Opioid cessation products under attack by FTC & FDA

Together with the FDA, the FTC issued joint warning letters to 11 marketers and producers of allegedly unapproved opioid cessation products.  The letters allege that the companies used online platforms to make unsubstantiated claims about their products’ ability to treat opioid addiction and withdrawal.  Letters were sent to:

  1. Opiate Freedom Center (Opiate Freedom 5-Pack)
  2. U4Life, LLC (Mitadone)
  3. CalmSupport, LLC (CalmSupport)
  4. TaperAid (TaperAid and TaperAid Complete)
  5. Medicus Holistic Alternatives LLC (Natracet)
  6. NutraCore Health Products, LLC (Opiate Detox Pro)
  7. Healthy Healing, LLC (Withdrawal Support)
  8. Soothedrawal Inc. (Soothedrawal)
  9. Choice Detox Center, Inc (Nofeel)
  10. GUNA, Inc (GUNA-ADDICT 1)
  11. King Bio, Inc. (AddictaPlex)

The CDC estimates that over 2 million people abused or were dependent on prescription opioids in 2016, and tens of thousands of people die from opioid overdoses annually.  The need for effective treatments is clear, but the FTC and FDA have targeted specific companies they believe misrepresented their products.

FTC crackdown on opioid cessation products: 3 things to know

  • In its warning letters, the FDA is mainly concerned with claims that the products marketed by these companies are not effective treatments for opioid addiction or withdrawal symptoms, despite being marketed as such.
  • The letters call for responses from the companies within 15 business days.  Responses must include details on how the companies plan to address the concerns raised in the warning letters.
  • A so-called fact sheet was included in the FTC press release with help from the Department of Health and Human Services to direct consumers with opioid addiction needs to certain companies and discredits the use of herbs or “kratom” supplements.

What specific claims made the FTC see red?

Allegedly unproven claims that were identified in the letters included:

  • “#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 letters even referenced specific enforcement actions taken in the past against similar companies.  Opioid cessation product companies have been put on notice and should review these cases and address their marketing practices in light of these actions.