FDA News

FDA warns Nutra Pharma against 'bogus products' for chronic pain, addiction

Scott Gottlieb
Scott Gottlieb

The FDA has issued a warning letter to Nutra Pharma Corp., ordering the company to cease what it describes as illegal marketing of unapproved homeopathic products that claim to treat opioid addiction as well as chronic pain associated with rheumatoid arthritis, fibromyalgia, cancer, diabetes and other serious conditions.

“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 press release. “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.”

In its letter, dated March 11, the FDA referenced several Nutra Pharma products including “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.” According to the FDA, these products are unapproved new and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

U.S. Food and Drug Administration 
The FDA has issued a warning letter to Nutra Pharma Corp., ordering the company to cease what it describes as illegal marketing of unapproved homeopathic products.
Source: FDA

In addition, the FDA warned that the products may also confuse consumers because their names are similar to FDA-approved drugs.

According to the FDA, claims made by Nutra Pharm on its Nyloxin website include:

  • “Nyloxin ... treats conditions that cause chronic pain;”
  • “Cobra venom saw its 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;”
  • “Today, cobra venom is being studied for treating various forms of pain, cancers, autoimmune and neurological disorders;”
  • “Researchers in China are examining the possibility that cobra venom can be used to treat drug addiction;” and
  • “Treatment of the Cobrotoxin in 90 cases with heroin dependence.”

The Nutra Pharm website also included a claim that its products were intended for “rheumatoid arthritis and chronic joint pain,” according to the FDA’s letter.

“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,” Gottlieb said in the release. “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.”

The FDA has requested that Nutra Pharm respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.

Asked for comment, Rik J. Deitsch, MS, CEO for Nutra Pharm, told Healio Rheumatology the company is currently drafting its response and will work with the FDA to make any suggested changes.

“It appears that the FDA is going after companies that claim to be a solution for the ‘opioid crisis,’” Deitsch said. “We have made that claim because we have actual evidence as an opiate replacement and have seen product users reduce or get off of their opiate drugs with our OTC pain reliever, Nyloxin. We also have a published rat study that provided evidence that Nyloxin out-performed morphine in the treatment of chronic pain.”

According to Deitsch, “almost all drug companies get a warning letter every now and then.”

“It’s the FDA’s job as the industry watchdog,” he said. “The letter lays out their potential concerns. The company then either argues their points or takes corrective action or both. We will take all of the corrective action to make sure that Nyloxin remains available to the people that need it most.”

In the FDA press release, Gottlieb said the FDA has “great concern” for Americans living with chronic pain or cancer who may have exhausted traditional treatment options, as well as those battling opioid addition.

“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,” Gottlieb said in the release. “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.” – by Jason Laday

Scott Gottlieb
Scott Gottlieb

The FDA has issued a warning letter to Nutra Pharma Corp., ordering the company to cease what it describes as illegal marketing of unapproved homeopathic products that claim to treat opioid addiction as well as chronic pain associated with rheumatoid arthritis, fibromyalgia, cancer, diabetes and other serious conditions.

“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 press release. “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.”

In its letter, dated March 11, the FDA referenced several Nutra Pharma products including “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.” According to the FDA, these products are unapproved new and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

U.S. Food and Drug Administration 
The FDA has issued a warning letter to Nutra Pharma Corp., ordering the company to cease what it describes as illegal marketing of unapproved homeopathic products.
Source: FDA

In addition, the FDA warned that the products may also confuse consumers because their names are similar to FDA-approved drugs.

According to the FDA, claims made by Nutra Pharm on its Nyloxin website include:

  • “Nyloxin ... treats conditions that cause chronic pain;”
  • “Cobra venom saw its 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;”
  • “Today, cobra venom is being studied for treating various forms of pain, cancers, autoimmune and neurological disorders;”
  • “Researchers in China are examining the possibility that cobra venom can be used to treat drug addiction;” and
  • “Treatment of the Cobrotoxin in 90 cases with heroin dependence.”

The Nutra Pharm website also included a claim that its products were intended for “rheumatoid arthritis and chronic joint pain,” according to the FDA’s letter.

“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,” Gottlieb said in the release. “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.”

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The FDA has requested that Nutra Pharm respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.

Asked for comment, Rik J. Deitsch, MS, CEO for Nutra Pharm, told Healio Rheumatology the company is currently drafting its response and will work with the FDA to make any suggested changes.

“It appears that the FDA is going after companies that claim to be a solution for the ‘opioid crisis,’” Deitsch said. “We have made that claim because we have actual evidence as an opiate replacement and have seen product users reduce or get off of their opiate drugs with our OTC pain reliever, Nyloxin. We also have a published rat study that provided evidence that Nyloxin out-performed morphine in the treatment of chronic pain.”

According to Deitsch, “almost all drug companies get a warning letter every now and then.”

“It’s the FDA’s job as the industry watchdog,” he said. “The letter lays out their potential concerns. The company then either argues their points or takes corrective action or both. We will take all of the corrective action to make sure that Nyloxin remains available to the people that need it most.”

In the FDA press release, Gottlieb said the FDA has “great concern” for Americans living with chronic pain or cancer who may have exhausted traditional treatment options, as well as those battling opioid addition.

“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,” Gottlieb said in the release. “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.” – by Jason Laday