HEALTH

FDA, FTC crack down on distributors making unapproved cold, flu relief claims

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission last week issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA. And because none of the ingredients listed are in fact monographed OTC cough, cold or flu symptom relievers, those products would additionally need to be filed as "new drugs."

A total of eight warning letters were issued Feb. 11. Another, addressing Flu and Cold Defense LLC, was issued last month. 

A few of the distributors that received the warning letters were hawking generic Tamiflu without a prescription, or circumventing the need for a prescription by having an "on-staff" doctor write a prescription upon a completed transaction. Others were claiming their products were dietary supplements or were making claims outside of those approved under an OTC monograph. 

None of these scenarios relieves the distributors of applying for that over-the-counter drug approval, the agencies noted. 

The firms issued warning letters included Discount Online Pharmacy, Kosher Vitamin Express, Medsnoscript, Oasis Consumer Healthcare, Secure Medical, Sun Drug Store, Supplementality LLC and Vitalmax Vitamins. Each of the distributors have 15 days to reply to the agencies outlining corrective action. 


Like this story? Find us on Facebook for more insight, analysis and the latest in drug store news. Join the conversation.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

CDC: Flu activity drops to 3.2%, still above national baseline of 2.2%

BY Michael Johnsen

ATLANTA — For the week ended Feb. 9, influenza activity decreased to 3.2% — still above the baseline of 2.2%, but an indicator this year’s flu season is on its way out. 

Eleven states and New York City were still experiencing high influenza-like illness activity, while 10 states reported moderate activity.

On a regional basis, more than one in three patients who presented with influenza-like illnesses tested positive for the flu in region 5 (Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin) and region 9 (Arizona, California, Guam, Hawaii and Nevada). Region 2, which includes New Jersey, New York, Puerto Rico and the U.S. Virgin Islands, reported that 20% of their ILI patients tested positive for the flu. 


Like this story? Find us on Facebook for more insight, analysis and the latest in drug store news. Join the conversation.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

FDA seizes tainted product from Florida’s Globe All Wellness

BY Michael Johnsen

SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.

“Companies that distribute products containing undisclosed drugs are not only breaking the law, they also are putting consumers at risk,” stated Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “With these kinds of hidden dangers, consumers cannot make informed decisions about the products they are taking.”

“Two important protections for the public are that a firm may not sell new drugs unless they have been tested and approved by the FDA and a firm may not make false or unsubstantiated claims about drugs they sell,” said Melinda Plaisier, acting associate commissioner for regulatory affairs. “The FDA must and will take aggressive enforcement action.”

Several of the seized products contain sibutramine hydrochloride (sibutramine), the active ingredient in the obesity drug Meridia. In December 2010, Meridia was withdrawn from the U.S. market after clinical data demonstrated that the drug increased the risk of heart attack and stroke.

Globe All markets its products with claims that its products can lower blood pressure and cholesterol, among others. Under the Federal Food, Drug and Cosmetic Act, products offered for such use are considered to be drugs, since they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. 

During inspections of Globe All conducted in October 2012 and February 2013, the FDA also found that the company distributed dietary supplements that were not manufactured in accordance with the current good manufacturing practice requirements for dietary supplements.  

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?