November 26, 2019
“The FDA will continue to take action against companies that stand to profit from marketing violative products, especially when it involves one of the most important health crises of our time. Opioid withdrawal is a serious health condition, and we want companies to know that they cannot make claims that products can cure or treat opioid withdrawal symptoms unless the product is approved by the FDA for that purpose. When products are allowed to make unsubstantiated medical claims, consumers might forgo or delay FDA-approved treatments and take an alternative product instead,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We need manufacturers and distributors to understand that they are responsible for evaluating their products prior to marketing, including the labeling, to ensure that they meet all federal requirements. We’ll continue to take actions, like this one today, to protect the public health.”
Today, the U.S. Food and Drug Administration issued a warning letter to EPH Technologies, Inc. of New Mexico for marketing and selling unapproved and misbranded drugs, including Detoxoplex as a treatment for opioid withdrawal symptoms. The company is also marketing several other products with unproven claims that they can treat medical conditions, including migraines and dizziness. Because these products have not been demonstrated to be safe and effective for these conditions, they are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. The FDA is issuing this warning to protect consumers from products that, without approval by the FDA, are making claims to diagnose, mitigate, prevent, treat or cure medical conditions.
The FDA continues to encourage the development of additional safe and effective products to treat opioid withdrawal symptoms. In May 2018, the FDA approved Lucemyra (lofexidine hydrochloride), the first non-opioid treatment for the mitigation of withdrawal symptoms associated with abrupt discontinuation of opioids. In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is intended to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid. In patients with opioid use disorder (OUD), withdrawal is typically managed by substitution of another opioid medicine, followed by gradual reduction or transition to maintenance therapy with FDA-approved medication-assisted treatment drugs such as methadone, buprenorphine or naltrexone; or by various medications aimed at specific symptoms, such as over-the-counter remedies for upset stomach or aches and pains.
The FDA remains committed to using federal authorities to assist those currently addicted to opioids, while taking steps to prevent new cases of addiction.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco product.