Homeopathic Drugmaker Violated Production Standards, FDA Says
A New York maker of homeopathic medicines that include toxic ingredients ran afoul of the FDA because it made drug-like claims for its products but did not manufacture them to the standards invoked by the claims, the agency said in a warning letter.
HomeoCare Laboratories said its HBP Relief “relieves symptoms associated with high blood pressure (hypertension)” and that its IBS Relief “gently helps correct a dysfunctional digestive system,” the letter said.
The company also violated current good manufacturing practices by failing to: establish written procedures for production, follow adequate procedures for in-process testing of production batches, test and validate incoming supplies, and perform annual reviews of the quality of its products.
HomeoCare also failed to test for strychnine in a tincture that can contain the toxin, the agency said.