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FDA warns marketer of illegal tianeptine supplement about unapproved drug treatment claims.

Public health officials are warning consumers that some products marketed to treat opioid addiction may do more harm than good. Supplements containing the unapproved antidepressant tianeptine (marketed as Coaxil or Stablon) carry potential side effects that the CDC says can “mimic opioid toxicity and withdrawal.”

The FDA recently took action against the marketer of one of these illegal tianeptine supplements, Vicaine, noting in a warning letter to MA Labs the following Only drugs can be marketed as having the ability to diagnose, cure, treat, prevent or mitigate a disease, and the only way for a product to gain legit drug status is by getting FDA approval, which means any product that doesn’t get FDA approval can’t say it has the ability to diagnose, cure, treat, prevent or mitigate a disease.:

  • “Prohedonic Opioid-Stimulant Complex”
  • “Produces both Stimulatory and Opiate-like Effects”
  • “Induces Euphoria…”

The agency also sent a letter to the marketer of three other illegal tianeptine supplements — Tianaa Red, Tianaa White and Tianaa Green — for similar claims.

In a press release, the FDA said these products may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery, and put them at greater risk of death.

Remember, readers, marketing supplements as having the ability to treat, cure, alleviate the symptoms of, or prevent developing diseases and disorders (in this case, opioid use disorder) is simply not permitted by law. If a supplement really could do all that, then it would be a drug subject to rigorous study and testing to gain FDA approval.

Find more of our coverage on purported opiate withdrawal treatments here.

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