The U.S. Food and Drug Administration (FDA) in May posted warning letters to five companies that produce products labeled as homeopathic. It accused them of significant violations of current good manufacturing practice regulations.
Four of the warning letters pertain 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. An additional letter outlined a company’s failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes. The FDA announced the warnings May 14, 2019.
“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, MD. “When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk.”
The FDA noted that it has not approved products labeled as homeopathic for any use and that they may not meet modern standards for safety, effectiveness, and quality. “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.” The warning letters went to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC, doing business as WePackItAll. They all describe failures to conform to regulations due to improper methods, facilities, or controls for manufacturing, processing, and packing.
Earlier this year, the FDA issued separate warning letters to additional companies regarding products in violation of its regulations and labeled as homeopathic. On April 1, the FDA warned homeopathic firms for putting consumers at risk with significant violations of manufacturing quality standards, and on March 19, they took action against a marketer of unapproved products claiming to treat addiction, chronic pain, and other ailments.
In December 2017, the FDA proposed a risk-based enforcement approach. The approach prioritizes enforcement and regulatory actions of products labeled as homeopathic and marketed without the required FDA approval that have the greatest potential to cause risk to consumers (“FDA to Regulate Some Homeopathic Products; CFI Hails Move,” Skeptical Inquirer, March/April 2018).