Bill Overview
Title: Federal Clarity for Kratom Consumers Act
Description: This bill requires the Food and Drug Administration (FDA) to hold a hearing and establish a task force on the health and safety of products with kratom (an herbal substance that produces opioid- and stimulant-like effects). It also prohibits the FDA from regulating kratom products in a manner that is more restrictive as compared to regulations for food, dietary supplements, or dietary ingredients.
Sponsors: Sen. Lee, Mike [R-UT]
Target Audience
Population: People who consume kratom products
Estimated Size: 3000000
- Kratom is consumed mainly as an herbal supplement with opioid- and stimulant-like effects, often by individuals seeking its purported benefits, such as pain relief and mood enhancement.
- The global availability of kratom is increasing, particularly in countries where it remains legal as an herbal supplement.
- Kratom consumers can include people looking for alternatives to traditional medicine, those interested in natural remedies, and individuals in regions where kratom use is culturally significant.
- The number of potential kratom consumers is growing due to the increasing availability of information and accessibility through online platforms.
Reasoning
- Kratom users primarily include people seeking alternative pain relief or mood enhancement therapies.
- The FDA's regulation of kratom aligns with the approach for other dietary supplements, impacting kratom producers and possibly increasing transparency and safety for consumers.
- A well-structured hearing and task force could lead to increased awareness and understanding, affecting consumer confidence positively.
Simulated Interviews
Construction worker (Florida)
Age: 34 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 15/20
Statement of Opinion:
- I rely on kratom to manage my pain, and I'm worried about any changes that might make it harder to get.
- I feel that a safety review could be beneficial if it doesn't restrict access.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 4 |
| Year 20 | 7 | 3 |
Yoga instructor (California)
Age: 26 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 12/20
Statement of Opinion:
- I like using kratom because it's natural, but I want to know it's safe.
- This policy seems like a good balance; it could make kratom safer without banning it.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Entrepreneur (Texas)
Age: 40 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 10/20
Statement of Opinion:
- As both a user and a seller, clarity on regulations is crucial.
- This helps legitimate sellers and educates consumers, which is beneficial in the long run.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 9 | 5 |
| Year 5 | 9 | 5 |
| Year 10 | 10 | 4 |
| Year 20 | 9 | 3 |
Retired nurse (New York)
Age: 51 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 6.0 years
Commonness: 8/20
Statement of Opinion:
- I support more research and regulation; it reassures me about the product's safety.
- However, I hope it remains available and not overly restricted.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 8 | 3 |
| Year 20 | 7 | 3 |
College student (Oregon)
Age: 19 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 14/20
Statement of Opinion:
- I think kratom should be safe and legal, much like other supplements used on campus.
- I trust that this policy could inform us better without removing access.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 6 | 4 |
Software developer (Illinois)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 13/20
Statement of Opinion:
- I use kratom as part of my productivity routine, and changes in supply could be problematic.
- I support regulation that prioritizes consumer safety and informs us better.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 4 |
Holistic health coach (Nevada)
Age: 55 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 11/20
Statement of Opinion:
- The policy could empower and educate consumers, which I appreciate as a practitioner.
- However, I am concerned about any undue limitations on access for those who benefit.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 4 |
| Year 20 | 7 | 4 |
Stay-at-home parent (Georgia)
Age: 31 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 6.0 years
Commonness: 9/20
Statement of Opinion:
- Clarity on safety and regulations would reduce stigma, which is a plus for me.
- Hope it doesn't become too expensive or inaccessible.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 3 |
| Year 20 | 8 | 3 |
Veteran (Ohio)
Age: 60 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- As a veteran, I want my health choices respected and safe.
- I am hopeful that this policy will positively affect my ability to choose kratom safely.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 3 |
| Year 5 | 7 | 3 |
| Year 10 | 8 | 3 |
| Year 20 | 8 | 2 |
Environmental scientist (Arizona)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 10/20
Statement of Opinion:
- I value the consistency and reliability of my supplements.
- The policy's structured review might enhance trust while supporting sustainable practices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Cost Estimates
Year 1: $5000000 (Low: $4000000, High: $6000000)
Year 2: $3000000 (Low: $2000000, High: $4000000)
Year 3: $0 (Low: $0, High: $0)
Year 5: $0 (Low: $0, High: $0)
Year 10: $0 (Low: $0, High: $0)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Some states have their own strict regulations or bans on kratom, affecting the uniform application of the Federal guidelines.
- International findings on kratom's effects could influence public opinion and subsequent policies at the federal level.
- The public health community has mixed views on kratom’s safety and efficacy, which may affect the task force's findings and recommendations.