The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have turned their attention to companies illegally marketing products to help with opioid withdrawal and addiction. The agencies sent letters to the marketers and distributors of the products with warnings about their product claims. According to the 2016 National Survey on Drug Use and Health, nearly 12 million Americans over 12 years of age misused opioids in the year leading up to the report. Furthermore, it reported that more than two million people in the United States have an opioid use disorder.
A total of 11 companies were issued joint warning letters from both the FDA and FTC, with a further four contacted by the FTC. Among the products targeted by the agencies, and which consumers should be wary of, are the Opiate Freedom 5-Pack, Mitadone, CalmSupport, TaperAid, Opiate Detox Pro, Soothedrawal, AddictaPlex, Gun-Addict 1, and Natracet.
In recent months, the FDA has taken a number of steps to tackle the opioid epidemic, including changing the indication of cough & cold medication containing opioids to exclude pediatric use. In November 2017, it approved the NSS-2 Bridge, the first device approved reducing the symptoms of opioid withdrawal and the same month it also approved the first once-monthly buprenorphine injection as a treatment option for moderate to severe opioid use disorder.
Other measures it has taken to address opioid addiction include raising awareness of the availability of opioid pain medication with abuse deterrent formulations (ADFs) and smoothing the regulatory pathways for more of these medications in the future. There are currently ten different drugs that fall into this category, including Hysingla ER (hydrocodone) and Xtampza ER (oxycodone). In some cases, alternatives to opioid pain relievers may be a better treatment option.
Commenting on the latest warnings to companies marketing unapproved opioid withdrawal products, FDA commissioner Scott Gottlieb, MD, said: "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." He added that the FDA and FTC would continue working together to crack down on unapproved products marketed as treatments for opioid addiction and withdrawal.
If you or someone close to you is struggling with opioid dependence or abuse, speak to a physician or drug counsellor for help and advice on the best way to come off opioids safely and effectively. Alternatively contact the Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline on 1-800-662-HELP (4357) or click here for an online treatment locator.
