Botulism in Infant Formula and FDA Knowledge of Facility Deficiencies
Lessons for EU FSMP Manufacturers and Importers That Could Save Your Business from a Recall

The Sturgis case is not merely an American media precedent. It is a textbook example of a cascade of systemic failures: neglected verification of ingredient suppliers, an ineffective HACCP system, delayed communication with the supervisory authority, and — most critically from the perspective of EU law — the absence of documented risk management that could have served as a shield in administrative proceedings. EU rules governing FSMP create an apparently watertight safety net, but enforcement practice shows that manufacturers routinely confuse notification with authorisation, and documentary compliance with actual product safety.

FSMP in the EU: What This Product Is in Legal Terms and Why the Regulatory Regime Is Stricter Than for Ordinary Food

Food for special medical purposes (FSMP) is defined in Article 2(2)(g) of Regulation (EU) No 609/2013 as food that is specially processed or formulated and intended for the dietary management of patients under medical supervision. Infant formula and follow-on formula are additionally governed by Commission Delegated Regulation (EU) 2016/127, while FSMP for infants falls under Delegated Regulation (EU) 2016/128. These two delegated acts constitute hard law, not guidelines.

The key distinction from food for general consumption is this: an FSMP manufacturer is required to notify the competent authority of the Member State of the product's placement on the market (Article 9 of Regulation 609/2013), but notification does not constitute authorisation. The authority does not approve the composition — the manufacturer bears full responsibility for compliance with the compositional requirements set out in Regulation 2016/128. This distinction is of enormous significance in post-incident proceedings: the authority may find a violation even if the product was previously notified and no objections were ever raised.

• Regulation (EU) 2016/128 (FSMP): detailed compositional requirements, including microbiological limits consistent with the Codex Alimentarius and requirements for raw materials
• Regulation (EU) 2016/127 (infant formula): limits for Cronobacter spp. and Salmonella spp. — zero tolerance in 10 samples of 25 g each
• Regulation (EC) No 852/2004: general food hygiene requirements, including HACCP — applies to all stages of FSMP production
• Regulation (EU) 2017/625: powers of control authorities, including the right to suspend batches, order withdrawals, and mandate closure of production lines

Expert Tip: Expert Tip: Manufacturers frequently assume that because the authority did not challenge the notification, the product is 'approved'. Article 9 of Regulation 609/2013 does not provide for an approving decision — the authority's silence following notification does not constitute authorisation and provides no protective shield in post-inspection proceedings or in civil litigation brought by injured parties.

What Exactly Happened in Sturgis and Why This Is Not Solely an FDA Problem

The FDA's March 2022 report on Abbott's Sturgis facility (publicly available as the FDA Establishment Inspection Report [TO BE VERIFIED — FDA report reference number]) revealed: traces of Cronobacter sakazakii in the production environment, roof leaks, inadequate cleaning and disinfection procedures, and the absence of effective verification of control measures. FDA inspectors visited the facility in 2021 — several months before the first infant illnesses were reported. The product continued to be distributed nonetheless.

From the perspective of EU law, the analogy is as follows: had a similar situation occurred in the EU, the control authority acting under Article 137 of Regulation (EU) 2017/625 would have had the right — and the obligation — to order immediate corrective measures following the very first inspection revealing non-conformities. Article 138(2)(b) of Regulation 2017/625 expressly provides for an order to withdraw a product from the market or have it destroyed. A food business operator who continues production after being notified of non-conformities without a documented corrective action plan accepted by the authority exposes itself to criminal sanctions under national law (in Poland: Article 100(1)(1) of the Act of 25 August 2006 on food and nutrition safety).

One aspect of the Abbott case is particularly troubling for importers: the FDA was aware of the issues, yet the formula continued to reach the market for months. In the EU, an importer bears joint liability for a product's compliance with requirements — Article 15(1) of Regulation (EC) No 178/2002 prohibits the placing on the market of unsafe food regardless of whether the importer was aware of the problem. 'I did not know' is not an effective defence if the importer failed to conduct a supplier audit.

Expert Tip: Expert Tip: An importer of FSMP from third countries (including the United States) should, prior to each consignment, hold a current audit report for the manufacturer's facility, microbiological test results for the batch (Cronobacter, Salmonella, Listeria), and confirmation that the facility does not appear on the FDA's list of facilities with open corrective actions or on the RASFF database. This is not a recommendation — it is the minimum due diligence standard when defending against an allegation of infringement of Article 17 of Regulation 178/2002.

The RASFF System as a Mechanism That Moves Faster Than Manufacturers Expect

The Rapid Alert System for Food and Feed (RASFF) operates under Article 50 of Regulation (EC) No 178/2002. When a Member State authority identifies a serious direct or indirect risk to human health associated with food, it is obliged to notify the European Commission without delay; the Commission then disseminates the alert to all Member States. The time from notification to visibility of the alert in the RASFF database is frequently 24 to 48 hours.

Enforcement practice of the Polish Chief Sanitary Inspectorate (GIS) shows that Polish manufacturers and importers often learn of a RASFF entry from the media or from business partners rather than from their own monitoring systems. Yet a RASFF entry automatically triggers the manufacturer's or importer's obligations under Article 19 of Regulation 178/2002: immediate withdrawal from the market, notification of the competent authority, and documentation of all steps taken. Failure to document a response within 24 hours of becoming aware of the problem may itself be treated as an independent ground for a finding of infringement.

• RASFF alerts concerning FSMP and infant formula in 2022–2023 related primarily to: Cronobacter sakazakii contamination, the presence of Salmonella spp., incorrect composition (non-conformity with labelling declarations), and aflatoxins in whey protein [TO BE VERIFIED — number of alerts for the relevant year]
• A RASFF entry as a 'border rejection' upon import results in a prohibition on placing the consignment on the EU market and an obligation to destroy it or return it to the country of dispatch (Article 21 of Regulation 2017/625)
• A manufacturer whose product has been entered in RASFF can expect an immediate GIS inspection and a demand for documentation of the entire HACCP system, not merely the batch in question

Ingredient Supplier Auditing as a Legal Obligation, Not a Best Practice

In the Abbott case, one of the key problems was contamination of the production environment — not a direct raw material. In the EU, Article 5 of Regulation (EC) No 852/2004 places food business operators under an obligation to implement procedures based on HACCP principles. Critical control points (CCPs) in FSMP production must cover not only process parameters but also the verification of raw material suppliers, including milk proteins and hydrolysates used in hypoallergenic formulas.

Annex I to Regulation (EU) 2016/128 sets out detailed compositional requirements for FSMP for infants, including limits for undesirable substances. A manufacturer who cannot document that every supplier of whey protein or casein has undergone an audit covering verification of antibiotic use, mycotoxins, and microbiology does not meet HACCP requirements — which constitutes grounds for the imposition of administrative sanctions by the GIS without any need to demonstrate actual harm to health.

Expert Tip: Expert Tip: The minimum documentation for an ingredient supplier audit for FSMP consists of: a technical specification for the raw material including pathogen limits, a certificate of analysis (CoA) for each batch, an audit report for the supplier's facility (at least once every two years) or the supplier's FSSC 22000 or IFS Food certification. The absence of any one of these documents during a GIS inspection constitutes a recorded non-conformity with Article 5 of Regulation 852/2004 and grounds for initiating administrative proceedings.

Civil and Criminal Liability in Poland: What Specifically Is at Stake Following an Incident

The Act of 25 August 2006 on food and nutrition safety (Journal of Laws 2006 No 171, item 1225, as amended) provides in Article 100(1) for a fine for placing on the market foodstuffs that fail to meet health quality requirements. Administrative sanctions are one matter. Criminal liability under Article 165 § 1(2) of the Penal Code (creating a danger to the life or health of many persons by manufacturing or placing on the market harmful substances) carries a custodial sentence of between 6 months and 8 years.

A manufacturer's civil liability for a defective product is governed by the Act of 23 April 1964 — the Civil Code (Articles 449¹–449¹⁰), implementing Directive 85/374/EEC. The manufacturer is liable on a strict liability basis — without any need to establish fault. If an infant contracts botulism or a Cronobacter infection following consumption of FSMP, the injured party need only demonstrate: a product defect, damage, and a causal link. This represents a fundamentally different allocation of the burden of proof compared to tortious liability.

• GIS administrative fine: up to PLN 200,000 for breach of food safety requirements (Article 103(1) of the Food Safety Act) [TO BE VERIFIED — current penalty level following any amendments]
• Criminal penalty: Article 165 § 1(2) of the Penal Code — up to 8 years' imprisonment; where death results, Article 165 § 3 of the Penal Code — up to 12 years
• Civil liability: strict liability basis, no upper cap on compensation, possibility of claiming a periodic allowance for permanent impairment of the child's health (Article 444 § 2 of the Civil Code)
• Revocation of FSMP notification by the authority: entails an obligation to withdraw the entire product range from the same production line, not only the batch in question

graph TD
    A[RASFF entry or
notification from authority] --> B{Has the product
been identified
in the warehouse?}
    B -- Yes --> C[Batch placed on hold
within 2 hours]
    B -- No --> D[Initiation of
backward traceability
Art. 18 Reg. 178/2002]
    D --> C
    C --> E[Written notification to GIS
— within 24 hours max]
    E --> F[Notification of
business partners and
retail networks]
    F --> G[Consumer communication
if product has reached
households]
    G --> H[Documentation of all
steps and retention
for 5 years]
    H --> I[Internal audit
of incident root causes
and HACCP correction]

What EU Importers Should Do Before Placing Their Next Order from the United States or China

Importers of FSMP into the EU operate under the regime of Article 17(1) of Regulation (EC) No 178/2002: responsibility for compliance with food law rests with the food business operator at every stage of the supply chain. 'I was unaware that the supplier had issues with the FDA' does not exclude liability — liability is excluded only by demonstrating that the importer exercised due diligence, which in practice means a documented supplier qualification system.

Article 47 of Regulation (EU) 2017/625 lists the categories of food subject to enhanced controls upon import. FSMP for infants may be included in the list set out in the Commission Implementing Regulation on enhanced official controls on imports (Commission Implementing Regulation (EU) 2019/1793, as amended) — importers should verify on each occasion whether their product appears on the current list, which is updated on a regular basis.

• STEP 1: Before signing a contract with a supplier outside the EU — request a current inspection report from the third-country regulatory authority (e.g. an FDA Establishment Inspection Report for US suppliers) and verify that the facility has no open Warning Letters
• STEP 2: Include in the supply agreement an audit right clause and an obligation to notify the importer immediately of any regulatory action taken against the facility
• STEP 3: For each batch — obtain a CoA with test results for Cronobacter spp. (zero in 10 × 25 g), Salmonella spp. (zero in 5 × 25 g), and aflatoxin M1 (≤ 0.025 µg/kg in accordance with Regulation (EU) 2023/915)
• STEP 4: Notify the GIS of the FSMP before its first placement on the Polish market (Article 9 of Regulation 609/2013 in conjunction with Article 29 of the Food Safety Act) — not after the first delivery
• STEP 5: Maintain a traceability system capable of withdrawing a specific batch within 4 hours of a recall decision being taken — the GIS may require this during an inspection

Expert Tip: Expert Tip: GIS enforcement practice shows that the most frequently identified non-conformity during inspections of FSMP importers is the absence of a product recall procedure tailored to the specific characteristics of FSMP for infants. A 'general' procedure allowing 72 hours for a withdrawal does not meet the requirements — for FSMP for infants, authorities expect a plan providing for action within 24 hours, given the particular vulnerability of the target group.