Bubs Australia has lodged a letter of intent with the FDA for permanent market access in the USA to October 2025 and beyond. It is one of eight infant formula manufacturers globally to receive FDA regulatory acknowledgement, enabling the safe import of all six Bubs Infant Formula products under the enforcement discretion.
Bubs announced lodgement of the Letter of Intent to the FDA as required under FDA Guidance for Industry – Infant Formula Transition Plan for Exercise of Enforcement Discretion (Transition Plan) issued on 1 October 2022.
The Transition Plan is applicable only to those that have received the enforcement discretion and provides a clear regulatory pathway and framework of requirements for Bubs Infant Formula to gain permanent access without interruption to supply to American families.
The FDA intends to issue a Letter of Acknowledgement in response to the Letter of Intent, which if appropriate, will state that the enforcement discretion will be extended under the Transition Plan until October 2025, provided that the manufacturer continues to make meaningful progress toward compliance with the Transition Plan.
Bubs founder and CEO, Kristy Carr said that given the overwhelming positive response received from American parents, caregivers, health care professionals and retailers, Bubs was pleased to be able to commit to remaining in the United States for the long term.
“We are pleased to announce confirmation of our continued commitment to work with the U.S. Food and Drug Administration and welcome this important FDA announcement.
“Since first receiving a green light from the FDA on 27 May 2022, allowing Bubs to import all six of our safe and clean infant formula products into the United States, we have worked closely with the Biden Administration, the U.S. Department of Health and Human Services, the FDA, and leading retailers across the country to ensure continued supply of Bubs Infant Formula were directed to those areas with the greatest need.
“This commitment and the FDA’s announcement also mean American parents who are already safely using Bubs Infant Formula products, as well as our retail partners now stocking our formula in 6,500 stores across 42 states, can remain confident in ongoing supply, without interruption, providing more choices for American families seeking safe, clean nutrition for their children.
“Importantly, the FDA announcement also provides continued support for the ongoing expansion of our U.S. distribution footprint, as we look forward to launching Bubs Infant Formula products in various new retail groups in the months ahead,” said Carr.
Bubs Infant Formula is now ranged in 6,500 stores within the country’s largest infant formula retailers; Walmart, Kroger, Albertson Safeway, Target, Whole Foods, Buy Buy Baby, Meijer, Hy-Vee, Thrive.com and Amazon.
Bubs executive chair, Dennis Lin, said consumers could continue to have the highest level of confidence in the safety and quality of Bubs products while it works with the FDA to complete the regulatory requirements.
“Our long-standing commitment to the United States means we are ready to move expeditiously to complete the FDA process as we continue to expand our U.S. team and ramp up production.
“This together with the other important regulatory milestone of the new SAMR GB registration pathway for Bubs China Label Infant Formula products, means we are truly placed in the ideal position of being able to access the world’s top two infant formula markets – China and the USA. Once achieved, this will be a global first for any Australian or New Zealand company,” said Lin.
