GMP is NOT a Choice! Kratom Vendors Have a Responsibility to the Community

Kratom Vendors and GMP Blog Title

The goal that our Kratom Community strives for is not impossible, unattainable or even remotely out of our grasp. In fact, it’s been done before.  In the short time since CBD products have hit the shelves we have seen that industry publicly condemn the bad actors. Those who were not following the laws quickly switched gears to get on board with compliance.

 

Why has the Kratom industry not done the same thing? We at the Botanical Education Alliance have tried to gently guide the industry into compliance. With the recent Salmonella scare issued by the CDC (although we at the BEA do not feel this can actually be attributed to Kratom) it has come to our attention that several large importers of Kratom are not in fact following GMP guidelines.

 

When a customer chooses to spend their hard-earned wages on a product in an earnest attempt to improve their quality of life, it is unjustifiably and morally abhorrent to provide them a product hasn’t been tested for safety. Certain vendors are doing this all while taking no responsibility and fearing no consequences.

 

Product is not being prepared and handled correctly at source, and this is not being identified when it reaches the US as it is not being tested properly and handled correctly at this side either.

 

For instance, one of these companies’ website states they’re selling kratom capsules where “the capsules are measuring devices” and then in the preceding paragraph talks about how Kratom affects you when you ingest it and continues with instructions of use for consumption.

 

NDI Steps to Resolve Adulteration

The BEA cannot and will not support vendors that aren’t following the rules and regulations for customer safety. Consequently, we’re taking a hard stance on NDIs along with supporting the enforcement of GMP kratom marketing practices.

 

The following instructions are for all Kratom Vendors that sell and market dietary supplements containing any ingredient (i.e. powder, capsules, leaves, extract) derived from kratom leaf.

 

Kratom Vendors must:

1. Submit a new dietary ingredient (NDI) notification to FDA for the specific kratom ingredient they are selling, at least 76 days prior to marketing a product that contains the ingredient; [NOTE: There may be some resistance to this for raw leaf but the fact that FDA has publicly stated that kratom is an NDI probably means that industry must now either document pre-DSHEA marketing of the leaf, or comply with the NDI notification provision.]

 2. Provide on supplement labels all information that is material in light of any consequences that may result from its use;

 3. As with any dietary supplement:

  • Formulate kratom-containing supplements to ensure that the products are reasonably expected to be safe;

  • Refrain from making any claims on labels or in labeling that the supplement is intended for use to diagnose, cure, mitigate, treat or prevent any disease, including, for example, treatment of chronic pain, anxiety or depression, or to treat opioid withdrawal symptoms;

  • Manufacture kratom products in facilities that are registered with FDA as food facilities, and that are in compliance with the FDA dietary supplement current good manufacturing practice rule (21 CFR 111);

  • Submit all serious adverse event reports received in association with the kratom-containing products to FDA in compliance with 21 U.S.C. § 379 aa-1;

 4. Refrain from marketing kratom products to children, and provide labels that specifically state that the product is not for use by those under 18 years of age.

These stated instructions are concise and clear-cut for any company to adhere to. We sincerely hope that other organizations will follow suit and advocate for the same procedures.

 

Simply put, kratom legality is at stake and our future depends on vendors following the procedures. Compliance is not an option that we have the privilege to choose or abide by, it is the ONLY option! Vendors must comply or kratom will inevitably lose its legal status across America.