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FDA, FTC warn companies selling unapproved opioid cessation products
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The FDA and the Federal Trade Commission sent joint warning letters to 11 companies for marketing and selling 12 illegal and unapproved products that claim to treat opioid addiction and withdrawal.
“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” Scott Gottlieb, MD, commissioner of the FDA, said in a press release. “People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims.”
These 12 opioid cessation products have not been proven safe or effective, and may pose serious health risks, prevent patients from seeking appropriate therapies that have been FDA-approved, delay recovery and increase their risk for death, according to the FDA.
Combatting the opioid crisis and providing effective treatments to the more than 2 million individuals with an opioid use disorder in the United States is a high priority of President Donald J. Trump and his administration. To aid in this fight, the FDA is making strides to help those with opioid addiction access safe and effective medication assisted treatments and to eliminate the stigma related to these therapies. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), treatment that includes FDA-approved medications can reduce the risk of death by 50%.
“Opioid addiction is a serious health epidemic that affects millions of Americans,” Maureen K. Ohlhausen, acting chairman of the FTC, said in the release. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments. We will continue to work together with the FDA to address this important issue.”
The companies warned include Opiate Freedom Center ( for selling Opiate Freedom 5-Pack), U4Life LLC (Mitadone); CalmSupport LLC (CalmSupport), TaperAid (TaperAid and TaperAid Complete), Medicus Holistic Alternatives LLC (Natracet), NutraCore Health Products LLC (Opiate Detox Pro), Healthy Healing LLC (Withdrawal Support), Soothedrawal Inc. (Soothedrawal), Choice Detox Center Inc. (Nofeel), GUNA Inc. (GUNA-ADDICT 1) and King Bio Inc. (AddictaPlex).
These companies make unsubstantiated and illegal claims that their products cure, treat or prevent opioid addiction, according to the FDA. They are expected to inform the FDA and FTC about the actions that they will take to address the concerns raised by the agencies within 15 working days. Failure to do so may result in seizure or injunction, according to the release.
The AMA applauded the FDA and FTC’s action to crackdown on misleading opioid treatments.
“This aggressive and timely action will save lives,” Patrice A. Harris, MD, chair of the AMA Opioid Task Force, said in a press release. “Our patients with substance use disorder need safe and effective treatment, not sham treatments that fleece them and prey on the stigma surrounding this disorder.”
“Physicians have several tools to help patients overcome an opioid addiction,” he added. “If patients are drawn to unapproved treatments, they face delays — and even death — by the time they realize the ineffectiveness of these heavily promoted ‘treatments.’”
He continued, “It should go without saying that people with substance use disorders are vulnerable and easily victimized by promises of a quick and painless recovery. Our patients have enough obstacles in accessing treatment, whether it is prior authorization, insurance issues or a shortage of treatment options. Thanks to the FDA and FTC action, they have one fewer obstacle.”