Arsenic in Infant Rice Cereal: What FDA's 100 ppb Action Level Does and Doesn't Tell Parents
When parents look up arsenic in infant rice cereal, the number they usually find is 100. The guidance identifies an action level of 100 micrograms per kilogram (µg/kg) or 100 parts per billion (ppb) for inorganic arsenic in infant rice cereals. Many people read that number as the point where cereal stops being safe, but that isn’t what it means.
Why babies get a limit of their own
Babies eat far more rice for their size than adults do. Relative to body weight, infant rice intake is about three times greater than adults’, and people eat the most rice relative to their weight at approximately 8 months of age. That’s the age when many babies are just starting solids.
The FDA proposed the limit through a draft guidance in 2016, and the agency accepted public comments on the proposed action level for 90 days. The proposed number matched the level the European Commission set for rice used in food for infants and young children. The agency finalized the 2016 draft. It said it acted because exposure to inorganic arsenic is associated with neurodevelopmental effects.
Other research raised the same concern. A JAMA Pediatrics study followed children for several years and found that babies who ate rice cereals had higher concentrations of arsenic in their urine than babies who didn’t.
What an action level is
Under federal rules, an action level marks a level of contamination at which a food may be regarded as adulterated. The FDA will consider action levels, in addition to other factors, when considering whether to bring enforcement action.
An action level is also not binding. FDA guidance documents do not establish legally enforceable responsibilities, and the word “should” in them means that something is suggested or recommended, but not required. The agency uses an action level instead of a formal tolerance when technological or other changes that might affect the appropriateness of the tolerance are foreseeable in the near future.
How the number was chosen matters too. The guidance calls the level one that is achievable by industry with the use of current good manufacturing practices. The 2016 proposal was based on a risk assessment and on an evaluation of the feasibility of reducing inorganic arsenic in infant rice cereal. It tells you where the FDA may step in.
What the FDA’s own testing found
The FDA’s “Arsenic in Food” page links to Analytical Results: Testing for Inorganic Arsenic in Rice Cereal for Infants, posted March 2020. These are older data. In 2018, the FDA collected and tested 149 infant rice cereals, including both white and brown rice products.
The results show steady improvement. In 2018, 76% of samples were at or below 100 ppb, compared to 47% in 2014 and 36% between 2011–2013. In the 2014 round, nearly half (47 percent) of samples met the proposed action level of 100 ppb, and a large majority (78 percent) was at or below 110 ppb inorganic arsenic.
The FDA presented these numbers as progress. They also mean that about one in four cereals tested in 2018 were still above the action level. Brown rice did not come out ahead, either. White rice cereals improved the most, and they tend to have lower levels of inorganic arsenic overall. The FDA says it will continue to monitor research developments to see whether new data justify changing the action level.
| Date | Event | Impact |
|---|---|---|
| August 2000 | General action-levels guidance issued (fda.gov) | Framework for contaminant limits |
| 2011–2013 | FDA cereal sampling (fda.gov) | 2011–2013 — 36% at or below 100 ppb |
| 2014 | 2014 — FDA retail sampling found 47% of samples met the proposed action level | 47% met proposed level |
| 2016 | 2016 — Draft 100 ppb level proposed | 90-day comment period |
| 2018 | 149 cereals tested (fda.gov) | 76% at or below 100 ppb |
| March 2020 | 2018 results posted (fda.gov) | Public testing data released |
| August 2020 | Final guidance issued (fda.gov) | 100 µg/kg action level in force |
What to put in the bowl
Parents don’t get to decide how much arsenic is in a box of cereal. They do get to decide how often rice shows up in their baby’s diet, and that’s the practical lesson in both the FDA’s and pediatricians’ advice.
The FDA says iron-fortified rice cereal is a good source of nutrients but shouldn’t be the only source, and does not need to be the first source. It lists oat, barley, and multigrain as other iron-fortified cereals that can be a baby’s first or early cereal.
UR Medicine’s Dr. Ruth Lawrence points to the American Academy of Pediatrics’ advice: don’t feed rice cereal every day and don’t make it the only food in the meal. She also suggests adding barley, quinoa, and oats and choosing iron-fortified cereals, since iron supports brain development. She recommends introducing single-grain cereals one at a time so you can see how your baby reacts to each one. She also notes that rice cereal still has real advantages. It’s easy to digest and doesn’t trigger an allergic reaction the way the gluten in wheat can.
The bottom line
The 100 ppb level sets a standard for manufacturers. It doesn’t tell parents whether a particular bowl of cereal is good or bad. The FDA’s testing shows manufacturers have cut arsenic a lot since 2011, but the most recent public data come from 2018 samples, and about a quarter of those were still above the action level. The step parents can take is the one the FDA and pediatricians both recommend: rotate oat, barley and multigrain cereals so rice is one grain among several.
Sources
- fda.gov – “Arsenic in Food” (2024)
- fda.gov – “FDA Makes Available Results from Testing of Infant Rice Cereal for Inorganic Arsenic | FDA” (2020)
- fda.gov – “Guidance on Inorganic Arsenic in Rice Cereals” (2020)
- fda.gov – “FDA Issues Final Guidance for Industry on Action Level for Inorganic Arsenic in Infant Rice Cereals | FDA” (2020)
- fda.gov – “FDA proposes limit for inorganic arsenic in infant rice cereal | FDA” (2016)
- urmc.rochester.edu – “Baby Food for Thought: How Safe is Rice Cereal? | University of Rochester Medicine” (2016)