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Reports: FDA may be looking at regulating cigars

BY Alaric DeArment

NEW YORK — The Food and Drug Administration is looking to regulate flavored cigars, according to published reports.

According to the New York Times, the FDA intends to regulate cigars and other tobacco products, much as it regulates cigarettes, but it hasn’t given a timetable. Under the Family Smoking Prevention and Tobacco Control Act of 2009, the agency banned almost every flavor of cigarette except menthol — including candy, fruit and clove flavors — but flavored cigars and pipe tobacco are still permitted.

The article cited Nielsen market data as showing that since 2008, cigar sales at convenience stores have increased nearly 40%, and more than half of cigars sold through that channel are flavored.

According to an August 2012 report by the Centers for Disease Control and Prevention, cigarette smoking among teenagers declined by 33% between 2000 and 2011, while use of cigars and other tobacco products increased by 123%.

 

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FDA approves Supernus epilepsy drug

BY Alaric DeArment

ROCKVILLE, Md. — The Food and Drug Administration has approved a new epilepsy drug made by Supernus Pharmaceuticals, the company said Monday.

Supernus announced the approval of Trokendi XR, a once-daily, extended-release formulation of the drug topiramate. As part of the approval, the FDA granted Supernus a waiver for some of the requirements for studies of the drug in children and a deferral for submission of other post-marketing data due in 2019, followed by clinical assessments in 2025.

"We are very excited about the approval of Trokendi XR and its upcoming launch," Supernus president, director and CEO Jack Khattar said. "This is excellent news for Supernus, its shareholders and patients with epilepsy. We remain committed to the epilepsy community and very much look forward to now having two products, Trokendi XR and Oxtellar XR, available to patients."


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DrFuhrman.com discontinues supplement cancer claims following National Advertising Division challenge

BY Michael Johnsen

NEW YORK — DrFuhrman.com on Monday informed the National Advertising Division that the company has discontinued certain advertising claims — including “anti-cancer” and cancer treatment claims — made for the company’s Immunotect dietary supplement.

The claims at issue were challenged by the Council for Responsible Nutrition.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

As part of its routine monitoring program, and in conjunction with NAD’s initiative with CRN to expand the review of advertising claims made for supplements, NAD requested that DrFuhrman provide substantiation for more than a dozen claims. 

 

 

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