FDA Issues Warning to Tobacco Manufacturers for Illegal Sales of Flavored Cigarettes

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“The FDA has issued warning letters to four tobacco manufacturers for selling flavored cigarettes that are labeled as little cigars or cigars, according to its news release. Swisher International Inc., Cheyenne International LLC, Prime Time International Co., and Southern Cross Tobacco Company Inc. all violated the Family Smoking Prevention and Tobacco Control Act by doing so, according to the agency.

“Flavored cigarettes appeal to kids and disguise the bad taste of tobacco, but they are just as addictive as regular tobacco products and have the same harmful health effects,” said Mitch Zeller, director of FDA’s Center for Tobacco Products. “Because about 90 percent of adult daily smokers smoked their first cigarette by the age of 18, continued enforcement of the ban on cigarettes with characterizing flavors is vital to protect future generations from a lifetime of addiction.”

The agency said the products are likely to be offered to someone as cigarettes based on presentation, appearance, and packaging. Having come to this conclusion, the agency has also determined the products are adulterated because they contain a natural or artificial characterizing flavor.”

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FDA Updates Safety Label Warnings for Fluoroquinolones Again

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“The U.S. Food and Drug Administration on July 26 approved stepped-up safety labeling changes for a class of antibiotics called fluoroquinolones, both to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. “Fluoroquinolones have risks and benefits that should be considered very carefully,” said Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

Fluoroquinolones are antibiotics that kill or stop the growth of bacteria. They are effective in treating serious bacterial infections, but an FDA safety review found both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system. The side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent, according to the agency, which first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture; in February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning, and in August 2013 the agency required updates to the labels to describe the potential for irreversible peripheral neuropathy (serious nerve damage).”
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FDA Launches New Program, openFDA

“The FDA has launched openFDA, a new program that makes it easier for members of the public—including researchers and web developers—to access large, public health datasets collected by the FDA, the agency reports. The initiative has been launched in alignment with the Presidential Executive Order on Open Data, as well as the Department of Health and Human Services Health Data Initiative.

According to the FDA, the program will make “the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis.”OpenFDA uses a search-based API to collect large amounts of already-existing public data. It also allows users to search through text within the data and rank results—in a similar fashion to Google. Users can then build their own apps on top of openFDA, according to the FDA.

“The openFDA initiative leverages new technologies and methods to unlock the tremendous public data and resources available from the FDA in a user-friendly way,” said Walter S. Harris, the FDA’s chief operating officer and acting chief information officer, in the FDA’s press release. “OpenFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.”

 

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FDA Proposes Expedited Medical Device Access Program

“The FDA has proposed a new, expedited access program for medical devices that would give patients with serious conditions earlier access to high-risk medical devices. The proposed program—the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (EAP)—is designed for patients whose needs are unmet by current technology, the FDA reports.

The program “features earlier and more interactive engagement with FDA staff—including  the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval—features that, taken together, should provide these patients with earlier access to safe and effective medical devices,” according to FDA.”

 

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FDA Proposes More Oversight on Tobacco Products

“FDA has proposed extending its tobacco authority to include oversight on more products, including e-cigarettes, as part of the Family Smoking Prevention and Tobacco Control Act. The proposal would include products that are currently unregulated, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah, dissolvables, and more, FDA announced.

Currently, FDA regulates cigarettes, cigarette tobacco, roll-your-own-tobacco, and smokeless tobacco. The proposed rule would require makers of the “newly deemed” tobacco products register with the FDA, report product and ingredient listings, only market new products after the FDA reviews them, not distribute free samples and more. In addition, companies would have to include health warnings and minimum age and ID restrictions. The FDA also proposes different compliance dates for various provisions so that all regulated entities have adequate time to comply with requirements.  “This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said HHS Secretary Kathleen Sebelius in FDA’s press release. The proposed rule will be available for public comment for 75 days.”

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