Opioid Addiction, Withdrawal Cures Being Marketed Draw Warning Letters from FDA, FTC

Federal regulators issued warning letters this week to a number of companies that are marketing products they indicate will help combat opioid addiction and withdrawal, which are not approved and may pose a threat to unwitting consumers who are in need of opioid addiction treatment. 

Twelve warning letters were issued jointly by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), according to a January 24 FDA news release. The letters accuse the companies of making unsubstantiated claims and marketing unapproved products for treatment of a serious health problem.

The FDA warned that scams such as these pose a serious risk to consumers because the products have not been proven effective or safe. Additionally, if customers use these products, it may keep them from getting truly effective and appropriate treatment or help for their opioid addiction.

The warnings also indicate selling unapproved products to treat opioid addiction is a violation of the Federal Food, Drug, and Cosmetic Act. Similarly, making claims concerning therapeutic qualities of a product that are unproven is a violation of the Federal Trade Commission Act concerning deceptive advertising.

Opioid drug overdoses have reached an all time high in the U.S. over the past few decades. Despite headway in reducing abuse of narcotic painkillers, overdose deaths continue to increase. In fact, opioid deaths each year now outnumber breast cancer fatalities.

The agencies warn opioid addiction is a serious health problem that affects millions of Americans. The epidemic often stems from unnecessary prescriptions. Thus, people who struggle with opioid addiction need proven treatments to help them toward their goal of recovery. While steps have been taken, including improved prescribing oversight and improved dosing and duration among some doctors, the crisis has reached epidemic proportions.

The new warnings were issued to 11 companies for 12 products, including:  Opiate Freedom 5-Pack, Mitadone, CalmSupport, TaperAid & TaperAid Complete, Natracet, Opiate Detox Pro, Withdrawal Support, Soothedrawal, Nofeel, GUNA-ADDICT 1, and AddictaPlex.

The letters indicate that the companies made sensational, unproven claims about their products, such as: “#1 Selling Opiate Withdrawal Brand,” “Safe and effective [. . .] to ease many physical symptoms of opiate withdrawal,” and “Break the pain killer habit.”

The companies are required to respond to the warnings within 15 working days to detail the actions they plan to take to address the violations. Failure to correct violations may result in law enforcement action such as seizure or injunction.

Reducing the number of Americans addicted to opioids is one of the agency’s top priorities, FDA officials say. That includes promoting treatments and therapies for addiction which are proven to be effective, not simply advertised to be effective. Allowing unsafe or ineffective treatments to be sold on the market delays a users path to recovery.

“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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”