Is the FDA Poised to Ban a Century-Old Natural Remedy?
September 19, 2009
Major Pharmaceuticals has put out a press release saying that they've been forced to shut down production of all natural desiccated thyroid drugs, a treatment for hypothyroidism that has been in use for over a century. Major received notice from the FDA that their complete line of desiccated thyroid drugs can no longer be manufactured, and that the FDA is pulling the designation that allowed them to sell these drugs.
Major is also saying that the FDA is requiring that all manufacturers that wish to continue manufacturing submit an NDA or ANDA (New Drug Application or Abbreviated New Drug Application) for approval. Desiccated thyroid drugs were in use in the early 1900’s, and already on the market when the government regulatory groups to oversee medications were formed, so they never went through the new drug application process.
Biotech, Time Cap Labs, and Major are no longer manufacturing natural desiccated thyroid drugs. RLC and Forest are now the last makers of natural desiccated thyroid drugs in the U.S., and their products are unavailable or in short supply in throughout the nation.