A Texas lawsuit against Gerber Products Co. and Nestlé USA claims the companies deceived parents by labeling their baby food as “safe” and “rigorously tested” despite internal tests showing dangerous levels of arsenic and lead. The legal action centers on the gap between Gerber’s marketing claims and its supplier specifications—the contracts that define allowable metal levels in ingredients and testing protocols.
According to the attorney general’s office, Gerber’s internal testing identified 67 batches of rice flour containing more than nine times the federal arsenic limit for bottled water. Carrots tested at up to 17 times the bottled-water limit for cadmium, and sweet potatoes at nearly 10 times the limit for lead. Despite these findings, Gerber continued selling the products while promoting them as pure and thoroughly tested.
The lawsuit, filed under the Texas Deceptive Trade Practices Act, focuses on how supplier specifications determine what companies can legally claim. Your supplier specification determines which product claims you can defend and how quickly customers can approve you. The case also reveals that Gerber’s testing during this period often examined ingredients rather than finished products, meaning infants may have ingested metals that were not detected until later stages.
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Gerber’s defense and legal challenges ahead
Gerber denies the allegations, stating its products comply with FDA limits for heavy metals and that contamination is controlled through careful ingredient sourcing, supplier requirements, testing, and quality controls. However, two factors may weaken Texas’s case: the state compared results to bottled-water standards instead of food regulations, and the testing occurred before the FDA’s 2025 lead limits for baby food took effect. The court will determine whether these distinctions hold legally.
While the legal dispute unfolds, the FDA has emphasized the role of supplier specifications in preventing contamination. In Chapter 12 of its draft preventive controls guidance—released days after the Texas lawsuit—the agency advises manufacturers to treat arsenic, cadmium, and lead as hazards requiring supply-chain programs. This includes setting metal limits in purchase agreements, mandating periodic supplier testing, and reviewing their data before accepting shipments.
FDA’s stricter limits and compliance hurdles
The FDA’s final lead guidance, issued in January 2025, set action levels of 10 ppb for most processed baby foods and 20 ppb for single-ingredient root vegetables and dry infant cereals. For cadmium, proposed levels range from 10 ppb for fruits and vegetable mixtures to 25 ppb for single-ingredient carrots. Yet FDA data shows compliance will be challenging: only 84% of single-ingredient carrot samples met the proposed 25 ppb cadmium limit, meaning roughly one in six batches would exceed it.
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Consumer Reports found that even when brands meet FDA action levels, they may still fall short of parental expectations. For instance, Gerber Rice Cereal averaged 63 ppb inorganic arsenic, below the FDA’s action level for infant rice cereal but above Consumer Reports’ own threshold. This discrepancy highlights why supplier specifications must exceed regulatory minimums if companies want to justify claims like “pure” or “safe.”
Plum Organics’ voluntary steps to rebuild trust
Plum Organics resolved its portion of the inquiry differently. The company agreed to follow FDA guidance on lead, use EU limits for cadmium and inorganic arsenic, and maintain a 10 ppb internal limit for mercury in pouches. Plum will also publish results that parents can search by UPC or lot number and will not ship product that fails to meet these standards.
The FDA’s comment period for cadmium guidance closes January 21, 2027, and the Texas lawsuit will take months to resolve. Meanwhile, manufacturers are already revising supplier programs to include numeric limits for arsenic, cadmium, and lead, tied to lot-level testing and finished-product verification. Brands that survive scrutiny will be those that treat these specifications as more than paperwork, proving with data what is actually in their products.
- Ingredient-specific metal limits for arsenic, cadmium, and lead, with numeric thresholds tied to FDA action levels or stricter benchmarks. Generic compliance statements are insufficient when purity claims are made.
- Testing frequency and scope requiring suppliers to test each lot for metals before shipment, using accredited labs and FDA-recommended methods. Finished-product testing, at least quarterly, must verify that supplier data applies to final goods.
- Exceedance protocols defining steps for when test results exceed limits, including immediate holds, retesting, rejection, and manufacturer notifications. Responsibility for each action must be assigned, with all decisions documented.
- Traceability requirements linking every test result to a lot code, allowing consumers or regulators to trace contamination to its source. This transparency is becoming a market advantage, as seen with Plum’s commitment to publish lot-specific data.
- Finished-product verification, as Gerber’s testing often stopped at raw materials, leaving finished products unchecked. Quarterly finished-product analysis ensures processing steps do not introduce new risks.
- Claim alignment ensuring that before marketing materials use terms like “tested,” “pure,” or “safe,” quality assurance confirms that specifications and test data support those claims. Without this link, deceptive trade practice allegations may arise even if products meet regulatory limits.
