FDA, FTC Crackdown on Marketing Unapproved Opioid Addiction, Withdrawal Products

The FDA and Federal Trade Commission (FTC) sent joint warning letters to the marketers and distributors of 12 opioid cessation products for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.

Selling these unapproved products with claims that they can treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act, the letter stated. Making unsubstantiated therapeutic claims is also a violation of the Federal Trade Commission Act, which prohibits deceptive advertising.

“Using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery and put them at greater risk of death,” wrote the FDA in a press statement, adding that patients receiving FDA-approved medication-assisted treatment cut their risk for death in half, according to the Substance Abuse and Mental Health Services Administration (SAMHSA).

(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).

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

All of the companies use online platforms to make illegal claims about their products’ ability to cure, treat or prevent a disease. Examples of claims made include: “#1 Selling Opiate Withdrawal Brand”; “Imagine a life without the irritability, cravings, restlessness, excitability, exhaustion anddiscomfort”; and “Break the pain killer habit.”

The FTC, in coordination with SAMHSA of the Department of Health and Human Services, issued a fact sheet to help consumers get real help for opioid addiction or withdrawal, while avoiding products that promise but do not deliver help. The fact sheet has tips that consumers and health practitioners alike can share with those considering help for opioid addiction or withdrawal.

Health care professionals and consumers are encouraged to report any adverse events 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 via fax to (800) FDA-0178.