Bill Overview
Title: Protecting Infants from Formula Shortages Act of 2022
Description: This bill imposes requirements on manufacturers of infant formula and medical foods for individuals with inborn errors of metabolism. A manufacturer of such a food must notify the Food and Drug Administration (FDA) of any circumstance that is likely to lead to a meaningful disruption of the U.S. supply of the food, including a discontinuance or interruption of manufacturing. The manufacturer must submit the notification at least six months prior to the cause of the disruption or, if that is not possible, as soon as practicable. The FDA must provide the Department of Agriculture and appropriate organizations information about the cause of the disruption. The FDA must inform a person (an individual or entity) of their failure to comply with these notification requirements. If the failure continues for a certain time period, the person shall be subject to fines, imprisonment, or both. During a public health emergency, the FDA may impose additional conditions for such notifications and designate additional categories of food that are subject to the notification requirements. The bill also requires each manufacturer of such a food to develop and maintain a redundancy risk management plan that identifies and evaluates risks for each manufacturing establishment for the food.
Sponsors: Sen. Casey, Robert P., Jr. [D-PA]
Target Audience
Population: Infants dependent on formula and medical foods
Estimated Size: 7000000
- The bill addresses potential formula shortages which directly affect infants who rely on formula as their primary source of nutrition.
- Infants with specific medical conditions requiring specialized medical foods also depend on uninterrupted supply lines.
- The bill mandates manufacturers of these goods to notify the FDA of potential disruptions, directly affecting operational procedures and possibly supply outputs.
- Parents and guardians of infants are impacted as they require assured access to these products.
- Healthcare providers and hospitals involved in infant care and nutrition are indirectly affected.
- The entire supply chain for infant formula and medical foods, including suppliers, distributors, and retailers, would experience procedural impacts due to the new regulatory requirements.
Reasoning
- The estimated target population is 7 million infants in the U.S., based on birth rates and formula dependency rates.
- The policy primarily affects parents or guardians of infants who rely on formula, manufacturers and employees involved in the production of infant formula and medical foods.
- Healthcare providers, while indirectly affected, play a crucial role in advising parents on nutrition options and managing potential shortages.
- Manufacturers need to comply with new notification and redundancy planning requirements, potentially affecting operational costs and product pricing.
- The budget constraints and the policy focus limit the impact to primarily within the U.S., affecting only the relevant domestic supply chains.
Simulated Interviews
IT Professional (Austin, TX)
Age: 30 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- I had concerns about formula shortages, especially during emergencies or supply chain disruptions.
- This new policy seems reassuring; knowing manufacturers must notify about potential shortages could prevent panic buying and shortages.
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 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Logistics Manager (Des Moines, IA)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 8/20
Statement of Opinion:
- Supply chains are often overlooked until a crisis hits. This policy could improve preparedness.
- If implemented well, it might prevent the horror stories of parents unable to find formula.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 4 |
| Year 20 | 5 | 3 |
Stay-at-home mom (San Francisco, CA)
Age: 28 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- Keeping consistent access to formula is vital for my twins' growth and health.
- This policy sounds like a good safety net for parents like me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 5 |
| Year 2 | 7 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 6 | 3 |
| Year 10 | 6 | 3 |
| Year 20 | 5 | 2 |
Pediatric Nurse (New York, NY)
Age: 36 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 4.0 years
Commonness: 7/20
Statement of Opinion:
- This legislation could relieve stress for many parents struggling to access formula.
- From a healthcare perspective, it ensures consistent provisioning for those infants who cannot breastfeed.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 4 |
| Year 20 | 7 | 4 |
Retail Worker (Miami, FL)
Age: 25 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 4.0 years
Commonness: 3/20
Statement of Opinion:
- I can't afford to stock up on formula; it's important to know it'll be on the shelves when I need it.
- This bill gives me hope I won't have to worry about where the next can will come from.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 4 |
| Year 2 | 6 | 3 |
| Year 3 | 6 | 3 |
| Year 5 | 5 | 2 |
| Year 10 | 5 | 2 |
| Year 20 | 4 | 2 |
Policy Analyst (Boston, MA)
Age: 55 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 1.0 years
Commonness: 10/20
Statement of Opinion:
- I see this bill as a proactive step toward averting crises we've seen in the past.
- Its success will depend on manufacturers' compliance and the FDA's enforcement capabilities.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Biochemist (Seattle, WA)
Age: 33 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This legislation will increase our production responsibilities but should stabilize our supply chain.
- The redundancy plans might increase costs, but they are necessary to avoid disruptions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 4 |
College Student (Phoenix, AZ)
Age: 22 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 10/20
Statement of Opinion:
- I've seen parents panic when there's no formula on the shelves.
- It'll be interesting to see if this law changes anything; maybe more consistent stocking will ease the pressure at stores.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 5 | 3 |
| Year 20 | 4 | 3 |
Food Safety Inspector (Chicago, IL)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- I anticipate more stringent protocols at manufacturing plants, but that's a good thing for safety.
- Ensuring supply chain reliability falls in line with overall public health responsibilities.
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 | 7 | 5 |
| Year 20 | 7 | 5 |
Retired Teacher (Atlanta, GA)
Age: 60 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 9/20
Statement of Opinion:
- I've seen shelves empty, and it's terrifying when you're responsible for a child.
- This policy seems like a sensible approach to preventing those situations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 5 | 3 |
| Year 10 | 5 | 3 |
| Year 20 | 4 | 2 |
Cost Estimates
Year 1: $50000000 (Low: $40000000, High: $60000000)
Year 2: $40000000 (Low: $30000000, High: $50000000)
Year 3: $35000000 (Low: $25000000, High: $45000000)
Year 5: $30000000 (Low: $20000000, High: $40000000)
Year 10: $25000000 (Low: $15000000, High: $35000000)
Year 100: $10000000 (Low: $5000000, High: $15000000)
Key Considerations
- Ensuring FDA and manufacturers have adequate resources to manage new compliance duties.
- Implementation of risk management plans can deter shortages but require careful planning.
- Balancing administrative cost increase against the potential long-term savings from fewer shortages.