Category Archives: FDA

07.11.19

What I wish I knew 15 years ago about American Spirits cigarettes

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I used to wait tables. I started as a teen at my family’s restaurants before smoke-free workplace laws swept the nation. Like most restaurants at the time, we had a smoking section, and I oftentimes was assigned to it. I was thrilled when the city eventually adopted a clean indoor air ordinance, and a few […]

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , .

05.15.19

A tale of two sentiments two weeks after FDA permits the sale of IQOS

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It’s been just over two weeks since the U.S. Food and Drug Administration (FDA) authorized the sale of Philip Morris’ IQOS heated tobacco product (HTP) system in regular tobacco and menthol flavors. It’s also been exactly two years since the premarket tobacco product application (PMTA) for this product that creates an aerosol (not smoke) from […]

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , .

04.04.19

Reflecting on progress made in tobacco and nicotine products regulation under FDA Commissioner Gottlieb

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Tomorrow is Commissioner Gottlieb’s last day on the job at the U.S. Food and Drug Administration (FDA), and he’s been treating these last few days much like he has his entire two-year tenure: with carefully thought out and coordinated communication about both in-process and potential future FDA actions. While the agency has been hard at […]

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , , .

02.11.19

Reality check: Cigarettes are the only reason reduced risk tobacco products are even a thing

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First, a confession. I’m a total public health nerd. I’ve been absolutely captivated by the prevention of disease at a population level since I was introduced to the concept late in college. From the science that drives it to the programs, policies, and laws that either embrace or hinder it and everything in between and […]

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , , , .

01.25.19

Develop your skills blending law, science, and policy as a Tobacco Regulatory Science Fellow at the U.S. Food and Drug Administration

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At my high school graduation, a friend and I had a short dialogue speaking to our graduating class about where our futures were headed. “What do you want to be when you grow up?” I asked her. She confidently answered, “A horse.” After an awkward moment or two went by, she continued with, “Or at […]

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , .

12.11.18

Furthering Tobacco Control Requires a Broader Perspective

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Tobacco control efforts in the U.S. have predominantly been a state, local, and increasingly tribal endeavor with landmark federal reports and legislation spurring or guiding local actions. When I started in tobacco control at the local level in 2006, the CDC’s Best Practices for Comprehensive Tobacco Control Programs was our roadmap. It focused our efforts […]

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , , , , .

08.17.17

Is There Any Reason to Allow Cigarette Companies to Send Coupons (or Any Other Advertising) to Nonsmokers?

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  A recent study in the Nicotine & Tobacco Research journal confirms that the tobacco industry sends discount cigarette coupons to non-smokers in the USA and that some of those receiving the coupons become smokers. The study concludes that its findings support more restrictive policies to curtail the use of tobacco product discount coupons because […]

Posted in FCTC, FDA, Tobacco, uncategorized ; Tagged: , , , , , , , , , .

05.05.17

Louisiana Proposes that the Federal Government Bypass Patent Restrictions to Acquire Cheaper Hepatitis C Drugs

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Anyone who follows U.S. public health issues – or who reads my blog posts – knows that the cost of the drugs needed to treat Hepatitis C infections is very high. The cost of these drugs is of particular concern to state health authorities who are charged with providing health care for Medicaid recipients and […]

Posted in FDA, Healthcare, uncategorized ; Tagged: .

04.13.17

Direct to Consumer Genetic Testing: Risks and Opportunities

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Accurate genetic testing stands to transform modern medicine by offering effective, personalized treatment. Last week, the U.S. Food and Drug Administration (FDA) authorized marketing of the first direct-to-consumer (DTC) genetic health risk (GHR) tests. Individuals in the US can now purchase DTC tests and gain potentially useful information on their genetic predisposition to 10 diseases […]

Posted in FDA, Non-Communicable Diseases ;

03.10.17

FEDERAL TOBACCO CONTROL DURING THE TRUMP YEARS – AND TOBACCO PRODUCT INSERTS

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Although the federal Tobacco Control Act gives the U.S. Food and Drug Agency extensive authorities to regulate tobacco products and their marketing, labeling, and sale, the Trump Administration’s new pro-business, anti-regulation approach might put some serious obstacles in the way of any significant new FDA regulations to reduce the massive amounts of tobacco use and […]

Posted in FDA, Tobacco ; Tagged: , , , , , , , , , , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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