FDA Sends Warning Letter to Company Marketing Unapproved Chronic Pain Treatments

The FDA recently announced they have posted a warning letter to Nutra Pharma Corp. According to the FDA, Nutra Pharma Corp has illegally marketed unapproved products that are labeled as homeopathic with claims about their ability to treat addiction and chronic pain.

“One of our most important obligations is to protect consumers from those who would prey on them with bogus claims and fraudulent products,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “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.”

According to Dr Gottlieb, patients with chronic pain or those battling opioid addiction, “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.”

 The FDA warning letter issued to Nutra Pharma is for the following 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,” the agency noted.  

The FDA has asked Nutra Pharma to respond within 15 working days. If the company fails to correct the violations outlined in the warning letter, legal action may be taken without further notice.

“Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program,” the FDA concluded.  

—Julie Gould

Reference:

The US Food and Drug Administration. FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions [press release]. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633813.htm. Accessed March 19, 2019.