FDA Communications About Baby Formula

In the midst of the baby formula shortage, the U.S. Food and Drug Administration has compiled resources for companies and parents.

A website provides “information about additional products headed to the U.S.” I find the language rather jargony and apparently targeted to companies seeking “enforcement discretion,” a technical term. The audience doesn’t seem to be parents.

A statement about the organization’s work sounds defensive and, again, not audience focused:

“We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. as quickly as possible,” said FDA Commissioner Robert M. Califf, M.D. “We continue to work closely with our U.S. government partners and domestic and international manufacturers to identify additional formula product that will be available to parents and caregivers in the weeks and months ahead. It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”

The following paragraph is a good one for business students to revise. If this were intended for worried parents, how could the segment be more reassuring? What is most important to parents? (Hint: When will products be available?)

On Tuesday, the FDA announced that it informed Kendal Nutricare that the agency is exercising enforcement discretion for the importation of certain infant formula under the Kendamil brand. Under the agency’s recent increased flexibilities regarding importation of certain infant formula products, the company initially estimates that about 2 million cans of infant formula (over 50 million full-size, 8-ounce bottles) are expected to land on U.S. store shelves beginning in June. Kendal Nutricare also currently has over 40,000 cans in stock for immediate dispatch. The FDA also announced that it is not objecting to the release of about 300,000 cans of EleCare amino acid-based infant formula previously produced at Abbott Nutrition’s Sturgis, Michigan, facility to individuals needing urgent, life-sustaining supplies of this specialty formula on a case-by-case basis. These products will undergo enhanced microbiological testing before release.