Bill Overview
Title: Keep Infant Formula Safe and On the Shelves Act of 2022
Description: This bill requires the Food and Drug Administration (FDA) to periodically inspect infant formula manufacturing facilities and addresses related issues. The FDA must periodically conduct inspections, including unannounced inspections, of infant formula manufacturer facilities. If the FDA makes a notable regulatory finding at such a facility, the manufacturer must undergo a comprehensive food safety audit that includes a root cause analysis, enhanced testing, and comprehensive environmental samples. A manufacturer of infant formula or essential medical food must notify the FDA no later than five business days after becoming aware of circumstances that could lead to a shortage of the relevant product in the United States. Further, the FDA must create and annually update a list of U.S. manufacturing facilities that could be converted to manufacture infant formula during a shortage. In the event of a shortage, the FDA may require infant formula manufacturers to provide certain information, such as the quantity of formula in a manufacturer's inventory. The bill also establishes under statute that food, including infant formula, is a critical material essential to the national defense and therefore subject to authorities under the Defense Production Act of 1950. (Such authorities authorize the President to take various actions, such as requiring businesses to prioritize certain government contracts and incentivizing the domestic industrial base to expand the production of critical materials.) The Occupational Safety and Health Administration must issue a fact sheet and provide technical assistance to infant formula manufacturers to promote compliance with occupational health and safety standards.
Sponsors: Rep. DeLauro, Rosa L. [D-CT-3]
Target Audience
Population: Consumers and caregivers of infant formula globally
Estimated Size: 5000000
- The primary group impacted by this bill consists of individuals and families that utilize infant formula for feeding infants. This includes infants who rely on formula as their primary food source.
- The bill indirectly impacts parents, caregivers, and families who might experience stress and health risks during infant formula shortages.
- The bill addresses manufacturers of infant formula as they will need to comply with new regulations and inspection protocols.
- As the bill mandates the FDA's role in monitoring and managing formula production, the FDA's operations will be impacted by the increased workload and responsibilities.
- The bill affects the national populace overall due to its consideration of infant formula as critical to national defense, potentially invoking the Defense Production Act.
Reasoning
- The policy is primarily aimed at preventing infant formula shortages, which directly impacts parents and caregivers of infants who rely on formula. The impact on these groups will mostly be positive, but the degree of improvement in wellbeing could vary.
- Infant formula manufacturers might experience initial disruptions due to compliance requirements, but enhanced safety regulations could lead to long-term operational stability and fewer risks of recalls or production halts.
- Caregivers' principal concern is the availability and safety of the formula. Therefore, any impact on wellbeing would be closely related to avoiding shortages and securing safe product standards.
- The FDA will likely experience increased operational demands due to more frequent inspections and the obligation to manage and mitigate shortages proactively.
- With a sizeable budget spread over several years, the policy intends to foster stable improvements without overwhelming financial outlays. The target population includes those who directly purchase and rely on infant formula.
- It's important to include a mix of socio-economic groups, as formula usage can range from those who use it exclusively to those who only supplement breastfeeding.
Simulated Interviews
Marketing Specialist (Chicago, IL)
Age: 28 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- I really worry about not being able to find formula, especially after last year's shortage.
- Safety is important, but availability is my main concern.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 8 | 4 |
| Year 3 | 8 | 4 |
| Year 5 | 9 | 6 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
IT Consultant (Austin, TX)
Age: 34 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- Having reliable formula available is a huge relief for both my wife and me.
- We focus a lot on safety and quality. I welcome more inspections.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 9 | 5 |
| Year 3 | 9 | 5 |
| Year 5 | 9 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Student (Miami, FL)
Age: 23 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 4.0 years
Commonness: 7/20
Statement of Opinion:
- I don't have the means to stock up, so knowing the formula will always be available helps.
- I'm glad they're making sure the formula stays safe too.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 4 |
| Year 2 | 7 | 3 |
| Year 3 | 7 | 3 |
| Year 5 | 7 | 4 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Stay-at-home mom (Denver, CO)
Age: 30 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- I need formula to supplement breastfeeding, but I'm always nervous about shortages.
- More inspections sound good to me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 6 |
| Year 20 | 8 | 7 |
Infant Formula Manufacturing Plant Manager (Columbus, OH)
Age: 45 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- Our plant will have to meet a lot of new demands.
- I'm nervous about audits, but they might help stabilize our supply chain.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 4 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Pediatric Nurse (Atlanta, GA)
Age: 39 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- It's crucial for infants' health that formula be both available and safe.
- Policy sounds like it protects against shortages, which is my main concern.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 9 | 6 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 7 |
Accountant (New York, NY)
Age: 27 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 6.0 years
Commonness: 5/20
Statement of Opinion:
- Formula prices and availability stress me out.
- I'm optimistic about the policy preventing more shortages.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 8 | 4 |
| Year 3 | 8 | 3 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 6 |
| Year 20 | 8 | 7 |
FDA Regional Inspector (Tulsa, OK)
Age: 52 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 7.0 years
Commonness: 1/20
Statement of Opinion:
- We have a lot on our plate now with increased checks.
- The focus on safety aligns with our mission.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 4 |
| Year 20 | 7 | 6 |
Executive (Los Angeles, CA)
Age: 31 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- I've heard horror stories about formula shortages.
- A policy addressing this is reassuring when expecting my first child.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 9 | 8 |
Logistics Coordinator (Seattle, WA)
Age: 38 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 4.0 years
Commonness: 3/20
Statement of Opinion:
- Ensuring stable formula supply is challenging yet crucial.
- This policy might stabilize the logistics and supply chains.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $70000000 (Low: $50000000, High: $100000000)
Year 2: $72000000 (Low: $51000000, High: $102000000)
Year 3: $74000000 (Low: $52000000, High: $104000000)
Year 5: $78000000 (Low: $55000000, High: $110000000)
Year 10: $85000000 (Low: $60000000, High: $120000000)
Year 100: $150000000 (Low: $100000000, High: $220000000)
Key Considerations
- The FDA's capability to execute additional inspections effectively will directly determine the enforcement success of the bill.
- The willingness and capacity of infant formula manufacturers to adapt to these regulatory changes will affect overall market stability and the incidence of shortages.
- Depending on the extent of required investments in facilities and production changes, costs to manufacturers could impact pricing and availability in the short term.
- Implementation under the Defense Production Act could grant expedited production capabilities but also implies the need for coordination and compliance from manufacturers.