Class Module:
Kratom
Product Labeling
Ensuring Safety &
Transparency Through
Proper Product Labeling
This page features educational content from Dr. Erin Berthold.
Why Proper Labeling Matters
In the previous modules, we explored how leaf kratom’s effects can vary based on factors like serving size, route of administration, and any other substances you may be taking. Because of these factors, it’s crucial to choose leaf kratom products that are both manufactured and labeled properly, so you always have the information you need to use them safely.
Essential Label Components
Product Type Declaration
The label should clearly state the type of kratom ingredient used in the product, if it’s a dried leaf powder or an extract. This distinction is important because leaf and extract have varying potencies leading to differences in intensity of effects.
Alkaloid Content Information
The label should specify the total amount of mitragynine and 7-OH in a serving of the kratom product. This is generally indicated in milligrams.
Extracts are different from ground leaf products. If a product contains an extract, it should specify both the total amount of extract and the percentage of alkaloids.
- For example: If the product is a 45% extract, the label should read: Mitragyna speciosa (kratom) 45% extract – 100 mg
- This would mean that of those 100 mg of extract, 45% is alkaloids, so there are 45 mg of alkaloids in one serving.
Quantitative Declarations
The label must include specific quantitative declarations for the active components per serving. The active components that are included in the definition “total alkaloids” are mitragynine, speciociliatine, speciogynine, and paynantheine as these are the four found in highest abundance in M. speciosa.
The Amount
of Mitragynine
The label should also declare the amount of 7-hydroxymitragynine as a % of the total alkaloids defined above. 7-hydroxymitragynine should not be present as more than 2% of the alkaloid fraction in any kratom product. Using the example previously mentioned, 100 mg of a 45% extract contains 45 mg total alkaloids. So the 7-hydroxymitragynine amount should be no greater than 0.9 mg.
FDA Required
Supplement Facts Panel
The label must include a supplement facts and/or nutrition facts panel according to FDA requirements.
Ingredient List
If the product is not dried leaf powder, the label should list all additional ingredients in the product. This ensures transparency in the product’s composition.
Usage Instructions
- The serving size
- The recommended number of servings that can be safely consumed within a 24-hour period
Safety Warnings
Age and Pregnancy Restrictions Leaf kratom products should state that leaf kratom should not be used by individuals who are:
- Under 21 years of age
- Pregnant, breastfeeding, or planning to become pregnant
Why Exact
Numbers Matter
Having exact numbers on the label lets you compare back to what you’ve learned in the previous modules and estimate how much mitragynine might enter your bloodstream. Without these details, you won’t know how much actives you are ingesting per serving.
For example, if you see “Mitragyna speciosa extract 100 mg” but there’s no indication of whether it’s a 40% or 80% extract, then you can’t tell how much mitragynine is in a serving.
Clear
Usage Measurements
For example: Recommended Use: Take 2 grams (1 serving) per day. Do not exceed 2 servings (4 grams) in a 24-hour period.
Scientific
Serving Sizes
The serving sizes and daily recommendations should be based on available scientific data and the manufacturer’s specific product safety testing. If a product doesn’t provide clear instructions, it’s important to approach it with caution.
See The Perfect Label
Healthcare Consultation
The label must include a statement recommending that consumers consult a healthcare professional prior to use, especially if they have any pre-existing medical conditions or take other medications.
Child Safety
The label should contain a caution to keep out of reach of children.
Habit-Forming Warning
The label should include a warning that it may be habit-forming or cause physical dependence.
Drug Interaction Warning
The label should include a warning that leaf kratom may interact with certain medications and potentially alter their effects.
Avoid Illegal Health Claims
You should avoid any product that makes label claims like “pain-reliever,” “cures opioid use disorder,” or “good for depression” as there are currently no approved structure/function claims for kratom products.
If you see a company making health-related claims about kratom, you have the right to ask why they made those claims and what scientific evidence supports them. Responsible companies should be able to provide clear answers about their claims and compliance with regulations.
Company Information
Manufacturer Details The label should clearly state the name and place of business of the processor, manufacturer, packer, and/or distributor. This information helps confirm where the product is made and assures accountability.
Making Informed Decisions
By checking labels carefully and understanding the information provided, you can make safer and more informed decisions about your leaf kratom use. Proper labeling is essential for consumer safety and informed choice.