The FDA and Federal Trade Commission posted joint warning letters to the marketers and distributors of 11 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. An additional four letters were sent to unnamed companies.
The federal agencies’ Jan. 24 announcement targeted companies that made unsubstantiated claims placing their products either under FDA or FTC jurisdiction. The agencies allege the products are new unapproved drugs or were advertised with false claims.
However, the website, Pain News Network, wrote: “The U.S. Food and Drug Administration is following through on its threat to crackdown on companies selling kratom and other herbal supplements as treatments for opioid addiction and withdrawal.
Of the 11 companies named by the FDA, not one of the companies’ products listed by the FDA show kratom as an ingredient. While some of the sites appear to be taken down, National Kratom Coalition was able to track down the 11 products by other means.
NKC reviewed the products mentioned in the warning letters. Some of the products’ active ingredients included ginger root, ginseng, St. John’s Wort, gotu kola, caffeine, and caladium seguinum, a homeopathic ingredient made from a flower to help with impotency.
Pain News Network did not respond to multiple requests for comment why they mentioned kratom in their story.
The letters are the latest effort to combat what FDA Commissioner Scott Gottlieb called a “proliferation” of unapproved products claiming to treat opioid addiction. In a statement, Gottlieb said “unscrupulous vendors who are trying to capitalize on the epidemic by taking advantage of consumers and selling products with baseless claims.”
Gottlieb has pushed for the greater use of medication-assisted approaches to fight the opioid epidemic and warned that phony remedies could divert people from getting the right treatment. The FDA chief received millions of dollars from pharmaceutical companies when he worked in the private sector. His investment holdings include many pharmaceutical companies awaiting their products to be approved by the FDA.
The FDA/FTC latest activity is a warning shot to kratom vendors who make claims about their products that cannot be substantiated.
“The law clearly states that you can not make false claims. This is done to protect sick people that will try anything to feel better, said NKC President, James Devers. “The FDA actually helps Americans here. And companies that refuse to follow the laws meant to protect us should be held accountable.”