FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions- Drug Information Update

The U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions The FDA issued a warning letter to Nutra Pharma for their products: “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 products also may confuse consumers because its name is similar to FDA-approved drugs. Examples of claims made include: “Nyloxin . . . treats conditions that cause chronic pain.” “[C]obra venom saw its primary use in the treatment of cancer and arthritis. Reportedly the venom was used to treat liver cancer, lung cancer, esophageal cancer, skin cancer, and leukemia.” “Today, cobra venom is being studied for treating various forms of pain, cancers, autoimmune and neurological disorders.” “Researchers in China are examining the possibility that cobra venom can be used to treat drug addiction.” “Treatment of the Cobrotoxin in 90 cases with heroin dependence.” Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat chronic pain is a violation of the Federal Food, Drug, and Cosmetic Act. For more information, please visit: Nutra Pharma Corp