FDA cracks down on misbranded Halifax diabetes product
Neuragen is a licensed natural health product
Health authorities in the United States have ordered a Halifax biomedical company to change the way it advertises nerve pain medication to Americans.
Late last month the U.S. Food and Drug Administration wrote Origin Biomed outlining its objections to marketing claims made by the company on social media about its over-the-counter nerve pain medication Neuragen.
The U.S. government considers it a prescription drug because it claims to treat medical conditions like diabetes.
"Your products are prescription drugs because they are intended to treat diseases that require diagnosis and treatment by a physician. Their labels fail to bear the symbol ‘RX only,’" wrote the administration.
The company was given 15 days to tone down the medical claims, which executive chairman Carlo Shimoon said they’ve done.
"We’ve removed any reference to the word nerve," he said.
Shimoon blames the problem on confusion between its Canadian and American website.
He said the FDA was concerned only with its U.S. website. In Canada Neuragen is not considered a drug and is a licensed natural health product.
"We don’t have any recalls that we know of that we need to participate in. They have no issues other than our website," he said.
Health Canada said no adverse medical effects have been reported.
Origin Biomed, with just seven employees, has received $7 million in provincial government financial assistance and another $3 million from Ottawa.