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Health alerts, smuggling and counterfeiting: the current state of the infant formula market


The beginning of 2026 exposed one of the most sensitive vulnerabilities of fast-moving consumer goods trade in Latin America: the safety of infant formulas. Within a few weeks, two health authorities in the region — Colombia’s National Institute for Food and Drug Surveillance (INVIMA) and Mexico's Federal Commission for Protection against Health Risks (COFEPRIS) — issued independent alerts which, although responding to distinct phenomena, converge on the same diagnosis: the premium infant nutrition market is an attractive target for illicit trade, smuggling and counterfeiting, with consequences that transcend commercial matters and directly impact public health.


The Colombian case originated on 26 January 2026, when INVIMA issued a health alert regarding specific batches of the Alula Gold Premium and Alula Gold Comfort Premium formulas, marketed by Sanulac Nutrición Colombia S.A.S. The alert identified contamination with the cereulide toxin, a metabolite associated with the Bacillus cereus bacterium with the capacity to generate food poisoning syndromes in infants, a population of maximum physiological vulnerability. The origin of the notification was not national, but arrived through two international surveillance mechanisms: the International Food Safety Authorities Network (INFOSAN) and the European Union's Rapid Alert System for Food and Feed (RASFF), which demonstrates that the detection of the risk occurred outside Colombian borders before activating the local response. INVIMA published a list of more than thirty presentations and affected batches, with expiries until the end of 2027, and requested territorial health secretariats to carry out active search, inspection and control actions, in addition to urging distributors not to commercialise the indicated batches, under warning of sanitary security measures. Sanulac, for its part, voluntarily initiated the market recall of the contaminated batches, a response that mitigates the immediate risk but does not eliminate the exposure derived from informal distribution channels.


A similar pattern, though of a different nature, occurred in Mexico. COFEPRIS issued an alert in January 2026 regarding counterfeit products of Abbott Nutrition's Similac line, detected mainly in e-commerce and digital marketplaces; research originated from the previous year. Unlike the Alula Gold case, this is not a quality problem in legitimate production, but rather pure counterfeiting: the manufacturer is unaware of the origin of the counterfeit batches, which implies a total absence of certainty regarding the hygiene, ingredients and processes under which they were manufactured. The Mexican authority urged the population to refrain from purchasing infant formulas on digital platforms of dubious origin and to report suspicious establishments or sales profiles.


Although both episodes have different origins; one derived from a failure detected at an advanced stage of quality control and the other from deliberate counterfeiting, their joint reading reveals a deep-seated regional situation. The Colombian infant formula market already showed structural vulnerability towards illegal trade: INVIMA itself has issued previous alerts for the sale of formulas without sanitary registration through e-commerce, a conduct classified as fraudulent food in accordance with Resolution 2674 of 2013. This means that, beyond the Alula Gold alert, an indirect but critical risk exists: that recalled batches reappear in informal or digital channels, evading controls and reaching vulnerable consumers anyway without knowledge of the health risk they represent.


To this is added the risk of brand counterfeiting, with documented precedents in the Colombian dairy segment. INVIMA has previously warned about the counterfeiting of powdered milk from brands such as Proleche and Induleche, which confirms the established capacity of organised crime to replicate packaging and mass-market dairy products. Under that logic, a premium brand like Alula Gold, undergoing an image crisis derived from cereulide contamination, becomes an attractive target for counterfeiters seeking to exploit the media situation and the established consumer distrust. The Similac case in Mexico confirms that this dynamic is not hypothetical: highly recognised international brands have already been effective victims of counterfeiting.


The regulatory and operational dimension of the problem is also not limited to a single country. Sanulac reported the same cereulide contamination in Mexico, in products imported from France, and in Chile it notified an equivalent alert to SERNAC for Alula Gold formulas distributed between 2025 and 2026. The simultaneous exposure in three Latin American markets multiplies recall costs, complicates regulatory procedures before different authorities and amplifies the reputational impact transnationally, requiring companies to undertake simultaneous legal and communications coordination across multiple jurisdictions.


Finally, the reputational and emotional dimension of the phenomenon cannot be underestimated. Infant formulas constitute, probably, the mass-consumer product with the highest emotional sensitivity in the market, given that they directly involve the health of infants. Any health alert in this segment activates a media and social response disproportionate compared to other products, generating brand abandonment even among consumers who never purchased the affected batches.


In synthesis, the executive summary of risks that emerges from both precedents allows the identification of five main fronts: the smuggling of recalled batches, classified as a high risk due to its direct impact on public health and exposure to regulatory sanctions; brand counterfeiting, also at a high level, with consequences for corporate reputation and the legal liability of manufacturers; contamination in the supply chain, at a medium-high level, translated into recall costs and eventual litigation; multinational regulatory exposure, equally medium-high, associated with higher operational costs and sanctions in different jurisdictions; and reputational damage among consumers, at a medium level, with a direct incidence on the loss of market share. Together, these risks configure a scenario in which health safety, the supply chain and the monitoring of illicit trade cease to be independent variables to become a single comprehensive management problem for the infant nutrition industry in the region.



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