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

Learning and eating remotely

By Daniel Pessar* (Guest Blogger)

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

School administrators across the country have their work cut out for them. The shift to remote instruction has improved compliance with social distancing mandates but has also created challenges for families and invited questions about the quality of online education. Modern schools, however, are more than just places of instruction—they are also hubs of support service activity for students. From providing guidance counselors and speech therapists to nurses and probation officers, schools are equipped to do much more than just teach. And many of the services offered by schools are less easily transferable to the web than classroom learning.

chairs classroom college desks
Photo by Pixabay on Pexels.com

 

Food provision programs are one such example. The U.S. Department of Agriculture (USDA) administers federal programs including the National School Lunch Program (NSLP), the School Breakfast Program (SBP), and the Summer Food Service Program (SFSP) which exist to bring nutritious food to school-age children. The Child Nutrition Programs, including the ones listed above, cost the United State over $20 billion each year—translating to well over 7 billion meals and snacks—and are administered with the help of a long list of laws and regulations.

But like many other school services, food programs are designed to provide meals on site and not remotely. For example, program sponsors (e.g., schools, camps, or governments) must agree, in writing, to numerous rules including to, Maintain children on site while meals are consumed.”  7 CFR § 225.6(e)(15)

To allow the food programs to continue despite the virus-related upheaval, the USDA has relaxed several rules, including the requirement to have students eat on site. Although some rule waivers are being issued on a state-by-state or case-by-case basis, the USDA issued an all-states waiver in this case:

[The law and regulations require that] child nutrition program meals must be served in a congregate setting and must be consumed by participants on site. However, FNS [USDA’s Food and Nutrition Service] recognizes that in this public health emergency, waiving the congregate meal requirements is vital to ensure appropriate safety measures for the purpose of providing meals and meal supplements.

COVID–19: Child Nutrition Response #2 (March 20, 2020), Food and Nutrition Service, U.S. Department of Agriculture

Another important rule waiver deals with the requirement that students be present for food pickup. Given the concerns about students having to leave home in the current environment of recommended isolation—especially those students who may not feel well—the USDA granted another all-state rule waiver:

[The law and regulations] envision Program operators providing meals directly to children, not to parents and guardians picking up meals at non-congregate meal sites on behalf of their children. However, FNS recognizes that in this public health emergency, continuing to require children to come to the meal site to pick up meals may not be practical and in keeping with the goal of providing meals while also taking appropriate safety measures.

COVID–19: Child Nutrition Response #5 (March 25, 2020), Food and Nutrition Service, U.S. Department of Agriculture

Questions remain:  Will these meals—designed to be healthy and produced with children in mind—actually get into the hands of the intended recipients? Even if they do, will students eat the food if they have unhealthy alternatives available? These and many other questions face school administrators and policymakers trying to navigate the new environment.

But at least food provisions can be handed to parents and guardians and sent home to students. The same cannot be said for counseling and therapy services, health services, and many other offerings. Without new avenues for connecting with students and distributing all resources, the pandemic disruption will continue to result in a dramatic decrease in support services to the students who need them most.

*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

President Trump Signs Executive Order to Keep Meat Processing Plants Open

by Diana Winters

Thousands of workers at meat processing and packing plants have contracted coronavirus* and over 20 have died.  As of last week 13 plants had closed down for some period of time resulting in a significant reduction in the nation’s meat slaughter (pork and beef) capacity.

Yesterday, April 28, President Trump signed an Executive Order declaring meat plants “critical infrastructure” and directing the Secretary of Agriculture, Sonny Perdue, to ensure that processing plants remain open.

The Order requires that continued operations be in compliance with guidance from the CDC and OSHA regarding safety in plants, but because this guidance is voluntary, labor representatives fear that workers will continue to be put at risk by working in meat plants.  Moreover, some meat plant workers insist they will not be ordered to come to work.

Some scholars have speculated that the main purpose of the Order is to block local objections and potentially protect the meat processing and packing industry from liability for coronavirus contracted on the job.  The issue of tort liability is being discussed more broadly in relation to the gradual reopening of the economy, and certain representatives for business are asking the Trump administration to include a liability shield in any future relief legislation.

As we consider the effects of this Executive Order, perhaps this is a good time to remember that poor diet has been linked to worse outcomes from Covid-19, and that excess meat consumption has been linked to many diet-related diseases.  Maybe a (temporary) reduction in the meat supply can be tolerated?

 

*Many of the articles linked in this post, as well as many others, are linked in the Resnick Center’s UCLA Law LibGuide to Covid-19 and Food Law.

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

by Diana Winters

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.*

Feeding Children During the Pandemic – HER teleconference

by Diana Winters

There has been a recent spate of articles about several studies showing that a very high number of patients who ended up hospitalized with Covid-19 had underlying health conditions, with obesity being one of the most common.[1]  These studies are largely observational and preliminary, but have still garnered attention.  At the same time, concerns about supply chain disruption and increased economic insecurity have also highlighted the need to prepare for a rise in global hunger and malnutrition.  With this backdrop, as well as the announcements that many schools across the country will be closed for the rest of the school year, Healthy Eating Research (HER) held a teleconference for media on feeding children during the pandemic, which discussed availability, distribution, and nutritional content.  HER is a national program of the Robert Wood Johnson Foundation (RWJF), which supports research on policy, systems, and environmental strategies that promote healthy eating among children.  The call addressed many issues around feeding children during this crisis, including the following.

During a normal school year, schools across the country provide approximately 30 million children with free and reduced-price school meals.  These meals provide up to two-thirds of these children’ daily nutritional needs.  As of right now, however, 48 states have closed their schools because of the Covid-19 pandemic, and 30 states have announced that schools are closed until the fall.  The impact of this on the availability and quality of food for children is immense.

There has been significant federal legislation to address feeding children during the pandemic.  This legislation includes Pandemic EBT, where states can request waivers to provide SNAP benefits for the families of children eligible for free or reduced-price lunch, emergency benefits, where all SNAP beneficiaries can receive emergency benefits, funds to bolster new SNAP enrollees, and legislation to adapt the emergency feeding of children during school closures to encompass summer feeding nutritional standards.

All of these actions are taking place while the Trump administration is simultaneously trying to weaken nutritional standards for school lunches.  In mid-April, a federal court struck down a 2018 Agriculture Department rule that reversed nutrition standards for sodium and whole grains in school meal programs.

Moreover, the Trump administration has taken action to cut down on SNAP benefits.  The four major reforms the administration has pushed–including making it harder for states to request time limit waivers, restricting states’ ability to make families categorically eligible based on their eligibility for another program, standardizing the method for determining state allowances, and denying noncitizens citizenship or green cards if they participate in federal aid programs—are currently stalled during the pandemic.

Dr. Sara Bleich, Professor of Public Health Policy at the Harvard Chan School of Public Health, estimates that the SNAP rolls will go up to higher numbers than during the 2008 recession because of the unprecedented unemployment figures.

More legislation is needed to protect children from food insecurity and the resulting health detriments, said Dr. Bleich.  Dr. Bleich explained that we should look for the government to increase the size of SNAP benefits, which is a proven policy intervention to stimulate the economy and improve health, to provide personal protective equipment (PPE) for food service staff, and to provide more funding for school districts impacted by the school year closures.

Elisabet Eppes, MPH, Program Innovation Director at the National WIC Association, spoke about how the WIC (Women, Infants and Children) program is adapting to the pandemic.  WIC is a special supplemental nutrition program for pregnant and postpartum women, and their infants and small children.  It is a federal program, administered and run by states, that provides nutrition education, health care referrals, breast feeding support, and nutrition funding.  It is provided through paper vouchers and electronic benefit cards.

The WIC program is facing steep challenges during the pandemic.  Many WIC office are closed as the staff helps with other pandemic-related tasks.  WIC participants are having trouble acquiring WIC food because of food supply problems at grocery stores.  At the same time, more families need WIC right now because of increased unemployment.  WIC agencies are adapting to the pandemic, and legislation has been passed and is pending to provide the program with extra money and to ease administrative requirements.  Moreover, states are exploring possibilities for online orders and curbside pickups.

The impact of the pandemic on feeding children is immense, and its effects will be felt for years to come, on our nation’s public health and on its economy.  These issues are of critical importance.

 

[1] The articles here can be found linked on the Resnick Center’s guide to food law and Covid-19 resources, found here.

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.

 

Schools and Food

Every day I get email updates from the Los Angeles Unified School District, where my two younger children are students.  These emails discuss distance education and celebrate the amazing teachers working to keep their students learning, but the emails are focused on food.  The amount of children who depend on the school system for at least two of their meals per day is staggering.  To attempt to address this need, the district, the second biggest school district in the country, opened 60 grab and go food centers for its students and their families.  Yesterday it provided 90,000 meals.

In Los Angeles, 80% of students qualify for free or reduced-price meals, and in some areas the percentage is close to 90%.  The New York School system includes close to 114,000 homeless children.

Right now, we have to feed these kids, but this crisis has made stunningly clear the role of schools in our food system, the magnitude of which is far broader than school lunch and shows that arguments about the nutritional profile of school food are of immense and critical importance.

 

By 2030 50% of American adults will be obese, and 25% will be severely obese

by Diana R. H. Winters

If the predictions from a recent New England Journal of Medicine article (pay-walled, but 3 free articles a month available with account creation) come true, the implications–for our nation’s health, for our health care system, and for our economy–are vast.  The study shows that by 2030, almost half of American adults will be obese and a quarter will be severely obese.  The study authors were meticulous in their methods to increase the reliability of their projections.

The study found that there is great variation among states, with over 29 states projected to have higher than 50% obesity, and a large variation in the prevalence of obesity according to income.  Severe obesity will be much more common among low-income adults than higher income adults.

The study also notes that the health consequences of this magnitude of obesity in the population are enormous, and will likely increase socioeconomic disparities.

Although the researchers are light on policy suggestions, the authors do write that, “a range of sustained approaches to maintain a healthy weight over the life course, including policy and environmental interventions at the community level that address upstream social and cultural determinants of obesity, will probably be needed to prevent further weight gain across the BMI distribution.”

In the New York Times, Jane E. Brody notes in covering this study that the United States has done very little to address the food environment that has led to such a marked increase in obesity (since 1990, obesity in the United States has doubled).  Policy interventions such as taxes on sugar-sweetened beverages, portion control, and partnering with restaurants and food manufacturers to reformulate food to be more healthy would be a start.

In fact, another article published today in the New York Times shows that multifaceted policy intervention can have a huge effect on consumption.  It is four years since Chile passed a series of sweeping laws to combat obesity including raising taxes on sugar-sweetened beverages, and “advertising restrictions on unhealthy foods, bold front-of-package warning labels and a ban on junk food in schools,” and there has been a marked drop in the consumption of sugar-sweetened beverages.  That article cited a public health policy professor from Harvard University who said “the early results suggested that a raft of food policies, not just stand-alone measures like soda taxes, were needed to address a growing obesity crisis that is affecting nations rich and poor.”

As the study and these articles note, time is short.  The costs of obesity at this magnitude are enormous – on quality of life, on health care spending, on the economy, on socioeconomic disparities.  We need these policies, and we need them now.

 

 

For Your Meatless Monday Reading Pleasure

by Diana R. H. Winters

Recently there has been a lot of interest in plant-based meat substitutes and their potential role in reducing global meat consumption and the environmental impact of meat production.

This week’s Economist discussed how plant-based meat can reshape the market, and its environmental potential.  The article, under the headline of “Fake Moos“, explains, however, that companies marketing plant-based meat substitutes must radically increase their reach to make much of a difference.

In today’s New York Times, David Yaffe-Bellany discusses how this may happen in “The New Makers of Plant-Based Meat?  Big Meat Companies.”  This article explains that Tyson, Smithfield, Purdue, and other meat producers are moving into the meat-substitute space.  The oddest product being introduced?  A “blended” product introduced by Purdue and Tyson, which combines meat and vegetable protein.  Weird.

And last week, Tad Friend at The New Yorker profiled Impossible Burger, and its founder’s ambition to “wipe out all animal agriculture and deep-sea fishing by 2035.”

Why the sudden fascination with bleeding vegetable protein?  Perhaps it rings a hopeful note after last month’s bleak climate news, providing a way forward for individual action.  But first, we have to stop flying these burgers across the Atlantic…..

Once again, scientists say not to give children juice

by Diana R. H. Winters

In my house, I frown on recreational juice drinking by my children.  My kids get juice on their birthdays, sometimes.

I am happy to say that a panel of scientists has issued new nutritional guidelines for children supporting my draconian approach.  Kids under five should drink milk and water, and every once in a while, a half of a cup of 100% fruit juice.

And although I am delighted to have these recommendations to hand to my poor kids when they ask for juice, I do wish this wasn’t news, because as coverage of this study explains, “[r]ecommendations to limit juice are not new.”

Dr. Richard Besser, president and chief executive of the Robert Wood Johnson Foundation says, “When we talk about empty calories that are consumed through beverages and the number of calories people get from sugar-sweetened drinks, we’re not just talking about soda . . . Juice is another source of calories that nutritionally aren’t terrific.”

 

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