FDA’s strategy ushers in a new era for the infant formula industry, emphasizing resiliency and safety, with manufacturers challenged to adapt to stricter regulations, innovate and anticipate market shifts.
The agency’s long-term national strategy, released late last week, aims to strengthen the resiliency of the US infant formula supply chain by addressing vulnerabilities in production, supply and regulatory oversight.
The 2022 infant formula shortage exposed unprecedented vulnerabilities in the US supply chain, including an overreliance on a handful of manufacturers and gaps in regulatory preparedness. FDA’s long-term national strategy intends to avoid future shortages, bolster consumer confidence in US infant formula safety and availability and encourage innovation and diverse competition in the market.
To ensure safety and prevent contamination in formula production facilities, FDA says it will conduct yearly safety inspections, including microbiological and nutritional sampling of infant formula and improve training for inspectors (e.g. in-person workshops). FDA’s contamination prevention efforts include a strategy to prevent Cronobacter sakazakii illnesses linked to powdered infant formula and will weave in new research from the National Advisory Committee on Microbiological Criteria in Foods (NACMCF) to enhance food safety practices, detection methods and supply chain resiliency, according to FDA. Further, the agency intends to collaborate with manufacturers to streamline best practices for sampling, corrective actions or root cause analyses.
In terms of strengthening supply chain, FDA encourages manufacturers to diversify production facilities and reduce reliance on single suppliers for critical ingredients. Further, FDA recommends manufacturers, particularly specialty formula manufacturers, develop redundancy risk management plans (RRMPs) in the event of disruptions such as pandemics or facility closures. Manufacturers also are encouraged to track production and inventory levels for early detection of potential supply disruptions.
For new and existing manufacturers, FDA intends to streamline premarket reviews by prioritizing and expediting reviews of new formula submissions to reduce the risk of shortages.
On a global level, FDA highlighted the need for global regulatory harmonization to improve supply chain flexibility during shortages, including continued participation in international standards committees, like Codex Alimentarius – which is a joint initiative between the Food and Agriculture Organization (FAO) and the World Health Organization (WHO).
Biotech-derived ingredients may help future-proof infant formula market
Biotech companies like All G and Arla Foods aim to address infant formula supply in the US.
Last month Sydney-based biotech company All G’s recombinant bovine lactoferrin achieved Generally Recognized as Safe (GRAS) status in the US, and regulatory approval for use in China. All G’s lactoferrin is identical to the protein in women’s breast milk, and can be used across a variety of applications, including infant formula.
Arla Foods’ whey protein hydrolysates, also GRAS, is cost comparable to other active ingredients like lactoferrin, HMOs and alpha-lactalbumin that target gut health, immunity and allergies in infants. The company’s manufacturing facility in Europe produces a variety of hydrolysates in large quantities to reach a global market and contribute towards shortage risks.
