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FDA urges infant-formula firms to strengthen supplier oversight
The FDA tied its push to two separate multi-state infant botulism investigations involving ByHeart and Nara Organics, plus a separate cereulide-linked contamination event that affected 10 countries.
The U.S. Food and Drug Administration on July 13 urged infant-formula manufacturers and their supply-chain partners to increase substantive oversight of suppliers after multiple recalls and recent botulism-related cases, including what the agency said were the first U.S. infant-formula botulism outbreaks in nearly 50 years.
In a letter, the FDA said it investigated two multi-state outbreaks of infant botulism associated with powdered infant formula from two separate brands, ByHeart and Nara Organics, and that the products were recalled. The agency said it expects companies to know where ingredients come from, how they are produced, what risks they carry, and whether those risks are effectively controlled.
The FDA also pointed to a global contamination event from late 2025 through early 2026 involving cereulide intoxication, with nearly 150 suspected and confirmed cases reported across 10 countries, traced to contaminated arachidonic acid oil used as an ingredient. Separately, in May, New Zealand’s a2 Milk recalled three batches of its a2 Platinum formula sold in the U.S. after detecting cereulide.
The FDA said these public-health events reflect a pattern that warrants attention from both the agency and the infant formula industry, and it recommended that manufacturers and supply-chain partners closely monitor safety signals such as recall notifications, outbreak investigations, and import alerts. The agency said it is continuing to investigate the root causes of the 2025 and 2026 infant botulism outbreaks, according to Insurance Journal.
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