Texas Attorney General Ken Paxton has filed a lawsuit against Gerber, alleging the company falsely labeled its baby food as “safe” and “rigorously tested” despite internal lab results showing arsenic and lead levels far exceeding federal limits. The legal action centers on Gerber’s supplier specifications, which determine what marketing claims can be legally supported and how quickly retailers can approve the products.
Between 2017 and 2019, Gerber’s internal testing revealed 67 batches of rice flour containing arsenic levels more than nine times the bottled-water standard. The lawsuit also highlights carrots with cadmium levels up to 17 times the federal limit and sweet potatoes with lead levels nearly ten times the allowable amount. During most of this period, Gerber tested individual ingredients rather than the complete meals infants consume, and mercury testing occurred infrequently.
Gerber now includes a QR code on its jars linking to test results, but the Texas agency argues that a code on the back of a package does not resolve misleading claims on the front. The company insists its products comply with FDA limits and maintains heavy metals are controlled through careful ingredient sourcing, supplier requirements, testing, and quality controls.
Days after the lawsuit was filed, the FDA released Chapter 12 of its draft preventive controls guidance, advising manufacturers of baby and toddler foods to treat arsenic, cadmium, and lead as hazards requiring supply-chain oversight. The guidance recommends embedding numeric limits in purchase agreements and requiring suppliers to conduct periodic testing, submitting results annually.
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. On the same day it released Chapter 12, the agency proposed cadmium action levels: 10 ppb for fruits, vegetables other than single-ingredient carrots, and mixtures 20 ppb for yogurts, puddings, and custards 25 ppb for single-ingredient carrots and single-ingredient meats The agency noted that only 84% of single-ingredient carrot samples met the proposed 25 ppb cadmium limit.
Under 21 CFR 117.410, verification activities can include onsite audits, sampling and testing, and review of a supplier’s food safety records. A well-drafted specification must clarify whether measurements apply to ingredient lots, finished products, or both, specify who conducts testing and its frequency, and outline actions for exceedances. Without these details, marketing claims like “tested” or “pure” risk legal challenges over misleading assertions.
Plum Organics responded to the Texas inquiry by agreeing to adopt FDA lead guidance, apply European Union limits for cadmium and inorganic arsenic, and enforce a 10 ppb internal limit for mercury in its pouches. The company will also publish lot-level test results searchable by UPC or lot number and will not distribute product failing to meet these standards.
The FDA recommended that manufacturers of food for babies and young children control arsenic, cadmium, and lead through their supplier programs, with limits written into specifications and purchase agreements. Your supplier specification determines which product claims you can defend and how quickly customers can approve you.
The FDA’s comment period for the cadmium proposal remains open until January 21, 2027.