The Tobacco Products Scientific Advisory Committee (TPSAC) is an advisory panel of the United States Food and Drug Administration organized to provide advice, information and recommendations to the FDA commissioner on matters related to the regulation of tobacco products.It was created in accordance to the Family Smoking Prevention and Tobacco Control Act, signed into law by President Barack Obama on June 22, 2009. The Committee was inaugurated during its March 30–31, 2010 meeting.
TPSAC consists of 12 members, including a chairperson, all of whom are selected by the FDA commissioner from among experts in medicine, medical ethics, science and technology related to the manufacture and use of tobacco products. Nine voting seats are held for academics and practitioners in the field of health care, while three non-voting seats are held for industry representatives. Members serve for overlapping terms of four years.Meetings are held approximately four times per year, with all meetings publicly announced in the Federal Register at least 15 days before each meeting.
The Committee's purpose is to review and evaluate safety, dependence, and health issues relating to tobacco products and to provide appropriate advice, information and recommendations to the Commissioner of Food and Drugs on the following topics:
On March 1, 2010, the Wall Street Journal reported that proposed committee members Jack Henningfield and Neal L. Benowitz, had served as consultants to GlaxoSmithKline, and Benowitz to Pfizer as well, both pharmaceutical firms that market smoking cessation drugs.Their selection by the FDA has drawn criticism as "lax on conflict of interest" by the Boston Globe . Meanwhile, advocacy group Americans for Limited Government has raised concerns about funding received by TPSAC chair Jonathan Samet from GlaxoSmithKline and other pharmaceutical companies. In January 2011, Gregory N. Connolly resigned from the committee following allegations of conflicts of interest citing payments to provide deposition or trial testimony in lawsuits against tobacco companies.
In February 2011, Lorillard and R.J. Reynolds filed a federal lawsuit to try to block the advisory committee action or force the FDA to disregard its advice, stating three of the eight panel members had financial conflicts of interest from legal and consulting work against tobacco companies.On July 21, 2014, U.S. District Court Judge Richard Leon (Washington, DC) ruled that "FDA erred in determining that the members didn't have conflicts of interest" and that the appointments were arbitrary and capricious. FDA was also ordered to reconstitute the TPSAC.
On March 18, 2011 the panel concluded that removing menthol cigarettes from the market would benefit public health in the United States, but stopped short of recommending that the FDA take any specific actions like restricting or banning the additive. A progress report on panel findings is expected in July 2011.
In March 2011, the tobacco industry released a report to the FDA in response to the TPSAC decision claiming menthol cigarettes are no riskier than regular cigarettes and should not be regulated differently.The U.S. District Court decision from July 21, 2014 ruled that "Conflicts of interest — whether actual or perceived — undermine the public's confidence in the agency's decision-making process and render its final product suspect", blocking the TPSAC report on menthol cigarettes from being used for regulatory purposes.
An Interactive Public Docket on the TPSAC was established to allow interested members of the public to discuss the Committee's work.The IPD includes discussion forums on TPSAC sub-topics including Studies and Concepts Under Review, Member Statements and Committee Governance.
Pall Mall is an American brand of cigarettes produced by R. J. Reynolds Tobacco Company in Winston-Salem, North Carolina, and internationally by British American Tobacco at multiple sites. As of 2012, Pall Mall is R. J. Reynolds' highest selling brand.
Kretek are cigarettes made with a blend of tobacco, cloves and other flavors. The word "kretek" itself is an onomatopoetic term for the crackling sound of burning cloves.
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), is an important United States Supreme Court case in the development of American administrative law. It ruled that the Food, Drug, and Cosmetic Act did not give the Food and Drug Administration (FDA) the authority to regulate tobacco products as "drugs" or "devices". This was later superseded by the Family Smoking Prevention and Tobacco Control Act, which granted the FDA the authority to regulate such products.
Newport is an American brand of menthol cigarettes, currently owned and manufactured by the R. J. Reynolds Tobacco Company. The brand was originally named for the seaport of Newport, Rhode Island. It is the best-selling brand of menthols in the world.
Nicotine marketing is the marketing of nicotine-containing products or use. Traditionally, the tobacco industry markets cigarette smoking, but it is increasingly marketing other products, such as electronic cigarettes and heat-not-burn products. Products are marketed through social media, stealth marketing, mass media, and sponsorship. Expenditures on nicotine marketing are in the tens of billions a year; in the US alone, spending was over US$1 million per hour in 2016; in 2003, per-capita marketing spending was $290 per adult smoker, or $45 per inhabitant. Nicotine marketing is increasingly regulated; some forms of nicotine advertising are banned in many countries. The World Health Organization recommends a complete tobacco advertising ban.
A menthol cigarette is a cigarette flavored with the compound menthol.
Tobacco harm reduction (THR) is a public health strategy to lower the health risks to individuals and wider society associated with using tobacco products. It is an example of the concept of harm reduction, a strategy for dealing with the abuse of other drugs. Tobacco smoking is widely acknowledged as a leading cause of illness and death, and reducing smoking is vital to public health.
A flavored tobacco product is a tobacco product with added flavorings. Flavored tobacco products include types of cigarettes, cigarillos and cigars, hookah and hookah tobacco, and various types of smokeless tobacco. Flavored tobacco products are especially popular with youth and have therefore become targets of regulation in several countries.
Ventilated cigarettes are considered to have a milder flavor than regular cigarettes. These cigarette brands may be listed as having lower levels of tar ("low-tar"), nicotine, or other chemicals as "inhaled" by a "smoking machine". However, the scientific evidence is that switching from regular to light or low-tar cigarettes does not reduce the health risks of smoking or lower the smoker's exposure to the nicotine, tar, and carcinogens present in cigarette smoke.
The Family Smoking Prevention and Tobacco Control Act, is a federal statute in the United States that was signed into law by President Barack Obama on June 22, 2009. The Act gives the Food and Drug Administration the power to regulate the tobacco industry. A signature element of the law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking. The Act also bans flavored cigarettes, places limits on the advertising of tobacco products to minors and requires tobacco companies to seek FDA approval for new tobacco products.
Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress. With this statute, the Food and Drug Administration (FDA) was given the ability to regulate tobacco products.
Regulation of electronic cigarettes varies across countries and states, ranging from no regulation to banning them entirely. For instance, e-cigarettes are illegal in Japan, forcing the market to use heat-not-burn tobacco products for cigarette alternatives. Others have introduced strict restrictions and some have licensed devices as medicines such as in the UK. However, as of February 2018, there is no e-cigarette device that has been given a medical license that is commercially sold or available by prescription in the UK. As of 2015, around two thirds of major nations have regulated e-cigarettes in some way. Because of the potential relationship with tobacco laws and medical drug policies, e-cigarette legislation is being debated in many countries. The companies that make e-cigarettes have been pushing for laws that support their interests. In 2016 the US Department of Transportation banned the use of e-cigarettes on commercial flights. This regulation applies to all flights to and from the US. In 2018, the Royal College of Physicians asked that a balance is found in regulations over e-cigarettes that ensure product safety while encouraging smokers to use them instead of tobacco, as well as keep an eye on any effects contrary to the control agencies for tobacco.
The scientific community in United States and Europe are primarily concerned with the possible effect of electronic cigarette use on public health. There is concern among public health experts that e-cigarettes could renormalize smoking, weaken measures to control tobacco, and serve as a gateway for smoking among youth. The public health community is divided over whether to support e-cigarettes, because their safety and efficacy for quitting smoking is unclear. Many in the public health community acknowledge the potential for their quitting smoking and decreasing harm benefits, but there remains a concern over their long-term safety and potential for a new era of users to get addicted to nicotine and then tobacco. There is concern among tobacco control academics and advocates that prevalent universal vaping "will bring its own distinct but as yet unknown health risks in the same way tobacco smoking did, as a result of chronic exposure", among other things.
A modified risk tobacco product (MRTP) is a legal designation in the United States for a tobacco product that poses lower health risks to individual users and the population as a whole when compared to existing products on the market such as cigarettes. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration broad authority to regulate tobacco products; the FDA's power extends to approving or rejecting MRTP applications.
A vape shop is a retail outlet specializing in the selling of electronic cigarette products. There are also online vape shops. A vape shop offers a range of e-cigarette products. The majority of vape shops do not sell e-cigarette products that are from "Big Tobacco" companies. In 2013, online search engine searches on vape shops surpassed searches on e-cigarettes. Around a third of all sales of e-cigarette products take place in vape shops. Big Tobacco believes the independent e-cigarette market is a threat to their interests.
Neal L. Benowitz is an American academic physician and professor of medicine at the University of California, San Francisco (UCSF), with expertise on the pharmacology of nicotine and tobacco addiction.
Juul Labs, Inc. is an American electronic cigarette company which spun off from Pax Labs in 2017. It makes the Juul e-cigarette, which packages nicotine salts from leaf tobacco into one-time use cartridges.
The Society for Research on Nicotine and Tobacco (SRNT) is an international organization that studies and shares research on nicotine and tobacco use from a public health and scientific perspective. It is the largest organization focused on nicotine and tobacco, with members in 40 countries. SRNT’s work has been used by the World Health Organization and governments in setting policies on topics such as tobacco advertising, taxation, smoke-free laws, and smoking cessation. SRNT has been particularly active in work on the WHO Framework Convention on Tobacco Control and the Tobacco Master Settlement Agreement in the US. SRNT is a nonprofit organization and publishes the scientific journal Nicotine and Tobacco Research. SRNT does not accept funding from the tobacco industry. The organization does accept funding from pharmaceutical companies that make medications to help people quit smoking.
The short-term and long-term adverse effects from electronic cigarette use remain unclear. The long-term effects of e-cigarette use are unknown. The risk from serious adverse events, including death, was reported in 2016 to be low. 39 deaths associated with the use of vaping products have been confirmed in the US, as of November 5, 2019. The long-term health consequences from vaping is probably to be slighter greater than nicotine replacement products. They may produce less adverse effects compared to tobacco products. They may cause long-term and short-term adverse effects, including airway resistance, irritation of the airways, eyes redness, and dry throat. Serious adverse events related to e-cigarettes were hypotension, seizure, chest pain, rapid heartbeat, disorientation, and congestive heart failure but it was unclear the degree to which they were the result of e-cigarettes. Less serious adverse effects include abdominal pain, dizziness, headache, blurry vision, throat and mouth irritation, vomiting, nausea, and coughing. Short-term adverse effects reported most often were mouth and throat irritation, dry cough, and nausea.