Most recalls are voluntary. Here's why this one is different.
The Food and Drug Administration is requiring a Las Vegas company called "Triangle Pharmanaturals" to recall its herbal supplements of kratom—a tropical evergreen—after discovering some were contaminated with salmonella.
This is the first time ever that the national agency has had to use its power to remove a product from market, after, according to an official statement, the manufacturer explicitly refused to comply with the FDA's request of a voluntary recall.
This is not the first time that the FDA has asked people to stop using their products—earlier this year, the group warned shoppers that kratom had been linked to a salmonella outbreak. At that point, upwards of 90 people had been sickened in 35 different states, according to Bloomberg.
Kratom is already a controversial product. Often found in capsule and powder form, the alternative treatment used for pain, anxiety, opioid withdrawal, and illicit drug dependence is made from a plant native to Southeast Asia.
However, there is no legitimate medical evidence showing the supplement is effective—and no support for the claims that it can be used as a way to ween users off addictive drugs. In fact, the FDA has been cracking down on kratom sales because chemically, it resembles an opioid, reports CBS News.
As kratom is marketed and sold as a dietary supplement, however, producers haven't been required to prove its safety outright.
In addition to the concerns of salmonella contamination, the FDA has asked producers to refrain from labeling the product as a dietary supplement—but, as of now, they haven't banned the product altogether.
“Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law, and is endangering consumers; we will pursue all avenues of enforcement under our authority,” wrote Commissioner Scott Gottlieb in the official statement posted to the FDA's website yesterday.
For now, the FDA is focused on pulling all of the affected kratom capsules off shelves—but the same statement also confirmed that the national agency will be targeting the contested supplement in the future.
“We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately,” Gottlieb said.