PORTLAND, Maine — U.S. marshals have seized drug products at Portland-based Global Biotechnologies Inc. after allegations that the firm’s products were sold as medical treatments without first having been certified as safe and effective by federal regulators.
The U.S. marshals were acting on a request by the U.S. Food and Drug Administration, and pursuant to a warrant issued by U.S. District Court, the FDA announced Wednesday.
“The public relies on the FDA to keep companies from claiming that their products improve medical conditions or diseases,” said Armando Zamora, acting director of the office of enforcement in the Office of Regulatory Affairs, in a statement. “Using these products in the mistaken belief that they will cure a disease — especially when they cannot do so — represents a danger to the public’s health.”
Calls placed by the Bangor Daily News to Global Biotechnologies Inc. and the FDA were not immediately returned on Wednesday.
According to an administration announcement, the Portland company’s products, including Glucanol, Healthy Trac, Immunol and Lactopril, meet the FDA definition of “drugs” because Global Biotechnologies promoted them to treat diseases.
The agency goes on to state that the firm did not provide “adequate directions for use” of the drugs, however, violating the Federal Food, Drug and Cosmetic Act.
FDA regional director Gail Costello wrote in a 2006 warning letter to company officials that “your products are not generally recognized as safe and effective for the above referenced conditions.”
She wrote that products such as these, designated as “new drugs,” cannot be sold legally in the United States without FDA approval, which is granted “on the basis of scientific data submitted by drug sponsors to demonstrate that the drug is safe and effective.”
In Wednesday’s announcement, the FDA claimed Global Biotechnologies responded to the warning letter with a pledge to remove drug claims from its labeling, but a recent inspection found that the company continues to make illegal claims.
Look at what the FDA approves…
They aprove drugs that have rediculouse side effects.
Who knows what this company was selling, but I feel if it is herbal, they sould keep their hands in their own pockets.
If the product meets a reasonable standard of safe use, and does NOT claim to be anything other than a supplement, the hands stay in the pockets. Once the manufacturer and/or distributor starts claiming disease-curing or -managing effects, they must adhere to FDA regulations.
That’s right cant. The FDA approved Vioxx and how many people did this kill? But it was alright because of FDA said so. We are supposed to trust our government agencies.
Does this mean that Carter’s Little Liver Pills was a snake oil sham, too?
Here is the warning letter http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075791.htm
This has been going on for over 6 years and they are just now doing something about it. Someone needs to take roll call here also and see why there have been no follow ups.