The Food and Drug Administration

FDA Clears First Tobacco Product for Marketing

For the first time since it was given the power to regulate tobacco, the US Food and Drug Administration (FDA) has authorized marketing of a new product. The agency said that eight new smokeless snus products, to be sold in the United States under the "General" brand name by Stockholm-based Swedish Match AB, are now authorized under the premarket tobacco application pathway, which was established by the 2009 Family Smoking Prevention and Tobacco Control Act. Snus cannot be marketed as "FDA-approved," however. "Today's action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed, as long as the public health can be protected," said Mitch Zeller, director of the FDA's Center for Tobacco Products, in a statement. This is the first time any tobacco maker has completed the rigorous premarket tobacco application review process at the agency; others have had products approved by proving they are substantially equivalent to what is already on the market. The agency said that Swedish Match provided evidence that "these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively." The agency also agreed with the company that snus' availability would not result in substantial new use, delay quit attempts, or attract ex-smokers. Swedish Match had been seeking separately to remove warnings that snus is harmful, but the agency has not yet ruled on that request. In that separate application, Swedish Match was seeking to have the 10 types of snus it [...]

Charlotte Parker2015-11-13T15:25:42-07:00November, 2015|Oral Cancer News|

Alternative Tobacco Products as a Second Front in the War on Tobacco

Source: www.jamanetwork.comAuthors: Samir Soneji, PhD; James D. Sargent, MD; Susanne E. Tanski, MD, MPH; Brian A. Primack, MD, PhD Associations Between Initial Water Pipe Tobacco Smoking and Snus Use and Subsequent Cigarette Smoking: Results From a Longitudinal Study of US Adolescents and Young Adults Importance Many adolescents and young adults use alternative tobacco products, such as water pipes and snus, instead of cigarettes. Objective To assess whether prior water pipe tobacco smoking and snus use among never smokers are risk factors for subsequent cigarette smoking. Design, Setting, and Participants We conducted a 2-wave national longitudinal study in the United States among 2541 individuals aged 15 to 23 years old. At baseline (October 25, 2010, through June 11, 2011), we ascertained whether respondents had smoked cigarettes, smoked water pipe tobacco, or used snus. At the 2-year follow-up (October 27, 2012, through March 31, 2013), we determined whether baseline non–cigarette smokers had subsequently tried cigarette smoking, were current (past 30 days) cigarette smokers, or were high-intensity cigarette smokers. We fit multivariable logistic regression models among baseline non–cigarette smokers to assess whether baseline water pipe tobacco smoking and baseline snus use were associated with subsequent cigarette smoking initiation and current cigarette smoking, accounting for established sociodemographic and behavioral risk factors. We fit similarly specified multivariable ordinal logistic regression models to assess whether baseline water pipe tobacco smoking and baseline snus use were associated with high-intensity cigarette smoking at follow-up. Exposures Water pipe tobacco smoking and the use of snus at baseline. Main Outcomes [...]

Charlotte Parker2015-10-14T12:26:30-07:00October, 2015|Oral Cancer News|

Why the FDA Needs to Start Regulating Lab Tests

Source: modernhealthcare.comAuthor: Merrill Goozner The Food and Drug Administration's proposal to regulate the accuracy of laboratory-developed tests has drawn heated opposition from the laboratory testing industry, hospitals and most medical specialty societies. Only oncologists favor tighter oversight.It's not just cancer docs who should be concerned. We're entering a new era where there will be much more genetic testing. Higher standards are necessary. Since 1988, routine laboratory tests performed inside labs have come under the Clinical Laboratory Improvement Amendments, which has largely exempted them from FDA oversight. Only if a company sold test kits to hospitals or physician offices did the FDA regulate them as medical devices, with attendant performance and manufacturing standards.Until recently, this didn't present much of a problem. Most lab tests are fairly routine—testing blood for cholesterol, sugar or sodium, for instance. A robust industry dominated by large national companies like LabCorp, Quest Diagnostics and ARUP Laboratories provides a market-based solution for ensuring those tests are affordable and high quality. Hospitals and physician offices that conduct their own in-house tests benefit from the exemption, too. Some large institutions that operate their own labs save money because of their economies of scale. Major academic medical center labs operating under CLIA also play a leading role in developing new tests for rare or hard-to-treat conditions.But in recent years, there has been a proliferation of new tests based on genetic information that are being marketed by independent firms making claims that have not been validated by clinical trials or other scientific methods. They claim to show a person's propensity [...]

Charlotte Parker2015-01-12T12:03:39-07:00January, 2015|Oral Cancer News|

Cigarette Marketing Declined, but Smokeless Tobacco Marketing Doubled in Recent Years

Source: PR Newswire WASHINGTON, Aug. 1, 2011 /PRNewswire-USNewswire/ -- The following is a statement from Matthew L. Myers, President, Campaign for Tobacco-Free Kids: The Federal Trade Commission on Friday reported that cigarette marketing expenditures in the United States declined from $12.5 billion in 2006 to $10.9 billion in 2007 and $9.9 billion in 2008. The FTC also reported that smokeless tobacco marketing increased from $354.1 million in 2006 to $411.3 million in 2007 and $547.9 million in 2008. When measured from 2005, smokeless tobacco marketing has more than doubled (from $250.8 million to $547.9 million). While it is a positive step that cigarette marketing has declined, the tobacco companies continue to spend huge sums to market their deadly and addictive products. Counting both cigarette and smokeless tobacco marketing, the tobacco companies spent $10.5 billion on marketing in 2008 – nearly $29 million each day and 52 percent more than they spent at the time of the 1998 settlement of state lawsuits against the industry, which was supposed to curtail tobacco marketing. Tobacco companies in 2008 spent 20 times more to market tobacco products than the states currently spend on programs to prevent kids from smoking and help smokers quit (the states spent $517.9 million on such programs in fiscal year 2011). This huge mismatch between how much tobacco companies spend to encourage tobacco use and how much states spend to discourage it is a major contributing factor to the slowing of smoking declines in recent years. It is especially troubling [...]

Oral Cancer Foundation News Team - A2011-08-02T09:44:39-07:00August, 2011|Oral Cancer News|