FDA Investigation, Enforcement, Seizure, and Recall of Products Reported to Contain Kratom
Mitragyna speciosa, well known as Kratom originates from Southeast Asia and Thailand. Those who grew this type of plant in their farms used it for different reasons. The leaves to the plant were chewed by farmers to increase their stamina, energy and reduce fatigue. In the past few years, Kratom has gained popularity in the U.S for it has been used as supplements and also as a pain killer.
It has become a growing interest to both the consumers and the government. Kratom comes in various forms; this includes pills, leaves, powders, capsules and also tea. One can also get products that contain kratom in them online, authorized shops and also in paraphernalia stores in U.S and Europe. Statistics have shown that over three million citizens consume Kratom in America
Due to the increasing rate of kratom consumers, the United State FDA decided to do an investigation on kratom’s supplements and also on its other uses. Their main concern is its effectiveness, safety, not going through clinical examination and not complying to go through FDA’s process to evaluate the products.
Due to the issues stated above, FDA, other federal agents, other states and the local authorities have conducted a crackdown on this product. The FDA has really tried to fight against the rising popularity of kratom while DEA has listed it among the illegal schedule 1 product and most of the country and cities and town have banned and also made it a criminal offense to consume kratom
FDA Import Alerts for Kratom-Containing Products
Over the past ten years, the consumption of kratom has rapidly increased in the U.S, which has made the FDA be more concerned on the issue of safety and effects that it has on consumers. In the year 2012, FDA acted upon their concerns by giving out the alert to identify the product as an illegal drug and categorizing it under Detention Without Physical Examination product.
When a product has the DWPE status, it means that it is in compulsory detention for any future shipments. They say the only kratom that is shipped is subjected to both FDA and DWPE regulations because it is a supplement or it has a dietary element but they do not provide adequate information to assure the consumers of the risks or either injury. Also, according to Section 201(p) [of the Food, Drug, and Cosmetic Act] kratom is considered a new drug.
What made the FDA stop the circulation of kratom is because of lack of enough evidence that would establish its safety and also certain issues on toxicity in different organ systems. Here are some of the health issues that the FDA had raised that can affect the consumers; respiratory depression, aggression, hallucinations, tremors, vomiting, and nausea among others. They also associate kratom with death.
After the first import alert, the FDA has continued to issue the import alert on all products that contain kratom in 2014 and 2016. In February 2014 the alert focused on supplements that contain kratom. In the year 2016 December, the alert reissued its so-called ‘red list’ due to the increase of imported dietary supplements that contain the substance.