The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products.
The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is a violation of the Federal Food, Drug and Cosmetic Act and also violates the Federal Trade Commission Act, according to the FDA and FTC.
“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” FDA Commissioner Dr. Scott Gottlieb said in prepared remarks.
“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.”
“Opioid addiction is a serious health epidemic that affects millions of Americans,” acting FTC chairman Maureen Ohlhausen added. “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 posted joint warning letters to 11 companies – Opiate Freedom Center, U4Life, CalmSupport, TaperAid, Medicus Holistic Alternatives, NutraCore Health Products, Healthy Healing, Soothedrawal, Choice Detox Center, Guna and King Bio. The FTC sent four other warning letters to different marketers of opioid cessation products.
All of the companies use online platforms and have made illegal claims about their products, according to the FDA and FTC, like “#1 selling opiate withdrawal brand” and “safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.”
One company wrote on its site, “imagine a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms.” Another said “break the pain killer habit.”
The FDA and FTC warned the companies that it needs responses within 15 working days and that failure to correct violations could result in actions including seizure or injunction.