FDA Takes a Bite Out of Nyloxin

By Pat Anson, PNN Editor

It’s fair to say that cobra venom isn’t high on the list of go-to analgesics for most chronic pain sufferers. But that hasn’t stopped Nutra Pharma from cashing in on the appeal of an exotic, non-opioid pain reliever.

The Florida company’s main product – Nyloxin – is a homeopathic-based medicine that contains a tiny amount of cobra venom, which supposedly contains compounds that block pain signals from reaching the brain. Like other homeopathic products, Nutra Pharma’s CEO says only a small amount of the active ingredient is needed to make Nyloxin sprays and gels effective.

“Our regular strength product is 70 micrograms per milliliter of cobra venom,” CEO Rik Deitsch told PNN. “Our product is based on over a hundred years of research utilizing cobra venom at these dilution levels.”

But a complaint filed last fall by the Securities and Exchange Commission raises doubts about Nutra Pharma claims that it had 1,300 cobra snakes on a Florida farm that it “milks” monthly for venom.

“Nutra Pharma never had a cobra farm, never had cobras, and indeed had never produced cobra venom,” the SEC said.

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The only ones getting milked may be Nutra Pharma’s investors. The SEC complaint alleges Deitsch used manipulative insider stock trades and “a series of materially false or misleading press releases” to defraud investors out of nearly $1 million.

This week the U.S. Food and Drug Administration got into the act by sending a warning letter to Deitsch for illegally marketing unapproved products with false claims about their ability to treat chronic health conditions.  

“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

They may be inexcusable, but they’ve been going on for years with little government oversight. Nutra Pharma’s multi-level marketing touts Nyloxin as “clinically proven to treat moderate to severe chronic pain.” and its website has dozens of glowing reviews from customers.  In a video on its YouTube channel, one customer even claims Nyloxin helped him become the first rheumatoid arthritis sufferer to climb Mt. Everest.   

The FDA commissioner says its time for deceptive marketing claims to end.

“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,” said Gottlieb. “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.”

It’s good that Gottlieb wants to protect consumers, but he fails to recognize that many Americans are turning to products like Nyloxin because they’re losing access to opioid therapy.  Denied the pain medication that most have safely used for years, patients are experimenting with alternative treatments, including some that are dubious or even fraudulent, such as compounded pain creams and cannabis skin patches.

PNN’s recent survey of over 5,800 patients found that 20 percent had tried medical marijuana or kratom for pain relief. Even more (26%) had used alcohol and a small number (4%) had turned to illegal drugs such as heroin. One in ten said they were getting prescription opioids from family and friends or buying them on the black market — which is being flooded with “Mexican Oxy” and other counterfeit pills laced with fentanyl.

Is it any wonder that people are buying Nyloxin? Or that Nutra Pharma is touting it as a “non-narcotic” and “safe” homeopathic solution to the opioid crisis? In a sense, policymakers have done all the marketing for them.

“I can tell you we have hundreds, if not thousands of people that have reduced or gotten off their opiates with Nyloxin,” said Deitsch, who intends to comply with the FDA request and continue selling Nyloxin. “We are answering the FDA warning letter. We are making the changes to the website and the claims they have asked us to make. But it is a great product and we stand by it.”