Category: Food Safety

Safe to Eat? States vs. Feds in the Food Dye Debate

by Candace Yamanishi*

There is a shifting sentiment against the use of synthetic food dyes in the US food supply. As citizen-led advocacy groups have been raising their voices about the health concerns of artificial food dyes, several states have introduced or passed legislation banning or limiting the use of certain synthetic food dyes in food products. These efforts reflect the growing concerns over links between artificial dyes (such as Red No. 3, Yellow No. 5, and others) and potential effects on children’s learning and attention, as well as possible risk of carcinogenic effects. These state-wide initiatives have now captured the attention of the federal government and the larger food industry as a whole. Since the U.S. Food and Drug Administration (FDA) maintains nationwide regulatory authority over food additives, a crucial question emerges: can state bans and restrictions on FDA approved food dyes stand, or will they be preempted by federal law?

Continue reading “Safe to Eat? States vs. Feds in the Food Dye Debate” →

To Eat or Not to Eat: For Consumers in a City Without a Food Allergen Ordinance, The Choice Could Be Life or Death

by Melissa Deng*

For many of us without food allergies, we don’t think twice about choosing to dine at a restaurant or order take-out––often, the biggest concern is picking which restaurant you feel like eating at, what to order, and comparing costs.  But for individuals with food allergies, the choice between dining in and ordering out can mean life or death.  Even so, cities you might think are more “food allergy-friendly” like Los Angeles, which has a colloquial reputation for having a vibrant food scene, may not have an ordinance specifically governing food allergen training in restaurants––even while more than fifty percent of adults with food allergies and over forty percent of children with food allergies in the United States have experienced a severe food allergic reaction (of note is that emergency treatment for anaphylaxis resulting from a food allergic reaction increased by 377 percent between 2007 and 2016). 

What gives?  For starters, the restaurant industry is of course profit-driven, and restaurant associations have a significant impact on lobbying for or against legislation.  From an economic perspective, restaurant management might be wary of the increased costs an ordinance specifically mandating food allergen training would impose, compounded by the fact that the restaurant industry generally experiences high turnover (reportedly, there was a 28% average turnover rate for restaurants in LA last year).  From a legal perspective, restaurants might not want to face increased liability: with an ordinance that mandates training, plaintiffs can more easily make a prima facie case of negligence by showing that the restaurant’s conduct deviated from an established standard of care.  And from a psychological perspective, restaurant staff might have misconceptions about their role in preventing food allergic reactions (for example, believing that the onus falls solely on customers to order a dish that doesn’t have food allergens) and might not realize the potentially fatal consequences, such as anaphylaxis resulting from a food allergic reaction.   What this means is that consumers with food allergies are unfairly subjected to a burdensome and dangerous dining experience where each restaurant chooses which food allergen procedures to follow and to what degree. 

It is precisely this issue that drove us at the Resnick Center for Food Law & Policy, in collaboration with a professor and clinical immunologist at UCLA, to begin collecting both hospital-based and anecdotal evidence on instances of food-related anaphylaxis in the city, and pursuing the task of proposing a food allergy ordinance in the City of Los Angeles that will mandate a separate food allergen training for all restaurant employees in the city.  In the beginning stages of the project, we sought to answer two underlying questions: how do restaurants communicate allergen information to their consumers; and are they effectively training their personnel in allergen disclosure for menu labeling or food handling?

Continue reading “To Eat or Not to Eat: For Consumers in a City Without a Food Allergen Ordinance, The Choice Could Be Life or Death” →

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” →

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:” →

JOB POST! Summer Internship, Harvard Law Food Law & Policy Clinic

Summer interns have the opportunity to engage in action-based learning to gain a deeper understanding of the complex challenges facing the food system, including hands-on experience conducting legal and policy research for individuals, community groups, and government agencies on a wide range of food law and policy issues. Interns are challenged to develop creative legal and policy solutions to pressing food issues, applying their knowledge from the law school classroom to real-world situations.

Summer interns will be eligible for a financial stipend of up to $4,000 from the Food Law and Policy Clinic, should they be unable to secure funding from other sources (we ask interns to demonstrate proof of having sought other funding but not receiving it). It is anticipated that the summer intern program will be in person this summer. 

The internship will run from May 31 to August 5.

Click here for the link to information and the application. The deadline to apply is 1/21/22, but early applications are strongly encouraged and applicants are being accepted on a rolling basis.

Repast – New Episode! Protecting the Liver, Feeding the Gut, and Changing Society with Dr. Robert Lustig

Listen to the new episode of Repast, a food law and policy podcast from the Resnick Center.

This month, Michael and Diana talk with Dr. Robert Lustig about his new book, Metabolical, The Lure and the Lies of Processed Food, Nutrition, and Modern Medicine.  They talk about the health harms caused by processed foods and the massive increase in sugar consumption over the last several decades; possible societal interventions to address these problems; how the processed food public health battle is like the battle over tobacco; and more, including Dr. Lustig’s personal advice to all of us as to what healthy foods do: “Protect the liver, feed the gut.”

Dr. Robert Lustig is Professor emeritus of Pediatrics, Division of Endocrinology at the University of California, San Francisco (UCSF). He specializes in the field of neuroendocrinology, with an emphasis on the regulation of energy balance by the central nervous system.

 Michael T. Roberts is the Executive Director of the Resnick Center for Food Law & Policy at UCLA Law.

 Diana Winters is the Deputy Director of the Resnick Center for Food Law & Policy at UCLA Law.

You can order Dr. Lustig’s new book, Metabolical, here.

You can find Dr. Lustig’s previous book, The Hacking of the American Mind: The Science Behind the Corporate Takeover of Our Bodies and Brains, here, and his book, Fat Chance, here.

A Historical Perspective on Regulating Eating Places Amid a Pandemic

by Brian Fink*

The ferocity and turmoil of the Covid-19 pandemic has, at times, been compared to the so-called Spanish Flu of 1918–1920.  Dr. Anthony Fauci, the nation’s top infectious disease expert, said in July 2020 that the Covid-19 pandemic could reach the same tragic magnitude as the Spanish Flu.  The United States lost about 675,000 people to that virus.  In February 2021, it had already lost 500,000 to the new one.  There are many comparisons to be made, and the present feels frighteningly familiar.

That is why I decided to see for myself how we regulated restaurants, bars, and the rest of the budding American hospitality industry during the Spanish Flu.  To do that, I analyzed scores of newspaper stories and advertisements from between 1918 and 1920.

What I discovered was déjà vu: a global pandemic, mask mandates, forced quarantines, fake news and newspapers fanning the flames of fear, eating places and entertainment venues shuttered, curfews and restricted hours of service, restaurants struggling to survive, businesses deemed essential and nonessential, anti-vaxxers, hairbrained explanations of how the virus started, an economy on the brink, and, oh, the fighting and the politics.

Continue reading “A Historical Perspective on Regulating Eating Places Amid a Pandemic” →

Resnick Center faculty and staff recent speaking events

Executive Director Michael T. Roberts recently spoke by Zoom for the San Marino Rotary Club on the “Role of Food Law in everyday consumer products: Olive Oil and Honey. How do we know what’s in our plates?” Regarding the presentation, he commented, “I was thoroughly impressed with the quality of questions from the members. We ran 30 minutes overtime, as questions about Ractopamine (animal drug) and Isotopes (chemical fingerprinting) surfaced.” A video of the talk is here.

Also this week, Assistant Director Diana Winters participated in a Duke Law Food Law Society Zoom panel on Slaughterhouses and Covid-19, with David Muraskin from Public Justice, Hannah Connor from the Center for Biological Diversity, and Delcianna Winders, the Director of Lewis & Clark Law School’s Animal Law Litigation Clinic. The panel discussed failures in food safety and worker protection regulation that have led to the rampant spread of Covid-19 in meat processing plants.

Boosting shell egg supply during the pandemic

By Daniel Pessar* (Guest Blogger)

 

In response to the COVID-19 pandemic, countless government agencies at the federal, state, and local levels are working to relax certain rules to help industry operate and respond to the needs of the public. For example, the U.S. Food and Drug Administration has issued a host of temporary policies to facilitate increased production of hand sanitizer, sterilization of respirators, and increased availability of shell eggs for retail sale. This last effort impacts countless Americans and will be the focus of this post.

Just as the FDA has an interest in helping medical supplies manufacturers and users to have enough inventory on hand, it seeks to respond to the changes in supply and demand in food markets, such as the current trends in the market for shell eggs. Shell eggs are the eggs many of us purchase in supermarkets, as distinguished from the processed egg products—available in liquid, frozen, or dried form—sold to restaurants and prepared foods manufacturers. Because of the pandemic, there are more people buying more shell eggs and fewer people eating in restaurants. As a result, the egg industry asked the FDA to help make it easier for them to direct more eggs to meet shell egg demand, rather than being sent for further processing.

The Egg Safety Rule, codified in 21 CFR 118, requires egg producers to follow certain rules meant to reduce the risk of Salmonella Enteritidis (SE), a leading cause of foodborne illness in the United States. While the safety rules for shell egg producers are much stricter than the safety rules for processed egg product producers, the relaxed rules for processed eggs are only available if all of a producer’s eggs receive the relevant treatments. Under the regulations,

If all of your eggs that are produced at the particular farm receive a treatment as defined in 118.3, you must comply only with the refrigeration requirements in 118.4(e) for production of eggs on that farm and with the registration requirements in 118.11.

21 CFR 118.1(a)(2)

As a result, processed eggs producers shifting even ten percent of their supply to the shell egg market would result in significant compliance effort and cost for all eggs being produced.

The FDA recognized this and provided conditions under which SE risk could be mitigated in a satisfactory manner without triggering most of the Egg Safety Rule requirements that would normally be triggered, including certain time-sensitive testing and inspection requirements.

eggs

Photo credit: Michael Bußmann from Pixabay

While the FDA has demonstrated flexibility, its guidance is narrowly tailored. The temporary policy regarding the Egg Safety Rule is meant to remain in effect only for the duration of the public health emergency and to apply only to producers of processed egg products—not to existing shell egg producers. As well, the FDA’s guidance does not apply to poultry houses with laying hens over 45 weeks of age at the time the guidance was issued. This is because SE is most likely to be detected in poultry houses with laying hens between 40 and 45 weeks old. Mandatory testing done under the new guidance, to hens already 45 weeks old, have a higher chance of missing the SE threat.

But the relief is real. As supply chain managers across the economy scramble to adapt to the coronavirus upheaval, some have to reimagine their operations. Equipment, staff, and logistics issues can come together to present a daunting challenge, especially to small businesses. With its emergency guidance concerning the Egg Safety Rule, the FDA plays a small but important role in helping industry adapt. Egg product suppliers will now have an easier time meeting the current demand for shell eggs.

 

*Daniel Pessar is a third-year student at Harvard Law School. Before law school, he worked in the real estate investment industry for six years. He is the author of three books and numerous articles. He can be contacted at dpessar@jd20.law.harvard.edu.

Meat Production and Covid-19 – Shortages Coming?

by Diana R. H. Winters

One of the country’s largest pork processing facilities announced that it is closing indefinitely.  The Smithfields Foods, Inc. plant in Sioux Falls, South Dakota will close after almost 300 of its workers tested positive for coronavirus.  The plant employs 3700 workers and produces about four percent of the pork production in the United States.

Other major meat producers, including JBS USA and Tyson, have closed facilities after workers tested positive, and in some instances, died.

These closures illuminate significant worker safety problems at meat production plants.  Manufacturers have been slow to provide protective equipment to low-wage workers standing close together to process meat and have pressured employees to remain working even if sick.

Moreover, these closures are one of many Covid-19 food supply chain issues resulting from the shutdown, which also include the inability of food producers to repackage food meant for institutional or restaurant use for retail use.  The New York Times reported on the resulting massive food waste this past weekend.

All of the articles linked in this post can be found in the Resnick Center’s and the UCLA Law Library’s resource guide to Covid-19 and food law.  Here in the blog we will occasionally highlight important trends and stories we see emerging.  Please explore our guide, and forward relevant material for inclusion in the guide.

 

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