FDA Regulations

On Fifth Anniversary of Landmark Tobacco Law, Leading Health Groups Call on FDA to Prioritize Three Actions To Accelerate Progress Against Tobacco Use
June 19, 2014

President Obama signed the Family Smoking Prevention and Tobacco Control Act into law on June 22, 2009. The law gives the U.S. Food and Drug Administration the authority to regulate the manufacturing, marketing, and sale of tobacco products (e.g., banning the sale of candy and fruit-flavored cigarettes). In addition, the FDA regulations removed some previous preemptive language around the enactment of tobacco advertising and sales of tobacco products laws, and now permits municipalities and states to consider laws that would regulate and restrict the time, place and manner of cigarette advertising, consistent with the First Amendment.

New rules, which went into effect on June 22, 2010, limit the sale and marketing of cigarettes and smokeless tobacco by:

  • Prohibiting the sale of cigarettes or smokeless tobacco to people younger than 18;
  • Prohibiting the sale of cigarette packages with less than 20 cigarettes;
  • Prohibiting distribution of free samples of cigarettes;
  • Restricting distribution of free samples of smokeless tobacco; and
  • Prohibiting tobacco companies from sponsoring any athletic, musical or other social or cultural events, among other things.

There are a number of excellent online resources to aid you in your efforts to prevent youth tobacco addition and to comply with FDA regulations. For general information about the law, review:

The FDA launched an online resource to educate retailers and the public about the regulations as well: http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/default.htm

FDA News

FDA Takes Steps Toward Ruling on Menthol Cigarettes
New York Times (blog) - July 23, 2013

WASHINGTON The Food and Drug Administration inched closer on Tuesday to a decision on whether to ban menthol in cigarettes, releasing its own scientific review that found the mint flavoring made it easier to start smoking and harder to quit. The agency also published a notice in the federal register calling for input from the public on the potential regulation on menthol in cigarettes, another step in the rulemaking progress that began in 2009 when Congress exempted menthol from a ban on flavors in cigarettes.

FDA Cites Likely Risks of Menthol Cigarettes
Wall Street Journal - July 23, 2013

The law banned the use of all flavoring in cigarettes except menthol, but the FDA's tobacco-products advisory committee was ordered to study the issue. In 2011 ...

FDA tobacco chief speaks at industry meeting
WFAA - May 16, 2013

WILLIAMSBURG, Va. (AP) Changes in the marketplace have forced the public health community to wrestle with the idea that some tobacco products may pose less of a health risk than others, the new head of the Food and Drug Administration's tobacco control efforts told an industry group on Thursday. Mitch Zeller, who took over as director of the FDA's Center for Tobacco Products in March, also told attendees at the Tobacco Merchants Association annual meeting in Williamsburg that the agency is making progress on a backlog of more than 3,500 new product applications, how it plans to address menthol cigarettes and its plans to regulate other tobacco products like cigars and electronic cigarettes. "You all sell a lawful product," Zeller said. "Our job is to regulate the manufacture, sale and marketing of the tobacco products within our jurisdiction. And we try to do it efficiently, effectively and fairly."

EDITORIAL: Wins and Losses in the Fight Against Tobacco
New York Times - April 29, 2013

Cigarette packages are unlikely to carry graphic warning labels anytime soon as a result of separate actions by the Supreme Court and the Food and Drug Administration. That is a setback, though perhaps temporary, for the federal governments campaign to reduce the health damage caused by this highly lethal product. The silver lining is that the Supreme Court left intact most of the F.D.A.s powers to regulate this industry.

FDA to take action soon on tobacco decisions
Winston-Salem Journal - April 24, 2013

WASHINGTON - The new health regulator in charge of tobacco said the Food ... major decisions from the effects of menthol to the marketability of newer products. ... the agency's authority over e-cigarettes, cigars and other tobacco products.

High court keeps tobacco marketing restrictions intact
fox6now.com - April 22, 2013

The U.S. Supreme Court turned aside an appeal from tobacco companies seeking to block a federal law that further restricts the marketing, packaging and event promotion of cigarettes.

Supreme Court Lets FDA Move Forward with Graphic Cigarette Warnings and Other Tobacco Regulations
Sacramento Bee - April 22, 2013

WASHINGTON, April 22, 2013 -- /PRNewswire-USNewswire/ -- The following is a statement of Susan M. Liss, Executive Director, Campaign for Tobacco-Free ... In a victory for the nation's health, the U.S. Supreme Court today let stand an appellate court ruling that upheld most provisions of the landmark 2009 law granting the Food and Drug Administration authority over tobacco products, including the requirement for large, graphic cigarette warning labels. The Supreme Court declined to hear the tobacco industry's appeal of a March 2012 ruling by the U.S. Court of Appeals for the Sixth Circuit.

Justices decline to hear tobacco warning law challenge
Terra.com - April 22, 2013

The Supreme Court on Monday declined to hear a tobacco industry challenge to a federal law that expanded restrictions on the advertising and marketing of cigarettes. Those challenging the provisions of the 2009 Family Smoking Prevention and Tobacco Control Act included companies owned in part or in full by Reynolds American Inc, British American Tobacco Plc, Imperial Tobacco Group Plc and Lorillard Inc.

Justices decline to hear challenge to tobacco law
Reuters - April 22, 2013

The U.S. Supreme Court on Monday declined to hear a tobacco industry challenge to a federal law that expanded restrictions on the advertising and marketing of cigarettes. The provisions of the 2009 Family Smoking Prevention and Tobacco Control Act ...

FDA loosens restrictions on nicotine replacement products
Yahoo! News (blog) - April 1, 2013

The FDA plans to remove both these restrictions in response to claims by critics that they may cause some smokers to abandon attempts to quit if they have a ...

Rising sales of e-cigarettes spur call for regulations
The Hill - February 28, 2013

An anti-smoking group is renewing pressure on federal regulators to examine the safety of electronic cigarettes. The American Cancer Society Cancer Action Network wants the Food and Drug Administration (FDA) to investigate how the devices work, what ingredients they contain and the potential effects they could have on users. ...

FDA veteran to spearhead tobacco regulatory efforts; current director to step down in March
Minneapolis Star Tribune - February 22, 2013

RICHMOND, Va. - A Food and Drug Administration veteran who helped spearhead efforts to regulate the tobacco industry in the 1990s is taking over the agency's Center for Tobacco Products. Mitch Zeller will become the center's director on March 4, FDA Commissioner Margaret Hamburg said in an internal memo sent late Thursday and confirmed by The Associated Press. ….

FDA should do more with its authority over tobacco products
Washington Post - February 5, 2013

IN 2009, PRESIDENT Obama signed the Tobacco Control Act, which gave the Food and Drug Administration (FDA) authority over tobacco products. It was a signal moment in the fight against smoking. Tobacco use is the leading cause of preventable death in the country, racking up 400,000 premature deaths in America every year and holding 40 million Americans in the grip of addiction. After decades of education campaigns, cessation programs and increasing taxes, the U.S. smoking rate is stuck at about a fifth of the adult population. And after a string of headline-worthy achievements, the FDA’s tobacco program has been a little quiet lately. …So far, the agency has asserted authority over only cigarettes and smokeless tobacco, not products such as cigars, pipe tobacco or e-cigarettes. Until it claims broader jurisdiction, it can’t compel the examination of ingredients and assess their relative lethality, let alone regulate more aggressively. …

Court upholds block on graphic cigarette warnings
MyrtleBeachOnline – August 24, 2012

A federal appeals court on Friday left intact a court judgment that ordered tobacco companies to do corrective advertising about the dangers of smoking.

Medical News: FDA Issues Long List of Harmful Tobacco Components
MedPage Today, 2010-08-27
John Gever, Senior Editor, MedPage Today

Forget tar and nicotine -- the FDA is proposing to list as harmful or potentially harmful more than 100 chemicals found in tobacco and tobacco smoke, paving the way for tighter regulation of commercial tobacco products.

The agency's Center for Tobacco Products released the draft list in advance of an advisory committee meeting Monday to review proposed criteria for classifying tobacco and smoke components as harmful. . . .

The 100-plus compounds -- ranging from acetaldehyde to vinyl chloride -- identified in briefing documents by the FDA staff already appear on lists of hazardous chemicals developed by the Environmental Protection Agency, the International Agency for Research on Cancer, the National Toxicology Program, and the National Institute of Occupational Safety and Health.

Tobacco and its smoke contain a bewildering array of organic compounds as well as elemental heavy metals including lead, cobalt, cadmium, and even uranium (including the weapons-grade isotope, U-235).

The agency will ask the committee's guidance in determining how much weight to put on those lists and the research on which they're based, which was often animal studies with "limited evidence" for human health effects. ...