Tag Archives: TOBACCO

FDA Announces New Steps to Protect Youth From Tobacco Harms; National Youth Tobacco Survey Results Released

On November 15, FDA and the Centers for Disease Control (CDC) published the results of the National Youth Tobacco Survey (NYTS).  As summarized in their joint Statement, the “NYTS is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”  Results of the survey showed a 78 percent increase from 2017 … Continue Reading

FDA Announces Meeting to Discuss Eliminating Youth E-Cigarette Use

On September 12, 2018, FDA Commissioner Dr. Scott Gottlieb announced FDA’s Youth Tobacco Prevention Plan in response to the perception that use of e-cigarettes has become an “epidemic”.  Dr. Gottlieb’s concern is based on preliminary data from the National Youth Tobacco Survey, expected out in November, which suggests that the number of high-school-age children reporting … Continue Reading

FDA Emphasizes Continued Commitment to Develop a Strong Tobacco Product Application Review Process

In an October 22, 2018 press release, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s ongoing commitment to significantly reduce tobacco-related disease and death, with particular emphasis on protecting kids from the dangers of nicotine. In order to do so, FDA asserted the critical need to have an efficient regulatory process that puts novel products, … Continue Reading

FDA Collects Thousands of Pages of Documents in Inspection of JUUL Labs

On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan to stop adolescent use of, and access to, vapor products.  FDA followed up on its announcement by issuing 17 warning letters for marketing e-liquids in allegedly misbranded and misleading packaging found  to be appealing to youth.  In September, FDA announced that it has issued … Continue Reading

FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

In a September 12, 2018 press release, FDA announced its largest coordinated enforcement effort in agency history to address what it described as an “epidemic” of e-cigarette use in minors, based on not-yet-released survey data.  As part of its enforcement since June 2018, FDA has issued 1,300 warning letters and imposed civil penalties on brick-and-mortar … Continue Reading

FDA and CDC Release Results of 2017 National Youth Tobacco Survey

On June 7, FDA and CDC released the results of the 2017 National Youth Tobacco Survey.  Total number of high- and middle-school tobacco users of any tobacco product continued to fall to unprecedented levels, dropping over 20% between 2011 and 2017, from approximately 4.56 million to 3.62 million youth users.  Comparing tobacco use as a percentage … Continue Reading

FDA and FTC Take Enforcement Action on E-Liquids That Resemble Foods

FDA has joined the Federal Trade Commission (FTC) in issuing warning letters to 13 companies that market nicotine-containing e-liquids in packaging that has the appearance of being foods that appeal to children, such as juice boxes, candies, and cookies. FDA and FTC took action based on the risk that consumers, especially children, may confuse the … Continue Reading

FDA Targets Tobacco Products Claims

Pursuant to Section 201(rr) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, a “tobacco product” is any product made or derived from tobacco intended for human consumption, but excludes drugs, devices, and combination (drug-device) products. A product is a drug, device, or combination product if it is intended to … Continue Reading

Tobacco Turmoil

FDA’s regulatory authority extended to all tobacco products. As covered previously on this blog, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any … Continue Reading

Viva Vaping

Royal College of Physicians encourages e-cigarette use as a substitute for smoking. Public health authorities worldwide have long known and publicized the health risks associated with smoking and tobacco use.  Smoking still remains the leading cause of preventable death in the United States.  As FDA prepares to publish its “Deeming Regulation” — which is expected to … Continue Reading

Nicotine News

CPSC likely to gain new authority over packaging of some nicotine-containing e-liquid products. The Consumer Product Safety Commission (CPSC) currently implements the Poison Packaging Prevention Act of 1970 (PPPA), which requires certain household substances to have packaging that makes it significantly difficult for children under five years old to open within a reasonable amount of … Continue Reading

Snus News

FDA issues its first marketing authorizations for new tobacco products. FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act).  A “new tobacco … Continue Reading

Cigarette Break

FDA issues order to stop further sale and distribution of four cigarette products. As highlighted recently on this blog, FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco … Continue Reading

FDA Burns Tobacco

FDA issues Warning Letters to three tobacco manufacturers regarding “additive-free” and “natural” claims. FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control … Continue Reading
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