The F.D.A. recently warned about the “deadly risks” of kratom, a botanical substance that has been marketed as a safe treatment for opioid withdrawal. More and more businesses promote unproven remedies under the guise of dietary supplements that are not regulated like drugs. CreditJoe Raedle/Getty Images
Chris Beekman, whose company sells the dietary supplement Opiate Detox Pro, does not understand what all the fuss is about.
“If it works, it works,” Mr. Beekman, the owner of NutraCore Health Products, said in an interview. “If it doesn’t, it doesn’t.” His customers, addicts trying to shake a dependence on opioids, can always get their money back, he said.
Opiate Detox Pro’s label says, “Opioid addiction ease,” and the company’s website claims, “Our ingredients are the most effective on the market for treating withdrawal symptoms.”
Mr. Beekman said he did not have scientific evidence to prove that the product worked, and would not be conducting research to buttress the company’s claims.
“It’s just not going to happen,” he said, citing what he called the prohibitive cost of scientific studies and clinical trials.
Peter Lurie thinks that is an unacceptable position from someone who sells supplements that purport to treat addiction. Dr. Lurie, a former Food and Drug Administration official, runs the nonprofit Center for Science in the Public Interest, which on Friday urged the F.D.A. and the Federal Trade Commission to crack down on businesses that target addicts with products that make unproven health claims.
The F.D.A. has already zeroed in on another supplement, kratom, a botanical substance that has been promoted as a safe substitute for opioids and an adjunct to opioid use. Last month, the agency issued a public health advisory for kratom, warning that the product carried “deadly risks,” and linked about three dozen deaths to it. Earlier, the agency had ordered that kratom imports be seized and told companies to take it out of supplements.
In general, the agency can fine companies that make and distribute them, or take other enforcement actions. In the past few weeks, reacting to other agency warnings, Amazon has stopped making available some products claiming to assist in opioid withdrawal.
“We monitor the products sold on our website, and when appropriate, we remove products from the website,” said Erik Fairleigh, an Amazon spokesman.
The move has upset those who sell the supplements.
“They pulled us all down,” said Allen Wetmore, a spokesman for NutraCore Health Products. “They claim we were trying to treat addiction as a disease.”
Because dietary supplements are regulated differently than food and drugs, these products do not require clinical trials before entering the market. But the trade commission, which regulates advertising, and the drug agency can enforce rules against fraudulent health claims. And the drug agency’s website notes that the array of dietary supplements making health claims has grown tremendously in recent years. “Though the benefits of some of these have been documented, the advantages of others are unproven,” the website says.
When they claim to treat diseases, including addiction, supplements shift into the category of drugs, and companies wanting to make such claims must follow the drug agency’s approval process to show that their products are safe and effective.
Scott Gottlieb, the F.D.A. commissioner, has made expanding available medical therapy for treating opioid-use disorders a key goal of the agency, which has approved several drugs and devices for opioid-withdrawal treatment.
F.D.A. Commissioner Scott Gottlieb called for expanding medical therapies to treat opioid withdrawal. Eric Thayer for The New York Times
The Center for Science in the Public Interest recently conducted a market analysis to identify companies promoting dietary supplements as effective aids for opioid withdrawal. The group contacted eight online sellers and requested any scientific evidence they had to substantiate health claims made by their products.
The results offer a glimpse into the loosely regulated field of dietary supplements, and a case study of how businesses are capitalizing on efforts by addicts eager to break their habits amid what has become a national opioid epidemic.
“We’re looking at hundreds of thousands of people who are addicted to opioids, many of whom are desperate,” Dr. Lurie said. “It’s a situation with very limited treatment options compared to the demand, and unto the breach come these unscrupulous dietary supplement manufacturers, who know people are desperate and likely to try them.”
One company, identified on its website as Mitadone U4Life, promotes a product called Anti Opiate Aid Plus. The site claims to “help ease withdrawal symptoms associated with the use of OxyContin, morphine, Oxycodone,” and other drugs. The website also promises that its product “helps eliminate cravings, symptoms and helps you quit.”
Another company, Opiate Freedom Center, markets a product called the Ultimate Recovery System, saying it is “made to help you ease withdrawal symptoms, shorten detox length, improve emotional well-being, provide nutritional support to the brain during detox.”
As with some other companies contacted by The New York Times for this article on Thursday, the Mitadone supplement sellers appear to have changed the wording on their website. Jay Lal, a spokesman for Mitadone, said it had hired a law firm to help it become compliant with drug agency guidelines.
Several of the companies named in the center’s report defended their practices, pointing out that their websites offer disclaimers and advise customers to consult their doctors.
On Friday, the F.D.A. responded to the Center for Science in the Public Interest’s complaints about these companies.
“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,” said Theresa Eisenman, a spokeswoman for the drug agency.
“Health fraud scams like these can pose serious health risks, and the F.D.A. cautions the public to instead seek out medication-assisted treatments that have met the scientific rigor of F.D.A. approval,” Ms. Eisenman said.