The U.S. Food and Drug Administration (FDA) has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations.
Four of the warning letters pertain to companies who 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 outlines a company’s failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.
According to the FDA, Homeopathy is an alternative medical practice that was developed in the late 1700s.
Homeopathy is generally based on two main principles:
- That a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, a principle known as “like-cures-like”; and
- The more diluted the substance, the more potent it is, which is known as the “law of infinitesimals.”
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; and
- 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.
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 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. The FDA tested multiple samples and found these 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.
In December 2017, the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval that have the greatest potential to cause risk to patients.