|Dr. Robert Bogosian|
Six years after an initial warning that claims its products can cure diseases are a violation of federal law, the FDA apparently has decided enough is enough and sent in U.S. Marshals to seize products from a Maine company.
The agency announced yesterday that on May 31, marshals rounded up products from Global Biotechnologies of Portland, ME, based on a warrant issued in federal court. It says the labels on such products as Glucanol, Healthy Trac, Immunol, and Lactopril claim that they can "can diagnose, cure, mitigate, treat or prevent human diseases," violating federal laws.
In a telephone interview, company President Robert Bogosian, Ph.D., said the product had been quarantined but remained at the facility. He said there is nothing wrong with the product, that he is working with his compliance officer and expects the FDA will release the products when the labeling issues are resolved. He said after the 2006 warning letter, the company made adjustments to its labeling and resolved issues with the agency. He believes there have been changes in the law since then but that it is so broad, it is difficult to comply with.
"I think they are trying to make an example of me and l don't know why," Bogosian said.
An FDA spokesperson could not be reached to confirm Bogosian's explanation. The agency has recently sent marshals in to seize products from a number of companies it says are violating FDA regulations, including one whose products are tied to a spate of infections in a neonatal unit.