The U.S. Food and Drug Administration 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.
“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, M.D. “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 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.
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.
Another warning letter was issued to Newton Laboratories for human drug CGMP and misbranding violations, as well as unapproved new animal drug violations. 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. For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. Producing such a product without proper manufacturing controls may lead to super-potent drugs, which could be a potential poisoning risk for consumers.
Earlier this year, the FDA issued separate warning letters to additional companies regarding violative products labeled as homeopathic:
- [4/1/19]: FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
- [3/19/19]: FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions
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. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA stated when it issued the draft guidance that it would consider taking additional enforcement and/or regulatory actions, consistent with its current compliance policies, in the interest of protecting the public.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program.
- Complete and submit the report online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178. For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.