FDA Warns Florida Company About Distributing Unapproved Drugs

FDA's letter alleges Nutra Pharma Corp. of Coral Springs, Fla., illegally markets unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, and other serious conditions.

The U.S. Food and Drug Administration on March 19 posted its warning letter to Nutra Pharma Corp. of Coral Springs, Fla., alleging the company illegally markets unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, and other serious conditions.

The letter cites several 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 may confuse consumers because their names are similar to FDA-approved drugs, the agency's March 11 letter states.

FDA requested responses from Nutra Pharma within 15 working days and warned that failure to correct violations may result in legal action without further notice, including, without limitation, seizure and injunction.

"One of our most important obligations is to protect consumers from those who would prey on them with bogus claims and fraudulent products. We've dedicated new resources to our enforcement work, and I consider these activities the cornerstone of our consumer protection mission and one of our most significant institutional obligations. We're especially focused on those who would exploit Americans harmed by the opioid crisis with the false promise of products that can treat pain or addiction, but that offer no such benefit," said FDA Commissioner Dr. Scott Gottlieb.

"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," he continued. "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. We have great concern for the millions of Americans who live with chronic pain or cancer, and for whom traditional treatment options have been exhausted, as well as those battling opioid addiction. They deserve new advances in care that can address pain without the risk of addiction, not the deception of bogus products that offer no proven benefit. We'll continue our efforts to protect consumers from such false claims, while also working to advance the development of new treatment options, including non-addictive products for pain management and innovative products for the treatment of opioid use disorder."

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