Bill Overview
Title: Babies Need More Formula Now Act of 2022
Description: This bill addresses the regulation of infant formula, including by authorizing the Food and Drug Administration (FDA) to waive certain requirements related to importation. The FDA may waive labeling requirements related to the importation (or distribution or sale) of infant formula from a country with requirements that provide a similar assurance of safety as U.S. requirements. The FDA must, when appropriate, enter into arrangements to harmonize U.S. regulatory requirements pertaining to infant formula with the requirements of other nations. The bill imposes time lines for the FDA to respond to submissions for market approval for new infant formula. The FDA must also issue guidance as to what types of changes in the ingredients of infant formula, if any, may not require a new growth study to meet FDA requirements. The bill also authorizes a person to import, without prior notice to the FDA, up to a three-month supply of infant formula for personal use from a country with formula safety standards similar to U.S. standards, such as Canada. Before recommending or requiring a recall of infant formula due exclusively to a labeling deficiency, the FDA must ensure that the recall will not negatively affect the supply of formula in the United States. The bill also requires the FDA to (1) notify Congress no later than 24 hours after initiating a formula recall, and (2) provide certain information to formula manufacturers about restarting production after an inspection of a manufacturing facility impacted by a recall.
Sponsors: Rep. Stefanik, Elise M. [R-NY-21]
Target Audience
Population: Infants and their caregivers/parents relying on infant formula worldwide
Estimated Size: 3800000
- The bill directly targets the regulation of infant formula, impacting infants who require formula for their nutrition.
- The legislation affects caregivers and parents who rely on infant formula to feed their babies by potentially increasing the availability of formula.
- Healthcare providers who guide and support infant nutrition will be impacted as their recommendations may evolve based on new regulatory guidelines and formula availability.
- Infant formula manufacturers and their operations will be impacted by modified regulatory processes and guidelines.
- Countries with infant formula safety standards comparable to the U.S. may find new market opportunities.
Reasoning
- The target population mainly includes parents or caregivers of infants who use formula. This includes diverse socio-economic and cultural backgrounds, given the universal nature of child-rearing.
- Healthcare providers like pediatricians might not directly use formula but will be influential in guiding formula choices; their wellbeing won't be directly impacted, but their professional practices will.
- Infant formula manufacturers are indirectly affected economically and operationally. Their wellbeing is more aligned to business success and compliance comfort, not personal wellbeing.
- Policy impact will vary by region; areas closer to borders or ports may see quicker benefits from import changes.
- Cost limitations suggest moderate initial policy reach primarily impacting immediate import and labeling changes. Longer-term effects will depend on broader adoption and supply changes.
- The scale of potential beneficiaries (target ~3.8M) is substantially large, but the direct impact may only reach a fraction (depending on existing market penetration of foreign formulas).
Simulated Interviews
Stay-at-home mother (Los Angeles, CA)
Age: 32 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- I'm hopeful this policy will make it easier to get formula, especially during shortages.
- Having more brand options could better suit my baby's needs and my budget.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
Pediatrician (Chicago, IL)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 10/20
Statement of Opinion:
- It's crucial that formulas are safe, so if there are more options that are compliant, that's a good thing.
- Education on imported formulas will be key to helping parents make safe choices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Infant formula manufacturer employee (Austin, TX)
Age: 38 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- This policy could streamline some of our processes, ensuring faster market entry for new formulas.
- We need to ensure our labeling aligns well to avoid potential recalls.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Single mother (New York, NY)
Age: 25 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- Sometimes it feels impossible to find affordable formula, especially during scarcity.
- If this helps me find cheaper alternatives, I'll be very grateful.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 4 |
Logistics manager for a formula import company (Seattle, WA)
Age: 35 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- It's essential for us to keep up with clever regulatory requirements to avoid delays.
- Any simplification in the import process could improve our operations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Farmer and parent of twins (Rural Kentucky)
Age: 42 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- We often have to travel far to find the organic formula we trust.
- I'd welcome anything that makes getting safe, varied formula options cheaper and easier.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 5 | 5 |
| Year 10 | 5 | 4 |
| Year 20 | 5 | 4 |
Healthcare policy analyst (Boston, MA)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 6/20
Statement of Opinion:
- This policy is a move towards making infant nutrition more secure in crisis situations.
- We need to balance the import freedom with rigorous safety checks.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Import/export business owner (Miami, FL)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 4.0 years
Commonness: 8/20
Statement of Opinion:
- This could be a business opportunity if we increase import capacity responsibly.
- Efficient management of labeling can avoid unexpected halts in distribution.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 6 |
Nurse practitioner (San Diego, CA)
Age: 30 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 9/20
Statement of Opinion:
- It's always beneficial to have more formula choices that are safe for babies.
- We'll need resources to correctly advise parents on the best options available.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 7 |
Retired economist (Philadelphia, PA)
Age: 60 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 0.0 years
Commonness: 12/20
Statement of Opinion:
- It is promising that this policy could stabilize formula availability and indirectly lessen economic variability for families.
- There might be long-term benefits in expanding international trade partnerships because of this.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Cost Estimates
Year 1: $3000000 (Low: $2500000, High: $3500000)
Year 2: $2500000 (Low: $2000000, High: $3000000)
Year 3: $2500000 (Low: $2000000, High: $3000000)
Year 5: $2000000 (Low: $1500000, High: $2500000)
Year 10: $1500000 (Low: $1000000, High: $2000000)
Year 100: $500000 (Low: $400000, High: $600000)
Key Considerations
- The FDA must balance new regulatory practices with maintaining safety and quality standards.
- Potential international trade implications due to increased importation and harmonization of standards.
- Public and industry perception of changes in safety regulation could impact adoption and acceptance of new imported formulas.
- Innovation in formula manufacturing and composition could be stimulated by altering regulatory requirements.