On April 8 the FDA reissued an import alert pertaining to Kratom. This alert is meant to guide workers in the field to detain products containing Kratom at the U.S. borders. However, don’t fret; the supply of Kratom in the U.S. is not in danger.
What is the Kratom FDA Import Alert?
The Import alert issued by the FDA is specifically called Import Alert 54-15. Simply, it lists several companies whose shipments are subject to detention without physical examination (DWPE) at U.S. borders. This order has been in effect as early as 2014, so why is this news now?
The published date of the import alert has been updated because of additions to the listed companies who have been so-called “red listed.” Basically, nothing about the actual wording of the import alert has changed. The only new thing present is the updated list of companies whose products are now subject to detention without physical examination.
Why is there a Kratom FDA Import Alert?
So why is Kratom even on an import alert list? Well, that has a lot to do with product labeling and FDA approval. Kratom is not approved by the FDA for sale as a nutritional or dietary supplement. So, the products from companies on the red list are there usually because of mislabeling. Kratom is legal for sale as a ‘food’ product, and confiscated Kratom products are not complying with this label.
This labeling issue is important, because it speaks to the still present need for more research on Kratom, and regulation of Kratom to ensure that customers are consuming safe, and quality products. The current concern is that Kratom “appears to be a dietary supplement or contains a dietary ingredient that is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.” If the Kratom Consumer Protection Act could be passed country wide there would be an easy distinction between safe and legal Kratom, and adulterated products.
FDA Position on Kratom
The FDA’s stance on Kratom is a little confusing for anyone who knows all of the facts. While the FDA import alert on Kratom states that ” there does not appear to be a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient. In fact, the scientific literature disclosed serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts”
However, this is confusing given the information the FDA withheld from the public that was finally published by the American Kratom Association. This revealed that the information used by the FDA to try and criminalize Kratom was rescinded because it was incorrect. The US Department of Health and Human Services sent a letter to the FDA detailing how Kratom does not meet requirements to be banned, Further, they highlight the “significant risk of immediate adverse public health consequences for potentially millions of users” if Kratom were to be banned. Read the full text of this letter here.
What the American Kratom Association Thinks
A representative from the American Kratom Association (AKA) said that the import alert is important, because of how Kratom is being imported into the US. The AKA does not support Kratom vendors who market their products as dietary or health supplements. This is exactly the type of products that the import alert is targeting. The AKA specifies, though, that the FDA does not have the authority to confiscate Kratom that is unadulterated and sold as food with no dietary or health claims.
The AKA held a Kratom FDA import alert webinar to discuss the subject. You can watch the full video of that below.
We’ve seen a little bit of panic from customers worried about their supply of Kratom. We urge you not to worry! Our supply of Kratom isn’t going anywhere. The general shipment of pure unadulterated Kratom into the US is not at risk. However, Kratom is still facing defamation from the FDA, and Kratom advocates will need to continue in their vigilance to keep safe and natural Kratom in the hands of customers that need it.