Bill Overview
Title: Dietary Supplement Listing Act of 2022
Description: This bill imposes various requirements on dietary supplements, including by requiring the person (an individual or entity) responsible for introducing a supplement into interstate commerce to register the supplement with the Food and Drug Administration (FDA). Under this bill, the responsible person must register with the FDA specified information about each dietary supplement to be offered for sale, including (1) a list of all ingredients required by regulation to appear on the label; (2) the conditions of use; (3) any warnings and precautions; (4) certain claims characterizing the relationship between certain nutrients in the supplement and a disease or a health-related condition; (5) the responsible person's contact information; and (6) the locations where the supplement is manufactured, packaged, labeled, or held. For a supplement that is offered for sale on the date that is 18 months after this bill's enactment (the effective date), the responsible person must submit the required information to the FDA no later than 60 days after the effective date. A supplement that is not offered for sale on the effective date may not be offered for sale until the responsible person has submitted the required information. The FDA must establish a system that provides a unique identifier for each registered dietary supplement and a publicly accessible electronic database that allows a user to obtain certain information about a registered supplement.
Sponsors: Sen. Durbin, Richard J. [D-IL]
Target Audience
Population: People consuming dietary supplements
Estimated Size: 165000000
- Dietary supplements are consumed by millions worldwide, impacting various demographics and socio-economic groups.
- Dietary supplement market includes vitamins, minerals, amino acids, and herbs consumed for health benefits.
- Consumers include individuals seeking to improve health, manage conditions, or enhance performance, covering a wide age range.
- Global awareness and consumption of dietary supplements have been on the rise due to an increasing focus on health and wellness.
- The US is one of the largest markets for dietary supplements, therefore a significant portion of the affected population resides there.
Reasoning
- The policy is designed to regulate the dietary supplement industry, aiming to ensure consumer safety and product transparency. It targets not just consumers but also manufacturers and businesses who are part of the dietary supplement supply chain.
- Among US consumers, there's a significant diversity in the reasons for taking supplements—from general health maintenance to specific health-condition management. This diversity is reflected in the varying levels of impact the policy will have, as not all supplements or manufacturers will be affected equally. Small-scale sellers might face more challenges than large corporations.
- Given the limitations in budget, the policy may initially focus on larger manufacturers and high-demand supplements due to cost efficiency. Thus, consumers using less common or niche products may see less immediate impact or benefit.
- Consumers' well-being is affected not just by the availability of supplements, but by the overall confidence in product safety and effectiveness. Therefore, increased regulation can improve general well-being by providing assurance of product safety, while during the transition period, there might be concerns over product availability and potential price changes.
- Feedback from different demographics will show varied perspectives, with some expressing relief over stricter controls and others concerned about potential bureaucratic hurdles or reduced market diversity.
Simulated Interviews
Fitness Instructor (California)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 12/20
Statement of Opinion:
- I'm glad there will be more transparency with the supplements I use daily. It's essential to know exactly what's in these products.
- However, I'm concerned that some of my favorite brands might not be able to meet the regulations promptly.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Health Blogger (New York)
Age: 50 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- I think it's high time we have regulations to ensure supplements are accurately labeled and safe.
- My concern is these regulations could drive up prices and limit options on the market.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 7 |
Registered Nurse (Texas)
Age: 28 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 10/20
Statement of Opinion:
- More detailed information on supplements is a great thing for consumer confidence.
- I'm a bit worried about the transition phase and if the policy will make some essential supplements temporarily unavailable or more expensive.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Dietary Supplement Business Owner (Florida)
Age: 42 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 6.0 years
Commonness: 4/20
Statement of Opinion:
- I understand the importance of regulation, but as a small business owner, the cost and logistics of complying with new rules are daunting.
- There could be significant challenges ahead in adapting to these new demands.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 7 |
| Year 20 | 7 | 7 |
Retired Pharmacist (Ohio)
Age: 65 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- This policy looks like a step in the right direction for consumer safety and product reliability.
- I just hope it doesn't cause a disturbance in the availability of supplements I rely on.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Student (Illinois)
Age: 23 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 14/20
Statement of Opinion:
- It's good to know more about what's in my supplements, but price changes worry me as I'm on a tight budget.
- We need to watch if this leads to less competition in the market.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 8 | 7 |
Nutritionist (Washington)
Age: 39 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- As a nutritionist, these regulations mean I can recommend supplements with more confidence.
- There might be challenges initially for some products, but long-term benefits are worth it.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Holistic Health Practitioner (Arizona)
Age: 54 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 6/20
Statement of Opinion:
- Introducing transparency in the labeling is important, yet I'm concerned about the potential bureaucratic hurdles this will create.
- Especially for herbal supplements, the change might restrict availability or increase costs significantly.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 6 |
| Year 2 | 5 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Software Engineer (Colorado)
Age: 30 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- The policy sounds good in theory for safety, but I'm a bit apprehensive about changes to the products I use regularly.
- Not sure if this will affect my ordering options online.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Organic Farmer (Vermont)
Age: 47 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 4.0 years
Commonness: 5/20
Statement of Opinion:
- Any move towards clarity and honesty in labeling aligns with my values, but execution of the policy can be tricky.
- Certain supplements might become more difficult to obtain sustainably.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Cost Estimates
Year 1: $30000000 (Low: $25000000, High: $40000000)
Year 2: $25000000 (Low: $20000000, High: $35000000)
Year 3: $25000000 (Low: $20000000, High: $35000000)
Year 5: $23000000 (Low: $18000000, High: $30000000)
Year 10: $21000000 (Low: $16000000, High: $28000000)
Year 100: $15000000 (Low: $10000000, High: $20000000)
Key Considerations
- The total cost to the FDA and supplement industry will depend significantly on the complexity and capacity of the database system to be developed.
- The FDA's ability to enforce compliance through information verification and audits is essential for the success of the act.
- The participation rate and accuracy of the information provided by dietary supplement companies are critical to the act’s effectiveness.