Save Kratom from a global or US ban!

The Issue

Save kratom from a global or United States ban!

This petition refers specifically to: FDA Docket No. FDA-2021-N-0739, which seeks comments regarding several substances, including kratom, prior to a meeting with the World Health Organization's 44th Expert Committee on Drug Dependence (ECDD) on October 11th, 2021. [4]

Kratom (Mitragyna speciosa) is an evergreen tree in the coffee family found naturally in southeast Asia. The leaves are dried and ground/consumed raw. The leaves contain natural alkaloids that can provide a wide variety of uses as an herbal remedy, but is most commonly used for energy, pain management, and sleep. Kratom has been used for centuries in southeast Asia, where it grows naturally.

Centuries of historical use and decades of recent use in the US, combined with the following data, should indicate that this plant is quite safe to use

Let's look at CDC statistics:
A CDC study notes that 27,338 overdose deaths occurred between July 2016–December 2017, but of those deaths, there were only "...seven for whom kratom was the only substance to test positive on postmortem toxicology, although the presence of additional substances cannot be ruled out (4)." [1]

By comparison, the CDC recognizes that 136 people die every day due to opioid overdose, and that: "Over 70% of the 70,630 (overdose) deaths in 2019 involved an opioid". [2]

In another comparison, CDC statistics also show that readily available tobacco products account for more than 480,000 US tobacco-related deaths per year! [3]

The FDA docket states that "Kratom does not have an approved medical use in the United States and has not been studied as a treatment agent in the United States." [4] However, herbal remedies are rarely studied as approved medical treatments due to their inability to be patented and lack of profit potential for pharmaceutical companies.

The millions, or tens of millions, that use kratom will say that it is a safe herbal remedy with many uses and should not be subject to an outright ban or scheduling as a substance. Please keep this natural herb accessible to all people.

Please share your comments regarding this matter; they reopened the docket for comments (now ends August 24, 2021): (please focus on how kratom and how it benefits you or those around you)
https://www.regulations.gov/commenton/FDA-2021-N-0739-0001

Sources:
[1]: CDC "Weekly / April 12, 2019 / 68(14);326–327" 
https://www.cdc.gov/mmwr/volumes/68/wr/mm6814a2.htm

[2]: CDC "Understanding the (opioid) Epidemic"
https://www.cdc.gov/opioids/basics/epidemic.html

[3]: CDC: "Tobacco-Related Mortality"
https://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/tobacco_related_mortality/index.htm

[4]: FDA-2021-N-0739
https://www.regulations.gov/document/FDA-2021-N-0739-0001

[image credit: "Thehealingeast" obtained through Wikipedia with license: Creative Commons Attribution-Share Alike 4.0 International]

This petition had 85 supporters

The Issue

Save kratom from a global or United States ban!

This petition refers specifically to: FDA Docket No. FDA-2021-N-0739, which seeks comments regarding several substances, including kratom, prior to a meeting with the World Health Organization's 44th Expert Committee on Drug Dependence (ECDD) on October 11th, 2021. [4]

Kratom (Mitragyna speciosa) is an evergreen tree in the coffee family found naturally in southeast Asia. The leaves are dried and ground/consumed raw. The leaves contain natural alkaloids that can provide a wide variety of uses as an herbal remedy, but is most commonly used for energy, pain management, and sleep. Kratom has been used for centuries in southeast Asia, where it grows naturally.

Centuries of historical use and decades of recent use in the US, combined with the following data, should indicate that this plant is quite safe to use

Let's look at CDC statistics:
A CDC study notes that 27,338 overdose deaths occurred between July 2016–December 2017, but of those deaths, there were only "...seven for whom kratom was the only substance to test positive on postmortem toxicology, although the presence of additional substances cannot be ruled out (4)." [1]

By comparison, the CDC recognizes that 136 people die every day due to opioid overdose, and that: "Over 70% of the 70,630 (overdose) deaths in 2019 involved an opioid". [2]

In another comparison, CDC statistics also show that readily available tobacco products account for more than 480,000 US tobacco-related deaths per year! [3]

The FDA docket states that "Kratom does not have an approved medical use in the United States and has not been studied as a treatment agent in the United States." [4] However, herbal remedies are rarely studied as approved medical treatments due to their inability to be patented and lack of profit potential for pharmaceutical companies.

The millions, or tens of millions, that use kratom will say that it is a safe herbal remedy with many uses and should not be subject to an outright ban or scheduling as a substance. Please keep this natural herb accessible to all people.

Please share your comments regarding this matter; they reopened the docket for comments (now ends August 24, 2021): (please focus on how kratom and how it benefits you or those around you)
https://www.regulations.gov/commenton/FDA-2021-N-0739-0001

Sources:
[1]: CDC "Weekly / April 12, 2019 / 68(14);326–327" 
https://www.cdc.gov/mmwr/volumes/68/wr/mm6814a2.htm

[2]: CDC "Understanding the (opioid) Epidemic"
https://www.cdc.gov/opioids/basics/epidemic.html

[3]: CDC: "Tobacco-Related Mortality"
https://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/tobacco_related_mortality/index.htm

[4]: FDA-2021-N-0739
https://www.regulations.gov/document/FDA-2021-N-0739-0001

[image credit: "Thehealingeast" obtained through Wikipedia with license: Creative Commons Attribution-Share Alike 4.0 International]

The Decision Makers

FDA: Food and Drug Administration
FDA: Food and Drug Administration
Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration
Secretary of Health and Human Services (HHS)
Secretary of Health and Human Services (HHS)
World Health Organization (WHO)
World Health Organization (WHO)
ATTN: ECDD: Ref: C.L.20.2021
44th Expert Committee on Drug Dependence (ECDD)
44th Expert Committee on Drug Dependence (ECDD)
ATTN: Ref: C.L.20.2021

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Petition created on August 13, 2021