- We recognize the frustration of Americans who need infant formula and that’s why the President and his Administration are working 24/7 to do more to make more infant formula supply. This shortage exists because Abbott closed a facility in MI because of safety concerns from the FDA. The FDA is working closely with Abbott to bring the facility back online – safely. Abbott and the FDA have agreed on detailed next steps to re-open Abbott’s Sturgis plant.
- We also have launched Operation Fly Formula flights to cut what is 3 week or longer travel timeline to 72 hours respectively. Now, we’ve transported the equivalent of 1.5 million 8 oz bottles. That will cover about 15 percent of the overall national volume of specialty formula that we need.
- Additionally, the FDA has announced that high quality, safe formula from other countries will be coming into the country. WIC waivers have been granted to all 50 states and USDA is working to cut additional red tape to get more formula to shelves. Some families might need to switch brands temporarily, which I know is cold comfort. But across the Administration, we are working 24/7 to get more infant formula supply out as quickly as possible.
These are new actions being taken to complement and build upon work the Biden-Harris Administration has been doing across the federal government since day one of the recall.
- The recall happened on February 17. On February 18, USDA issued detailed guidance to states on how to seek waivers in their WIC programs. We are building on that work with this week’s announcement urging states to cut all WIC red tape.
- In the time since, agencies have been working closely with manufacturers to help them optimize process and boost production. Because of quick action, today there is more infant formula coming off factory production lines in the U.S. than before the Abbott factory recall. That didn’t happen on its own.
- For the last three months, the FDA has been working with retailers to impose purchasing limits to prevent the possibility of hoarding.
- And of course, the scientists and experts at FDA have been working around the clock to determine how to safely get this one facility re-opened.
Make no mistake, there is absolutely more work to do. But the bottom line is we have been treating this situation with the seriousness it deserves and will continue to do so.
- Once the product lands in the U.S, manufacturers will work to distribute product through their existing distribution channels. We are working closely with companies to identify channels of most need, especially for specialty formula.
- The first shipment was amino acid-based formula, which is a specialty medical product that is distributed primarily through medical channels like hospitals and home health agencies.
- For the second shipment, which was extensively hydrolyzed (hypoallergenic) formula, once it arrived at Washington Dulles, the product was immediately transported to the Nestle distribution center near Allentown, PA where it will be sent for delivery through regular channels to major retailers nationwide, state WIC programs, and hospitals beginning as soon as this weekend.
- Fly Formula product from these first two shipments will be available to all 50 states.
- Generally speaking, Operation Fly Formula is helping safely accelerate our ability to get product into the United States.
- With the first two flights, we’ve cut 3 or more-week timelines into 72-hour windows. That is a huge difference.
- We expect that communities will benefit from Operation Fly Formula because it will allow manufacturers to move through their order backlogs more quickly, reducing the ultimate amount of time all stores will have to wait for formula.
For the first shipment, we expect the products to go through medical channels like hospitals and home health agencies and for the second shipment, the major retailers nationwide, state WIC programs and hospitals beginning as soon as this weekend.
- The first shipment is specialty medical products (amino acid-based formulas), and they are distributed primarily through medical channels hospitals and home health agencies, so we do not anticipate that will end up on store shelves.
- The second shipment, however, was extensively hydrolyzed (hypoallergenic) products. Once it arrived at Washington Dulles, the product was immediately transported to the Nestle distribution center near Allentown, PA where it will be sent for delivery to major retailers nationwide as well as state WIC programs and hospitals beginning as soon as this weekend.
- We have confirmed products will be available to all 50 states.
- Yes. We will rely on the manufacturers to work through their existing distribution channels, including retailers.
- FDA is prioritizing review of enforcement discretion applications with a clear distribution plan to get formula to American consumers quickly.
- We do not own the product and will not be distributing it directly. Companies will be managing distribution through their normal channels.
- In other words, families will get this product where they always do.
- Nestle has been very receptive to our requests about prioritizing distribution to hospitals and WIC agencies, but this is their job, not ours, so we cannot estimate how much each state will get.
- However, we have confirmed products will be available to all 50 states.
- It will depend on the exact regulatory status of the specific product. In general, this may include inspections by CBP, USDA, and FDA, and we have been working closely with our federal partners to expedite that process.
- All products will be labeled in English, but this may not include the standard U.S. label. (E. g. the nutritional information may look different from U.S. standards. FDA is exercising enforcement discretion to allow those sort of label differences.)
- The Nestle/Gerber product from the first two shipments was intended for the U.S. market, so it was already labeled in English with the standard U.S. label.