Health products will have a declaration of NULINE health products, a change announced by the Centers for Disease Control and Prevention on Monday.
The announcement follows an investigation of Nuline’s claims about the effectiveness of its drug, Nexium, and a similar product, Nuvigil.
Nulines main ingredient, phenylbutazone, was found to be a known human carcinogen in the U.S. in 2013, and the FDA recently banned its use.
The FDA also warned against the misuse of Nuvigil.
“Nuline was initially marketed as a natural anti-inflammatory agent and it’s marketed to be sold as a dietary supplement to help manage chronic pain,” the CDC said in a press release.
“However, the evidence in the public domain indicates that Nulini may be misbranded, misbranded as a pain reliever, and misbranded in other ways, particularly as a drug to treat chronic pain.”
The FDA also said that Nuvigor and Nexium are still subject to “expectant use” regulations.
“Although these drugs are effective and can be used for chronic pain, they are not approved for use in people who are at high risk of serious adverse reactions from them,” the FDA said.
“Nulines use of Nulfilide, a potentially carcinogenic agent, in the form of a non-steroidal anti-inflammatory agent may result in a higher risk of adverse reactions in people at high or increased risk of developing cancer.”
Nulinix’s website says its product is “designed to reduce inflammation, reduce pain, and reduce swelling.”
Nuvigil, Nulin’s other drug, was approved by the FDA in 2015 and is now approved in the European Union.
Nuvigs main ingredient is methotrexate, an opioid antagonist.
While Nulix and Nexigil are still banned from sale in the United States, Nuzix is still being marketed as an alternative to the prescription drug, Percocet.
The drug is also used in a number of countries, including the U, France, the Netherlands, Germany, and South Africa.
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