Tag Archives: FDA

Another Story We’ve Heard Before

As (hopefully) everyone in tobacco knows now, the U.S. Food and Drug Administration’s Center for Tobacco Products issued its long-awaited proposal to regulate e-cigarettes, cigars, little cigars, hookah, pipe tobacco and other tobacco products. This regulation proposes to extend basic authorities found in the Tobacco Control Act to all other tobacco products (including e-cigarettes, cigars, little cigars, hookah, and pipe tobacco), such as:

  • Registration by all manufactures with FDA, including a list of all tobacco products they sell
  • Disclosure of ingredients by manufacturers to FDA
  • Prohibit the sales of tobacco products to anyone under the age of 18
  • Eliminate free sampling of all tobacco products
  • Good manufacturing practice requirements
  • Premarket review for any “new” tobacco product
  • Premarket review of any product wishing to make a “modified risk or harm” claim

A week later, this headline caught my eye on the Center’s news article feed on our website. At the end of the article the commentator urges city and county decision makers in Arizona “to wait at least for the FDA to act on the current e-cigarette proposals before proceeding on their own with more regulations.” Read More »

FDA Releases Long Awaited Proposal to Regulate E-cigarettes, Cigars, and Other Tobacco Products

Federal Update: FDA Releases Long Awaited Proposal to Regulate E-cigarettes, Cigars, and Other Tobacco Products
April 24, 2014
 

This morning the U.S. Food and Drug Administration’s Center for Tobacco Products issued its long-awaited proposal to regulate e-cigarettes, cigars, little cigars, hookah, pipe tobacco and other tobacco products. When Congress passed The 2009 Family Smoking Prevention and Tobacco Control Act, it created FDA’s Center for Tobacco Products and gave it immediate authority over cigarettes, smokeless and roll-your-own tobacco products. In addition Congress gave authority to the agency to assert jurisdiction over other tobacco products, which FDA is finally doing today. The proposed regulation would also establish 18 as the nationwide minimum age for the legal purchase of tobacco products.

This regulation proposes to extend basic authorities found in the Tobacco Control Act to all other tobacco products (including e-cigarettes, cigars, little cigars, hookah, and pipe tobacco), such as: Read More »

FDA and NIH create Tobacco Centers of Regulatory Science

The Food and Drug Administration and the National Institute for Health have teamed up to grant $53 million to fund tobacco-related research. The funding is directed to create the first-of-its kind Tobacco Center of Regulatory Science, or TCORS. The TCORS program will bring in investigators from around the country to develop science-based research for the risks associated with tobacco use. The research conducted by the TCORS program will help with understanding the public health issues related to tobacco regulated products. “For the first time, under the Family Smoking Prevention and Tobacco Control Act, the federal government, through the FDA Center for Tobacco Products (CTP), is able to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products,” reported by FDA Commissioner Margaret A. Hamburg, M.D. “The FDA is committed to a science-based approach that addresses the complex public health issues raised by Read More »

Menthol and the FDA

 

Recently, the FDA released their report on Menthol which determined that menthol has been used to target youth, women, and African Americans and that it is linked to increased dependence on cigarettes. Although this is not news to the tobacco control movement, the report represents a significant shift in how we address menthol in this country.

According to a study produced by TRDRP “In high school neighborhoods, targeted advertising exposes Blacks to more promotions and lower prices for the leading brand of menthol cigarettes.” Menthol has been used to target youth and the African American population. According to the new report from the FDA “…the standard marketing mix approach of price, promotion, product and place has been used to drive menthol cigarette preference among the urban African American community.” Read More »

What we don’t know – E-Cigarettes

Recently, the World Health Organization issued a strong statement against the use of E-Cigarettes. It declared that “Until such time as a given ENDS (electronic nicotine delivery systems) is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes.”

This declaration is part of a growing trend to warn and inform consumers of electronic cigarettes that the dangers are not immediately known. At the national level, the FDA stated that e-cigarettes are not a cessation device and conducted initial lab tests that found e-cigarettes contain detectable levels of toxic chemicals, including an ingredient found in anti-freeze. Furthermore, these same lab tests found that cartridges labeled as nicotine free did in fact contain traceable amounts of nicotine. Read More »