In Search of Greener GRAS: How Regulatory Policy has Created the American Diet and How to Fix it

by Trey Catanzaro*

If you ask most Americans what food additives they may “generally recognize as safe,” it is highly unlikely that they would answer “propyl paraben” or “beta hydroxy acid.” Rather, they may say vinegar, olive oil, or black pepper. In fact, when asked about what “generally recognized as safe” means, a national poll found that 77 percent of respondents thought that standard meant the FDA has evaluated the product and determined it to be safe. However, under current FDA regulations, a company may self-determine whether its product is “generally recognized as safe” under FDA guidelines, and then bring it to market without even notifying the FDA as to its existence. In other words, there are currently thousands of chemicals in everyday food that the FDA has no clue even exist. As succinctly stated by the former Deputy Commissioner for Food at the FDA, “[w]e simply do not have the information to vouch for the safety of many of these chemicals.”

Most chemical additives enter the American food supply due to an exception in FDA pre-market review for ingredients that are generally recognized as safe (GRAS). In legislation drafted in 1958 to address the rising issue of additives in food, Congress specifically exempted certain ingredients which were “generally recognized . . . to be safe under the conditions of [their] intended use” from the definition of additives. Therefore, anything determined to be GRAS would not be subject to pre-market review and approval by the FDA. At the time of passing the amendment, the reasoning for the GRAS exemption was so that ingredients that had long been used in foods without apparent harmful effects, such as salt, sugar and other familiar substances, would not have to undergo extensive testing to be used in food products. However, the GRAS exemption continued to expand, eventually permitting companies to self-determine whether their ingredient was GRAS, and giving them the choice of whether or not to notify the FDA of their GRAS determination.

Under the present iteration of the rule, companies’ GRAS determinations are filled with a litany of conflicts of interest. Rather than relying on peer-reviewed data, companies often convene panels of experts to make a GRAS determination. These panels are frequently made up of the same small group of individuals who have made a career out of GRAS panel participation. To put this in perspective, a comprehensive study looked at convened GRAS determination panels from the year 2015 to 2020, and, out of the 732 panel positions available, there were a mere 7 individuals who filled 339 (46%) of these positions. Their determinations of safety are often never sent to the FDA for review. Further, even if a GRAS determination is sent to the FDA for notification, which is not required, and valid concerns are raised about the safety of the product, this does not always preclude the product from coming to market. Companies have the ability to voluntarily withdraw their petitions should they foresee unfavorable results from the FDA’s review. Therefore, after receiving health concerns from the FDA based on its review of a GRAS notification, the company may then withdraw its notification and continue to market the product. The FDA will then issue a letter of withdrawal without acknowledging the safety concerns raised during the review.

Continue reading “In Search of Greener GRAS: How Regulatory Policy has Created the American Diet and How to Fix it”

Restricted Access to the “First Food”: Dissecting Breastfeeding Injustices 

August was Breastfeeding Awareness Month. But as Chidera Anthony-Wise discusses below, this issue is critical year-round.

by Chidera Anthony-Wise*

Introduction 

The first food countless infants receive upon arrival into the world is breast milk. The health benefits of breastfeeding are remarkable for babies and mothers. Breast milk strengthens nervous system development and ocular ability of infants. Through breastfeeding, antibodies are introduced to infant immune systems, combatting various diseases. Conditions such as asthma, cardiovascular disease, obesity, type 1 diabetes, and sudden infant death syndrome (SIDS) are less likely among babies that are breastfed. Similarly, lactation is associated with a reduced risk in ovarian and breast cancers and type 2 diabetes in nursing mothers. According to the World Health Organization (WHO), it is strongly recommended to exclusively breastfeed babies for the first 6 months of life and subsequently accompany solid foods with breastmilk for up to 2 years or beyond. Still, there are a plethora of challenges that hinder the adherence to this expert advice. 

Breast milk offers all the nutrients, proteins, and hydration a baby needs for those first 6 months. The release of breast milk is through a “supply and demand” mechanism. If a nursing mother does not have preexisting health conditions that would limit milk production, a full supply of breast milk is dependent on feeding frequency. The provision of formula milk can decrease breast milk supply due to reduced breastfeeding sessions. Despite the WHO recommendation, 2.7 million of the 3.6 million infants born annually in the United States consume formula milk by the age of three months. 

Continue reading “Restricted Access to the “First Food”: Dissecting Breastfeeding Injustices “

Edible Vaccines: The Intersection of Agriculture, Medicine, and Regulation

by Chidera Anthony-Wise*

Farmers might just be the new pharmacists. 

Through scientific breakthroughs, plant products can be genetically modified to deliver immunity against diseases. These “edible vaccines” present remarkable possibilities at the intersection of agriculture and biotechnology. 

One such possibility is to assist immunization efforts on national and global scales. Many low-income nations and US cities such as Chelsea, Massachusetts and Hyde Park, New York lack essential access to vaccines due to expensive costs, maintenance challenges, and improper distribution. The use of common fruits and vegetables as vehicles to immunity could, for this reason, be a tool toward achieving equity. In addition to disease protection, edible vaccines can also be used to alleviate malnutrition because highly nutritious foods, such as tomatoes, lettuce, bananas, corn, and rice, are frequently used as host plants. 

History

In the 1990s, Dr. Charles Arntzen and his team spearheaded the production of an early edible vaccine, a surface protein antigen A derived from Streptococcus mutans successfully expressed in tobacco. This edible vaccine has the capability of alleviating infectious endocarditis, or bacteria occupation in the inner lining of the heart. Arntzen and his colleagues went on to develop a heat-labile toxin, B subunit in potatoes to potentially treat hepatitis B. There is a large focus on protein production in relation to edible vaccine efficacy, as antibodies and protective white blood cells are created by the immune system in the presence of spike (S) proteins. Therefore, to showcase that plant-derived hepatitis B surface antigen could generate a mucosal immune response, host plant potatoes have been optimized to become protein-rich. Other edible vaccine examples include transgenic carrots against HIV and E coli, lettuce against malaria, and spinach against rabies.

Continue reading “Edible Vaccines: The Intersection of Agriculture, Medicine, and Regulation”

The Urgent Need to Update the Regulation of GM Crops

by Alice Carli*

Humans have been altering plants for upwards of 10,000 years through a wide variety of techniques for genetic modification. In the 20th century, scientists developed transgenic genetic engineering, which combines DNA from two or more sources to achieve a desired trait. This discovery fundamentally altered our ability to manipulate crops and opened a Pandora’s box of commercial possibilities and political conflicts. More recently, the advent of CRISPR and other precision gene editing technologies has resurfaced tensions around the role of genetically modified (“GM”) crops in our agricultural and food systems.

Despite these longstanding tensions, the U.S. has the world’s largest production of GM crops by acreage, and it is estimated that over 75% of processed foods on our supermarket shelves contain genetically engineered ingredients.

At the same time, the country faces systemic sustainability challenges exacerbated by climate change and intensive monoculture farming. These include flooding, soil degradation, air and water pollution, and biodiversity collapse. Significant and holistic changes to U.S. agriculture are needed to tackle these problems.

If regulated effectively, GM crops have the potential to make U.S. agriculture more sustainable and climate resilient. When designed with climate-smart features, these crops can significantly enhance nutrient or photosynthesis efficiency, provide flood, drought, and disease resistance, and even improve soil carbon sequestration.

Continue reading “The Urgent Need to Update the Regulation of GM Crops”

The Poisoning of the Gerber Generation:

How Public Nuisance Law Could Address Heavy Metals in Baby Food in the Face of Regulatory Failure

by Lillian Matchett*

A cheerful jingle plays as beaming babies flash across a white background.  These children are the “Gerber Generation,” the voiceover tells you, and they have some big news to share: the nutrition they get in their first five years of life can affect their health forever.   “Think about that,” they say.

Gerber launched its Gerber Generation campaign in 2010 in the face of increased attention on childhood obesity, focusing on the health and nutritional needs of young children at a vital point in their development.  Gerber was right: what a child consumes in the first few years of their life is critically important, but as it turned out, there were other substances in at least some of the Gerber Generation’s food that could have a profound and lasting impact on children’s health.  In 2021, Gerber was one of several companies exposed for selling baby food containing concerning levels of heavy metals—toxins which, even in small amounts, can cause severe and irreversible cognitive impairment and physical illness in young children.

In 2021, a congressional subcommittee issued two reports finding high levels of heavy metals—lead, arsenic, cadmium, and mercury—in commercial baby foods from seven major manufacturers.  Heavy metals were present in baby foods from all companies, often at concentrations many times than that allowed under existing regulations for other food products.  The reports also illuminated failures of industry self-regulation, revealing that companies largely do not test their final products and often do not adhere to their own internal standards. 

Predictably, a deluge of litigation followed the release of the Congressional Reports.  Despite well-documented findings of high heavy metal levels in baby food and the known effects those substances have on children, lawsuits have thus far been mostly unavailing, failing on issues of causation and standing, though many are still making their way through the courts.  Regulatory and legislative solutions have also fallen short.  The FDA and Congress attempted to address the issue, but the FDA’s response has been slow and unenforceable, while legislation lacks bipartisan support, and has stalled in committee. 

Continue reading “The Poisoning of the Gerber Generation:”

Discovering agricultural careers with the USDA: a summer program for teens

by Rosalie Winters*

[This is one in a series of occasional posts by Los Angeles high school students working with and studying food systems.]

This summer I attended the AgDiscovery program at Lincoln University in Jefferson City, Missouri. AgDiscovery is a program for high school students, and it is run by the USDA at multiple land grant universities nationwide. It aims to help teenagers explore careers in agricultural sciences. Each program across the country is unique, specializing in animal science, plant science, agribusiness, or a combination of the three, with pieces added that may explore topics like agricultural history or urban farming. You are only allowed to apply to one school, so it is important to choose one that includes things you are passionate about. The program at Lincoln is a combination, providing students with an introduction to the many moving parts that make up the country’s agricultural systems. This appealed to me because while I was very interested in agriculture, I knew almost nothing about it. 

The program at Lincoln included four distinct components. The first of these was a lecture series on varying agricultural topics. For example, we heard an etymologist speaking about different invasive species of insects and how they can affect various crops; a speaker discussing native plants and showing us some of the different species native to Missouri; and had a lesson on scientific writing and how to put together research. These informative lectures allowed us to gain a background for the things that we were seeing and experiencing in person. 

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Exploring the Legal and Policy Implications Behind ‘High on the Hog’: Potential Solutions Forward (Part 4 of 4)

There are a variety of policy solutions that have the potential to help elevate and preserve Black cuisine and resolve inequities faced by Black Americans in the American food system. This post will explore ideas that relate to the preservation of Black culinary tradition, supporting Black farmers and culinary professionals, and increasing the access of culturally-relevant foods to Black communities in order to honor the richness of America’s culinary landscape. 

Preservation of Black Culinary Traditions

The preservation of Black culinary traditions is important to ensure that Black communities are able to celebrate their cultural heritage and to allow for greater recognition of Black people’s contributions to the culinary world. Initiatives like funding programs and grants to support culinary research, education, and documentation of traditional Black food practices could help with this cultural preservation. Furthermore, educational initiatives that introduce Black American cuisine into school curricula have the ability to educate young people about the cuisine’s significance and influence on American food. FoodCorps is an AmeriCorps grantee that has begun undertaking this type of initiative. During black history month of this year (February 2023), the organization held educational programming at elementary schools which taught black history through a culinary lens. 

Continue reading “Exploring the Legal and Policy Implications Behind ‘High on the Hog’: Potential Solutions Forward (Part 4 of 4)”

Exploring the Legal and Policy Implications Behind ‘High on the Hog’: Black Farmers, Land Loss and Its Implications (Part 3 of 4)

Throughout “High on the Hog”, one can see a deep connection between Black American culinary traditions and farming. However, this connection has been threatened by a variety of policies that have limited Black American land ownership and access. For example, certain policies by the USDA, which has earned itself a description as “the last plantation,” such as allowing local (mostly white) farmers to determine Black farmers’ eligibility for USDA funding, have led to Black Americans’ loss of land. In Pigford v. Glickman, the racial discrimination class-action brought against the USDA by Black farmers, the USDA agreed to the largest civil-rights settlement in U.S. history of $1.25 billion. However, many eligible Black farmers have not been compensated

The number of Black farmers in America has decreased dramatically over the past 100 years, with less than 2 percent of farms in the United States owned or operated by Black Americans. This figure is a significant decrease from 1920, when 14.3% of American farms were operated by Black farmers. While there was a small increase in the number of Black farmers from 1.3% to 1.4% between 2007 and 2012, both Black rural and urban farmers continue to face challenges including land access, zoning laws, and financing. Public policies in the agricultural sector have historically disproportionately favored large-scale farmers and contributed to the marginalization of Black farmers. 

Continue reading “Exploring the Legal and Policy Implications Behind ‘High on the Hog’: Black Farmers, Land Loss and Its Implications (Part 3 of 4)”

Exploring the Legal and Policy Implications Behind ‘High on the Hog’: Intellectual Property and Cultural Erasure (Part 2 of 4)

In “High on the Hog” episode three, we learn the stories of Hercules Posey and James Hemings, the enslaved private chefs of George Washington and Thomas Jefferson respectively. They were widely known and widely praised, yet there are no written recipes attributed to either chef. In Stephen Satterfield’s conversation with Hatchet Hall chefs Brian Dunsmoor and Martin Draluck, the chefs hint at the idea that Martha Washington’s widely praised recipe books may in fact contain recipes developed by the enslaved Hercules. 

Dishes like macaroni and cheese have become an American staple, yet most Americans are unaware that the dish was perfected and popularized by Hemings. Black Americans have long been culinary pioneers in this country and have shaped American cuisine at large. The erasure of Black American’s culinary contributions diminishes Black people’s role in America’s cultural tapestry and perpetuates the idea that Black cuisine is isolated from American cuisine at large. 

Furthermore, cultural erasure of Black culinary traditions is a significant risk because Black communities historically have faced limited access to resources and opportunities in the food industry. Unequal access to capital and credit have likely hindered the ability of Black chefs, restaurateurs, and food entrepreneurs to establish and grow their businesses. The lack of representation and access further perpetuates the erasure of Black culture within the food industry and hampers the promotion and preservation of Black culinary traditions.

Continue reading “Exploring the Legal and Policy Implications Behind ‘High on the Hog’: Intellectual Property and Cultural Erasure (Part 2 of 4)”

Exploring the Legal and Policy Implications Behind ‘High on the Hog’: The Rise of Black Culinary Tradition (Part 1 of 4)

This four-part blog series is inspired by the Netflix docu-series, “High on the Hog: How African American Cuisine Transformed America.” I will delve into the legal and public policy implications behind the narratives presented by series host, Stephen Satterfield, throughout the show’s four episodes. This blog series aims to explore the impact of laws and policies on the development and preservation of Black Americans’ culinary heritage. 

There’s little doubt that the history of slavery in the Black American story is a factor in the culture’s culinary development. “Soul food is the African-American version [of comfort food] —  a cuisine forged during several centuries as a response to persistent trauma from slavery and oppression,” says lawyer, public policy advisor, and culinary historian Adrian Miller

Continue reading “Exploring the Legal and Policy Implications Behind ‘High on the Hog’: The Rise of Black Culinary Tradition (Part 1 of 4)”

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