CSPI to FDA and FTC: Crack Down on Supplements Marketed for Opioid Withdrawal

With millions of Americans addicted to heroin, oxycodone and other opioids, various products marketed as dietary supplements have emerged in the U.S. market to help addicts wean off the potent—and potentially fatal—drugs.

Federal regulators are concerned the products could dissuade addicts from taking effective, safe medicines, prolonging their addiction, possibly further endangering their health and making them additional victims of fraud.

Last week, a watchdog group urged FDA and the Federal Trade Commission (Commission) to crack down on eight dietary supplements marketed as opioid withdrawal aids. The Center for Science in the Public Interest (CSPI) emailed the companies, requesting scientific studies to establish their products were more effective than a placebo.

The responses, the consumer advocacy group advised federal regulators, “were often flip, cursory, riddled with pseudo-scientific jargon, or frighteningly ill-informed."

“These ineffective products are like salt in the wound for patients struggling with addiction to opioid pain medicine or with symptoms of withdrawal," said CSPI President Peter G. Lurie, M.D., in a press release.

Lurie, CSPI noted, co-led the Health and Human Services (HHS) prescription drug working group while he was an associate commissioner at FDA.

“These unscrupulous companies are exploiting the ongoing opioid epidemic, diverting desperate patients from proven effective treatments to unproven ones, all in the service of their bottom lines," Lurie said.

Drug overdoses killed around 64,000 people in the United States in 2016, a rise of more than 22 percent over drug deaths recorded the previous year, The New York Times reported in September. And of the lethal drug overdoses in 2015, addiction to opioids was driving the epidemic, with more than 20,000 overdose deaths related to prescription pain relievers, according to the American Society of Addiction Medicine.

The opioid withdrawal aids identified by CSPI are largely comprised of herbal ingredients, minerals and vitamins, the watchdog group said. The cost of the products range from US$20 to $182 per month.

Asked for evidence to substantiate its claims, the marketer of “Mitadone Anti Opiate Aid Plus" purportedly told CSPI: “We don’t really have any scientific studies as such currently, it takes years & millions of dollars to do that however the product has been working to help ease symptoms for most people that have taken it along with their program, all we can say is proof is in the pudding."

Founder of Herbal Product Responds to Allegations

Richie Ogulnick, the founder of TaperAid, one of the products examined by CSPI, denied he was exploiting consumers.

“There is plenty of evidence that the herbs and vitamins used in opiate-detox supplements like ours (and others) ameliorate the symptoms associated with opiate withdrawal,” he said in an email to INSIDER. “Our particular product is based on an herbal formula used in Vietnam that has helped tens of thousands of heroin and opium addicts.”

He contended the government of Vietnam supports use of the Vietnamese formula, called Heantos, and that the United Nations Development Programme concluded it was effective after studying it.

“Many of these people say that TaperAid has changed their lives and given them freedom from opiates for the first time in years,” Ogulnick said. “People have literally called us crying and thanked us for this.”

He said the handful of individuals who did not experience effects from the products were provided a full refund.

“We are not interested in overstating the effects of TaperAid,” Ogulnick said. “If it helps people, that's what matters.”

Ogulnick argued the FDA-approved treatments for addiction to opioids are detrimental.

"While they do ameliorate withdrawal symptoms, they are a prison sentence of their own," he said. "These drugs are even more addictive than heroin; they are brutal on people's long-term health, and a person's chance of weaning off them is negligible."

Medicus Holistic Alternatives LLC, which sells another product mentioned in CSPI's investigation (Natracet), denied "any and all allegations that appear or are inferred in the CSPI press release."

"Our content has always displayed an FDA disclaimer, been free of claims and contained multiple references stating ... Natracet is not a 'magic bullet' or cure-all and that professional help should be the necessary first course of action," the company said in an email to INSIDER.

The website includes a disclaimer that its statements haven't been evaluated by FDA, and that the product isn't intended to diagnose, treat, cure or prevent any disease.

The company also referenced a statement on its website that in order to be compliant with FTC guidelines, it makes no implied or express claims concerning the efficacy of its herbal dietary supplements.

None of the other companies whose products were subject to CSPI’s investigation immediately responded to INSIDER’s requests for comment.

According to CSPI, one of the products (“Midatrexone Opiate Withdrawal Aid") had been sold on Amazon and eBay. The consumer advocacy group reported the product no longer appears to be sold on Amazon, but according to an addendum outlining CSPI’s research, the supplement was still available on eBay as of Nov. 29.

Neither Amazon nor eBay immediately responded to a request for comment, and the seller of the product could not be immediately reached for comment.

FDA, FTC Comment on Opioid Products

CSPI requested FDA bar the sale of the products as unapproved and/or misbranded drugs. Separately, the Commission was asked to file charges against the manufacturers for claims that were allegedly unsubstantiated and obtain refunds for consumers.

“The Commission remains concerned about products making false promises to help treat those addicted to opioids, as demonstrated by the law enforcement actions we’ve taken in this area," an agency spokesperson said in an emailed statement. “We welcome the CSPI submission and will review it carefully as we consider next steps."

CSPI’s letter was addressed to FTC Acting Chairman Maureen Ohlhausen.

FDA, which reviews pharmaceutical drugs for efficacy and safety, has reported concerns over the use of alternative treatments for opioids, including dietary supplements containing kratom. In November, FDA Commissioner Scott Gottlieb, M.D., suggested the use of kratom—a botanical from Southeast Asia—could exacerbate the opioid epidemic and pose safety concerns. CSPI’s research excluded supplements containing kratom.

CSPI wrote to Gottlieb and Steven Tave, FDA’s director of the Office of Dietary Supplement Programs.

“FDA believes strongly that people who are addicted to opioids should have access to safe and effective treatments for their addiction," an FDA spokesperson said in an emailed statement. “Unfortunately, unscrupulous vendors are trying to capitalize on the opioid epidemic by illegally marketing products as dietary supplements, with unproven claims about their ability to help in the treatment of opioid use disorder, or as all-natural alternatives to prescription opioids. Health fraud scams like these can pose serious health risks, and the FDA cautions the public to instead seek out medication-assisted treatments that have met the scientific rigor of FDA approval."

FDA referenced its recent warning on kratom as evidence that the agency will continue to act when it learns of products that have not been proven effective or safe to treat serious medical conditions, but claim to achieve such benefits.

“We appreciate CSPI bringing these products to our attention and we encourage any concerned organizations and individuals to report suspicious products to the FDA," the FDA spokesperson said.