April 23, 2019

FDA Warns Homeopathic Drug Producers For Violations of CGMP

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 marketed for serious diseases and the product has not been shown to offer clinical benefits. Products labeled as homeopathic have not been approved by the FDA for any use and may even not meet standards for quality and safety, according to the FDA. These products may be made from plants, healthy or diseased animal or human sources, minerals, and chemicals. They are marketed as natural, safe, and … [Read more...]

FDA Warns Nutra Pharma Group For Illegally Marketed Unapproved Products

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 Nyloxin Oral Spray, Nyloxin Topical Gel, Nyloxin Topical Roll-On, Nyloxin Topical Roll-On ES, Nyloxin Professional Size Pump Topical Gel and Regular Strength Sample Pack. These names are similar to other FDA-approved drugs and may confuse consumers. The claims on these products include "treats conditions that cause chronic pain," and "Cobra venom saw its primary use in the treatment of cancer and … [Read more...]

FDA Proposes New Enforcement to Protect Consumers from Unproven Homeopathic Drugs

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 potentially harmful ingredients or don't meet current good manufacturing practices. FDA Commissioner Dr. Scott Gottlieb said in a statement, "In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in … [Read more...]

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