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Tobacco slowed FDA

Tobacco companies have introduced almost no new cigarettes or smokeless tobacco products in the U.S. in more than 18 months, because the federal government did not allow them to do this, Associated Press review has found. This is an unprecedented break in the industry, which historically has introduced dozens of new products every year, and reflects its increasingly complicated relationship with the Food and Drug Administration, which in 2009 began to regulate tobacco. FDA officials say review of applications for new products so long due to “significant shortcomings”, but because the agency takes additional help in reviewing tobacco products that pose risks to public health. Industry executives say cigarettes are not changed in any meaningful way and the delay does not make sense. They say that change is as simple as changing the … Read entire article »

Filed under: Tobacco laws, Tobacco news

The FDA’s Dr. Lawrence Deyton on the tests of leadership

One thing that comes to mind was back early in the HIV era. I was at the National Institutes of Health. We were just beginning the early HIV clinical research. We were learning a lot, but not fast enough. People were dying, and we didn’t have the knowledge or the medicines to effectively treat HIV infection. We were just beginning to test the first antiviral drugs, and people living with HIV and their advocates were upset because they weren’t hearing as much as they wanted to hear from NIH or from government. There were demonstrations at FDA, at NIH, downtown on the National Mall.  During one of those demonstrations, an effigy of me was burned. Yes, a straw figure with my … Read entire article »

Filed under: Featured

FDA Action Plan

The U.S. Food & Drug Administration (FDA) just released a document titled “Enforcement Action Plan for Promotion & Advertising Restrictions” that details the agency’s strategy to gain compliance with tobacco promotional and advertising regulations and the prohibition on the sale of cigarettes and smokeless tobacco to underage youth, reported the NATO E-News Bulletin. It affects manufacturers, distributors and retailers. The action plan will use “tobacco marketing surveillance” on a routine basis to monitor and evaluate promotional and advertising materials in print media and retail point-of-sale (POS) displays. It will also conduct compliance checks with an underage minor to attempt to purchase cigarettes or smokeless tobacco products. A state agency under contract with the FDA will conduct the compliance checks either in addition to other state mandated retail compliance checks or in place of … Read entire article »

Filed under: Tobacco news

Big Tobacco and Tar Out of Them

The Senate on Thursday overwhelmingly approved legislation that would give government broad new authority to regulate tobacco products, slash nicotine content and restrict advertising.Health advocates cheered the 79-17 passage of the bill, saying it could prevent thousands of deaths and reduce the $100 billion in annual health-care costs linked to tobacco usage. Tobacco allies said the new regulation would cost jobs, hurt farmers and maintain the market dominance of tobacco giant Philip Morris, the maker of Marlboros.The bill would direct the Food and Drug Administration (FDA) to regulate the content and marketing of tobacco products. It would allow the agency to alter the chemical makeup to affect the taste and, health advocates hope, the addictive qualities of tobacco products. Under the bill, nicotine in cigarettes could be cut … Read entire article »

Filed under: Tobacco companies

Center for Regulatory Effectiveness Asks from FDA Transparency

The watchdog group Center for Regulatory Effectiveness (CRE) today launched an initiative to bring sunlight and transparency to the Food and Drug Administration’s tobacco advisory committee examining the potential regulatory efforts surrounding menthol cigarettes, dissolvable tobacco products and other issues.  As to the broader issue of governance, the tobacco advisory committee is an operating arm of FDA, not an ad hoc committee of experts who render advice on select issues assigned by a regulatory agency and as such should be transparent and accountable to the public. Through the launch of a new Web-based Interactive Public Docket (IPD), members of the public will now be able to voice their support or concern about the work of a government panel that is currently looking into the regulation of tobacco products. The IPD will … Read entire article »

Filed under: Tobacco news