Immune System | Nutrition | Organic | Parent Advice | Power Up | Video

Episode 2: Diet and Immune Function

Michelle Perro, MD

Published: September 14, 2021

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Action Items

Regulatory Oversight

Enhanced Regulations:

The FDA and other regulatory bodies must establish stricter guidelines and permissible limits for toxic metals in infant formula. This action has been already put into our place since our meeting with the FDA prior to the release of our data reported in this blog by Moms Across America.

Regular Testing:

Mandatory, routine testing for heavy metals in all infant formula products should be enforced to ensure compliance with safety standards.

Transparent Reporting:

Companies should be required to disclose test results publicly, promoting transparency and accountability.

Proactive Measures by Companies

Sourcing and Production Controls:

Infant formula manufacturers must implement rigorous controls over their raw materials and production processes to minimize contamination.

Regular Audits:

Frequent internal and third-party audits should be conducted to ensure adherence to safety protocols and identify potential sources of contamination.

Research and Development:

Investment in research to develop technologies and methods for removing or reducing heavy metal content in infant formulas.

Remediation Solutions

Advanced Filtration Systems:

Implementing advanced filtration technologies during production to remove toxic metals.

Ingredient Substitution:

Identifying and using alternative, less contaminated sources of raw materials.

Chelating Agents:

Exploring the use of safe chelating agents that can bind to metals, making them less bioavailable and reducing their toxic effects.

What the Data Means to Moms

For mothers and caregivers, these findings can be alarming. However, it is essential to understand the implications and take informed steps to ensure the safety of their infants. Breastfeeding remains the best option for infant nutrition, when possible, as it naturally minimizes exposure to contaminants.

Recommendations Based on Data

Prioritize Breastfeeding:

Whenever possible, opt for breastfeeding to provide the safest and most natural nutrition for your baby.

Choose Carefully:

When breastfeeding is not an option, select infant formulas that have been independently tested and verified for low levels of toxic metals.
Maximize moms’ diet utilizing organic regenerative whole foods, including an array of fermented foods, filtered water, and nutritional supplements, such as prenatal vitamins and probiotics.

Stay Informed:

Keep abreast of the latest research and reports on infant formula safety to make informed decisions.

Advocate for Change:

Support initiatives and petitions calling for stricter regulations and safer infant formula products. (See the end of this article for a petition/call-to-action.)

Sample Considerations

The recommendations based on our findings proved challenging since all formulas tested positive for aluminum and lead. Other difficult considerations were based on the fact that not all metals are equally toxic and it is unclear whether having more metals at lower amounts was more toxic than fewer metals with higher amounts. The literature did not prove helpful in this regard.

Hence, the best attempts were made to offer advice for concerned parents based on this one study of toxic metals without other concomitant toxicants studied. A scorecard was designed, rating the formulas from 1 – 3, with 1 being the best based on 5 toxic metals studied and without consideration of other factors. The formulas were chosen for lowest levels of lead, mercury and cadmium. Lower levels of aluminum were considered since they all tested positive. There were no ideal formulations, and the recommendations were based on the 20 tested. There were differences in the two samples of the same formula which may not be statistically significant.

Overall formula recommendations:¹

Similac Sensitive infant formula
Kirkland ProCare Non-GMO infant formula – NOTE: My top choice factoring in other contaminants/pesticides
PurAmino hypoallergenic powder infant formula (For babies with digestive issues requiring predigested formulas)

Formula recommendations:²

Gerber Good Start Gentle Pro
Earth’s Best Organic Sensitivity Formula

Formula recommendations:³

Enfamil Sensitive Infant Formula
Similac Total Comfort Infant Formula
Up & Up Gentle Premium Powder Infant Formula
Up & Up Non-GMO Hypoallergenic Powder Infant Formula
Enfamil Plant-Based Soy Powder Infant Formula

Strategic Recommendations

Targeted Research

Understand Contamination Sources:

Conduct further research to understand the sources of metal contamination in infant formulas, including soil contamination with pesticides, water used in manufacturing, and packaging materials.

Long-Term Health Impacts:

Investigate the long-term health impacts of chronic exposure to low levels of these metals in infants.

Consumer Guidance

Interpreting Lab Results:

Educate parents on how to interpret lab results and select formulas with the lowest possible contamination levels.

Support Safe Feeding Practices:

Provide resources and support for parents to transition to safer feeding practices, whether through breastfeeding support or safer formula alternatives.

Enhanced Testing Protocols

Rigorous Testing:

Mandate formula manufacturers to adopt more rigorous testing protocols, including testing for a broader range of contaminants and more frequent testing intervals.

Standardized Procedures:

Advocate for standardized testing procedures across the industry to ensure consistency and reliability in reported results.

Supply Chain Transparency

Transparency:

Push for greater transparency in the supply chain of infant formula ingredients.
This includes sourcing, production processes, and quality control measures.

Traceability:

Implement traceability measures to identify and mitigate contamination sources promptly.

Policy and Advocacy

Environmental Contamination:

Support policy initiatives aimed at reducing environmental contamination, as many of these metals enter the food chain through polluted air, water, and soil.

International Cooperation:

Advocate for international cooperation to address the global nature of food safety, as ingredients are often sourced from multiple countries.

Summary

The presence of toxic metals in infant formula is a critical issue that demands immediate action.

Public education is crucial to raise awareness among parents and caregivers about the potential risks and safety measures. Regulatory action by Congress is necessary to empower the FDA and other agencies to enforce stringent safety standards. Additionally, formula companies must take corrective actions to ensure their products are safe.

To address this issue, we are initiating a petition to urge Congress to remove any barriers preventing the FDA from enforcing these necessary regulations. In the meantime, parents can consider various supplements that may help offset the toxicity, although this should be done in consultation with healthcare professionals.

By working together—regulators, companies, and consumers—we can ensure that infant formula products are safe and healthy for our most vulnerable population, our babies.

Our Petition:

Please cut and paste this letter, add 1-3 sentences at the top to personalize it and increase the chances of it being read, and send it directly to your Senator and Representative today!

Find your Senator and Representatives’ emails and telephone numbers here.

Dear Senator_____ or Representative _______,

I am writing to ask for your support in making baby food and formula safer for our babies. Will you support the Baby Food Safety Act of 2024 and insist that baby formula is included? Please authorize the FDA with the ability to do their job and protect human health. Baby formula is often the ONLY food a baby consumes for the first six months of their lives and must be monitored for heavy metals. Our babies ARE our future and they are the most vulnerable. If swift action is not taken, babies from both sides of the aisle will continue to be severely impacted and their mental, physical, and reproductive health issues will affect the future of America.

GMOScience and The New MDS, Moms Across America, a national educational nonprofit dedicated to empowering mothers and others to create healthy families and communities, today announces the results of testing for five toxic metals in 20 infant formula products. Samples included organic as well as non-organic and plant-based as well as animal product formulas sold by four of the major producers of infant formula in the United States and across the globe. Two samples of each product were tested, for a total of 40 samples.

Concerning findings include:

100% of the 40 samples tested contained aluminum and lead.
57% of the samples tested positive for arsenic, 55% for mercury, and 35% for cadmium.
Six of the 20 formulas were positive for all five toxic metals in both samples.
At 41,000 ppb, aluminum levels in a goat’s milk baby formula were 4000 – 40,000x higher than other metals in the formulas tested and exceed limits set by the FDA for maximum safety level of aluminum for a preemie.
Levels of mercury in four samples measured above the limit allowed by the FDA in drinking water.
Levels of cadmium in both samples of one formula were nearly twice the level allowed in drinking water.

The FDA concluded many years ago that babies and young children are particularly vulnerable to the harmful effects of food contaminants because of their small bodies and rapid cellular growth. In 1962, the FDA launched the Total Diet Study, recently published in July, 2002, analyzing 910 foods, including only four infant formulas. Two of the four formulas contained toxic metals, including uranium. In April 2021, the FDA announced its “Closer to Zero” plan, wherein it committed to proposing allowable levels of lead in various baby foods by April 2022, levels of inorganic arsenic by April 2024, and cadmium and mercury sometime after 2024. None of those deadlines, however, have been met, and all of them have been removed from the Closer to Zero website.

To date, the only actionable limits the agency has set are for one toxic metal only (inorganic arsenic) in one type of baby food product (infant rice cereal).

Citing findings of nearly 400 childhood lead poisoning cases in fall 2023 linked to recalled cinnamon applesauce pouches. A coalition of 20 Attorneys General led by New York’s Attorney General Letitia James issued a letter to the FDA on February 15 of this year to call on the federal agency to protect babies and young children in the United States from lead and other toxic metals in baby food. That letter followed an October 2021 petition and subsequent June 2022 petition, asking the FDA to issue specific guidance to the baby food industry to require testing of all finished food products for lead and other toxic metals.

It has been over two years! Action must be taken now!

Moms Across America, GlyphosateFacts, and GMOScience presented the new baby formula test results and science from Stephanie Seneff and others in meetings with congressional representatives and the FDA in Washington, DC from April 29 to May 2. They were informed by Jim Jones, Deputy Commissioner for Human Foods at the FDA, that the agency is waiting for Congress to pass legislation that would mandate testing for lead and other harmful chemicals in food. On May 9, US lawmakers introduced the Baby Food Safety Act of 2024, which, with Congressional approval, would allow the FDA to regulate and enforce limits on levels of heavy metals found in baby food and potentially formula.

Please support the Baby Food Safety Act of 2024 and insist that baby formula is added to the bill so that the FDA may regulate and monitor levels of heavy metals in both baby food and baby formula.

Thank you.

Signed with Gratitude,

Your constituent __________________

References:

https://www.fda.gov/food/resources-you-food/infant-formula#oversee
https://www.fda.gov/food/resources-you-food/infant-formula
https://www.fda.gov/food/buy-store-serve-safe-food/handling-infant-formula-safely-what-you-need-know
https://www.fda.gov/food/consumers/agricultural-biotechnology
https://www.fda.gov/food/people-risk-foodborne-illness/food-safety-infants-toddlers
https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/enforcement-discretion-manufacturers-increase-infant-formula-supplies#regular
https://www.fda.gov/media/71695/download?attachment
https://www.scirp.org/journal/paperinformation?paperid=53106
https://www.researchgate.net/profile/David-Kennedy-40/publication/333582853_Environmental_toxicants_and_infant_mortality_in_America_Peertechz_Journal_of_Biological_Research_and_Development_11_36-61/links/5d111f6592851cf440492ee1/Environmental-toxicants-and-infant-mortality-in-America-Peertechz-Journal-of-Biological-Research-and-Development-11-36-61.pdf
unsafe at any level
https://reneedufault.com/
https://gmoscience.org/
https://www.momsacrossamerica.com/
https://www.ewg.org/research/ewgs-guide-infant-formula-and-baby-bottles
https://www.inonaround.org/baby-formula/
https://projecttendr.thearc.org/
https://hbbf.org/
https://www.hbbf.org/solutions/healthy-baby-foods
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415012/: Developmental pesticide exposure reproduces features of attention deficit hyperactivity disorder
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8871549/:Prenatal Mercury Exposure and Neurodevelopment up to the Age of 5 Years: A Systematic Review
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5461492/:Fetal and postnatal metal dysregulation in autism
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1764574/:Lead and mercury exposures: interpretation and action

https://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Chemical_Use/WheatPostharvestChemicalUseFactSheet.pdf