Opioid cessation products come under federal scrutiny

Warning letters were sent to the marketers and distributors of 11 opioid cessation products Wednesday for illegally marketing products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal.

“Opioid addiction is a serious health epidemic that affects millions of Americans,” said Maureen K. Ohlhausen, acting chair of the Federal Trade Commission. “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.”

These products haven’t been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies, Ohlhausen said.

The FTC, along with Substance Abuse and Mental Health Services Administration, issued a fact sheet to help consumers get real help for opioid addiction or withdrawal, while avoiding products that promise but don’t deliver help. It has tips that for people considering help for opioid addiction or withdrawal. Patients receiving FDA-approved medication-assisted treatment cut their risk of death in half, according to SAMHSA.

The 11 companies receiving warnings are: Opiate Freedom Center for Opiate Freedom 5-Pack; U4Life for Mitadone; CalmSupport for CalmSupport; TaperAid for TaperAid & TaperAid Complete; Medicus Holistic Alternatives for Natracet; NutraCore Health Products for Opiate Detox Pro; Healthy Healing for Withdrawal Support; Soothedrawal Inc. for Soothedrawal; Choice Detox Center Inc. for Nofeel; GUNA Inc. for GUNA-ADDICT 1; and King Bio Inc. for AddictaPlex.

The FTC sent four additional warning letters to other marketers of opioid cessation products.

All of the companies use online platforms to make unproven claims about their products' ability to cure, treat, or prevent a disease, she said. Examples of claims made include:

• “#1 Selling Opiate Withdrawal Brand”
• “Imagine a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms.”
• “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.”
• “Break the pain killer habit.”
• “Relieve Your Symptoms…addiction, withdrawal, cravings.”

The FTC and Food and Drug Administration have asked the companies to reply in 15 days. The companies are to tell the agencies of the actions taken to address their concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.

Health care professionals and consumers can report any adverse reactions related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or sent by fax to 800-FDA-0178.