Understanding Heavy Metals in Baby Formula: Insights from Abbott

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Link to Abbott website: Facts for Parents About Heavy Metals and Infant Formula

Some excepts:

Consumer Reports published a report on the levels of heavy metals in U.S. infant formulas. In response, we want to share some important information with parents regarding the report.

  • First and foremost, Abbott’s Similac infant formulas are safe, and parents can use them confidently.
  • The results reported by Consumer Reports for our infant formulas meet the regulations for heavy metals already set by the European Commission and Health Canada. FDA is currently developing limits for infant formula in the U.S.
  • Abbott has a multi-step quality process for heavy metals to ensure that levels are below the relevant regulatory requirements in the countries we serve.

Occurrence of Heavy Metals

Heavy metals are naturally occurring in the environment, including in the soil, water, or air where foods are grown.  As a result, they are present in low levels in almost anything we eat or drink, including in baby food, all brands of infant formula, fruits and vegetables, and human breast milk.

Commitment to Safety and Quality…

The levels of heavy metals that Consumer Reports detected in Abbott’s formulas are very low—just a few parts per billion. To put that in perspective, a single ppb equals a single grain of sand in 730 pounds of sand.

Approach to Heavy Metals…

Individual ingredients that we believe may contain trace heavy metals (due to absorption from the natural environment) are tested during the qualification process before we approve them for use in our products.  We also have an ongoing surveillance testing program after the qualification process designed to periodically test samples of ingredients and finished products to ensure that our supplier and ingredient qualification process is working as intended...Parents can continue to use them with confidence. 

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Comparing Infliximab, Adalimumab, and Vedolizumab in Adults and Children with Ulcerative Colitis

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O Atia et al. Infammatory Bowel Diseases, 2025, 31, 617–624. Durability of the First Biologic in Children and Adults With Ulcerative Colitis: A Nationwide Study from the epi-IIRN

This was a nationwide Israeli study with 15,111 patients with UC, of whom 2322 (15%) received biologics, with a median follow-up of 7.0 years. The dataset includes ~98% of the Israeli population; “the accuracy of medication data is high, as the Israeli health care system provides medications almost free of charge through the HMOs, and the electronic dispensing of drugs contributes to reliable and precise data.”

Key findings:

  • After 5 years of treatment, 43% of the patients with UC sustained their first biologic
  • The durability rate was similar between pediatric-onset and adults after 1 and 5 years from initiation of treatment (72% and 43% vs 71% and 43%, respectively)
  • Durability of adalimumab vs infliximab after 1 or 5 years was similar, whether prescribed as monotherapy (65%/46% vs 63%/33%, respectively) or combotherapy (78%/56% vs 91%/58%, respectively)
  • Durability of infliximab at 1 yr and 5 yrs was higher as combotherapy (85%/50%) vs monotherapy (69%/42%; , P = .007), while it was similar for adalimumab (80%/52% vs 74%/52%)
  • The durability rate was similar for vedolizumab monotherapy at 1 yr and 5 yrs (77%/56%) compared with adalimumab monotherapy (69%/52%), and infliximab monotherapy (73%/55% vs 62%/44%). However, combotherapy of antitumor necrosis factors (TNFs) had longer durability than vedolizumab (85%/50% vs 75%/43%), respectively;

My take: When looking at the durability plots, the three main biologics in this study, infliximab, adalimumab and vedolizumab, performed similarly. Whether therapeutic drug monitoring would influence theses results is not clear. It is interesting that a recent study in the pediatric population found that combination therapy was important for adalimumab and not infliximab (see: Why Do Children Taking Adalimumab Benefit from Methotrexate Dual Therapy?)

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Also, from AGA Today (3/20/25): FDA Approves Guselkumab To Treat Patients With Crohn’s Disease

HCPlive (3/20, Campbell) reports the FDA on Thursday announced the approval of “guselkumab (Tremfya) for the treatment of adults with moderately to severely active Crohn disease.” The announcement from Johnson and Johnson claims the “approval is based on data from multiple phase 3 trials, including the GALAXI trials, which found guselkumab outperformed ustekinumab (Stelara) for multiple endoscopic endpoints. The agent now boasts indications for moderately to severely active Crohn disease and moderately to severely active ulcerative colitis (UC).” This is the fourth indication for guselkumab in the US

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Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

AASLD Guidelines: Challenges of Liver Fibrosis Testing in Pediatrics

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This guideline reviews and recommends blood-based tests as a tool to help determine the likelihood/severity of liver fibrosis in the presence of chronic liver disease. Most of the guideline focuses on adult liver disease. For pediatrics, the guideline makes the following recommendation:

In the pediatric patients with chronic liver disease, AASLD suggests the use of simple, cost-effective, and readily available blood-based NILDA [Non-invasive Liver Disease Assessment], such as APRI or FIB-4, for the detection of advanced fibrosis (F3-4) (ungraded statement).

Technical Remarks:

  • Some blood-based NILDA in children have good accuracy in detecting advanced fibrosis but have difficulty discriminating earlier stages of fibrosis.
  • FIB-4 does not perform as well in children as it does in adults, particularly very young children, due to the inclusion of age in the index.
  • Rapid growth in children and attendant fluctuations in alkaline phosphatase can confound interpretation of blood or collagen-based NILDA tests in pediatric liver disease.
  • There are insufficient biopsy validated data to recommend biomarkers for evaluating fibrosis in pediatric NASH and α1AT at this time.
  • In the pediatric population with CLD, there is growing but insufficient evidence to recommend blood-based NILDA as endpoints to monitor changes in fibrosis over time.

Despite the guidance recommendation, reading the text makes one leery about relying on these tests:

  • For example with biliary atresia: “The utility of APRI to assess or predict liver fibrosis in BA is mixed in the current literature.”
  • “In conclusion, blood-based NILDA tests in children vary widely in their accuracy, even in detecting F3-4 fibrosis, and have difficulty discriminating earlier stages of fibrosis. These tests also have different disease-specific thresholds that correlate with histopathologic fibrosis and differ from adults. APRI and FIB-4 have been the most studied NILDA tests in children, but there is still insufficient evidence to recommend blood biomarkers as endpoints to monitor changes in fibrosis over time. Any blood-based NILDA that includes age (Table 5) should be used cautiously in children.“

My take: This practice guideline, while recommending use of blood-based tests for fibrosis even in the pediatric age group, makes a fairly compelling argument that they are unreliable in children. Elastrography is likely to be more useful, though also imperfect, in the pediatric population.

Algorithm Recommended for Adults:

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Identifying Biliary Atresia in Infants: New Guidelines

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S Harpavat et al. Pediatrics Pediatrics (2025) 155 (3): e2024070077. (Open Access!) Guidance for the Primary Care Provider in Identifying Infants With Biliary Atresia by 2–4 Weeks of Life: Clinical Report

Recommended Screening:

  • Office visit at 2-4 weeks of age (by 4 weeks of life)
  • Check fractionated bilirubin: If there is any pale, gray or white stools, If there is any jaundice in eyes or skin, or If there is a prior history of abnormal direct or conjugated bilirubin*
  • If direct or conjugated bilirubin is 1 mg/dL or higher, urgent consult to GI
Stool color classification

“The most important result is the initial direct or conjugated bilirubin level, which will be “high” in BA starting at birth.11,17,18 “High” is defined as exceeding the laboratory’s derived reference range, even if only by 0.1 mg/dL In the period before 2 weeks of life, “high” is not defined by exceeding a fixed cut-off or exceeding a bilirubin ratio.”

Additional Recommendations:

  • The authors indicate that followup blood testing is NOT needed if the following: 1. Any prior direct or conjugated bilirubin level that was normal (in reference range) or 2. Prior direct or conjugated bilirubin levels that were all abnormal but equivalent or decreasing over time. In this instance, equivalent or decreasing is defined as both (i) less than or equal to the initial level; and (ii) <1 mg/dL
  • “Consider adding direct or conjugated bilirubin testing when serum total bilirubin testing is performed. As mentioned earlier, many centers measure at least 1 serum total bilirubin level via heel stick or venipuncture to assess risk for bilirubin encephalopathy. Direct or conjugated bilirubin levels can be measured from the same heel stick or venipuncture sample, without needing an additional blood draw.”

My take: Any child with an elevated direct or conjugated bilirubin (above reference range) in the first two weeks of life needs to be carefully followed. This guideline also recommends using abnormal stool color and prolonged jaundice/icterus as prompting bloodwork.

In the past, it was consider normal in newborns to have elevated direct bilirubin IF there was a low ratio of direct bilirubin to total bilirubin (less than 20% in those with bilirubin >5 mg/dL). However, this can result in missed cases of biliary atresia.

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Safe Baby Formula Choices Based on Consumer Reports Testing

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From Consumer Reports, April 18, 2025: We Tested 41 Baby Formulas for Lead and Arsenic

This Consumer Reports article is likely to generate a lot of attention. Thanks to Dr. Seth Marcus for sharing this reference.

An excerpt:

While some formulas had concerning levels [of arsenic and lead], there are safer choices. After seeing our results, the FDA is pledging further action…

Consumer Reports tests in the past have found elevated levels of inorganic arsenic in fruit juice, baby food, and bottled water…Our tests found the highest inorganic arsenic level in Abbott Nutrition’s EleCare Hypoallergenic, at 19.7 parts per billion (ppb), and the second highest in Similac Alimentum at 15.1 ppb, also made by Abbott.

As we had expected, CR’s tests found lead in almost all the formulas. Lead levels ranged from 1.2 ppb to 4.2 ppb, which is below the FDA’s Closer to Zero goal, but CR’s experts believe those levels are too high...

Together the formula made by these three companies—Abbott, Mead Johnson, and Perrigo—makes up 79 percent of the U.S. market…They also said trace levels of heavy metals in the food supply are not an issue that is unique to infant formula…

Perrigo, which makes Dr. Brown’s formula and many popular store brands we tested, including Kirkland, Parent’s Choice, Member’s Mark, and Up&Up, also told us that it routinely screens its formulas for heavy metals. “These compounds and PFAS are also found in breast milk,” a spokesperson wrote. “Their levels in infant formula are insignificant and well below regulations in the United States and around the world.”

Contaminants from the environment pose a problem for our entire food supply, CR experts say. But the problem is much more urgent for formula, given how vulnerable babies who depend on it are.

The FDA has long been limited by a lack of both resources and authority to carry out all the oversight it’s tasked with. ..

Keep these test results in perspective. Environmental pollutants are pervasive in our food supply, and all the contaminants in our tests—arsenic, lead, BPA, acrylamide, and PFAS—have also been previously detected in breast milk, food, and water…

Never ever try to make your own baby formula or offer alternative foods. It’s unsafe from a nutrition standpoint…

Use clean water to mix into your powdered formula. The EPA sets limits on contaminants in tap water for most of the country, but not every part of it. If you drink water from a well, for instance, that water is not regulated by the EPA. So it’s a good idea to get well water tested for heavy metals and PFAS before using it…

“Good Choices”

  • A2 Platinum -A2 Milk Company
  • ByHeart Whole Nutrition -ByHeart
  • Happy Baby Organics -Danone
  • Kendamil Organic -Kendal Nutricare
  • Neocate Hypoallergenic -Danone
  • Parent’s Choice Infant -Perrigo
  • Similac 360 Total Care -Abbott Nutrition
  • Similac 360 Total Care Sensitive -Abbott Nutrition
  • Similac Sensitive -Abbott Nutrition
  • Similac Soy Isomil -Abbott Nutrition

“Worse Choices”

  • Dr. Brown’s SoothePro -Perrigo
  • Elecare Hypoallergenic -Abbott Nutrition
  • Enfamil Nutramagen -Mead Johnson
  • Enfamil ProSobee Simply Plant-Based -Mead Johnson
  • Kabrita Goat Milk-Based -Ausnutria
  • PurAmino Hypoallergenic -Mead Johnson
  • Similac Alimentum -Abbott Nutrition
  • Similac NeoSure -Abbott Nutrition
  • Similac Total Comfort -Abbott Nutrition
  • Up&Up (Target) Soy -Perigo

My take: Formula companies need to continue to work on minimizing all of the contaminants. Yet, if all families selected only CR’s “top choices,” there would not be enough formula for infants who are not breastfed. In addition, this problem is even more of an issue in children needing specialized hypoallergenic formulas.

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Meta-Analysis: PPIs Did Not Increase Risk of Cardiovascular Events

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Briefly noted -thanks to Ben Gold for this reference

AD Mosholder et al. The American Journal of Gastroenterology 2025; 120(2):p 362-369, Proton-Pump Inhibitors and Cardiovascular Adverse Events: A Meta-Analysis of Randomized Controlled Trials

Background: “Protopathic bias may result from the use of PPIs for cardiac symptoms mistaken for gastrointestinal symptoms (e.g. heartburn), producing a spurious association between cardiac events and PPI use. In addition, some cardiovascular risk factors may be more prevalent among users of PPIs eg. smoking, obesity) but may not be well captured in observational data sets, resulting in confounding.”

Methods: This meta-analysis included randomized trials with at least 100 subjects, treatment duration >30 days, and a non-PPI comparator (active or placebo). In total, this study examined 164 trials including 52 trials with PPI (n=14,998) vs placebo (n=8,323), 61 trials with PPI (n=12,505) vs any active comparator (n=8,566), and 51 trials with PPI (n=9,430) vs H2 receptor antagonist (n=6,050).

Key finding:

  • Cardiovascular outcomes were infrequent in randomized trials of PPIs, and our primary analysis found no overall association (summary incident rate ratio, MACE+ events, PPI:placebo, 0.72)

My take: This study found no clear association of cardiovascular events with PPI treatment.

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Andaman Sea, Thailand

Understanding Bleeding Risks in Percutaneous Liver Procedures —Who Needs FFP and Platelet Transfusions

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Background: “The most important factor contributing to bleeding risk in patients with liver disease is related to the presence of portal hypertension rather than coagulation abnormalities.1 The changes in the coagulation system in patients with cirrhosis create a re-balanced state, which is prothrombotic. Despite this well-known pathophysiology and recommendation against routine transfusion of blood products (especially fresh frozen plasma) by major guidelines, platelet and fresh frozen plasma transfusion remain a common practice before percutaneous liver procedures.2,3“

Methods: In this retrospective study from three centers in Spain, the researchers enrolled 1797 adults including 316 with cirrhosis (97% had compensated disease). They established a protocol that allowed, at the discretion of the radiologist, to transfuse patients with FFP or platelets if INR was 1.5 or greater or if platelets were 50,000 or below. The primary outcome of the study was major bleeding, which was defined as a drop in hemoglobin (2 or more units) or a need for transfusion of 2 or more units of blood within 1 week after the procedure. This study enrolled patients who underwent percutaneous liver biopsy (86% of cohort) and percutaneous ablation of liver tumors (14% of cohort). Only 6/25 (24%) with INR >1.5 received FFP. 16/22 (72%) with platelet counts below 50,000 received a platelet transfusion. Overall, 7 patients received FFP (1 with cirrhosis, 6 without) and 35 patients received platelets (16 with cirrhosis, 19 without).

Key findings:

  • Only 14 patients (0.8%) experienced major bleeding after the procedure, and there was no difference between those who had a diagnosis of cirrhosis versus those without cirrhosis. Bleeding occurred in 0.6% of patients with cirrhosis compared to 0.8% of those without.
  • Only 1 patient with an ablation procedure had major bleeding
  • Patients with a diagnosis of cirrhosis were more likely to receive a transfusion of any kind
  • Among those with major bleeding, none met the criteria for transfusion. That is, “no variable was identified to predict the risk of major bleeding.”

My take (borrowed from editorial): This study reinforces the recommendation that “correction of coagulation markers before procedures is unnecessary.”

The editorial notes that “the changes in the coagulation system in patients with cirrhosis
create a re-balanced state, which is prothrombotic.

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Dr. Maria Oliva-Hemker: Positioning Therapies for Pediatric Crohn’s Disease

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Recently, Dr. Maria Oliva-Hemker gave our group an excellent update on Crohn’s disease therapies.  My notes below may contain errors in transcription and in omission. Along with my notes, I have included many of her slides.

Key points:

  • Early advanced therapy results in better outcomes (see The PROFILE study results below as one example)
  • Anti-TNFs are the only therapy with a specific FDA pediatric indication. Medications can take 8-10 years after use in adults for pediatric labeling
  • IL-23 specific agents (like risankizumab) are more effective than ustekinumab that target both IL-23/IL-12
  • Recent studies show that ustekinumab is effective in children. Also, in patients who respond to ustekinumab, there is good durability
  • Infliximab is a top-line therapy in Crohn’s disease
  • Risankizumab is a top-line therapy in both biologic-naive and biologic-exposed patients with Crohn’s disease. Higher maintenance doses may capture more patients.
  • Upadacitinib is a very good therapy in patients with prior advanced therapies with either Crohn’s or ulcerative colitis. It also has a rapid onset of action (within 2 weeks)
  • Vedolizumab is less effective in those who are biologic-exposed. However, patients with predominantly colonic (UC-like) involvement may be better-suited for this therapy
  • Close monitoring and treat-to-target approaches are recommended. Usually followup scope is undertaken after one year (&/or one year after switching therapy)
  • Combination advanced therapies have shown effectiveness but it is unclear which combinations are optimal
This slide shows the Montreal Classification, an organ-based phenotype, to describe the anatomic extent and behaviors of Crohn’s disease;. The figure on the right illustrates extraintestinal manifestations of IBD. It is expected that disease classification will rely more on a molecular based approach.
The STRIDE project which defined goals of treatment was the result of consensus achieved by the International Organization of IBD. The first recommendations came out in 2015 and then these were updated in 2021 to incorporate a pediatric component.
The PROFILE study with 386 adults showed how important early effective advanced therapies. Patients receiving infliximab/azathioprine within a median of 15 days from diagnosis had remarkably better outcomes compared to step up treatment with prednisone + azathioprine.
The cytokine IL12 and IL23 shown as circles with 2 subunits attaching to their receptors share a p40 subunit (shown in red). Ustekinumab binds to that p40 subunit thereby inhibiting both the IL12 and IL23 pathways. IL23 inhibitor. Risankizumab, Mirkizumab, Guselkumab inhibit only the p19 subunit (shown in blue) and so  they only downregulate the IL-23 pathway.
Jak inhibitors targets are intracellular in location.
Pediatric data: Multicenter 2015-2020; primary outcome was CS-free remission after 1 yr. Prior to use, 50% failed 1 anti TNF and 30% 2 anti TNF. At one year, 59/101 were in steroid free remission
Upadactinib studies: Oral induction dose for UC and CD is 45 mg daily for induction
and with reduction in maintenance to 30 mg or 15 mg
Due to limited head-to-head studies, network meta analyses provides indirect evidence of comparative effectiveness. It relies on how effective a medication was compared to placebo. One of the problems with these comparisons is that there are different populations in each of these studies.
In patients who need speed to reduce symptoms, upadacitinib is favored over IL-23 agents

Though Dr. Oliva-Hemker’s lecture did not focus on ulcerative colitis, she did note that their center has recommended frequent colonoscopies (often yearly) in many of their patients with the combination of ulcerative colitis and PSC. This is due cases of colon cancer in their pediatric cohort.

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Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Impact of CFTR Modulators on the Need for Liver and Lung Transplantation in Patients with Cystic Fibrosis

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M Mendizabal et al. Liver Transplantation 2025; 31: 412-416. Have CFTR modulators changed the need for liver and lung transplantation among patients with cystic fibrosis? An analysis of the UNOS database

This article notes that there have been 146,851 waitlistings and 95,254 liver transplants in the U.S. between 2012 and 2023. This includes 194 waitlistings and 138 transplants in patients with cystic fibrosis.

Key finding:

My take: This is great news for patients with cystic fibrosis. The drop in lung transplants is surely the tip of the iceberg. Think about your next breath! For patients with cystic fibrosis, these new medications make every single breath better. Longer followup is needed to determine if the long-term use of these agents may lower the rate of end-stage liver disease as well.

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Gene Therapy for Alpha-One Antitrypsin Deficiency

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An excerpt from NY Times:

Researchers have corrected a disease-causing gene mutation with a single infusion carrying a treatment that precisely targeted the errant gene.This was the first time a mutated gene has been restored to normal….

The study involved patients who have alpha-1 antitrypsin deficiency, or AATD, a genetic disease that affects an estimated 100,000 Americans…

When the nanoparticles reached the liver, the lipid layer peeled off, releasing the editor — a disabled CRISPR molecule that acted like a GPS for the genome and an enzyme to fix the mutation. The CRISPR molecule crawled along the patient’s DNA until it found the one incorrect letter that needed to be repaired among the three billion DNA letters in the genome. Then the editing enzyme replaced that letter with the correct one… Those who got the highest dose made enough normal alpha-1 antitrypsin to be in a range where no more damage should occur. 

My take: This is exciting news, though, long-term data is needed to determine if this will be a durable cure. Cost/availability will be an important consideration if effective.

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