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The FDA Is Going After Fake Opioid Addiction Cures

January 30th, 2018

The FDA Is Going After Fake Opioid Addiction Cures.

January 30, 2018

Ed Cara – Science writer at Gizmodo and pug aficionado elsewhere  Posts

Whenever tragedy rears its head, it’s an inescapable fact that grifters will come around looking for their next victims. The opioid crisis is sadly no exception. Companies with  fake opioid addiction cures, marketing so-called natural addiction cures have sprouted up to take advantage of struggling people. Now the federal government—as part of its professed, if inconsistent, pledge to remedy the crisis—is trying to root out some of these frauds.

On Wednesday, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) announced they had jointly sent warning letters to 11 companies they say are unlawfully labeling and marketing treatments claimed to treat opioid addiction; the FTC sent additional warnings to four other companies. The companies have been given 15 days to respond back with steps they would take to modify the branding and advertising of their products or face a further crackdown.

“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,” FDA chief Scott Gottlieb said in a statement. “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.”

The targeted products claim to provide a natural alternative or booster to legitimate drugs that reduce craving and withdrawal symptoms (“Soothedrawal, “Nofeel,” “Calmsupport,”), with listed ingredients like chamomile to relieve stress or amur cork bark to lower blood pressure. Still others go one step further with names that look similar to real medications, like methadone (“Mitadone”, “Naturcet”).

Some of the taglines include: “#1 Selling Opiate Withdrawal Brand,” “Break the pain killer habit,” and “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.” And many of the websites, Facebook pages, or YouTube videos selling the products even include supposed personal testimonials from recovered addicts or their family members.

 “My son started a 21-day taper process that included the Soothedrawal Daytime and Nighttime formulas… By incorporating the Daytime and Nighttime formulas into the tapering process, my son found that the withdrawal symptoms were reduced dramatically,” read one testimonial labeled “A Mother’s Story.”

None of the products listed in the announcement seem to include kratom (though some products claim to have a proprietary formula), a controversial herb that’s been used recreationally to achieve an euphoric high as well as to help treat pain and reduce opioid withdrawal symptoms. But last November, the FDA issued a skeptical warning for people to stay away from kratom for the time being, while advocating that it go through a formal drug review process to test its professed claims. In the meantime, though, the FDA has issued warnings against products containing kratom and continues to confiscate foreign shipments of it from entering the U.S.

Gottlieb, a Trump appointee who took the reins at the FDA last May, has been proactive in targeting quack companies. The agency has taken similar actions against homeopathic products (largely unregulated remedies that are basically just sugar pills) and stem-cell clinics selling bogus cures.

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