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Five companies with products considered homeopathic have been found to be in violation of the FDA’s current good manufacturing practice regulations.
Letters to four of the five companies specifically mentioned products labeled as sterile that were not sterile. The fifth letter concerned a company’s failure to have proper design, monitoring and control of manufacturing processes.
The letters were sent to Kadesh, U.S. Continental Marketing, Fill It Pack It, and Bershtel Enterprises, doing business as WePackItAll, which produces and packages homeopathic labeled Puriton Eye Relief Drops.
Newton Laboratories received a warning letter for human drug violations and unapproved animal drug violations. Newton Laboratories used ingredients such as nux vomica to treat conditions in infants and children. Nux vomica contains strychnine which is a poison used to kill rodents.
“It’s our public health obligation to protect consumers from unsafe products. 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,” said FDA acting commissioner Ned Sharpless. “When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk.”
Homeopathic products are not approved by the FDA.
