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

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.

Food Law News

Today was just chock full of food law & policy news.

1. The Supreme Court turned down challenges to two of California’s animal welfare laws: A) Proposition 2, California’s Prevention of Farm Animal Cruelty Act, which mandates that the state’s farm animals need be able to “turn around freely, lie down, stand up, and fully extend their limbs,” and B) CA’s foie gras ban.

The New Food Economy has a good summary of these laws and the challenges here: https://newfoodeconomy.org/supreme-court-animal-welfare-law-cage-free-egg-foie-gras-ban/

2. A federal judge in Iowa found the state’s “ag gag” law unconstitutional, saying that it violates the First Amendment.  https://www.desmoinesregister.com/story/money/agriculture/2019/01/09/ag-gag-law-iowa-struck-down-federal-judge-ia-agriculture-first-amendment-free-speech-puppy-mills/2527077002/

3. The government shutdown’s effect on food safety inspections has been widely noted: https://thehill.com/homenews/administration/424562-fda-says-most-food-inspections-have-been-halted-amid-shutdown.  FDA Commissioner Scott Gottlieb weighed in on Twitter, however, to explain that the FDA has NOT stopped inspections, but has postponed a small amount of routine inspections.  He wrote, “Food Safety During Shutdown: We’re taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities. 31% of our inventory of domestic inspections are considered high risk…”

See thread: https://twitter.com/SGottliebFDA/status/1083055700593516545

He also explained, “We wouldn’t have conducted inspections during the 2 weeks around Christmas and New Years, so this is really the first week where there might have been *some* inspections postponed while we put in place mechanisms to continue high risk food surveillance inspections during shutdown”

For more discussion on the background of food safety inspections, and for fantastic food policy tweeting in general see Politico’s Helena Bottemiller Evich’s tweets: https://twitter.com/hbottemiller

 

 

The foodralist paradigm

by Diana R. H. Winters

Laurie Beyranevand at the Vermont Law School and I wrote a paper about striking a balance between federal and state decision-making in the area of food policy, called Retooling American Foodralismand the University of Pennsylvania’s Regulatory Review wrote a thoughtful analysis of the paper here.  In the article, author Nicholas Bellos writes:

“[F]or an industry as sprawling and complex—and vital—as the nation’s agricultural sector, should states be the principal actors ensuring consumer safety?

In a recent paper, two scholars argue that they should. University of Vermont Law School’s Laurie Beyranevand and University of Indiana Robert H. McKinney School of Law’s* Diana Winters say that more states should take initiative like California to enact food safety regulations of their own, rather than depend on federal regulators to lead the way. The balance between federal and state decision-making—what they call “foodralism”—needs to tilt more toward state governments, they argue. States need to fill the gaps in the current patchwork of U.S. food regulations and serve as laboratories for developing new rules and standards.”

Retooling American Foodralism is forthcoming in the American Journal of Law and Medicine.

 

*Although I used to be at I.U. McKinney, I am now the Assistant Director of Scholarship at the Resnick Center for Food Law & Policy at UCLA Law.

 

Conference: FDA – Past, Present, and Future

Last Friday I attended a terrific conference sponsored by American University Washington College of Law’s Health Law and Policy Program and the Food and Drug Law Institute (FDLI) on the FDA – Past, Present, and Future.  From a discussion with four former FDA Commissioners—Califf, Hamburg, Kessler, and von Eschenbach—to a conversation with four former FDA chief counsels—Cooper, Hutt, Masoudi, Troy—the conference provided a fantastic perspective on the agency, both current and historical.  There was a keynote address by Henry T. Greely, the Director of the Center for Law and the Biosciences at Stanford Law School, and a plethora of fantastic breakout sessions on drugs, devices, tobacco and cosmetics, food and animal products, and biological products.  You can find the agenda and conference papers here.  This was a conference for the ages, and I was lucky to be there.

Reefer Madness

by Diana Winters

I just read two very interesting articles, both arguing that states and the federal government have to do more to regulate marijuana products as more and more states move to legalization. In Marijuana Edibles and “Gummy Bears,” published this month in the Buffalo Law Review, Paul J. Larkin, Jr. looks closely at marijuana edibles, discussing their retail distribution, potential harms, and regulatory options available to local, state, and federal governments. The solution Larkin advocates is compelling—that the FDA declare foods with THC as adulterated, and either seize such products or require edibles to comply with standards that reduce the risk that children would ingest the product.

In “High” Standards: The Wave of Marijuana Legalization Sweeping America Conveniently Ignores the Hidden Risks, forthcoming in the Ohio State Law Journal, Steve P. Calandrillo and Katelyn J. Fulton also focus on marijuana edibles and argue that these products pose special risks to the population. The authors make certain specific recommendations, including the increased study of edibles, a refinement of edible labels, a ban on edibles that resemble children’s candy, and more.

Beyond the specific issues of marijuana regulation, these articles are fascinating in regards to the federalism issues they present, especially in this time of some confusion about the federal government’s stance towards the state legalization of medical and recreational marijuana. I better go eat some “brownies” and try to figure it all out…

FDA Commissioner Scott Gottlieb Proposes Sweeping Label Updates – COMMENTS OPEN

by Diana Winters

On March 29, FDA Commissioner Scott Gottlieb spoke at the Consumer Federation of America’s National Food Policy Conference about how the agency “can make further improvements in public health by both empowering consumers with information and facilitating industry innovation toward healthier foods that consumers want.” He focused not just on reducing chronic disease, but also on how better information can help to narrow nutrition and health disparities.

As to specific steps, Commissioner Gottlieb discussed: (1) modernizing health claims, (2) re-defining “healthy”, (3) changing the process by which the agency reviews qualified health claims, (4) clarifying the term “natural”, and (5) modernizing the names for ingredients, and standards of identity. He also talked about implementing the new nutrition facts label and menu labeling rules, and working on reducing sodium in foods.

You can watch the speech here.

For an administration committed to deregulation, Commissioner Gottlieb’s stance is surprising, and exciting. The Center for Science in the Public Interest provided FDA with some great preliminary suggestions for moving forward. I’m opening comments for this post – what do you think about Commissioner Gottlieb’s speech? What should or shouldn’t FDA do?

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