June 25, 2019

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.

FDA Warning Letter Nutra Pharma Corp.

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┬áits 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,” according to the letter.

These medical claims can cause serious problems, if people use these unapproved products instead of seeking appropriate care and therapies from doctors. The FDA says that these products have not been demonstrated to be safe or effective. In fact, homeopathic products are not approved by the FDA for any use, and “may not meet modern standards for safety, effectiveness, and quality,” according to the FDA warning. Selling these products with these claims is a violation of the Federal Food, Drug, and Cosmetic Act.

Dr. Scott Gottlieb, FDA Commissioner, said in a statement, “Today, we posted a warning letter to a company preying on patients who may be seeking alternative treatments for chronic pain, cancers, arthritis and autoimmune and neurological disorders. Health fraud scams like these are inexcusable. These patients deserve proven treatments not false promises that can deter them from seeking otherwise effective care, and that can also contain ingredients or contaminations that can threaten their health.”

Treating chronic pain is difficult and the opioid crisis that is currently ongoing in the United States is one issue related to those medical conditions.

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