Court rules Smoking Everywhere’s electronic cigarette a tobacco product, not a drug
SUNRISE, Fla. An electronic cigarette designed to mimic the effects and traditional cigarettes qualifies as a tobacco product rather than a drug, a U.S. District Court ruled Friday.
The U.S. District Court for the District of Columbia ruled in favor of Smoking Everywhere in the company’s lawsuit against the Food and Drug Administration, which had ordered that the company’s electronic cigarettes be denied entry into the United States, saying that the cigarettes were unapproved drug-device combinations.
“This is an important decision because it defines the scope of FDA authority under the Federal Food, Drug and Cosmetic Act, the newly enacted Family Smoking Prevention and Tobacco Control Act and properly frames the application of the laws regulating the use of tobacco products in the United States,” said partner Walt Linscott of the law firm Thompson Hine, which argued the case.
Publix joins H1N1 efforts during National Influenza Vaccination Week
LAKELAND, Fla. To coincide with National Influenza Vaccination Week, Publix Pharmacies announced Wednesday an inoculation offer of the H1N1 vaccine for $10. The special pricing for the vaccine will remain in effect until the vaccine supply is depleted. Customers do not need an appointment for the vaccination, but are encouraged to call their local Publix Pharmacy to ensure an immunizing pharmacist is on duty and vaccine supply still is available.
In addition, every customer who receives an H1N1 vaccine from a Publix Pharmacy will also receive a coupon good for a $10 Publix gift card with a new or transferred prescription.
“While influenza is unpredictable, we know that if more people are vaccinated, the disease is less likely to spread in the upcoming months,” stated Maria Brous, Publix media and community relations director. “Our Publix Pharmacists are committed to the total health and wellness of our customers and their families.”
FDA finds Spiriva does not raise risk of heart attack, stroke
ROCKVILLE, Md. Data from a recent review of a treatment for chronic obstructive pulmonary disease do not support allegations that it raises the risk of stroke, heart attack or death, the Food and Drug Administration announced Thursday.
The FDA reviewed a 5,992-patient study of the Spiriva HandiHaler (tiotropium), made by Pfizer and Boehringer Ingelheim as a treatment for COPD, a disease that includes emphysema and chronic bronchitis.
In March 2008, an FDA Early Communication described data submitted by one of the companies suggesting a small increased risk of stroke in patients who had taken the inhaler’s active ingredient. An update in October of that year highlighted two additional publications suggesting an increased risk of stroke, heart attack and death in patients using the drug.