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
Table of Contents
- FDA Investigation, Enforcement, Seizure, and Recall of Products Reported to Contain Kratom
- FDA Import Alerts for Kratom-Containing Products
- Looking For Quality 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.
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During the import alerts, the federation impounded three separate products in September 2014, and January, August 2016. The federal requested the United State Marshals to seize almost 25000 pounds of kratom material which estimated value was more than $5 million of a well-known distributor in September. They also brought a case in American District Court for Central District of California against the owner with the help of the Department of Justice. The distributor had labeled the product as harmful and not suitable for consumption and that the product was for potpourri and incense, but a certain website had claimed that the substance was to treat diseases thus passing the test as an illegal drug.
The year 2016 the U.S Marshals impounded about 90,000 cans of the same supplements which contained kratom of $400,000. In the same year, they dealt with over 100 different cases of products containing kratom estimated to be of $150,000.
Salmonella Outbreak and FDA Mandatory Recall
Now, kratom has become a subject and is under great supervision, this is due to several states Salmonella outbreak.
Investigations conducted by FDA in conjunction with the Centers for Disease Control and Prevention indicate that illnesses were discovered in the first month of the year 2017, but announcements of the outbreak were in 2018. In March the outbreak was linked to kratom in form of powder.
After the investigations were over, 74% had consumed kratom and most of them had consumed it inform of powder. As for now, 199 persons from different states are reported to having the outbreak due to kratom use even though no deaths reported.
FDA has continued to encouraging recalls of all products that contain the kratom. In the history of FDA, this has been the first mandatory recall order for food products it has ever given.
DEA Listing as a Schedule I Drug
2016 when the FDA was impounding products, the debate of whether the substance is legal had really gained momentum when DEA said that it will place the 2 kratom elements on Schedule I together with other illegal drugs like (heroin). They justified the scheduling of kratom due to their findings that it is dangerous.
In October 2016, users as well as advocates faced a lot of criticism from the parliament and also a petition which was filed that contained more than 140,000 signatures. This made the DEA delay a scheduling process to give way for members of the public to participate and also a scientific investigation by the FDA. In 2018, FDA findings indicated that there was no evidence that indicated kratom is good for medicinal. Despite all the effort that the FDA had put in this, no official action that the DEA has taken in listing this substance as a Schedule 1 drug under the CSA.
State and City-wide Bans on Kratom
CSA has no power to control kratom, but certain cities and states have regulations and raise bans on possessions and the use of the drug. Some of the states include Washington, DC, Indiana, Arkansas, and Rhode Island among others. Countries include Denver, CO, and Jerseyville, IL among others. There are several states that have bills that have been presented to parliament focused in prohibiting and also regulating the use of kratom this includes New York, Kansas, Illinois, Mississippi, West Virginia, and Tennessee
It has been reported that both the consumers, advocates and also the retailers have taken this crackdown seriously. Each and every one of them is putting the effort into ensuring that the drug has been made legal. Kratom advocates have gone an extra mile by funding for scientific studies to be conducted, encouraging the quality of the substance after the salmonella outbreak.
According to the American Kratom Association (AKA), they strongly believe that the substance should be considered and be available as a food and also as a supplement. The association will do everything to make sure that kratom is made legal.