Thanks to your support, Moms Across America has collaborated with GMOScience and The New MDS to test toxic metals in baby formula, and we are extremely dismayed by the results. We had hoped some formulas would be free from toxic and heavy metals, but they were not. We were shocked to see such high levels of toxic metal aluminum present in goat's milk formula and urge the manufacturers and the FDA to immediately take action to resolve this issue.

The following report on the toxic metals by Dr. Michelle Perro, founder of GMOScience.org a 43 veteran pediatrician, clearly explains the problem we have and what we can do.

Moms Across America urges our network, the media, citizens or America and the world to insist that their elected officials take action to protect babies - the future of our countries, and ensure a safe future for us all.

Reposted from GMOscience.org

Why Study Toxic Metals in Infant Formula? An Overview of the Results

Michelle Perro, MD
CEO, GMOScience.org
5月, 2024

NOTE: The infant formula toxic metal study is a joint collaboration project by 禅ハニーカット, Stephanie Seneff, PhD、そして Michelle Perro, MD. The results of their study were presented in their monthly podcast, The New MDS on 5月 21, 2024.      

Infant formula is a crucial source of nutrition for babies who are not breastfed or is utilized as a supplement to breast-feeding. Ensuring its safety and quality is paramount since infants are particularly vulnerable to contaminants due to their developing biological systems. Toxic metals such as aluminum, lead, arsenic, cadmium, and mercury pose significant health risks. Chronic exposure to these metals, even in small amounts, can lead to developmental issues, cognitive impairments, and other serious health conditions. Hence, studying the presence of these toxic metals in infant formula is vital to safeguard the health and well-being of infants.

Combinations of toxic metals produce negative synergy and have not been assessed in regard to toxicity in terms of childhood development. All organ systems are at risk. There is a cumulative effect and levels increase during periods of high cellular turnover, pregnancy, lactation, during early infant growth, and with various nutrient deficiencies such as iron and vitamin D. Additionally, these metals can cross the sensitive infant’s blood brain barrier which is underdeveloped until approximately 6 months of age.

This study is part of a "Got Real Milk?" Campaign by GMOScioence.org 

Data Summary

In our study examining the presence of toxic metals in infant formula, all 40 samples tested positive for concerning levels of toxic metals, specifically aluminum and lead. Each type of formula was tested twice, yielding 20 distinct formula types in total. Here is a breakdown of the findings:

• 100% of the 40 samples tested contained aluminum and lead.
• 80% of samples had lead levels higher than the EPA allowable levels for drinking water.
• 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 - 40,000 X higher than other metals in the formulas tested and exceed limits set by the FDA for maximum safety level of aluminum for a preemie.
• The highest aluminum level detected was 200x higher than EPA allowable levels in drinking water.
• 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 top-scoring, least contaminated baby formulas tested were Kirkland ProCare Non-GMO infant formula, Similac Sensitive infant formula, and PurAmino hypoallergenic powder infant formula. 
• The lowest scoring, most contaminated baby formulas tested were 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.
• For a full list of products tested and results, read the accompanying article on GMOScience.org ここに. 
• From Dr. Renee Joy Dufault:
  “There were no common ingredients to explain any of the elevated levels except for corn syrup solids and vegetable oils.”
• From Dr. Gilles-Eric Seralini:
  “We have identified heavy metals and petroleum residues 6600 times more dangerous in conventional food than in equivalent organic products in Europe due to pesticides.”
• These results highlight a pervasive issue with heavy metal contamination in infant formula, underscoring the need for immediate attention and action.

Detailed Insights on the Data

Variability in Metal Concentrations

The concentration of toxic metals varies significantly across different brands and types of infant formula. For instance, aluminum levels range from 1.61 ppm to 41.0 ppm, indicating inconsistent contamination levels. Lead levels also show a wide range, from 0.208 ppb to 8.36 ppb. This suggests that some formulas are much safer than others, but all still contain detectable levels of lead.

High-Risk Formulas

Certain formulas, such as those made from goat milk, exhibit particularly high levels of aluminum. For example, Bubs Goat Milk Infant Formula showed the highest aluminum concentration at 41.0 ppm. Products like Enfamil Sensitive Infant Formula displayed notable levels of multiple heavy metals, including aluminum (8.87 ppm), arsenic (1.88 ppb), cadmium (ND), and mercury (0.442 ppb).

Cross-Contamination Concerns

The presence of multiple metals in the same sample indicates potential cross-contamination during manufacturing or from raw materials. For example, Earth's Best Organic Sensitivity Infant Formula contained detectable levels of aluminum, cadmium, and mercury, raising concerns about the purity of the ingredients used.

Organic vs. Non-Organic

Both organic and non-organic formulas were found to contain toxic metals, challenging the perception that organic products are inherently safer in terms of heavy metal contamination. For instance, Baby’s Only Organic Infant Formula contained detectable levels of aluminum (3.5 ppm) and lead (0.775 ppb), similar to non-organic counterparts.

Potential Health Implications

Chronic exposure to these metals, even at low levels, can have cumulative effects on infants, potentially leading to developmental and neurological issues, carcinogenic, as well as the initiating the development of chronic diseases later in life. Given the critical growth period in infants, even small amounts of toxic metals can have disproportionately large impacts as compared to adults.

Formulas Evaluated

While there are many formulas available to consumers, at least 50 were counted offering a confusing array of choices for parents. However, there are 4 main formula producers in the US including Abbot, Mead Johnson, Nestle, and Perrigo. Different companies utilize some of the bigger formula manufacturers. Formulas were prioritized for evaluation based on whether they contained high fructose corn syrup (HFCS), which may contain undeclared mercury as per the work of Dr. Renee Joy Dufault. Due to limited funding, we were only able to include one soy formula at this time. Future and further studies are necessary.

The following types of formulas were assessed; dairy-based, soy, organic, US, and international brands were selected. Brands were chosen based on the content of HFCS. Additionally, options were chosen depending on common places of purchase of formulas as well as whether parents were receiving governmental assistance programs such as the Women, Infants, and Children (WIC) Program.

Below are the list of formulas studied in alphabetical order:

Formulas studied in alphabetical order:

1. Baby's Only Organic Infant Formula with Iron
2. Bubs Goat Milk Infant Formula Stage 1
3. Bubs Organic Grass Fed Infant Formula Stage 1
4. Earth's Best Organic Sensitivity Infant Formula with Iron
5. EleCare Hypoallergenic Powder Infant Formula
6. Enfamil Sensitive Infant Formula
7. Enfamil NeuroPro Gentlease Powder Infant Formula
8. Enfamil Nutramigen Hypoallergenic Infant Formula
9. Enfamil Plant-Based Soy Powder Infant Formula
10. Gerber Good Start Gentle Pro Stage 1 Infant Formula
11. Holle Bio PRE Organic Infant Formula
12. Kabrita Goat Milk-Based Infant Formula
13. Kirkland ProCare Non-GMO Infant Formula
14. Mama Bear Hypoallergenic Infant Formula Powder with Iron
15. Pepticate Hypoallergenic Baby Formula
16. PurAmino Hypoallergenic Infant Formula
17. Similac Sensitive Infant Formula
18. Similac Total Comfort Infant Formula
19. Up & Up Gentle Premium Powder Infant Formula
20. Up & Up Non-GMO Hypoallergenic Powder Infant

Action Items

Contact your senators and representatives and tell them to 

1. INCLUDE baby formula in the Baby Food Safety Act of 2024
2. REMOVE the pre-emption 

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.
• 
  
  • 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 information 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 the 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.

Top Scoring:1

1. Kirkland ProCare Non-GMO infant formula 
2. Similac Sensitive infant formula
3. PurAmino hypoallergenic powder infant formula (For babies with digestive issues requiring predigested formulas)

Middle Scores: 2

1. Gerber Good Start Gentle Pro
2. Earth's Best Organic Sensitivity Formula

Lowest Scoring :3

1. Enfamil Sensitive Infant Formula
2. Similac Total Comfort Infant Formula
3. Up & Up Gentle Premium Powder Infant Formula
4. Up & Up Non-GMO Hypoallergenic Powder Infant Formula
5. Enfamil Plant-Based Soy Powder Infant Formula (most contaminated) 

Strategic Recommendations

Targeted Research

• Understand Contamination Sources:
  • Conduct further research to understand the sources of metal contamination in infant formulas, including soil contamination, 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.

概要

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.

参考文献

1. https://www.fda.gov/food/resources-you-food/infant-formula#oversee
2. https://www.fda.gov/food/resources-you-food/infant-formula
3. https://www.fda.gov/food/buy-store-serve-safe-food/handling-infant-formula-safely-what-you-need-know
4. https://www.fda.gov/food/consumers/agricultural-biotechnology
5. https://www.fda.gov/food/people-risk-foodborne-illness/food-safety-infants-toddlers
6. https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/enforcement-discretion-manufacturers-increase-infant-formula-supplies#regular
7. https://www.fda.gov/media/71695/download?attachment
8. https://www.scirp.org/journal/paperinformation?paperid=53106
9. 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
10. unsafe at any level
11. https://reneedufault.com/
12. https://gmoscience.org/
13. https://www.momsacrossamerica.com/
14. https://www.ewg.org/research/ewgs-guide-infant-formula-and-baby-bottles
15. https://www.inonaround.org/baby-formula/
16. https://projecttendr.thearc.org/
17. https://hbbf.org/
18. https://www.hbbf.org/solutions/healthy-baby-foods
19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4415012/: Developmental pesticide exposure reproduces features of attention deficit hyperactivity disorder
20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8871549/: Prenatal Mercury Exposure and Neurodevelopment up to the Age of 5 Years: A Systematic Review
21. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5461492/: Fetal and postnatal metal dysregulation in autism
22. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1764574/: Lead and mercury exposures: interpretation and action

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 ここに。

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.

We are also asking that this preemption be removed

PREEMPTION OF STATE AND LOCAL REQUIREMENTS REGARDING FOOD INGREDIENTS AND CONTAMI20 NANTS IN FOOD, INCLUDING INFANT AND TODDLER FOOD.—No State or political subdivision of a State may  establish or continue in effect with respect to contaminants in food, including infant and toddler food, food pouches made with fruit or vegetable puree or juice, and  juice, any requirement that is different from, or in addition to, or not identical with any requirement under this section, and relates to contaminant sampling and testing, contaminant limits, disclosure of contaminant test results, contaminant labeling, contaminant warnings, or any other matter related to contaminants in food.’’.

All states and citizens must have the right to disclose/discuss/label contaminants and make state laws regarding contaminants in all foods as necessary.

GMOScience そして The New MDS, アメリカ中のママ, 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 toxic aluminum and lead.
• 80% of samples had lead levels higher than the EPA allowable levels for drinking water.
• 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 exceeded the FDA's maximum safety level for aluminum in a preemie.
• The highest aluminum level detected was 200X higher than EWPA allowable levels in drinking water.
• 57% of the samples tested positive for arsenic, 55% for mercury, and 35% for cadmium.
• 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.
• Six of the 20 formulas were positive for all five toxic metals in both samples.

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 7月, 2002, analyzing 910 foods, including only four infant formulas. Two of the four formulas contained toxic metals, including uranium. In 4月 2021, the FDA announced its “Closer to Zero” plan, wherein it committed to proposing allowable levels of lead in various baby foods by 4月 2022, levels of inorganic arsenic by 4月 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 2月 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 10月 2021 petition and subsequent 6月 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!

アメリカ中のママ, GlyphosateFacts、そして 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 4月 29 to 5月 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 5月 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.
ありがとうございました。

Signed with Gratitude,
Your constituent _________

Thank you for taking action to protect our babies and our future!