By now you have likely heard that the FDA has banned Red Food Dye 3, which will take effect in 2 years in food and 3 years in ingested drugs. This is a great step in the right direction but it does beg the question: what about the other 41 synthetic dyes found in food and ingested drugs such as Red Food Dye 40, Yellow 5 and 6, Blue 1 and 2, and Green 3? According to Consumer Reports, after today’s ban, eight synthetic dyes are still approved for human consumption. Over 90% of candies, fruit-flavored snacks, and drink mixes contain one or more harmful ingredients. Without a doubt, all of these synthetic dyes have health concerns and should not be ingested.

In December, thanks to the support of many Moms Across America supporters, I was able to travel to Washington DC, meet with Senator and Representatives staff about the Safe School Meals Act of 2024 and Baby Food Safety Act, and also attend a Food and Nutrition Labeling hearing hosted by Senator Bernie Sanders. At that meeting, both Republican and Democratic elected officials berated the FDA specifically for taking over 15 years to get proper nutrition labeling on foods and beverages high in sugar. Senator Tuberville, who was in discussion with Vani Hari, pointed out that Red Food Dye 3 was banned in cosmetics but not in food, 30 years ago, due to the rat studies that showed it caused cancer. He questioned the reasoning.

I have heard much of that which was discussed in the hearing over the past twelve years working in our food movement, but there were a few things I heard, new excuses for not being able to do their jobs, that you, the American people, should know.

• The FDA Head of Human Foods, Jim Jones, gave Tuberville the explanation for the difference between EU and USA policy regarding Red Food Dye 3 because the EU has much more robust post-market studies. We don’t, he said, so we have different policies. Therefore, we have allowed a carcinogen in our food for 30 years longer.

This seems quite unreasonable considering the dangers posed by Red Food Dye 3. The FDA also has access to the EU's post-market studies and should be held accountable for ignoring these findings. Consumers have the fundamental right to be fully informed about the potential health risks associated with Red Food Dye 3.

When I brought up this critical concern in our meeting with the FDA after the hearing just this past week, he responded that they only get to read the executive summary of the studies. He added that 90-100% of the time, research summaries produced by industry-funded scientists present a significantly different interpretation of the science compared to those provided by government agencies or independent scientists. Of course, this is completely understandable. Nevertheless, I have difficulty believing that integral studies are unavailable. These findings provide the knowledge required to evaluate potential risks, and consequently, a much better job needs to be done not only to access post-market studies (which he said they would do) but in requiring pre-market studies - assessing the risks BEFORE the food additives get into our market and on our plates!

The fact is that about 10,000 food additives are allowed in our food in the USA. In Europe, they allow only 338. One of our GRAS (Generally Recognized as Safe) program citizen advocates, Marci Kenon, asked in our meeting with the FDA, “Why do Americans have so many more food additives than Europe, and do we need so many?” Jim Jones explained that the EU does not count the chemicals in plastic packaging that can leach into the food as food additives and we do. Gee, I wonder how many more chemicals that is - surely not over 9,662? More information should be provided to detail what compounds are taken into account by the FDA and EU. He added that many food ingredients that are not historically used in the manner in which they are being used, such as basil oil, are considered food additives, so we have many more food additives that are just considered food ingredients in the EU. Essentially, he was saying that our food regulations are STRICTER than the EU’s. Excuse me if I find that very hard to believe. Our categorization may be more encompassing, but that is part of the problem - when we have so many food additives to regulate the staff cannot keep up. So, in 1997, the FDA decided not to even try to keep up. They changed their policy to make the GRAS program, applying for a status that does not require safety testing but simply requires documents saying that the company has stated that their product is generally the same as similar food ingredients and, therefore should be recognized as safe. The FDA made the application for this meaningless status VOLUNTARY. So few are using it, and food additives are making their way into our food willy-nilly, many that are literally poisoning us, making us sick, causing hyperactivity, aggression, and giving us cancer.

Photo credit Debra William

• Senator Smith, in the FDA hearing held by Bernie Sanders in the FDA hearing, asked the FDA head, Robert Califf, about releasing the results of the testing they did for cadmium in applesauce. Califf stated that the problem was that the FDA has a confidential commercial information clause in their policies that does not allow them to release test result data which is considered proprietary business information. He asked Congress to change that policy, and Senator Smith said she would get to work on that.

This is obviously enraging and unethical. The FDA has a 7.2 billion dollar budget. The Human Foods Division has a 1.6 billion dollar budget, and they cannot release the information to the people, the Senators, and American taxpayers, who gave them the money? How ridiculous! It was in that moment that I seriously questioned the potential of an alignment for me to work with or at the FDA. With those kinds of restrictions, I might get myself into trouble. There is no way I could feel integrity testing foods and not releasing the information to the American people.

At the end of the hearing, I approached Robert Califf and questioned him about the value of test results that cannot be released to the public. I was angry but remained firm and calm. I was approached by his staff and gave them a packet of the MAA test results. I received an email the next day asking for a meeting.

To briefly summarize a few more points from the meeting:

I questioned the legality of the “confidential commercial information” policy and why this information is not made public. I asserted that it was an unenforceable policy because if information is being withheld that could harm babies, children, and individuals: that information must be released. Everyone should be allowed to know and understand the potential risks of consuming the heavy metals and other toxins in any food. I requested that they seek immediate legal counsel, as I had, and reassess their position on withholding that information.

Dr. Michelle Perro, John Fagan and I addressed the wide range of atrocious contamination of school lunches, baby formula, fast food, gluten-free food, and Girl Scout Cookies.
For example, 100% of fast food and Girl Scout Cookies were positive for Glyphosate, 93% of school lunches as well. Butanediol, a Central Nervous System Depressant that causes combativeness and aggression was found in 47% of the top ten fast food samples. 40-60% contained antibiotics including 1-4 samples of fast food and school lunches contained an aviary contraceptive. The minerals and vitamins were so low there is no possibility that any child consuming this food would meet their recommended daily intake of nutrients. Our children are being starved of nutrients and fattened and sickened by toxins.

• Vani Hari addressed the Red Food Dye and all synthetic dye issues.
• Marci Kenon addressed the futility and dysfunctionality of the GRAS program.
• Mark Doudlah and Kelly Ryerson addressed pesticide contamination and Carol Grieve addressed antibiotics in fast food, which is also fed to children in school lunches.

The FDA team, to whom we were grateful for attending the meeting, listened closely and responded readily. We are, however deeply dismayed by their lack of action regarding the reports we have filed regarding the contamination of the food samples we tested. There is simply no excuse, and is clearly more of a question of misplaced priorities. Claiming to be understaffed and underfunded to me, the head of a nonprofit with a tiny team and barely a shoestring budget did not land well.

We urge the FDA to reassess its priorities and pray that some fundamental wrongs will be righted going forward with the new administration.

How the FDA is Currently Working is Technically Illegal

As the head of the Human Foods Division of the FDA stated, they don’t have as much post-market research on foods and additives as the EU does.

The fact that they are doing any post-market research means that they are studying the effects of the ingredients on the human population. This means we are research participants without having agreed to it or given any informed consent. This is completely illegal in international law.

The Helsinki Declaration, formally known as the Declaration of Helsinki, is a set of ethical principles developed by the World Medical Association (WMA) for the medical community regarding human research. It was first adopted in 1964 in Helsinki, Finland, and has undergone multiple revisions, with the latest update occurring in 2013.

Key Principles of the Declaration of Helsinki:

1. Respect for Individuals:

• The declaration emphasizes the protection of human dignity, autonomy, and rights in medical research.
• It highlights the importance of obtaining informed consent from research participants.

2. Beneficence and Non-Maleficence:

• Research must prioritize the health, well-being, and rights of participants above the interests of science or society.
• Risks to participants must be minimized, and benefits must outweigh potential harms.

3. Scientific Validity:

• Research involving human participants must be based on sound scientific principles, thorough literature reviews, and prior laboratory and animal research, when applicable.

4. Vulnerable Populations:

• Additional safeguards must be implemented when research involves vulnerable groups to prevent exploitation and ensure equal protection.

5. Independent Review:

• All research protocols must undergo review by an independent ethics committee to ensure adherence to ethical standards.

6. Transparency and Accountability:

• Researchers must ensure the registration and publication of research findings. Negative and inconclusive results should also be shared to promote transparency.

7. Right to Withdraw:

• Participants have the right to withdraw from research at any time without penalty or consequences.

8. Post-Trial Access:

• After the study, participants should have access to interventions identified as beneficial during the research.

The Helsinki Declaration serves:

• The foundation for international research ethics and influences guidelines such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP).
• This declaration balances scientific advancement with the protection of human participants, ensuring research is conducted with integrity and respect.

Before releasing a medication, the pharmaceutical industry must follow strict clinical research procedures. It is difficult to understand why post-market data collection on the effects of specific food can occur without informing the consumer on the exact composition of the food being consumed and the potential health risks of consuming them. None of the procedures are being followed and thus, contravene to the Helsinki Declaration.. We, the subjects of their food ingredients experiment, have not been informed of the side effects on the label, we have not consented to the risk of those side effects, and the FDA has not taken action to reduce risks. Not having released the information about the side effects to the public of the impact of allowing these synthetic chemicals and toxins in our food supply for the past 30-40 years.

Access to clean, nutritious, and affordable food should be recognized as a fundamental human right, just as access to clean water is. Both are essential to human dignity, health, and survival, making them indispensable for the realization of other human rights.

The Universal Declaration of Human Rights (UDHR) explicitly recognizes the right to an adequate standard of living. Article 25 states that everyone is entitled to conditions necessary for their health and well-being, including access to food.

• A lack of access to nutritious food leads to malnutrition, obesity, and preventable chronic illnesses. Addressing this ensures not just survival but also the opportunity to lead a healthy and productive life.
• Clean and nutritious food is as critical to public health as clean water, forming the foundation of a healthy society.
• Food insecurity often stems from systemic inequality, disproportionately affecting marginalized communities. Recognizing food as a human right compels governments and institutions to address these disparities and create equitable access to resources.
• The right to food is deeply intertwined with other rights, such as education, work, and health. Without adequate nutrition, individuals cannot fully exercise these rights, perpetuating cycles of poverty and inequality.

Moms Across America continues to work to empower mothers and others with actions and solutions to create healthy communities. This includes striving to empower everyone to have access to safe, nontoxic, nutrient-dense food.

The Universal Declaration of Human Rights (UDHR) explicitly recognizes the right to an adequate standard of living. Article 25 states that everyone is entitled to conditions necessary for their health and well-being, including access to food. I would refer to the actual document.

• A lack of access to nutritious food leads to malnutrition, obesity, and preventable chronic illnesses. Addressing this ensures not just survival but also the opportunity to lead a healthy and productive life.
• Clean and nutritious food is as critical to public health as clean water, forming the foundation of a healthy society.
• Food insecurity often stems from systemic inequality, disproportionately affecting marginalized communities. Recognizing food as a human right compels governments and institutions to address these disparities and create equitable access to resources.
• The right to food is deeply intertwined with other rights, such as education, work, and health. Without adequate nutrition, individuals cannot fully exercise these rights, perpetuating cycles of poverty and inequality.

Moms Across America continues to work to empower mothers and others with actions and solutions to create healthy communities. This includes striving to ensure everyone has access to safe, nontoxic, nutrient-dense food.

We appreciate your support.

Note: This article was edited and supported by François Haman, Full Professor at the Faculty of Health Sciences at University of Ottawa.