Washington, D.C.–The Food and Drug Administration (FDA) announced that it has posted warning letters to five manufacturers of homeopathic products for significant violations of current good manufacturing practice (cGMP) regulations.
“It’s our public health obligation to protect consumers from unsafe products,” FDA Acting Commissioner Ned Sharpless, M.D., said in the announcement. “Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to manufacture and label their products appropriately. When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk.”
Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC, doing business as WePackItAll, jointly manufacture and package Puriton Eye Relief Drops, according to the announcement. FDA said multiple samples were tested and the drops were found to be non-sterile, and to have a high pH level. According to the FDA, this could lead to infection or eye injuries such as glaucoma, corneal scarring and loss of vision. In the warning letters issued to the companies, the FDA cited concerns including failures to conform to cGMP requirements due to improper methods, facilities or controls for manufacturing, processing and packing. The Agency noted that Kadesh issued a voluntary recall in November 2018 due to non-sterile production conditions at the manufacturing facility.
FDA also issued a warning letter to Newton Laboratories concerning human drug cGMP and misbranding violations, as well as unapproved new animal drug violations. According to the announcement: “Some of the company’s products labeled as homeopathic are indicated for treating conditions in infants and children, and they are manufactured from ingredients such as nux vomica, belladonna, aconitum napellus, and gelsemium sempervirents that pose potentially toxic effects.” Producing such products without proper manufacturing controls, FDA said, may lead to super-potent drugs that could be a potential poisoning risk for consumers.
As WholeFoods previously reported, in April the FDA issued warning letters to homeopathic companies King Bio Inc., Red Mountain Inc., Tec Laboratories Inc. and B. Jain Pharmaceuticals Pvt. Ltd.