FDA Warning Letter to Homeopathic Product Manufacturers due to Quality Issues

On June 19, 2020 the U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. During an inspection from June 18 to July 2, 2019 the FDA investigators observed specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.

Quality control unit

According to the FDA, the firm’s quality unit (QU) failed to have adequate oversight for homeopathic drug products and components that were received, manufactured, or distributed. Furthermore, the company lacked adequate written procedures describing the responsibilities for the QU. During the inspection, it came out that the manufacturing roles and responsibilities between the company and its suppliers were not clearly defined. Although the company became aware that one of the suppliers had been placed on import alert 66-40 "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs," the firm continued to distribute adulterated homeopathic drug products and components from that supplier.

Identity testing

The company purchased mother tinctures and other components from outside suppliers but failed to test each lot of component received for identity before release for use in drug manufacturing.

As a consequence, the FDA is now demanding, among others, a description of how each component lot will be tested for conformity with all appropriate specifications for identity, strength, quality, and purity.

Test methods

According to the FDA, the company also failed to adequately validate the test methods that were used to analyze the raw materials and finished drug products. For example, it was unclear how it is ensured that the bioburden method is adequate for use.

Unapproved New Drugs

In addition to the quality-related issues mentioned above, the statements made about the products on the companies' websites were found to be drug claims. According to the FDA, who revied the websites in detail, the claims used demonstrate that the products are drugs, because they "are intended to cure, mitigate, treat, or prevent disease and/or intended to affect the structure or function of the body of man or other animals." Moreover, these products are “new drugs”, "because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling."

The FDA summarizes the problem as follows: "These products are especially concerning from a public health perspective because they claim to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as cancer, diabetes, and hepatitis, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process."

For more details, see the Warning Letter published on the FDA's website.