Tag: FDA

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” →

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 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:” →

Reflections on the 6th Annual Food Law Conference: Current Trends & Perspectives Beyond the Beltway

by Alexa Libro*

Earlier this year, I had the pleasure of attending CLE International’s 6th Annual Food Law Conference. I vividly remember attending the previous food law conference in San Francisco in February of 2020, deliberating on whether it was appropriate to shake hands and how often to use hand sanitizer. A lot has changed since then, including food law. This evolution of food law was demonstrated in every session of this year’s food law conference. Ann Oxenham, the Acting Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition (CFSAN) at the US Food and Drug Administration spoke of tech-enabled traceability as a part of the FDA’s new era of smarter food safety. The General Counsel Roundtable session exemplified how food businesses had to adapt to navigate supply chain issues, labor issues, and remote work. Thus, ending the conference with a session on the future of food law was the perfect way to reflect on how food law has evolved and surmise its next evolution.

In the Future of Food Law session, Michael Roberts, the Executive Director of the Resnick Center, moderated a conversation with two of his former students, Evan Graham Arango and Jason Lawler. The conversation illustrated why food is currently top of mind for everyone, not just food lawyers. The pandemic forced us to think about where our food comes from. For many, it was the first experience with gardening or baking bread. For many, it was the first experience not finding numerous items on a grocery list. For many, it was the first or worst experience with food insecurity.

Evan Graham Arango, the owner, founder and farmer at Ojai Roots Farm in Ojai, California noted people’s interest in regenerative agriculture and eating locally. I’m speculating that many people, like me, watched documentaries about regenerative agriculture, such as Kiss the Ground and Biggest Little Farm, when they were stuck inside, and were inspired. Regenerative agriculture and its potential to sequester carbon from the atmosphere brings to the forefront the connection between our food system and climate change

Jason Lawler, an associate at Sidley Austin LLP, elaborated on how his work around the business of food interfaces with climate change realities. Businesses are aware that consumers vote with their wallets, which encourages existing businesses to voluntarily offset carbon and new businesses to form with the goal of sequestering greenhouse gases.

Michael Roberts posits that the future of food will revolve around information. As artificial intelligence gives us more insights into what to grow, how to grow it, where to grow it, and when to market it, he wonders how to democratize that information and ensure fairness in data collection and ownership. As a consumer, I wonder how all that information will be relayed to me so I can make good food choices. To all the current and aspiring food lawyers, I look forward to seeing how we navigate the future of food law and reflecting on our progress at the next food law conference.    

*Alexa is graduating this year from UCLA Law. She graduated from UCLA with a BS in neuroscience with highest honors and a minor in biomedical research in 2017. At UCLA School of Law, she has been coexecutive chair of the Food Law Society and is currently chief managing editor of the Journal of Environmental Law & Policy. She is also a research assistant with the Resnick Center.

Not labeled for retail sale, except during the coronavirus pandemic

By Daniel Pessar* (Guest Blogger)

This is the third in a series of occasional posts by Daniel Pessar on regulatory flexibility in the context of food law and the pandemic.

The novel coronavirus pandemic has led to health, economic, and political turmoil around the world. In response to this public health crisis, U.S. federal, state, and local governments have been seeking to contain the impact of the virus while minimizing the collateral economic impact. Although stay at home orders and social distancing rules have had the greatest impact on people, many laws, regulations, and rules have been suspended or relaxed in order to help individuals and organizations—especially those involved in the pandemic response—to be productive during these difficult times.

One agency relaxing regulatory measures is the U.S. Food and Drug Administration (FDA) which has been working to remove obstacles to the flow of essential goods throughout the economy. As supply chains have been disrupted and demand patterns have shifted, the FDA has worked to relax the enforcement of certain regulations which could slow the response of food manufacturers and distributers to the new food business landscape.

In March 2020, the FDA announced that it would relax the enforcement of certain labeling laws that are familiar to many shoppers who purchase packaged goods in bulk. These shoppers know that often the individual beverage containers or snack bags do not have the product’s nutrition information. Instead, they have a label which reads “This unit not labeled for individual sale” or some variation of that announcement. Labeling items within a multi-pack in this way gives manufacturers more flexibility in package aesthetics and design and can help a food business to better control the flow of products for retail sale. Retailers interested in selling these items individually would need to affix a compliant nutrition label on top of the manufacturer’s label to comply with federal law.

In addition to multi-unit packaged goods, FDA nutrition labeling regulations also provide exceptions for food served in most restaurants or in other establishments in which food is served for immediate human consumption (e.g., institutional food service establishments, such as schools, hospitals, and cafeterias; transportation carriers, such as trains and airplanes; bakeries, delicatessens, and retail confectionery stores where there are facilities for immediate consumption on the premises; food service vendors, such as lunch wagons, ice cream shops, mall cookie counters, vending machines, and sidewalk carts…)  21 CFR § 101.9(j)(2)(ii)

These exceptions do not give restaurants a blank check, however. Only food served for immediate human consumption may be served without the inclusion of the necessary nutrition information. Under normal circumstances, these regulations do not limit restaurants—they are in the business of serving food for immediate human consumption after all.

Yet all of the upheaval that has come with the coronavirus pandemic has turned this law into a costly obstacle to offloading excess ingredient inventory. Food establishments with extra meat, flour, or cheese—but fewer customers—might consider selling packages of supplies directly to customers in order to reduce the economic pressures they are facing. However, given that these supplies would not qualify as food for immediate human consumption, the restaurants would need to ensure that an appropriate label be designed and affixed to the food parcels. Further compounding this challenge is the fact that the large packages sent to the restaurants by manufacturers or distributers of food supplies often lack nutrition labeling as well—those companies qualify for a separate exception from nutrition labeling regulations (see 21 CFR § 101.9(j)(2)(v)).

Recognizing that this rule would hurt restaurants while reducing the amount of food being made available to consumers during the pandemic, the FDA stepped in to temporarily relax certain rules. In March 2020, The FDA issued a temporary policy to relax labeling requirements for restaurants seeking to sell these kinds of products. As long as the food was labeled with (1) statement of identity, (2) ingredient statement, (3) name and place of business of the food manufacturer, packer, or distributer, (4) net quantity of contents, and (5) allergen information, the FDA would not object to the product’s sale even if it lacked a Nutrition Facts label.

Other rules have not been suspended, however. Restaurants making nutrient content claims about these food products (“Low fat cheese” or “High fiber beans”) would face other labeling rules that have not been relaxed by the FDA’s temporary policy. In addition, the FDA guidance does not apply to any foods prepared by restaurants. Entrepreneurs interested in developing packaged foods to supplement their restaurant offerings during the pandemic will need to comply with the robust label requirements for packaged foods. But as long as the new guidance stays in effect, restaurants can more easily sell packaged foods—both perishable and non-perishable—from cooking oil and tomato sauce to snack packs and juice pouches.

As restaurants, bars, and bakeries see a dramatic slowdown in business, some are trying to capitalize on their supply chain to maintain some business activity. For example, Fort Defiance, a bar in the Red Hook section of Brooklyn, New York, now sells a range of food supplies online including cheese, tofu, and raw chicken.  The FDA’s new stance facilitates this flexibility.

*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

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.

Forthcoming Scholarship: “A Palatable Option for Sugar-Coated Palates”

by Diana Winters

UPDATE: The article was published Summer 2021, and can be found here.

Some good news!  UCLA Law 2L Nicholas Miller’s article, “A Palatable Option for Sugar-Coated Palates: Labeling as the Libertarian Paternalism Intervention that American Consumers Need”, will be published in the University of Florida Journal of Law & Public Policy early in 2021.

Nicholas is a second year law student at UCLA, where he is involved in a range of activities including OUTLaw and the Dukeminier Awards Journal of Sexual Orientation and Gender Identity Law. As the son of a caterer and a lawyer, he was naturally drawn to food law, which combines his love of food and his desire to understand the legal frameworks that protect society and guide behavior. He chose to write about labeling – specifically of sugar content – because it raises the issue of how to balance progressive public health policy and the historically American fear of paternalistic overreach by the government. He sees this dynamic of public health initiatives that impede on individual liberty at play now, amid the coronavirus pandemic, and hopes his analysis will help advance the dialogue on how best to guide people to make good decisions about their health.

Here is the abstract for the article:

Addressing nutritional health for Americans has proven uniquely challenging in a marketplace flooded with non-nutritious food products.  Compounding the issue, consumers consistently misjudge the contents of these processed foods and undervalue their pernicious effect.  At the same time, consumers are wary of overly intrusive or paternalistic government interventions, such as bans and portion limits.  This paper reflects on the effectiveness (or lack thereof) of previous attempts by the FDA to combat public health threats.  Finally, the paper proposes a path forward, with growing political momentum, that builds on the innovative food labeling models being tested in markets around the world.

We can’t wait to see this in print.

*If you would like to have forthcoming food law scholarship featured in the blog, please contact Diana Winters.*

New Scholarship: The New Food Safety

by Diana Winters

Emily M. Broad Leib and Margot Pollans recently posted The New Food Safety, forthcoming in the California Law Review, on SSRN.  The article argues for a comprehensive definition of “food safety” that encompasses “acute ingestion-related illness” (narrow food safety), “whole-diet, cumulative ingestion-related risks that accrue over time” (intermediate food safety), and “risks that arise from food production or disposal” (broad food safety).  The articles discusses why our current divided regulatory approach is problematic, and may actually exacerbate food-related harms.  In addition to calling for an expanded definition of “food safety,” the article proposes better interagency coordination and the creation of a single Food System Safety agency.

This compelling work  is applicable outside of the context of food, and will appeal broadly to scholars of the regulatory space.

FDA Commissioner Scott Gottlieb resigns

by Diana R. H. Winters

Much of the coverage of the resignation of FDA Commissioner Scott Gottlieb highlights his work to regulate the e-cigarette and tobacco industries and his mixed record on the opioid addiction epidemic.  See here, here, and here, for example.  Despite criticism for delaying certain e-cigarette regulations, Commissioner Gottlieb stood out in the Trump administration for his willingness to regulate and to challenge the tobacco, e-cigarette, and drug industries.  Similarly, and surprisingly, the FDA under Gottlieb continued to move ahead with certain Obama era nutrition policy initiatives and began to spearhead some of its own.  The agency moved ahead with changes to the nutrition facts label, with requirements that certain restaurants post calories on menus, and with an FDA initiative to reduce sodium levels in the food supply.  Moreover, in a speech to the National Food Policy Conference delivered in March 2018, Gottlieb outlined a new FDA nutrition strategy, designed to reduce the toll that poor nutrition takes on Americans’ health.  Gottlieb explained that the FDA would “use our tools and authorities to create better ways of communicating nutrition information to consumers so they can be empowered to make good choices. And we’ll advance new ways to make science-based claims that provide more incentives for food manufacturers to produce products with more healthful attributes.”

What’s next for the FDA?  As the FDA’s tobacco and e-cigarette initiatives are now up in the air, so are those regarding nutrition policy.

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