Updates on Formula Shortage

Page updated 7/13/22

Background

In February 2022, the U.S. Food and Drug Administration (FDA) announced investigation of consumer complaints of Cronobacter and Salmonella infections. All cases reportedly consumed powdered infant formula produced from the Abbott Nutrition facility in Sturgis, Michigan, and advised consumers against using specific logs of Similac, Alimentum, or EleCare powered infant formulas. Abbott soon issued a voluntary recall of powdered formulas manufactured in Sturgis. APFED is updating this page with resources and information as it becomes available.

 

Information and Resources from Abbott

• Current updates on Abbott’s Sturgis Plant and Formula Production
  • Link above includes updates on June 15 regarding facility flooding, which could delay production and distribution of new product for a few weeks.
• Abbott to Release EleCare(R) Amino Acid-Based Formulas to Help Meet Critical Patient Need (May 24, 2022)
• Letter and urgent medical need form for health care professionals with instructions and more information about how to order EleCare or EleCare Jr Vanilla for patients with urgent medical needs. (May 2022)
• SimilacRecall.com. This website is dedicated to this recall so that parents can get information, determine if the product they have is included in the recall using the lot locator, and learn how to secure a refund or replacement product.
• Abbott Consumer Relations Hotline: 1-800-986-8540
• Video for pediatricians on Similac.com
• Video for pediatricians on  EleCare.com

 

Information and Resources from FDA

• FDA Statement: FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers (July 6, 2022)
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program
• FDA Update: Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies (June 27, 2022)
• FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase US Supply (May 26, 2022)
• FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability (May 16, 2022)

• FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products (May 10, 2022)

Information and Resources from HHS

• US Department of Health and Human Services Infant Formula Website: hhs.gov/formula
• US Department of Health and Human Services Infant Formula Social Media Toolkit: https://www.hhs.gov/formula/social-media-toolkit/index.html

Information and Resources from the White House

• White House Fact Sheet on the Biden-Harris Administration’s Progress Addressing the Infant Formula Shortage:
• https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/17/fact-sheet-the-biden-harris-administrations-progress-addressing-the-infant-formula-shortage/
• White House Infant Formula Website: https://www.whitehouse.gov/formula

Information and Resources from Medical Societies and Nonprofit Organizations

• North American Society For Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) Tools for Infants and Children Affected by Formula Shortages: https://naspghan.org/recent-news/naspghan-tools-for-hcps-affected-by-formula-recall/
• Facts about imported baby formula from the American Academy of Pediatrics: https://downloads.aap.org/HC/ImportedFormula_FB.jpg
• The Patient Advocate Foundation (PAF) has announced a Pediatric Amino Acid Formula Emergency Assistance Fund to provide direct financial support to families impacted by amino acid-based formula shortages: https://www.patientadvocate.org/formulaemergencyassistancefund/

Information and Resources from Manufacturers of Other Brands of Amino-acid Based Formula

• Neocate’s blog post describes how they are addressing product demand, and they released this update.
• Update on EquaCare Jr. and Essential Care Jr. Availability (May 31)
• Puramino can be ordered online has a zip code locator to assist parents in finding the product locally. It may also be purchased through Amazon, Their customer number is 1-800-BABY-123 to assist parents with questions.

What You Can Do

• Speak to your doctor before making any changes to your/your child’s diet or before using an alternative to regular brand of formula (see below).
• Do not dilute formula, such as by adding water, in attempt to make your existing supply last, nor attempt to make your own formula.

APFED Advocacy

APFED is sharing information with patients and caregivers about the recall, and communicating questions and patient impacts to clinicians and researchers, the press, and to formula manufacturers. We are working collaboratively with research partners and other organizations to capture patient experience with accessing specialty ingredients and amino acid formulas during supply chain disruptions due to COVID and to this formula recall, and the impacts on disease management and health. The goal is a publication in the near future that documents barriers to access and can help inform future policies and frameworks to improve access to medical foods in the event of supply chain disruptions. We are also continuing our ongoing advocacy for passage of the Medical Nutrition Equity Act (see below for details).

 

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Medical Nutrition Equity Act

The current formula shortage is a significant crisis, and we expect resolution in the near future. For those who are denied reimbursement by insurance for elemental formula, the lack of access will continue until there is legislation to facilitate that access. Please join us in calling on Congress to resolve this issue through enactment of the Medical Nutrition Equity Act. Visit nutritionequity.org to learn more and to take action!

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