CSPI investigation shows manufacturers can’t support claims
The Center for Science in the Public Interest today urged the Federal Trade Commission and the Food and Drug Administration to take enforcement action to protect consumers from dietary supplements that are marketed as opioid withdrawal aids.
CSPI investigators found eight companies that were marketing supplements online with names like Mitadone Anti Opiate Aid Plus, Opiate Detox Pro, and TaperAid Complete. (CSPI’s investigation excluded supplements containing kratom—a botanical ingredient said to have opioid effects that has already come under scrutiny from federal authorities.) The products identified by CSPI are comprised largely of vitamins, minerals, and herbal ingredients, and cost from $20 to $182 per month. The watchdog group is concerned that consumers who believe the manufacturers’ claims may be diverted from the three FDA-approved medically assisted treatments for opioid withdrawal that have been shown to be effective in rigorous studies.
CSPI e-mailed the eight companies, asking each whether it could point to scientific studies showing that its product was more effective than a placebo. The responses “were often flip, cursory, riddled with pseudo-scientific jargon, or frighteningly ill-informed,” CSPI told the FDA and FTC. For example, the company marketing Mitadone Anti Opiate Aid Plus 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.”
TaperAid Complete’s response: “Nope, only informal studies with the 170 people I’ve shared it with so far.” And the maker of Opiate Detox Pro told CSPI: “Scientific studies are very costly, so no, there is no study.”
CSPI e-mailed the eight companies, asking each whether it could point to scientific studies showing that its product was more effective than a placebo. The responses “were often flip, cursory, riddled with pseudo-scientific jargon, or frighteningly ill-informed,” CSPI told the FDA and FTC.
Opioid dependence is a disease, and only products approved as drugs can be marketed to treat it, according to CSPI.
“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 Dr. Peter G. Lurie, who co-led Health and Human Services prescription drug working group while he was an associate commissioner at the 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.”
The nonprofit watchdog group asked the FDA to prohibit the sale of the substances as unapproved and/or misbranded drugs, and the FTC to file charges against the manufacturers for their unsubstantiated claims and, where possible, to obtain refunds for consumers.
The FTC has already taken enforcement action against two companies marketing withdrawal-aid supplements, obtaining refunds for consumers in one case. The marketer of Opiate Freedom Center Ultimate Recovery System, one of the supplements identified by CSPI, was recently referred to the FTC for enforcement action by the National Advertising Division, an industry self-regulatory program administered by the Council of Better Business Bureaus.