FDA Alerts

Nicotine Replacement Therapy Labels May Change
When nicotine replacement therapy (NRT) products were first marketed almost 30 years ago to help people stop smoking, there wasn't a lot of data available on how long consumers could safely use them, and whether they could be used in combination with other NRTs or with continued smoking.
FDA Drug Safety Communication: Chantix Heart Risk
The US Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
FDA Safety Communication: Chantix
The U.S. Food and Drug Administration (FDA) has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix ( varenicline ).
FDA Unveils Final Cigarette Warning Labels
The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.
FDA: Chantix (varenicline) May Increase Cardiovascular Risk
The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix ( varenicline ) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
Tobacco Control
The FDA  announced that it issued its first warning letters to retailers for the illegal sale of tobacco products to minors in violation of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Using state inspectors who have been commissioned by the agency, the FDA visited 493 different retail establishments in Mississippi over the past three months and issued 25 warnings. Mississippi was the first state to participate in the FDA’s State Enforcement Program, which got underway in the summer of 2010 and is designed to help enforce many provisions of t...