The FDA has released a joint warning with the FTC to 4 marketers and 11 distributors of unapproved opioid addiction therapies.
Scott Gottlieb, MD
The US Food and Drug Administration (FDA) released joint statements with the Federal Trade Commission (FTC) warning 4 marketers and 11 distributors of 12 opioid cessation products, due to the illegal marketing of unapproved therapies that claimed to be able 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,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “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. We’ll continue to work with our partners at the FTC to step up our actions against unapproved products being marketed for the treatment of opioid addiction and withdrawal.”
The companies distributing these products that were warned were:
The administration warned that fraudulent health scams can result in serious consequences for the community, cautioning that while these products claim to treat opioid addiction, they have not demonstrated safety nor efficacy, and could result in patients not seeking proper treatment.
Some of the claims made included:
Making such unconfirmed claims is a violation of both the Federal Trade Commission Act and the Federal Food, Drug, and Cosmetic Act.
“Opioid addiction is a serious health epidemic that affects millions of Americans,” acting FTC Chairman Maureen K. Ohlhausen, said. “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 FDA and FTC have requested responses within 15 business days, stating that failure to correct the violations will result in legal action, such as seizure of product or injunction.
“This aggressive and timely action will save lives. 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," Patrice A. Harris, MD, the chair of the American Medical Association's Opioid Task Force, said in a statement. "Physicians have several tools to help patients overcome an opioid addiction. 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.' 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.”
Additionally, in coordination with the Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services (HHS), the FTC released an opioid fact sheet, which details ways patients can get real, approved therapeutic help for addiction or withdrawal.
The FDA requests that health care professionals and consumers report any adverse events related to the mentioned product to the administration’s MedWatch adverse event program. The form can be completed here and submitted online, or can be faxed to 800-FDA-0178.
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