FTC challenges claims for opiate withdrawal products

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Is there a family or a workplace that hasn’t been touched in some way by the public health crisis of opiate addiction? It’s no wonder that advertisers are offering purported treatments. But an FTC settlement with a Texas-based business stands for the fundamental principle that companies’ health claims need the support of sound science.

The products at issue were Withdrawal Ease and Recovery Ease – and the names were the first of many representations that Catlin Enterprises made about what it pitched as “The Leader in Home Opiate Detox Since 2009.” Withdrawal Ease and Recovery Ease included daytime formulations of vitamins, minerals, and herbs. The nighttime versions had different herbal blends minus the vitamins and minerals. Among the ingredients were passionflower, milk thistle, turmeric, ginger, peppermint, pomegranate, and horseradish.

For people dependent on opiates, a major hurdle to recovery is withdrawal. The defendants positioned their products as a solution to that problem:

  • “Withdrawal-Ease customers have reported a significant decrease in the intensity of their withdrawal symptoms after using the system and following the instructions in our Opiate Withdrawal Survival Guide.”
  • “The brain is where many of your withdrawal symptoms originate. Withdrawal-Ease targets specific brain functions in order to help ‘reboot’ your brain’s natural chemical balance and function.”
  • “It’s the most effective and advanced natural treatment for opiate withdrawal and detox that you can buy.”

The defendants didn’t end there. In addition to making claims through consumer testimonials, they said the ingredients in Withdrawal Ease had been “proven efficacious under rigorous clinical trials” and specifically mentioned “Clinical Study Abstracts from The National Institutes of Health (NIH)” as proof of efficacy.

In addition, for people on the “road to recovery from opiate dependency,” the defendants touted Recovery Ease as an effective treatment for Post Acute Withdrawal Symptoms (PAWS), a serious medical condition sometimes reported after initial withdrawal symptoms have subsided.

Based on a review of the company’s so-called substantiation, the FTC charged that Catlin Enterprises and CEO George Catlin made deceptive claims about the products’ ability to significantly alleviate opiate withdrawal symptoms, increase the likelihood of overcoming dependency, or alleviate PAWS. What about the claim that clinical studies showed that Withdrawal Ease was effective?  False, alleged the FTC.

Under the terms of the proposed settlement, the defendants will need human clinical testing to support a host of addiction-related and disease treatment claims. Other health representations will need competent and reliable scientific evidence. Misleading claims about tests or studies are prohibited, too.

The proposed order imposes a $6.6 million judgment, which will be suspended based on the defendants’ inability to pay. There also is a clause that makes the full amount due if it turns out the defendants made any material misrepresentations or omissions in their financial statements.

This is the FTC’s second case challenging deceptive claims aimed at people struggling with opiate addiction. (The Sunrise Nutraceuticals settlement was the first.)

The topline takeway: Marketers that offer unsubstantiated answers to serious health problems can expect to hear from the FTC.
 

Comments

I saw a commercial for I believe "Refief24". Cannot find the site now, but I read the ingredients, and it was just vitamins. The same should apply to the OIC pharmaceutical commercials, that capitalize on this epidemic. I suffer from chronic pain, and my state has "all-out" declared war on my medication, which is ironically a medication used to treat addiction. I suspect political/financial gain motives or PROP Lobbyist interests, so it absolutely infuriates me when anyone or a company tries to capitalize on an epidemic.

I also see numerous claims for "pain relief" medication but it would help if they were a bit more honest and state exactly what kind of pain they're talking about. I was so desperate I almost ordered this "special pain cream" that according to numerous testimonies they applied it directly to the spot that was so painful, just a couple of drops of oil, and they swore to God they've used it for years; couldn't do without it. The problem is they don't realize what real pain is. My pain is severe, an 8-9/10, and I thought that would be great to relieve the devastating pain I have all day, every day. I knew I was wasting my time when I was reading the article, but it was from a very reputable company so I gave them the benefit of the doubt, wasted my time and clicked off. I just wish this kind of advertising was shut down as I'm already on a pain regimen but of course, they've lowered it to the point I'm starting to fear what's ahead for me.

I can definitely relate to the problems the “war on opiates” has created for people with legitimate chronic pain. Citing the dramatic increases in opiate use and overdose, the state of NJ has passed and continues to seek legislation that purports to address the problem. However, it seems to me that legislation making it more difficult for doctors to prescribe opiates, limiting the manufacture and supply of opiates, and imposing potential responsibility on pharmacists the fill opiate prescriptions and similar acts does little to address the problem. Much of what I have read about abuse and overdose comes from the flood of illegal opiates in NJ, mostly fentanyl and street drugs containing fentanyl. Legislation aimed at sources of pharmaceutical opiates does nothing to curb the problem of street drugs. Granted it may help to reduce diversion of prescription opiates, However, the supply of diverted prescription drugs on the black market is small compared to street drugs. Moreover, overdose cases seem largely due to the varying strength of street drugs and the resulting inability of the user to determine a safe dose. Diverted prescription drugs do not present this problem. The ineffectiveness of this legislation seems supported by the statistics that continue to rise in spite of it. The subject of the difficulties created for chronic pain sufferers has not been quantified and is never discussed. Also, because the opiate crisis publicity never mentions the clinical difference between drug addiction and drug dependancy, chronic pain sufferers have become stigmatized as addicts. The result? Nobody cares about us, especially the politicians who continue to advocate this legislation because it creates the perception that they are doing something to address the problem when they really aren’t.

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