A company promoting its cobra venom-based supplements as chronic pain relievers has crossed the Food and Drug Administration.
NutraPharma, maker of cobra-venom supplements Nyloxin, was promoting its drugs as an alternative pain treatment. This week, the FDA determined these supplements were unapproved new drugs, not homeopathic drug products. The decision was based on a review of Nyloxin’s websites and social pages.
The agency’s rationale, according to the warning letter, is that the cobra venom supplements were “intended to diagnose, cure, mitigate, treat, or prevent disease, and/or intended to affect the structure or any function of the body,” which makes them drugs under the Federal Food, Drug, and Cosmetic Act.
The FDA letter pointed out 20 instances in which the Nyloxin website or a social post claimed that cobra venom could treat conditions including cancer, fibromyalgia, Parkinson’s, diabetes, shingles, rheumatoid arthritis, and drug addiction. The agency took particular issue with claims that cobra venom was being researched as a drug-addiction treatment, writing in the letter that the “marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health.”
“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 Scott Gottlieb said in a statement about the warning letter.
Gottlieb’s statement also called the products “bogus,” “fraudulent,” and “scams.” NutraPharma did not respond to a request for comment.
Because the opioid crisis has been declared a public health emergency, FDA has cracked down on homeopathic products that claim to treat pain or addiction. The agency’s solution to addressing products like Nyloxin appears to be stripping them of homeopathic drug status, which allows them to be sold without undergoing the FDA approval process.
The warning letter also reprimanded NutraPharma for using the FDA logo in a misleading way. On the footer of Nyloxin’s website, the official FDA logo with the words “FDA registered” appeared next to the Nyloxin logo.
In the letter, the FDA wrote that it has no record of NutraPharma registering as a drug establishment with the agency and that the placement of the logo suggested Nyloxin products were approved or endorsed by the FDA, which they were not. The FDA logo has since been removed from the website.
NutraPharma has 15 days to respond to the letter. It must detail steps taken to correct the violations that span Nyloxin and the company’s entire web presence.