FDA Takes Action against Marketer of Unapproved Products Claiming to Treat Addiction

March 21, 2019
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The US Food and Drug Administration posted a warning letter to Nutria Pharma Corp. for illegally marketing unapproved products. The company was labeling their products as homeopathic, with claims about their ability to treat addiction and chronic pain. Nutria Pharma Corp. claimed that their products could treat pain associated with cancer, diabetes, fibromyalgia, and other serious conditions. Click the link to see Albuquerque's top rehab placement programs.

“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 offers no such benefit,” said FDA Commissioner Scott Gottlieb, M.D in a statement.

“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. 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.”

The warning letter was issued by the FDA for the following Nutra Pharma 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.

Nutra Pharma’s products had certain claims that may mislead consumers, particularly patients who are suffering from chronic pain.

“Nyloxin . . . treats conditions that cause chronic pain,” one product claimed. Another example of a claim from a Nutra Pharma product read: “[C]obra 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.”

The FDA recognizes the serious potential health risks associated with these health fraud scams. The products have not been demonstrated to be safe or effective. Another concern is that these products may keep some patients from seeking appropriate medical treatment with the use of FDA-approved therapies.

Selling unapproved products with claims that they can treat chronic pain is also a violation of the Federal Food, Drug, and Cosmetic Act.

The FDA is taking steps to ensure that safe medication-assisted treatment (MAT) is available to those who suffer from addiction. The agency is also tackling the stigma associated with these therapies. FDA-approved treatment methods have been demonstrated to be safe and effective.

In fact, patients who have received FDA-approved MATs cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration.

The FDA has requested responses from Nutra Pharma within 15 working days. The warning letter also states that failure to correct violations may result in legal action without further notice.

If someone in the family is struggling with opioid addiction, it is important to seek help. A combination of medical detox and behavioral therapy can go a long way in the fight against drug abuse. But because every individual is affected by addiction differently, a comprehensive program tailored to their specific needs is necessary. Look for a nearby addiction treatment facility today and find out how drug treatment programs work.



SOURCE: Press Advantage [Link]

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