott Gottlieb

Increasing access to, and use of, medicinal nicotine products to help people quit

FDA is examining actions and working with sponsors to increase access to, and use of, FDA-approved medicinal nicotine products intended to help smokers quit. The Nicotine Steering Committee held a public hearing in early 2018, which focused on Evaluating Safety and Efficacy of Nicotine Replacement Therapies (NRTs).

Educating the public and correcting misperceptions about nicotine

In December 2017, FDA launched an adult public education campaign, Every Try Counts, which offers messages of support to smokers trying to quit. The campaign encourages smokers to keep practicing the quit because every quit attempt is a step toward success.

Most people—especially smokers trying to quit—know that cigarettes are addictive, but many do not understand the role of nicotine in cigarette addiction. FDA is embarking on an effort to engage stakeholders and the public in an educational dialogue and correct common misperceptions around nicotine and addiction.

Science-Based Review of Tobacco Products

Extending certain compliance dates

The agency extended timelines to submit tobacco product review applications for deemed regulated products that were on the market as of August 8, 2016. The revised timelines afford the agency time to explore clear and meaningful measures to ensure tobacco products are less toxic, appealing, and addictive. In addition, the additional time will allow companies to develop higher quality, more complete applications informed by further guidance from the agency.

  • Applications to market deemed regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco, must now be submitted by August 8, 2021.
  • Applications to market deemed regulated non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, must now be submitted by August 8, 2022.

Requirements from the deeming rule that occurred prior to these new extended compliance dates must still be met. For example, mandatory age and photo-ID checks to prevent illegal sales to minors remain in effect and subject to enforcement by the FDA.

(Video) FDA’s New Regulatory Framework for Tobacco and Nicotine: the Role of Medicinal Nicotine

Seeking industry feedback on application process

FDA also plans to seek feedback to improve and enhance industry’s ability to comply with federal tobacco regulations through proposing new foundational rules, hearings seeking public comment and feedback, and guidance documents for regulatory compliance related to:

  • Premarket tobacco applications (PMTAs),
  • Modified risk tobacco product (MRTP) applications, and
  • Reports to demonstrate substantial equivalence (SE).

The FDA also plans to finalize guidance on how it intends to review premarket tobacco applications for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information and webinars.

Implementing product standards for safety

Future efforts will also explore additional product standards that could prevent injuries from known tobacco product risks, including:

The FDA has also begun exploring a product standard for e-cigarettes to help address existing concerns. As part of the standard, the agency will consider, among other things, levels of toxicants and impurities in propylene glycol, glycerin, and nicotine in e-liquids.

Youth Tobacco Prevention Plan

Preventing youth use of, and access to, tobacco products

A focused segment of the Comprehensive Plan, known as the Youth Tobacco Prevention Plan, aims to stop youth use of, and access to, tobacco products—especially e-cigarettes. Significant regulatory and research efforts related to access, marketing, and education are already underway.

Alt Text forMilestones of FDA's Comprehensive Plan for Tobacco and Nicotine Regulation image

SEPTEMBER 2018

  • Launching full scale e-cigarette messaging effort under “The Real Cost” campaign brand

MAY 2018

(Video) The FDA plans to reduce nicotine in cigarettes

  • Sent warning letters to companies misleading kids with e-liquids that resemble children’s food products
  • Requested critical product information from companies about the youth-appeal of their e-cigarettes

APRIL 2018

  • Unveiled Youth Tobacco Prevention Plan
  • Sent warning letters to retailers who illegally sold JUUL to underage youth
  • Requested critical information from JUUL Labs on marketing and research related to youth initiation and use
  • Provided update on provisional substantial equivalence review process

MARCH 2018

  • Published three advance notices of proposed rulemaking for public comment:
  • Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
  • Regulation of Flavors in Tobacco Products
  • Regulation of Premium Cigars

DECEMBER 2017

  • Launched “Every Try Counts” public education campaign to encourage adult smokers trying to quit cigarettes

NOVEMBER 2017

  • Launched “This Is Our Watch” program to educate retailers

SEPTEMBER 2017

  • Expanded “The Real Cost” campaign to include messaging on e-cigarettes

JULY 2017

(Video) FDA chief: Looking to regulate nicotine in cigarettes

  • Announced FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation
(Video) FDA Wants To Cap Nicotine Levels In Cigarettes | CNBC

Additional Resources

  • March 2019: Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan
  • November 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
  • September 2018: FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access
  • August 2018: FDA In Brief: FDA takes steps to improve efficiency, transparency of tobacco product application review process as part of comprehensive framework to reduce the disease and death related to tobacco products
  • August 2018: Advancing Tobacco Regulation to Protect Children and Families- Updates and New Initiatives from the FDA
  • June 2018: Upcoming Tobacco Product Listing Deadline June 30: What Does the Deadline Mean to You, and How is FDA Helping You Comply?
  • June 2018: Special Announcement - FDA Extends Comment Periods for ANPRMs and Draft Concept Paper
  • June 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
  • May 2018: FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products
  • May 2018: FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
  • May 2018: FDA, FTC take action against companies misleading kids with e-liquids that resemble children's juice boxes, candies and cookies
  • April 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes
  • March 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors--including menthol--in tobacco products
  • March 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels
  • November 2017: Guidance--Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Revised)
  • September 2017: A Nicotine-Focused Framework for Public Health, by FDA Commissioner Scott Gottlieb and CTP Director Mitchell Zeller in the New England Journal of Medicine
  • July 2017: Press Release--FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
  • July 2017: Speech--Protecting American Families: Comprehensive Approach to Nicotine and Tobacco

FAQs

What are 3 strategies for preventing the use of tobacco? ›

Strategies that comprise successful comprehensive tobacco control programs include mass media campaigns, higher tobacco prices, smoke-free laws and policies, evidence-based school programs, and sustained community-wide efforts.

Will FDA lower nicotine levels? ›

The US Food and Drug Administration (FDA) announced plans to develop a product standard that would set a maximum nicotine level in cigarettes and associated products to reduce their overall addictiveness and concomitant youth use.

Is vaping better than smoking 2022? ›

2.2 Biomarkers of toxicant exposure

significantly lower exposure to harmful substances from vaping compared with smoking, as shown by biomarkers associated with the risk of cancer, respiratory and cardiovascular conditions.

Does the FDA have the authority to regulate e-cigarettes? ›

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.

How can we prevent and control tobacco? ›

Tobacco Control Program

Prevent initiation of tobacco use among youth and young adults. Promote tobacco use cessation among adults and youth. Eliminate exposure to secondhand smoke. Identify and eliminate tobacco-related disparities.

What are 5 benefits of being tobacco free? ›

Benefits of Quitting
  • Clean Mouth. Nobody likes a dirty mouth. ...
  • Thin Blood. Another effect of quitting smoking is that your blood will become thinner and less likely to form dangerous blood clots. ...
  • Return of Cilia. ...
  • Normal Estrogen Levels. ...
  • Proper Healing.
4 Feb 2022

Are they banning nicotine in cigarettes? ›

July 26, 2022—In June, the U.S. Food and Drug Administration announced plans to develop a proposed product standard by May 2023 that would establish a maximum nicotine level in combustible tobacco products and reduce their addictiveness.

Is there a cigarette without nicotine? ›

The BILLY is the first Herbal green cigarette in the United States with No Tobacco and No Nicotine. Developed to help with nicotine addiction, but can be smoked even if not ready to quit.

What level of nicotine is in a cigarette? ›

The nicotine content in a cigarette can vary greatly from one brand to the next. On the low end, a single cigarette may contain about 6 milligrams (mg) of nicotine. On the high end, about 28 mg. The average cigarette contains about 10 to 12 mg of nicotine.

What does the FDA say about e-cigarettes? ›

To date, no e-cigarette has been approved as a cessation device or authorized to make a modified risk claim, and more research is needed to understand the potential risks and benefits these products may offer adults who use tobacco products.

Is the FDA going to 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.

Is Joe Biden getting rid of nicotine? ›

The Biden administration signaled Tuesday that it will develop a proposed rule to establish a maximum nicotine level in cigarettes and other tobacco products that will essentially lower the amount of nicotine in products available in the US.

What can we learn from tobacco control programs? ›

Included studies consistently showed that comprehensive tobacco control programs reduce the prevalence of tobacco use among adults and young people, reduce tobacco product consumption, increase quitting, and contribute to reductions in tobacco-related diseases and deaths.

Why is it important to learn about tobacco? ›

The longer a person smokes or is around smoke, the greater their chances of developing a smoking- related illness such as heart attack, stroke, cancer of the lungs or mouth or throat, and respiratory diseases such as emphysema and chronic bronchitis.

What are the main challenges in reducing tobacco use? ›

Smuggling of tobacco products by youth and ignorance of smokeless tobacco control approach are major challenges.

Is life better without nicotine? ›

Summary: Life without cigarettes is not all doom and gloom. In fact, successful quitters are more satisfied with their lives and feel healthier, both one year and three years afterwards, than those who continue to smoke.

What are the benefits of living tobacco and nicotine free? ›

Living tobacco and nicotine free reduces a person's risk of developing cardiovascular disease, various cancers, respiratory diseases, and experiencing complications during pregnancy. The benefits of tobacco-free living are particularly high for people who live with diabetes or other common chronic diseases.

What happens when you stop nicotine? ›

Other, less common nicotine withdrawal symptoms include headaches, fatigue, dizziness, coughing, mouth ulcers, and constipation (1, 2). The good news is that there is much you can do to reduce nicotine cravings and manage common withdrawal symptoms.

What type of drug is nicotine? ›

Nicotine is a stimulant drug that speeds up the messages travelling between the brain and body. It is the main psychoactive ingredient in tobacco products and so this Drug Facts page will focus on the effects of nicotine when consumed by using tobacco.

Is nicotine FDA approved? ›

FDA Tobacco

FDA-approved nicotine replacement therapies, also known as NRTs, are safe and effective products that contain nicotine and are designed to help adults quit smoking by delivering small amounts of nicotine to the brain without the toxic chemicals found in cigarette smoke.

Why do they put nicotine in cigarettes? ›

Nicotine is the primary reinforcing component of tobacco; it drives tobacco addiction. Hundreds of compounds are added to tobacco to enhance its flavor and the absorption of nicotine.

What is the healthiest cigarette? ›

Actually, the answer would be - none. There are simply no safe cigarettes. Even “light” and “all natural” might sound attractive and healthier, but they are not. They all contain harmful substances that we have mentioned.

What can I replace a cigarette with? ›

Nicotine chewing gum, lozenges, tablets, mouth sprays and inhalers are 'quick response products'. They can deliver nicotine as soon you're craving it, which helps if your need to smoke changes throughout the day.

What can I smoke that is healthy? ›

There is no safe smoking option — tobacco is always harmful. Light, low-tar and filtered cigarettes aren't any safer — people usually smoke them more deeply or smoke more of them. The only way to reduce harm is to quit smoking.

Which cigarette has most nicotine? ›

Nicotine Content

On average, Marlboro brand cigarettes had the highest level of nicotine (17.3 mg/g of tobacco, Standard error (SE) = 0.26), followed by Camel (15.8 mg/g of tobacco, SE = 0.52), then Newport (13.7 mg/g of tobacco, SE = 0.27).

How long does nicotine stay in your system? ›

People also process nicotine differently depending on their genetics. Generally, nicotine will leaves your blood within 1 to 3 days after you stop using tobacco, and cotinine will be gone after 1 to 10 days. Neither nicotine nor cotinine will be detectable in your urine after 3 to 4 days of stopping tobacco products.

Which tobacco has the highest nicotine content? ›

In general, moist snuff has the highest nicotine content and loose-leaf chewing tobacco has the lowest, with plug tobacco falling in the middle. Variability in nicotine content may affect smokeless tobacco use and should be considered when studying usage as a variable for adverse effects of ST use.

What are 3 regional resources that an individual can utilize when becoming tobacco free? ›

Regional resources that may be utilized in becoming tobacco-free include state phone anti smoking/tobacco quitting services, Nicotine Anonymous, local community support groups, the county health department, and various anti tobacco health or employee plans.

What strategies can you use to limit the amount of ETS you breathe? ›

Solutions
  • Politely ask the visitors of the home to refrain from smoking inside.
  • If someone in your home smokes, open windows to allow fresh air to circulate, and request that certain rooms remain smoke free.
  • Consider using air cleaners to remove contaminants from the air.

Which strategy is a good step for resisting smoking? ›

Which strategy is a good step for resisting smoking? Practice your responses to an offer to smoke before being asked. Which of the following is the BEST way to refuse an offer of tobacco products?

What is tobacco control program? ›

Government of India launched the National Tobacco Control Programme (NTCP) in the year 2007-08 during the 11th Five-Year-Plan, with the aim to (i) create awareness about the harmful effects of tobacco consumption, (ii) reduce the production and supply of tobacco products, (iii) ensure effective implementation of the ...

How are the factors that contribute to tobacco use related? ›

How are the factors that contribute to tobacco use related? The main factors that contribute to tobacco use are self-esteem, peer pressure, role models, and curiosity. Other factors can also contribute to an individual's tobacco use such as rebellion, ease of use, and boredom.

What support is available for people who have trouble quitting nicotine? ›

In addition to your treatment and support, referring your patient to a quitline, like 1-800-QUIT-NOW, can improve their chances of quitting. Quitlines provide free and confidential coaching to help your patients become—and stay—smoke free. Calling a quitline might be just what they need to quit for good.

How have high taxes on tobacco products impacted the number of people who use them? ›

The correct answer is option a. The number of tobacco users has decreased. When there is an increase in the taxes on tobacco, people will buy less tobacco because the price of tobacco has increased. The people will try to buy less of those goods whose price is more.

How can we prevent passive smoking? ›

How to avoid secondhand smoke
  1. If you smoke, quit. There are many resources to help you. ...
  2. Do not smoke or allow people to smoke in your house or car. Ask people who smoke to step outside.
  3. Find smoke-free restaurants, hotels, and rental cars.
  4. Ask caregivers and relatives to stop smoking around you and your children.

What are two public policies aimed at reducing ETS? ›

What are two public policies aimed at reducing ETS? No smoking in public places or around children. Signs that encourage people not to smoke.

What are some ways to say no to tobacco? ›

Strategies to resist the pressures to smoke
  • Say "No": "No thanks." "I'm not interested." ...
  • Change the subject.
  • Tell the truth: "I'm allergic." ...
  • Use humour. "I can't smoke. ...
  • Give a reason: "I don't want to smoke. ...
  • Provide other options: "I'd rather beat you at basketball!" ...
  • Leave.
  • Tell a story:
21 Feb 2019

Which is not a strategy for someone who wants to quit tobacco? ›

Which is NOT a strategy for someone who wants to quit tobacco? Maintain current daily behavior. Which is NOT a reason why many teens decide to quit using tobacco?

What's the benefits of quitting smoking? ›

improves health status and enhances quality of life. reduces the risk of premature death and can add as much as 10 years to life expectancy. reduces the risk for many adverse health effects, including poor reproductive health outcomes, cardiovascular diseases, chronic obstructive pulmonary disease (COPD), and cancer.

What are the objectives of national Tobacco Control program? ›

OBJECTIVES OF NTCP:

(i) Create awareness about the harmful effects of tobacco consumption. (ii) Reduce the production and supply of tobacco products. (v) Facilitate implementation of strategies for prevention and control of tobacco advocated by WHO Framework Convention of Tobacco Control.

Why is it important to learn about tobacco? ›

The longer a person smokes or is around smoke, the greater their chances of developing a smoking- related illness such as heart attack, stroke, cancer of the lungs or mouth or throat, and respiratory diseases such as emphysema and chronic bronchitis.

Why is tobacco a public health issue? ›

Smoking causes cancer, heart disease, stroke, lung diseases, diabetes, and chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. Smoking also increases risk for tuberculosis, certain eye diseases, and problems of the immune system, including rheumatoid arthritis.

Videos

1. FDA TOBACCO REGULATION
(CNN)
2. Vaping: Reshaping the FDA's regulations | IN 60 SECONDS
(American Enterprise Institute)
3. FDA moves forward with "bold" plan to limit nicotine in cigarettes
(CBS Mornings)
4. Clive Bates: What are the regulations the FDA is enforcing on the e-cigarette market? | VIEWPOINT
(American Enterprise Institute)
5. FDA: Regulatory Shift Targets Nicotine In Tobacco Products | NBC Nightly News
(NBC News)
6. FDA explores reducing nicotine levels in cigarettes in hopes to reduce addictiveness
(NewsChannel 5)

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