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Else Nutrition
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==== Infant formula ==== Infant formula does not technically require FDA approval before it can be marketed in the United States, but it cannot be marketed until the manufacturer receives a ‘no objection’ letter from the FDA. The formula must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula. The infant formula manufacturer must provide assurance that the formula will provide adequate nutrition for infants to thrive. The infant formula needs to undergo preclinical and clinical trials to this end, and the manufacturer must receive a ‘no objection’ letter from the FDA, effectively granting approval. The development of these trials has been completed, and collaborations are already in place with world-class investigators to oversee and advise on the clinical growth study protocols. Marketing and approval processes vary by country, though clinical research performed in one country can usually be used for approval elsewhere (as long as all jurisdictions’ requirements are met). Else’s clinical study is designed to meet both FDA and European Food Standards Authority (EFSA) requirements, and is planned to finish by the end of FY23. In addition, clinical research is being performed to validate clinical claims for Else’s product suite on growth, hypoallergenicity and tolerance. Edison notes there are ongoing delays in the reviewing process by the FDA and other regulatory agencies, primarily caused by the pandemic and the resulting refusal of medical centres to recruit subjects for clinical studies, the closure of testing laboratories and the imposition of restrictions. The clinical infant growth study is expected to complete by end FY23, with submission to the FDA filed thereafter. Management expects the overall cost of this to be c US$5–6m. The current shortage of infant formula in the US market has been widely publicised. While the shortage is particularly acute in the hypoallergenic segment (it was caused by the recall of Similac hypoallergenic lines), it has caused panic-buying among consumers and thus has become more widespread. Else’s infant formula is not yet available as the company is still going through the steps to meet FDA requirements to obtain a no-objection letter, but the general lack of availability of the bigger brands of formula should serve as a tailwind for a new and disruptive brand such as Else.
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