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.

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.

 

The Honey Wars

If you’ve ever tried to buy a jar of manuka honey, you know the price is anything but sweet.  This is because of the honey’s purported health and aesthetic benefits, which have caused its price to skyrocket.  The New York Times recently published an article about a dispute between New Zealand and Australia regarding when honey can be branded “manuka,” and by whom.  Find this fascinating read here.

 

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…..

ACLU sues Arkansas for “meat” labeling law

by Diana R. H. Winters

The ACLU, the Animal Legal Defense Fund, and the Good Food Institute are suing Arkansas on behalf of The Tofurky Company to challenge a new law that restricts producers of plant-based food products from using words like “meat,” “burger,” or “sausage” to label these items.  The complaint argues that the law restricts commercial speech, and thereby violates the First and Fourteenth Amendments, and the dormant Commerce Clause.  The law “creates consumer confusion where none existed before in order to impeded competition.”

The stated purpose of the Arkansas law is to “protect consumers from being misled or confused by false or misleading labeling of agricultural products that are edible by humans.”  Tofurky’s complaint states that there is actually no evidence that consumers are confused about plant-based meats, nor does the Arkansas law point to any such evidence.  Moreover, existing laws, both federal (FDCA, FMIA, PPIA, and FTCA) and state, prohibit misbranding and deceptive marketing.

The lawsuit asks for a declaration that the Arkansas law is unconstitutional and an injunction against its implementation.

Along with questions about state power, this case raises questions regarding the “reasonable” consumer.  Does a consumer buying a veggie burger think that burger contains meat?  Or that Tofurky deli slices made with “slow-smoked tender plant-based non-gmo ingredients,” are meat?  In most circumstances, the answer is no.  Consumers of plant-based meat products actively seek these items.  If we expect consumers to know that a “crunchberry” isn’t a real berry, and to have the wherewithal to check the nutrition facts label for the sugar content in a product labeled “healthy,” surely we can trust a consumer to understand that a veggie burger contains no animal meat.

New Scholarship: Holding the Animal Agriculture Industry Accountable for Climate Change

by Diana R. H. Winters

UCLA Law 3L Amit Liran has published “Holding the Animal Agriculture Industry Accountable for Climate Change: Merits of a Public Nuisance Claim Under California and Federal Law,” in the Villanova Environmental Law Journal (Vol. 30, Issue 1 (2019)).  This paper develops arguments for a public nuisance claim under both California state and federal common law against companies within the animal agriculture industry for their role in climate change and assesses the validity of such arguments.

About coming to this topic, Liran writes:

“I was first inspired to write Holding the Animal Agriculture Industry Accountable for Climate Change: Merits of a Public Nuisance Claim Under California and Federal Law            while enrolled in the “Introduction to Food Law and Policy” course taught by Professor Michael T. Roberts, the founding Executive Director of the Resnick Center for Food Law and Policy at UCLA School of Law.  Class discussions regarding civil food law claims based on misrepresentations of nutritional facts made me consider potential claims against huge forces in the food industry that—motivated by profits—have continuously pushed long-standing misconceptions regarding the nutritional value of modern food staples.  This strategy boosted consumption of their products and thereby materially contributed to today’s most pressing exigency: climate change.  Based on parallel claims that have been brought against fossil fuel companies, I developed and wrote about potential litigation strategies against the most culpable of such forces.”

 

Enjoy!

 

“Public Values in Conflict with Animal Agribusiness Practices” Conference at UCLA Law

By Michael T. Roberts

 

On February 23, 2019, the Resnick Center for Food Law and the UCLA Animal Law and Policy Program hosted a one-day conference at UCLA Law titled, “Public Values in Conflict with Animal Agribusiness Practices.” The conference featured three panels about subjects relevant to closing the gap between public values and animal agribusiness practices. These three panels addressed  the role and utility of undercover investigations, production method issues and consumer perceptions of labels, and private agreements with corporations as a way to improve business practices that affect workers and animals and to reduce animal products.

This conference was part of a joint Initiative on Animals in Our Food System between the Resnick Center and the UCLA Animal Law and Policy Program and funded by a generous gift from the Animal Welfare Trust. We previously co-hosted with the Animal and Law and Policy Program a Roundtable discussion on the legal and business considerations in how investments are made in plant-based enterprises. We have also incorporated law and policy issues related to animals in the food system in our classes and events. The Center is grateful for its association with the UCLA Animal Law and Policy Program and looks forward to future joint activities.

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.

Street Vending Decriminalized in L.A.

Just a note to follow up on our guest post by Joseph Pileri on October 3, 2018, discussing new legislation legalizing street vending across California.  This week, the Los Angeles City Council finalized an ordinance legalizing and regulating street vending, ahead of the state law discussed by Pileri that takes effect on January 1, 2019.  The city will implement a permit system, granting site-specific permits to vendors.  This system will take a year to develop, and until then, Los Angeles will regulate street vendors by requiring them to comply with certain rules and standards.

 

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