In recent kratom news, the American Kratom Association announced a new program on July 18th for ensuring consumers are safe from the dangers of contaminated kratom. On August 20th the AKA released their new set of compliance standards. This new set of standards is named the AKA Good Manufacturing Practice (GMP) Standards. This new program, according to the AKA, “establishes exacting manufacturing, labeling, and verification requirements for kratom dietary supplements.” This includes: disclosing the exact quantity of the alkaloids mitragynine and 7-OH present in each product, ensuring the products are free of all microorganisms, and administering anual aduits of all vendor facilities and kratom products.
This is a great effort from the American Kratom Association to prove once and for all to the FDA and DEA that kratom is safe for consumers. The Chairman of The American Kratom Association, David Herman, vowed “to seize and destroy any adulterated or contaminated kratom products, and to shut down the operations of unscrupulous vendors who fail to adhere to these standards.” If you are selling kratom, it is best to familiarize yourself now and get into compliance.
In positive kratom news, the AKA has also released a number of reports in the last few weeks that highlight the fact that adverse events and deaths the FDA claims are “associated” with kratom are actually the result of polydrug use; underlying medical conditions; the use of contraindicated prescription drugs; and adulterated kratom products. This is a huge leap for the kratom community because the truth is being shed on the safety of kratom. Finally!
What This Means for Consumers
For consumers, this is actually a great advancement for the kratom industry. This rigorous set of compliance standards will eliminate all the vendors floating around who are unethical and are currently using unsafe practices in their kratom distribution. Just like the vendors who were spraying their kratom with Tramadol, then selling it under the name “Krypton.” Needless to say, it was extremely unsafe to do this, and now we can be sure every vendor adheres to a universal set of rules for the distribution and marketing tactics of kratom.
What This Means for Vendors
As frustrating as it may seem at first, following these new rules will actually benefit you in the end. They are issuing certifications for all vendors who register and take part in a 3-rd party verification system. This means your kratom will be verified as safe by someone upon a random check. Qualified vendors will then be added to the verified list of AKA vendors that will be available to all kratom consumers. This means added sales and increased trust among consumers, both online and in brick and mortar stores.
The Compliance Procedures: Getting Started
Over the next 60 days, the AKA will begin training 3rd Party auditors on the new GMP Standards. This affords all vendors ample time to adhere to this new set of rules and regulations. They will be hosting training webinars over a course of several days to answer all questions that you may have regarding these changes.
Read below for a detailed overview of these new standards:
Standard Operating Procedures
Personnel
- Establish and follow written procedures to prevent microbial contamination from sick
or infected personnel and for hygienic practices at the facility. - Establish and implement a personnel compliance training program.
- Maintain documentation of the training.
Manufacturing Facility and Equipment
- Establish and implement procedures to ensure the facility is in a condition that
protects against the contamination of ingredients, finished products, and contact
surfaces. - Clean and sanitize storage, production, processing, and packaging areas according
to an established schedule. - Verify the effectiveness of cleaning and sanitation operations by conducting swabbing of contact surfaces according to an established
schedule and sampling plan.
Manufacturing Operations
- Establish and implement written procedures for the processes of (1) receiving
material; (2) quarantine; (3) production/processing; (4) packaging; (5) storage and
sale. Maintain records of following these procedures on a per-batch basis. - Document the rationale for what constitutes a “batch” or “lot” of product.
- Establish and implement a written randomized sampling plan to a degree that would
ensure a very low probability of an undetected contaminant. - Establish and implement a written procedure for analysis of raw materials for: (1)
microorganisms of public health concern; (2) heavy metals; (3) chemical
contaminants; (4) synthetic drugs; and (5) shelf-life testing. - Establish and implement a raw material receiving procedure to place incoming raw
materials on an initial quarantine pending receipt of test results and confirmation that
ingredient meets specifications. **This procedure should include a rejection protocol
for raw materials that do not meet specifications or whose analysis reveals the
presence of microorganisms of public health concern, heavy metals, chemical
contaminants, or synthetic drugs. - Establish and implement a written procedure for qualifying ingredient suppliers,
including the procedures that trigger the disqualification of the supplier.
Recordkeeping
- All records should be kept for a minimum of 1 year past the shelf life date of the
product, if shelf life dating is used, or 2 years beyond the date of distribution of the
last batch of dietary supplements associated with those records. - All records should be kept in a standardized manner so that they are readily
accessible at the manufacturing facility for review by an independent third party
auditor.
Master Manufacturing Records
- Establish and follow a written Master Manufacturing Record for each unique
formulation of kratom product that you manufacture, and for each batch size, to
ensure uniformity in the finished batch from batch to batch. - The Master Manufacturing Records must:
§ Identify specifications for the steps in the manufacturing process where
control is necessary to ensure the quality of the kratom product, and that the
kratom product is packaged and labeled as specified in the master
manufacturing record; and
§ Establish controls and procedures to ensure that each batch of kratom
product manufactured meets the specifications in the Master Manufacturing
Record. - The Master Manufacturing Records must include:
§ Name, strength, concentration, weight or measure of each ingredient used in
each product for each batch size;
§ A statement of the theoretical yield of a manufactured kratom product
expected at each step of the manufacturing process where control is needed
to ensure the quality of the product, and the expected yield when
manufacturing is completed, including the maximum and minimum
percentages of theoretical yield beyond which a deviation investigation of a
batch is necessary and material review is conducted and disposition decision
is made;
§ A description of packaging and a representative label, or a cross-reference to
the physical location of the actual or representative label;
§ Written instructions, including:- Specifications for each step in the manufacturing process where
control is necessary to ensure the quality of the kratom product and
that the kratom product is packaged and labeled as specified in the
master manufacturing record; - Procedures for sampling and a cross-reference to procedures for
tests or examinations;
- Specifications for each step in the manufacturing process where
- Specific actions necessary to perform and verify steps in the
manufacturing process where control is necessary to ensure the
quality of the kratom product and that the kratom product is packaged
and labeled as specified in the master manufacturing record.
Batch Production Records
- Establish and maintain batch production records each time you manufacture a batch
of a kratom product.
Batch Production Records must:
§ Include complete information relating to the production and control of each
batch; and
§ Accurately follow the appropriate Master Manufacturing Record, and each
step in the Master Manufacturing Record must be followed for each batch of
product.
The Batch Production Records must include: - The batch, lot, or control number of the finished batch of kratom product;
- The identity of the equipment and processing lines used in producing the batch;
- The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a crossreference to such records, such as individual equipment logs, where this information is retained;
- The unique identifier assigned to each component, packaging, and label used;
- The identity and weight or measure of each component used;
- A statement of the actual yield and a statement of the percentage of
theoretical yield at each phase of processing; - The actual results obtained during any monitoring operation;
- The results of any testing or examination performed during the batch
production, or a cross-reference to such results; - Documentation that the finished product meets the specifications established
for the product; - Documentation, at the time of performance, of the manufacture of the batch,
including the date on which each step of the master manufacturing record
was performed and the initials of the persons performing each step of the
master manufacturing record; the packaging and labeling operations; and
review by quality control personnel.
Traceability
- Maintain records of the full chain of custody and master records for all purchased
and sold items with standard double verification (e.g., a packer sign-off and Quality
Control manager sign-off). - Establish and implement a supply chain system that allows a vendor to determine
which customers received a given batch and from whom that batch of material was
initially supplied by.
Adverse Event Reporting System and Recalls
- Establish and implement a written Adverse Event Reporting System to:
o Review all product complaints to determine whether the product complaint
involves a possible failure to meet the specifications for the product, or any other
requirement in these standards or 21 C.F.R. Part 111 that, if not met, may result
in a risk of illness or injury; - Investigate any product complaint that involves a possible failure of a product to
meet any of its specifications, or any other requirement in these standards or 21
C.F.R. Part 111 that, if not met, may result in a risk of illness or injury; - Monitor consumers who experience an adverse health event related to a kratom
product; - Monitor potential contamination or adulteration of kratom products;
- Monitor vendors selling counterfeit, contaminated, or adulterated kratom
products; and - Monitor manufacturers or distributors of kratom products using health claims.
Recalls
- Establish and implement a written recall procedure and conduct mock recalls
according to the procedure.
Marketing Practices
Labeling and Advertising
- The labels, labeling, or advertising of any kratom product should not bear any
disease claims (i.e., claims regarding the treatment, cure, prevention, or
mitigation of disease) or unauthorized health claims. - The labels, labeling, or advertising of any kratom product should not bear any
structure/function claims. - The labels, labeling, or advertising of any kratom product should not reference
any research or clinical data. - Each finished product label must include a batch or lot number.
- Each finished product should be labeled to disclose the mitragynine and 7-OH
alkaloid content of the product. - Each finished product label must advise consumers to consult with a physician
for dosing information relative to alkaloid values. - No kratom products may be sold to individuals under the age of 18.
- The label should bear a statement that pregnant women should not use kratom
products during pregnancy. - All labels, labeling, or advertising should include the following statement: “This
product is not not intended to diagnose, treat, cure, or prevent any disease or
condition.”
In the Long Run
This is definitely quite a bit to absorb for you and your staff. However, in the end these steps will not only benefit you, but they will benefit the entire community. Most vendors have already, ideally, been doing a majority of these steps and should have little problems transitioning. Finally, the kratom community can be viewed as legitimate and safe.
Take it one day at a time. Everyone still has 60 days to train and get things in order. KratomUtopia wishes everyone the best of luck during this period! Stay tuned for more kratom news that you can trust!