The Food and Drug Administration (FDA) is warning five homeopathic product manufacturers for significant violations of current good manufacturing practice regulations (CGMP). Warning letters were sent to those companies. Four of the letters target companies who jointly produced a product labeled as homeopathic that was not sterile. The fifth outlines a company’s failure to have … Read more
The FDA has sent warning letters to four homeopathic drug producers for “significant violations of current food manufacturing practice (CGMP) regulations.” These products are labeled as homeopathic and marketed without FDA approval. The homeopathic industry has grown tremendously in the past several years. The government acknowledges the need to address situations where these products are … Read more
The FDA posted a warning letter to Nutra Pharma Corporation for illegally marketing unapproved products that were labeled as homeopathic and made medical claims. More specifically, the claims were about ability to treat addiction and chronic pain, including pain that is associated with cancer, diabetes, fibromyalgia, and other serious medical conditions. The targeted products include … Read more
The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that may be harmful. FDA is going to update its existing policy to address situations where these treatments are marketed for serious diseases and conditions, but have not shown any clinical benefits. The policy will also cover situations where these products contain … Read more