As the nation grapples with an opioid epidemic that is killing tens of thousands of Americans each year, five trade associations representing dietary supplement companies have issued an advisory discouraging the marketing of supplements to treat addiction to opioids and recommending addicts contact a healthcare professional immediately.
“We are unaware … of published scientific research that supports the use of any dietary supplement to treat opioid use disorder or to mitigate opioid withdrawal symptoms," the five supplement trade associations observed in a Dec. 20 press release, announcing the advisory. The groups also said dietary supplements are not permitted under federal law to make claims that their products cure or treat any diseases, including opioid addiction.
The advisory was announced after a consumer advocacy group urged federal regulators in December to crack down on eight dietary supplements marketed as opioid withdrawal aids. In response to the investigation by the Center for Science in the Public Interest (CSPI), Sens. Richard Blumenthal (D-Connecticut) and Edward Markey (D-Massachusetts) wrote to FDA and the Federal Trade Commission (FTC), urging the agencies to hold dietary supplement companies accountable for deceptive marketing practices and the sale of products targeting substance abuse disorders.
“Given the size and scope of this epidemic and the resulting demand for treatment options, it is unconscionable that many Americans seeking relief for themselves or for their struggling loved ones have been targeted by insidious scammers looking to profit from their recovery efforts by marketing fraudulent dietary supplements to them," the senators said in their letter to regulators.
Representatives of the American Herbal Products Association (AHPA) and Consumer Healthcare Products Association (CHPA)—two of the five trade groups that issued the advisory—said in interviews they had no knowledge that their respective members sold any products to treat opioid addiction.
However, Jay Sirois, senior director of regulatory and scientific affairs with CHPA, suggested it was important to make consumers aware of individuals “acting unscrupulously and preying on a vulnerable population.
“Again, the responsible members of the industry are pretty much united in support of keeping these products off the market," he said in a phone interview.
Michael McGuffin, president of AHPA, said he wasn’t aware that any of his trade organization’s members market products to treat addiction to opioids.
“If we saw that, we would say the same thing to them individually that we’ve just said to the marketplace generally: ... the law doesn’t allow these kinds of claims," he said in a phone interview.
He agreed that the trade groups issued the policy to make a statement to the broader market and perhaps “contextualize that the companies that belong to trade associations aren’t the problem companies."
McGuffin also emphasized it’s important to clearly convey that responsible members of the industry are committed to regulatory compliance.
The five trade groups endorsed the following advisory for consumers, manufacturers, marketers and retailers of dietary supplements.
• Retailers of dietary supplements, including online retail portals, should refuse to stock or sell any dietary supplements that claim to treat or cure opioid use disorder or addiction or claim to reduce the symptoms of opioid withdrawal.
• Manufacturers, marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for these conditions.
• Anyone in need of treatment for opioid abuse or addiction should contact a healthcare professional immediately. The National Institute on Drug Abuse has information on currently available effective medical treatments.
“Many dietary supplements have much to offer in terms of enhancing general well-being, providing essential nutrients and promoting good nutrition," the trade groups added.
However, they said only public health authorities or qualified healthcare professionals should recommend therapies for the treatment of opioid use disorder or addiction.
Laura MacCleery, director of regulatory affairs with CSPI, commended the trade associations for issuing the advisory.
“They obviously share legitimate concerns that consumers are being misled by these types of dietary supplements," she said in a brief interview with INSIDER. “And I think given the limited resources that FDA has for enforcement, having the trade associations take a clear position and represent their views among their members in terms of what’s permissible behavior is really helpful."
Regulatory agencies that police dietary supplements also responded to the trade associations’ advisory.
“The FTC is concerned about the deceptive marketing of unproven treatments for opioid addiction and withdrawal symptoms, and is pleased that the industry trade associations are helping to spread the word that supplements should not be marketed for those purposes," an FTC spokesperson said in an emailed statement.
Just one day after the trade groups announced their advisory, the Centers for Disease Control and Prevention (CDC) published a report that highlighted the seriousness of the nation’s growing opioid epidemic. Nearly 64,000 people died from drug overdoses in 2016 in the United States, CDC reported.
According to Trust for America’s Health (TFAH), a non-partisan organization, about two-thirds of the deaths were related to opioids, an increase largely fueled by deaths from fentanyl and other synthetic opioids.
John Auerbach, president and CEO of TFAH, described the growing number of deaths from opioids as “downright frightening—and it’s getting worse.
“Every community has been impacted by this crisis and it’s getting lots of headlines, yet we’re not making the investments or taking the actions needed at anywhere near the level needed to turn the tide," he said in a statement.
FDA, meanwhile, has identified activity to exploit the growing epidemic through the marketing of products that claim to be dietary supplements.
“The FDA believes strongly that people who are addicted to opioids should have access to safe and effective treatments for their addiction," Corinne Newhart, an FDA spokeswoman, 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."
Added Newhart: “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."
Kratom and Opioid Withdrawal
FDA’s top official, Scott Gottlieb, M.D., highlighted the agency’s concerns in an advisory last month about the health risks associated with kratom. The botanical is being used and marketed to treat conditions like anxiety, depression and pain, and it’s often taken for recreational use, according to Gottlieb.
“At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning," Gottlieb said in his Nov. 14 statement. “It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms."
The supplement trade groups did not mention kratom in their own recent advisory.
“Our position on kratom is it’s an herb or other botanical, which means that it can be sold as an ingredient in a dietary supplement," McGuffin of AHPA said, adding a few caveats.
He acknowledged FDA’s position on kratom has complicated the issues. According to FDA, kratom is a new dietary ingredient (NDI) subject to a safety-related notification to FDA under federal law. FDA also has raised concerns about the safety profile of kratom.
Gottlieb noted calls to U.S. poison control centers regarding the botanical have skyrocketed 10-fold from 2010 to 2015, and the agency is aware of reports of 36 deaths associated with the use of products containing kratom.
The kratom industry has pushed back against FDA's concerns that the botanical is a threat to public health. Following a review of an adverse event reporting database maintained by FDA, the American Kratom Association (AKA) disputed that any deaths from 2011 to 2017 were solely attributable to kratom.
“Kratom is an alternative to opioids, not a gateway to opioid abuse," Dave Herman, chair of the AKA’s board, said in a statement last month. “The American Kratom Association supports appropriate FDA regulations to ensure product quality and safety for consumers."
Companies that want to market kratom in a dietary supplement need to overcome FDA’s safety concerns and either file an NDI notification (NDIN) or document that their ingredient is not new, McGuffin observed. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), dietary ingredients marketed before Oct. 15, 1994 are exempt from an NDIN.
FDA has objected to several kratom-related NDINs, citing safety concerns. Even if kratom was lawfully marketed in a supplement, it couldn’t be promoted to treat opioid addiction.
“You can’t make any drug claim," said McGuffin, who recommended marketers of supplements steer clear of any claim that kratom treats chronic pain or opioid withdrawal symptoms, for instance.
Companies that ignore McGuffin’s advice—and the advisory of the five trade associations—do so at their peril.
Said Newhart, the FDA spokeswoman: “The agency will continue to act when it learns of the deceptive sale or advertising of products that claim to effectively treat serious medical conditions, but which have not been proven safe and effective for those purposes."