Metabolic Formula Supply Issues as a Result of the Abbott Product Recall – The Effects of the Formula Shortage on the Metabolic Community

The Abbott Nutrition Plant in Sturgis, MI. restarted production of metabolic products on August 1, 2022. In early July, Abbott stated that metabolic products would be available approximately 6-8 weeks after the start of production, but they have not provided a more specific timeline since then. Please see Supplier Updates for additional information. Affected products are listed here.

The Abbott Nutrition Plant in Sturgis, MI. re-opened on July 1, 2022. Production of Elecare has begun, but no timeline for the restart of manufacturing of metabolic formula has yet been provided. Please see Supplier Updates for additional information. Affected products are listed here.

The Abbott Nutrition Plant in Sturgis, MI. re-opened on June 4, 2022, although no timeline for the production of metabolic formula was provided. On June 15, 2022, it was closed due to storm damage. Please see Supplier Updates for additional information. Affected products are listed here.

On 5/11/2022 Abbott Nutrition released a statement saying that they would be able to re-start manufacturing at the Sturgis plant within two weeks subject to FDA approval, and that it would take 6-8 weeks after the restart of manufacturing for product to be available on shelves. The six-to-eight week period cited by Abbott is for standard baby formulas. While they will prioritize the production of metabolic and other speciality formulas, Abbott has said that

“metabolic formulas have a longer manufacturing process and we’ll be able to provide more information [on timing of availabilty] once the plant is up and running.”

The FDA has given no indication yet when they will clear the plant for re-opening, so the clock has not yet started. This means that once the FDA does approve the re-opening of the plant, it will be more than 2 months at the earliest before newly-manufactured metabolic formula can be shipped to patients from DMEs and pharmacies. Please keep this in mind as you work with your clinical team to ensure you have sufficient formula for the coming weeks and months. Other metabolic formula manufacturers continue to increase production, and all efforts should be made to transition to another brand when possible.

As of 4/28/2022 the FDA has cleared Abbott to release metabolic products from the Sturgis, MI facility that have already been manufactured. This will relieve some of the immediate supply issues but keep in mind:

It will take some time to process orders, which must go through your clinic. Abbott will be sending a one-month supply, free of charge, to patients designated by their clinics.
Clinics have been instructed to give priority to those who have not yet started transitioning to a non-Abbott product, or who are struggling with the transition. Abbott advises any other patients continue their transitions to non-Abbott products.
The FDA has not yet given clearance to Abbott to resume MANUFACTURING of any formulas at the Sturgis plant. There may be another supply lag/shortage depending on when that clearance comes. The FDA has not given a timeline for the manufacturing restart.

** PLEASE NOTE ** This situation has emphasized yet another way the metabolic community can be put at risk because of our reliance on medical nutrition. We need your stories of how the hold is affecting you to bring attention to this situation. Please click here to share your experience.

Update as of 4/22/2022:

The coalition of organizations named above would like to provide the following update on the situation created by the FDA hold on Abbott’s Sturgis, MI facility. Our original statement is provided here. We are communicating with NORD, the FDA, the American Academy of Pediatrics (AAP), Genetic and Metabolic Dietitians International (GMDI) and metabolic formula suppliers to provide as much information as possible and work toward a resolution of the situation. To make progress, we need your help. Submit your story to help the FDA understand the impact on our community.

The FDA has not yet provided a date for releasing the hold on Abbott’s Sturgis, MI. plant so that metabolic formula from that facility can be released for distribution. Their response to our request for an update was as follows:

The FDA fully understands the risk to metabolic patients of inadequate access to medical foods and have given a resolution of this issue their highest priority. They cannot provide additional information about process and timeline as this is an ongoing investigation. (As of 4/5/2022).

These articles have additional details on the FDA’s inspection of the plant:

The situation remains urgent for thousands of families who use Abbott metabolic products. Transition to a new product is difficult, time-consuming, and incredibly stressful. In addition, other formula companies have been reporting supply issues, with some products on backorder, as patients switch from an Abbott product to another metabolic formula. Statements from Nutricia, Vitaflo, and Abbott are below, and we await statements from Cambrooke and Mead-Johnson.

As a coalition of patient organizations supporting the IEM community, the health and safety of those in our community is paramount. We also understand that the FDA has a set of procedures they must follow to clear the plant. That said, the impacts on the metabolic community are severe, and our request to the FDA is to prioritize above all else the testing and clearing of the metabolic products that have been manufactured already so that they be distributed to the patient community. To support this request, the FDA needs to hear from affected individuals and their families. Please click here to share how the formula shortage– of products from Abbott or other companies — has affected you. As a coalition we will share your stories with the FDA and with the media where appropriate.

3/15/2022: As you are likely aware, the FDA has placed a manufacturing and shipping hold on all products produced at Abbott’s Sturgis, MI. plant due to reports of bacterial infection in several infants who consumed their Similac, Alimentum, or EleCare powdered infant formulas. Abbott has voluntarily recalled these products. All of Abbott’s metabolic formula products are produced in this plant and are therefore affected by the manufacturing and shipping hold. There have been no reports of bacterial infection in individuals using these products and no metabolic products have been recalled. It is not known when this hold will be lifted.

The undersigned organizations have consulted with metabolic dietitians from across the U.S. and Canada, and representatives of Genetic Metabolic Dietitians International (GMDI), the Southeast Regional Genetics Network (SERN), Abbott, Nutricia, and Vitaflo, among others.

While we hope that the situation at the Abbott plant will be resolved quickly, and that the FDA will release the hold and allow Abbott to resume manufacturing and shipping of metabolic products, we have concluded that the most prudent course of action is for all metabolic patients to work with their clinicians to transition to a new formula as soon as possible as the timeline cannot be predicted.

Please be patient with your clinical teams as they reach out to you to facilitate this transition. This situation has placed an enormous burden on staff on top of their regular responsibilities. Please also understand that some metabolic disorders put people at higher risk of decompensation, and hospitalization, than others. Clinical teams must prioritize those patients, but rest assured they are working hard to make sure all patients have sufficient supply of a formula that is palatable and meets their nutritional needs. Your dietitians understand the challenges involved in changing formula and are doing their best to provide alternatives which will be acceptable to each patient.

We have been in contact with the FDA to express our concerns. They are well aware that metabolic formulas are essential to the health of our community and have issued a statement specifically regarding the metabolic products.

We will stay on top of this situation and keep you informed as new information becomes available.

Abbott Products Affected by the Sturgis Plant Closure

Glutarex-1
Glutarex-2
Cyclinex-1
Cyclinex-2
Hominex-1
Hominex-2
I-Valex-1
I-Valex-2

Ketonex-1
Ketonex-2
Phenex-1
Phenex-2
Phenex-2 Vanilla
Pro-Phree
Propimex-1
Propimex-2

ProViMin
Calcilo XD
Tyrex-1
Tyrex-2
Similac PM 60/40

Organizations who have signed onto these statements include