Five Homeopathic Product Companies Warned on Violations

Four of the FDA's warning letters went to companies that jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their purportedly sterile products were not shown to be sterile and the fifth letter outlined a company's failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.

The U.S. Food and Drug Administration announced it has posted warning letters to five companies that produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations. Four of the warning letters went to companies that jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their purportedly sterile products were not shown to be sterile, according to the agency's news release, and the fifth letter outlined a company's failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.

"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 Dr. 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."

Products labeled as homeopathic have not been approved by the FDA for any use, and the agency warns that they may not meet modern standards for safety, effectiveness, and quality. Products labeled as homeopathic can be made from a wide range of substances, including ingredients derived from plants; healthy or diseased animal or human sources; minerals; and chemicals. "These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that are not adequately tested or disclosed to patients," FDA's release stated.

The warning letters issued to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC, doing business as WePackItAll, describe alleged failures to conform to CGMP requirements due to improper methods, facilities, or controls for manufacturing, processing, and packing. These companies jointly manufacture and package Puriton Eye Relief Drops, which are labeled as homeopathic. FDA reported that tested multiple samples and found the eye drops were non-sterile, which could lead to an eye infection, and had a high pH level, which could lead to eye injury such as glaucoma, corneal scarring, and loss of vision. Kadesh issued a voluntary recall in November 2018 due to non-sterile production conditions at the manufacturing facility.

Another warning letter was issued to Newton Laboratories for human drug CGMP and misbranding violations, as well as unapproved new animal drug violations. The ingredients include some that pose potentially toxic effects, according to FDA.

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