Administrative Law

Holy Crap: The First Amendment, Septic Systems, and the Strict Scrutiny Standard in Land Use Law

Sarah Bauer, MJLST Staffer

In the Summer of 2021, the U.S. Supreme Court released a bevy of decisions favoring religious freedom. Among these was Mast v. City of Fillmore, a case about, well, septic systems and the First Amendment. But Mast is about so much more than that: it showcases the Court’s commitment to free exercise in a variety of contexts and Justice Gorsuch as a champion of Western sensibilities. It also demonstrates that moving forward, the government is going to need work harder to support that its compelling interest in land use regulation trumps an individual’s free exercise rights.

The Facts of Mast

To understand how septic systems and the First Amendment can even exist in the same sentence, it’s important to know the facts of Mast. In the state of Minnesota, the Pollution Control Agency (MPCA) is responsible for maintaining water quality. It promulgates regulations accordingly, then local governments adopt those regulations into ordinances. Among those are prescriptive regulations about wastewater treatment. At issue is one such ordinance adopted by Fillmore County, Minnesota, that requires most homes to have a modern septic system for the disposal of gray water.

The plaintiffs in the case are Swartzentruber Amish. They sought a religious exemption from the ordinance, saying that their religion forbade the use of that technology. The MPCA instead demanded the installation of the modern system under threat of criminal penalty, civil fines, and eviction from their farms. When the MPCA rejected a low-tech alternative offered by the plaintiffs, a mulch basin system not uncommon in other states, the Amish sought relief on grounds that the ordinance violated the Religious Land Use and Institutionalized Persons Act (RLUIPA). After losing the battle in state courts, the Mast plaintiffs took it to the Supreme Court, where the case was decided in their favor last summer.

The First Amendment and Strict Scrutiny

Mast’s issue is a land use remix of Fulton v. City of Philadelphia, another free exercise case from the same docket. Fulton, the more controversial and well-known of the two, involved the City of Philadelphia’s decision to discontinue contracts with Catholic Social Services (CSS) for placement of children in foster homes. The City said that CSS’s refusal to place children with same-sex couples violated a non-discrimination provision in both the contract and the non-discrimination requirements of the citywide Fair Practices Ordinance. The Supreme Court didn’t buy it, holding instead that the City’s policy impermissibly burdened CSS’s free exercise of religion.

The Fulton decision was important for refining the legal analysis and standards when a law burdens free exercise of religion. First, if a law incidentally burdens religion but is both 1) neutral and 2) generally applicable, then courts will not ordinarily apply a strict scrutiny standard on review. If one of those elements is not met, courts will apply strict scrutiny, and the government will need to show that the law 1) advances a compelling interest and 2) is narrowly tailored to achieve those interests. The trick to strict scrutiny is this: the government’s compelling interest in denying an exception needs to apply specifically to those requesting the religious exception. A law examined under strict scrutiny will not survive if the State only asserts that it has a compelling interest in enforcing its laws generally.

Strict Scrutiny, RLUIPA, and Mast

The Mast Plaintiffs sought relief under RLUIPA. RLUIPA isn’t just a contender for Congress’s “Most Difficult to Pronounce Acronym” Award. It’s a choice legal weapon for those claiming that a land use regulation restricts free exercise of religion. The strict scrutiny standard is built into RLUIPA, meaning that courts skip straight to the question of whether 1) the government had a compelling government interest, and 2) whether the rule was the least restrictive means of furthering that compelling government interest. And now, post-Fulton, that first inquiry involves looking at whether the government had a compelling interest in denying an exception specifically as it applies to plaintiffs.

So that is how we end up with septic systems and the First Amendment in the same case. The Amish sued under RLUIPA, the Court applied strict scrutiny, and the government failed to show that it had a compelling interest in denying the Amish an exception to the rule that they needed to install a septic system for their gray water. Particularly convincing at least from Coloradan Justice Gorsuch’s perspective, were the facts that 1) Minnesota law allowed exemptions to campers and outdoorsman, 2) other jurisdictions allowed for gray water disposal in the same alternative manner suggested by the plaintiffs, and 3) the government couldn’t show that the alternative method wouldn’t effectively filter the water.

So what does this ultimately mean for land use regulation? It means that in the niche area of RLUIPA litigation, religious groups have a stronger strict scrutiny standard to lean on, forcing governments to present more evidence justifying a refusal to extend religious exemptions. And government can’t bypass the standard by making regulations more “generally applicable,” for example by removing exemptions for campers. Strict scrutiny still applies under RLUIPA, and governments are stuck with it, resulting in a possible windfall of exceptions for the religious.


Employee Vaccine Mandates: So, Are We Doing This?

Kristin Thompson, MJLST Staffer

Rewind to the beginning of September. President Biden had just announced a generalized plan for addressing the alarmingly slow rise in vaccination rates in the United States. His disposition was serious as he pleaded with the American public to go out and get vaccinated. During this address he laid out several different measures that, conceivably, would lead to a higher national vaccination rate. Included in this plan was a vaccine requirement for all federal employees and government contractors. This sanction did not come as much of a surprise, as federal employees had previously been asked to provide proof of vaccination to avoid stringent safety protocols in the workplace. What was surprising, however, was President Biden’s plea to the Department of Labor to develop a federal vaccine mandate or required weekly COVID testing for private companies employing more than one hundred employees.

In the wake of this announcement came many different responses. On the one hand there were some private U.S. companies already enforcing vaccine policies who seemed unrattled by a potential new federal mandate, and there were some companies who viewed it as a welcome opportunity to implement a vaccine policy by means of a third-party enforcer. On the other hand there were companies who loathe any type of government interference in their business activity and policy implementation, and those who have been specifically opposed to a vaccine requirement and may have even made promises to their employees saying as much. Those companies who opposed a vaccine mandate, in light of this plea from President Biden, had to start making strategic decisions on how they would move forward if the Department of Labor heeded the president’s request.

The questions that came following President Biden’s address were the same regardless of the company’s personal view. Would a federal mandate be legal, would it be constitutional, and would it ever come? This uncertainty hung in the air while private companies, those with 101 employees and 5,000 employees alike, began to prepare. Draft mandatory vaccine policies were made, legal counsel was requested, and employees were advised. Now all that was left to do was wait for the Department of Labor’s cue.

Fast-forward to November. The Department of Labor’s Occupational Safety and Health Administration (OSHA) released an emergency temporary standard (ETS) in line with President Biden’s plan. The goal of this standard being “to minimize the risk of COVID-19 transmission in the workplace,” and to “protect unvaccinated employees of large workplaces.” This standard mandates that all employers with more than 100 employees, including private companies, must require their employees get vaccinated or undergo weekly COVID tests and wear face masks while at work. The standard does not apply to remote workers, workers who predominantly work outside, or employees who work without other co-workers present.

The questions that arose after the ETS was announced were similar to those asked by companies directly after President Biden’s address. Is this ETS legal, is it constitutional, and when will we have to be in compliance? The last question seems to be easily answered; all requirements except weekly testing for unvaccinated employees must be met by December 6th, 2021. The weekly testing policy for unvaccinated employees must begin by January 6th, 2022. However, the immediate onslaught of lawsuits attempting to prevent the ETS have made these straightforward dates seem somewhat arbitrary. Companies now face a unique set of issues prompting even more, new, questions. Do we actually have to be in compliance by December 5th? What effect will these lawsuits have on the ETS? Are we just supposed to wait and see?

Legally, the situation private companies face is complex. As of November 12th, the Fifth Circuit had issued and subsequently reaffirmed a stay on the standard, meaning companies did not have to comply with the mandate. At that time, the Fifth Circuit was the only court that had issued a stay, although there were lawsuits pending in eleven of the twelve circuit courts. What complicated this Fifth Circuit determination was the question of whether or not it covered all U.S. companies; if your company is based in another Circuits’ jurisdiction was this Fifth Circuit stay relevant? The current ruling enjoins OSHA from enforcing the ETS, so while the Fifth Circuit did not write on whether their holding extended outside of their jurisdiction, its practical effect was, and is, felt everywhere. So then, what comes next? How long will this stay last, and who should private companies be looking to in planning their next move?

The Fifth Circuits’ stay will last until one of two things occur. The first is multidistrict litigation, where all outstanding lawsuits brought against the ETS will be combined, and one decision will be rendered by the Circuit Court on whether or not the stay shall be enforced. The first step of this process has already begun; on Tuesday November 16th the Sixth Circuit Court was chosen via a lottery process to preside over the multidistrict litigation. The Sixth Court is based in Cincinnati, Ohio and typically leans conservative. While this proclivity does not necessarily mean that the ETS is doomed, it does suggest that President Biden may ask the Supreme Court to take over the case, preferring the Supreme Court Justices over the Sixth Circuit’s judges. This introduces the second way the stay may be addressed, by a Supreme Court ruling. This alternative can be triggered by either a plea from the federal government directly asking the Court to end the Fifth Circuits’ stay, or via an independent decision by the Supreme Court to pluck this consolidated lawsuit out the Sixth Circuits’ hands.

However, if the Supreme Court is not called upon and chooses not to pull the case up on their own, the Sixth Circuit will have the authority to either end, modify, or extend the Fifth Circuits’ current stay on the ETS. This leaves companies with a choice; will they wait and see how the Sixth Circuit, or maybe even the Supreme Court, rules on the stay? Will they wait to see if the stay is extended and the deadline for compliance is pushed back, or will they start implanting the mandate now in the event that the stay is extinguished and December 5th compliance is reinstated?

There is a chance that an extended stay will allow these companies to push off vaccine mandates. There is also a chance that the stay will be terminated before December 5th and all original compliance deadlines will be the same. Both of these alternatives are further complicated when paired with the uncertainty surrounding timing. If a company decides to run the risk and hope for an extended stay, and the Sixth Circuit court issues a retraction of the stay on December 3rd, companies may still be forced to observe the December 5th compliance date. However, if they decide to comply right now and the stay is extended, they may regret acting so quickly. In the end the mass amount of uncertainty surrounding the ETS and resulting litigation is creating many tough decisions for private employers. While the choice to comply with OSHA’s currently suspended ETS may not be mandatory right now, it’s obvious that a failure to act may put them far behind schedule for creating and implanting an effective vaccine mandate policy. That failure to act has the potential to end in high OSHA fines as well as general pushback from the public. In the end the decision on how to treat this paused ETS is up to each individual company, as will be any consequences stemming from that choice.


You Wouldn’t 3D Print Tylenol, Would You?

By Mason Medeiros, MJLST Staffer

3D printing has the potential to change the medical field. As improvements are made to 3D printing systems and new uses are allocated, medical device manufacturers are using them to improve products and better provide for consumers. This is commonly seen through consumer use of 3D-printed prosthetic limbs and orthopedic implants. Many researchers are also using 3D printing technology to generate organs for transplant surgeries. By utilizing the technology, manufacturers can lower costs while making products tailored to the needs of the consumer. This concept can also be applied to the creation of drugs. By utilizing 3D printing, drug manufacturers and hospitals can generate medication that is tailored to the individual metabolic needs of the consumer, making the medicine safer and more effective. This potential, however, is limited by FDA regulations.

3D-printed drugs have the potential to make pill and tablet-based drugs safer and more effective for consumers. Currently, when a person picks up their prescription the drug comes in a set dose (for example, Tylenol tablets commonly come in doses of 325 or 500 mg per tablet). Because the pills come in these doses, it limits the amount that can be taken to multiples of these numbers. While this will create a safe and effective response in most people, what if your drug metabolism requires a different dose to create maximum effectiveness?

Drug metabolism is the process where drugs are chemically transformed into a substance that is easier to excrete from the body. This process primarily happens in the kidney and is influenced by various factors such as genetics, age, concurrent medications, and certain health conditions. The rate of drug metabolism can have a major impact on the safety and efficacy of drugs. If drugs are metabolized too slowly it can increase the risk of side effects, but if they are metabolized too quickly the drug will not be as effective. 3D printing the drugs can help minimize these problems by printing drugs with doses that match an individual’s metabolic needs, or by printing drugs in structures that affect the speed that the tablet dissolves. These individualized tablets could be printed at the pharmacy and provided straight to the consumer. However, doing so will force pharmacies and drug companies to deal with additional regulatory hurdles.

Pharmacies that 3D print drugs will be forced to comply with Current Good Manufacturing Procedures (CGMPs) as determined by the FDA. See 21 C.F.R. § 211 (2020). CGMPs are designed to ensure that drugs are manufactured safely to protect the health of consumers. Each pharmacy will need to ensure that the printers’ design conforms to the CGMPs, periodically test samples of the drugs for safety and efficacy, and conform to various other regulations. 21 C.F.R. § 211.65, 211.110 (2020). These additional safety precautions will place a larger strain on pharmacies and potentially harm the other services that they provide.

Additionally, the original drug developers will be financially burdened. When pharmacies 3D print the medication, they will become a new manufacturing location. Additionally, utilizing 3D printing technology will lead to a change in the manufacturing process. These changes will require the original drug developer to update their New Drug Application (NDA) that declared the product as safe and effective for use. Updating the NDA will be a costly process that will further be complicated by the vast number of new manufacturing locations that will be present. Because each pharmacy that decides to 3D print the medicine on-site will be a manufacturer, and because it is unlikely that all pharmacies will adopt 3D printing at the same time, drug developers will constantly need to update their NDA to ensure compliance with FDA regulations. Although these regulatory hurdles seem daunting, the FDA can take steps to mitigate the work needed by the pharmacies and manufacturers.

The FDA should implement a regulatory exception for pharmacies that 3D print drugs. The exemption should allow pharmacies to avoid some CGMPs for manufacturing and allow pharmacies to proceed without being registered as a manufacturer for each drug they are printing. One possibility is to categorize 3D-printed drugs as a type of compounded drug. This will allow pharmacies that 3D print drugs to act under section 503A of the Food Drug & Cosmetic Act. Under this section, the pharmacies would not need to comply with CGMPs or premarket approval requirements. The pharmacies, however, will need to comply with the section 503A requirements such as having the printing be performed by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician, limiting the interstate distribution of the drugs to 5%, only printing from bulk drugs manufactured by FDA licensed establishments and only printing drugs “based on the receipt of a valid prescription for an individualized patient”. Although this solution limits the situations where 3D prints drugs can be made, it will allow the pharmacies to avoid the additional time and cost that would otherwise be required while helping ensure the safety of the drugs.

This solution would be beneficial for the pharmacies wishing to 3D print drugs, but it comes with some drawbacks. One of the main drawbacks is that there is no adverse event reporting requirement under section 503A. This will likely make it harder to hold pharmacies accountable for dangerous mistakes. Another issue is that pharmacies registered as an outsourcing facility under section 503B of the FD&C Act will not be able to avoid conforming to CGMPs unless they withdraw their registration. This issue, however, could be solved by an additional exemption from CGMPs for 3D-printed drugs. Even with these drawbacks, including 3D-printed drugs under the definition of compounded drugs proposes a relatively simple way to ease the burden on pharmacies that wish to utilize this new technology.

3D printing drugs has the opportunity to change the medical drug industry. The 3D-printed drugs can be specialized for the individual needs of the patient, making them safer and more effective for each person. For this to occur, however, the FDA needs to create an exemption for these pharmacies by including 3D-printed drugs under the definition of compounded drugs.


Watching an APA Case Gestate Live!

Parker von Sternberg, MJLST Staffer

On October 15th the FCC published an official Statement of Chairman Pai on Section 230. Few particular statutes have come under greater fire in recent memory than the Protection for “Good Samaritan” Blocking and Screening of Offensive Material and the FCC’s decision to wade into the fray is almost certain to end up causing someone to bring suit regardless of which side of the issue the Commission comes down on.

As a brief introduction, 47 U.S. Code § 230 provides protections from civil suits for providers of Interactive Computer Services, which for our purposes can simply be considered websites. The statute was drafted and passed as a direct response by Congress to a pair of cases, namely Cubby, Inc. v. CompuServe Inc. and Stratton Oakmont, Inc. v. Prodigy Services Co.Cubby, Inc. v. CompuServe Inc., 776 F.Supp. 135 (S.D.N.Y. 1991) and Stratton Oakmont, Inc. v. Prodigy Services Co., 1995 WL 323710 (N.Y. Sup. Ct. 1995). Cubby held that the defendant, CompuServe, was not responsible for third-party posted content on its message board. The decisive reasoning by the court was that CompuServe was a distributor, not a publisher, and thus “must have knowledge of the contents of a publication before liability can be imposed.”Cubby, Inc. v. CompuServe Inc., 776 F.Supp. 135, 139 (S.D.N.Y. 1991). On the other hand, in Stratton Oakmont, the defendant’s exertion of “editorial control” over a message board otherwise identical to the one in Cubby “opened [them] up to a greater liability than CompuServe and other computer networks that make no such choice.” Stratton Oakmont, 1995 WL 323710 at *5.

Congress thus faced an issue: active moderation of online content, which is generally going to be a good idea, created civil liability where leaving message boards open as a completely lawless zone protects the owner of the board. The answer to this conundrum was § 230 which states, in part:

(c) Protection for “Good Samaritan” blocking and screening of offensive material

(1) Treatment of publisher or speaker

No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.

(2) Civil liability – No provider or user of an interactive computer service shall be held liable on account of—

(A) any action voluntarily taken in good faith to restrict access to or availability of material that the provider or user considers to be obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable, whether or not such material is constitutionally protected . . . .

Judicial application of the statute has so far largely read the language expansively. Zeran v. AOL held that “[b]y its plain language, § 230 creates a federal immunity to any cause of action that would make service providers liable for information originating with a third-party user of the service.”Zeran v. Am. Online, Inc., 129 F.3d 327, 330 (4th Cir. 1997). The court also declined to recognize a difference between a defendant acting as a publisher versus a distributor. Speaking to Congress’s legislative intent, the court charted a course that aimed to both immunize service providers as well as encourage self-regulation. Id. at 331-334. Zeran has proved immensely influential, having been cited over a hundred times in the ensuing thirteen years.

Today however, the functioning of § 230 has become a lightning rod for the complaints of many on social media. Rather than encouraging interactive computer services to self-regulate, the story goes that it instead protects them despite their “engaging in selective censorship that is harming our national discourse.” Republicans in the Senate have introduced a bill to amend the Communications Decency Act specifically to reestablish liability for website owners in a variety of ways that § 230 currently protects them from. The Supreme Court has also dipped its toes in the turbulent waters of online censorship fights, with Justice Thomas saying that “courts have relied on policy and purpose arguments to grant sweeping protection to Internet platforms” and that “[p]aring back the sweeping immunity courts have read into §230 would not necessarily render defendants liable for online misconduct.

On the other hand, numerous private entities and individuals hold that § 230 forms part of the backbone of the internet as we know it today. Congress and the courts, up until a couple of years ago, stood in agreement that it was vitally important to draw a bright line between the provider of an online service and those that used it. It goes without saying that some of the largest tech companies in the world directly benefit from the protections offered by this law, and it can be argued that the economic impact is not limited to those larger players alone.

What all of this hopefully goes to show is that, no matter what happens to this statute, someone somewhere will be willing to spend the time and the money necessary to litigate over it. The question is what shape that litigation will take. As it currently stands, the new bill in the Senate has little chance of getting through the House of Representatives to the President’s desk. The Supreme Court just recently denied cert to yet another § 230 case, upholding existing precedent. Enter Ajit Pai and the FCC, with their legal authority to interpret 47 U.S. Code § 230. Under the cover of Chevron deference protecting administrative action with regard to interpreting statutes the legislature has empowered them to enforce, the FCC wields massive influence with regard to the meaning of § 230. Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).

While the FCC’s engagement is currently limited to a statement that it intends to “move forward with rulemaking to clarify [§ 230’s] meaning,” there are points to discuss. What limits are there on the power to alter the statute’s meaning? Based on the Commissioner’s statement, can we tell generally what side they are going to come down on? With regard to the former, as was said above, the limit is set largely by Chevron deference and by § 706 of the APA. The key words here are going to be if whoever ends up unhappy with the FCC’s interpretation can prove that it is “arbitrary and capricious” or goes beyond a “permissible construction of the statute.” Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).

The FCC Chairman’s statement lays out that issues exist surrounding §230 and establishes that the FCC believes the legal authority exists for it to interpret the statute. It finishes by saying “[s]ocial media companies have a First Amendment right to free speech. But they do not have a First Amendment right to a special immunity denied to other media outlets, such as newspapers and broadcasters.” Based on this statement alone, it certainly sounds like the FCC intends to narrow the protections for interactive computer services providers in some fashion. At the same time, it raises questions. For example, does § 230 provide websites with special forms of free speech that other individuals and groups do not have? The statute does not on its face make anything legal that without it would not be. Rather, it ensures that legal responsibility for speech lies with the speaker, rather than the digital venue in which it is said.

The current divide on liability for speech and content moderation on the internet draws our attention to issues of power as the internet continues to pervade all aspects of life. When the President of the United States is being publicly fact-checked, people will sit up and take notice. The current Administration, parts of the Supreme Court, some Senators, and now the FCC all appear to feel that legal proceedings are a necessary response to this happening. At the same time, alternative views do exist outside of Washington D.C., and at many points they may be more democratic than those proposed within our own government.

There is a chance that if the FCC takes too long to produce a “clarification” of §230 that Chairman Pai will be replaced after the upcoming Presidential election. Even if this does happen, I feel that the outlining of the basic positions surrounding this statute is nonetheless worthwhile. A change in administrations simply means that the fight will occur via proposed statutory amendments or in the Supreme Court, rather than via the FCC.

 


COVID-19, Remote Technology, and Due Process in Administrative HearingsBrent

Brent Murcia, MJLST Staffer

Wherever you look, it seems like COVID-19 is dominating all the headlines these days (even this blog!)—and with good reason. The pandemic is a public health crisis on a massive scale, forcing all of us to change our lives to “socially distance” and help “flatten the curve.”

As of April 7, 95% of Americans were under some sort of “stay at home” order. With life-as-usual on hold, many people are turning to technology to keep things running. For example, in Boston, some celebrated St. Patrick’s Day with virtual concerts. Some people  celebrated Earth Day by tuning into National Park webcams. And of course, everyone from Minnesota Law students to the UK Cabinet is holding meetings (and happy hours!) on Zoom.

The legal system, of course, is not immune from the effects of this pandemic. Staff at government agencies, private law firms, and nonprofits are working from home. Some state legislatures are allowing remote voting for the first time. Many prisons have suspended in-person visits, including legal visits. Courts across the country are closed, delayed, or operating remotely. In section 150002 of the recent COVID-19 relief bill (the “CARES Act”), Congress authorized emergency video and telephone hearings for a variety of court proceedings, including detention hearings and felony pleas and sentencing. Even the United States Supreme Court will be moving to argument over the phone in May.  

As with many things in society these days, a number of these changes would have been unthinkable two months ago. Who could have imagined that certain courts, many of which require paper filings and ban the use of electronic devices in courtrooms, would soon holdarguments via video conference? The Supreme Court itself has famously never allowed live broadcasts of arguments (a subject of considerable debate). But with arguments moving to the phone, the Court will now allow the public to listen in real time.

As one would expect, the rollout of these sudden changes has not been entirely smooth. In many courts, things have gone well, with only “momentary audio hiccups and minor glitches.” But in March, a D.C. Circuit judge was dropped from an argument and missed several minutes. Last week, a Florida judge complained of lawyers making court appearances shirtless or in pajamas. One Australian barrister described remote court hearings as follows: “The judge couldn’t see anyone; lines dropped out regularly; witnesses didn’t know where to go; … subpoenaed material could not be accessed by anyone; feedback made it impossible to proceed.”

Some of these problems are silly—in the grand scheme of things, we have bigger worries than appropriate Zoom dress codes. But others have the potential to fundamentally impact proceedings—possibly affecting parties’ due process rights. This blog post briefly explores some of the issues that COVID-19 has brought to the forefront, with a particular focus on administrative processes. (For a comprehensive listing of the ways in which different federal administrative agencies are holding their hearings, see this great blog post from the Yale Journal on Regulation).

 Remote Hearings—An Overview

Remote proceedings are not exactly new. Even before the pandemic took hold, CourtCall—a company that facilitates remote appearances—had hosted six million such appearances since 1996. Many courts have long allowed certain remote appearances (sometimes requiring the consent of the parties, sometimes not). According to the Administrative Conference of the United States (ACUS), some agencies already conducted thousands of video hearings a year even before the pandemic. Still, until recently, such appearances were the exception, not the norm. And the use of remote technologies has generated controversy, even before its sudden widespread adoption.

Problems with Remote Hearings

Some people have expressed skepticism about the use of remote hearings, emerging in part from evidentiary concerns. As the BBC recently reported, video calls can make it “harder to process non-verbal cues like facial expressions, the tone and pitch of the voice, and body language.” That BBC story also referred to a 2014 study which found that even a 1.2 second transmission delay on a videoconferencing system “made people perceive the responder as less friendly or focused.” These effects can matter, considering the importance of perception and non-verbal cues in courtrooms. Additionally, one 1996 study in the University of Michigan Journal of Law Reform (before the advent of video technology) found that “parties to telephone hearings are less likely to exercise their rights to submit evidence through witnesses and documents than are parties to in-person hearings.”

Remote hearings can be particularly problematic in immigration hearings, which often involve language interpretation and the recounting of traumatic events. In early March—even before COVID-19 closures began—immigration courts in Texas began a pilot program to hold more hearings for unaccompanied children over videoconference, attempting to reduce a backlog of cases. One immigration attorney, forced by the virus to work with clients remotely, described the difficulty of doing so: “[w]e’re asking kids to open up and talk about the most personal and traumatic experiences of their lives and not even be making direct eye contact with them.” Remote hearings can affect the outcome of cases; a 2017 Government Accountability Office (GAO) study found that video hearings caused difficulties with language interpretation and affected immigration judges’ assessments of respondents’ credibility. A study in the Northwestern University Law Review found that respondents in video hearings were more likely to be deported. The American Immigration Lawyers Association opposes the use of video hearings for immigration for these reasons.

Problems with remote hearings also arise in settings that require public participation—like rulemakings and permit applications. In Minnesota, for instance, the state Pollution Control Agency (MPCA) recently delayed publication of a proposed Clean Cars rule, recognizing the importance of in-person comment and“ensuring that the public has opportunity to participate in the rule-making process.” At the same time, the MPCA moved forward with public meetings about Clean Water Act permits for the controversial Line 3 pipeline project, holding the meetings over the phone. More than 1,600 people called into the meetings, but only 400 were able to speak due to high volume. Some local organizers collected video comments, attempting to put a face to the public input, and called for the agency to hold in-person meetings once the pandemic has passed.

Finally, depending on the circumstances, remote hearings can also run afoul of specific public process requirements and open meeting laws. Lawyers in New Jersey, for instance, have highlighted a number of legal concerns arising from virtual land use board hearings. Laws about when and how meetings may be held electronically vary state to state; and amidst the pandemic, governors and legislatures have taken varying steps to clarify that authority. In Minnesota, the state legislature amended the open meeting law to account for the pandemic, expanding the circumstances under which meetings may be held remotely.

Benefits of Remote Hearings

Despite all of these problems, some lawyers have actually long advocated for an increase in virtual hearings. One common argument is that online hearings can help improve access to justice, addressing backlogs of millions of cases in some courts and agencies. Some argue that our current legal process is built more around “serving a place than serving justice.” One paper surveyed a number of other reasons why remote hearings may help in some contexts. Remote hearings can help in international cases or cases where the parties and witnesses live far apart; they can help with safety and security for parties, witnesses, and judges; they can help alleviate scheduling issues; and they can help in cases where traveling to court presents a significant burden for an individual, perhaps for economic reasons or due to a disability. (For a thorough summary of some of the ways in which technology—not just remote hearings—can help improve access to justice, see this 2012 article in the Harvard Journal of Law & Technology). 

Further, while some arguments against remote hearings focus on the importance of non-verbal cues in proceedings, others have disputed that importance. Some research has pointed out that there can be as much pseudoscience as science in attempts to interpret witness behavior. Some have questioned whether witness demeanor is even useful at all for assessing credibility. And while non-verbal cues can and do shape judge and jury reactions, this may not always be a good thing—reactions to certain behaviors can be shaped by implicit bias, furthering racial and other disparities. More research is likely needed on whether these disparities are exacerbated or lessened by different types of virtual hearings.

Finally, remote court hearings can create significant cost savings. For example, according to ACUS, the Social Security Administration’s Office of Disability Adjudication and Review saved $59 million in 2010 from using video hearings. These savings matter to people who have to navigate the legal system. A 2014 NPR investigation found, for example, that “the costs of the criminal justice system in the United States are paid increasingly by the defendants and offenders.” Many defendants are required to pay hundreds or thousands of dollars in court costs, even for constitutionally required services. Reducing court costs could help lower fees, reducing the burden on low-income parties. Additionally, law firms are saving money from virtual hearings too, potentially reducing the cost of legal services and improving access to representation down the road.

The potential for improved access and reduced costs from virtual hearings is promising, but comes with an important caution. As British lawyer Richard Atkinson wrote for The Guardian in 2012: “A more efficient justice system is possible, but the government needs to recognise that speed does not always equate to efficiency and efficiency should never be promoted over justice.”

Looking Forward

 As the effects of social distancing wear on, many of us look forward to the day when we can finally go “back to normal.” Without question, it will be a happy day when we can be with our loved ones, our friends, and our coworkers again. Lawyers will also be happy to return to the office, meet with clients in person, and advocate in real courtrooms.

At the same time, questions about remote hearings will not go away. Looking backward, some litigators will likely contest whether certain remote hearings conducted during COVID-19 were permissible. Looking forward, others will use our social distancing experience to argue that we should expand or reduce the use of remote hearings in the future.

There are no universal answers to these questions—the appropriateness of remote hearings depends on the applicable laws and the context of the case. In some cases, remote hearings can adversely affect parties’ rights; in others, they can actually improve access to justice. As one English judge wrote recently, “[i]t remains the obligation of all involved and at all stages of the hearing, to continue to evaluate whether fairness to all the parties is being achieved. Fairness cannot be sacrificed to convenience.” Our task, in these unprecedented times, is to move forward as best and as fairly we can—and to learn from these new experiences to better inform our approach to technology in the courtroom in the future.


COVID-19, Remote Technology, and Due Process in Administrative Hearings

Brent Murcia, MJLST Staffer

Wherever you look, it seems like COVID-19 is dominating all the headlines these days (even this blog!)—and with good reason. The pandemic is a public health crisis on a massive scale, forcing all of us to change our lives to “socially distance” and help “flatten the curve.”

As of April 7, 95% of Americans were under some sort of “stay at home” order. With life-as-usual on hold, many people are turning to technology to keep things running. For example, in Boston, some celebrated St. Patrick’s Day with virtual concerts. Some people  celebrated Earth Day by tuning into National Park webcams. And of course, everyone from Minnesota Law students to the UK Cabinet is holding meetings (and happy hours!) on Zoom.

The legal system, of course, is not immune from the effects of this pandemic. Staff at government agencies, private law firms, and nonprofits are working from home. Some state legislatures are allowing remote voting for the first time. Many prisons have suspended in-person visits, including legal visits. Courts across the country are closed, delayed, or operating remotely. In section 150002 of the recent COVID-19 relief bill (the “CARES Act”), Congress authorized emergency video and telephone hearings for a variety of court proceedings, including detention hearings and felony pleas and sentencing. Even the United States Supreme Court will be moving to argument over the phone in May.  

As with many things in society these days, a number of these changes would have been unthinkable two months ago. Who could have imagined that certain courts, many of which require paper filings and ban the use of electronic devices in courtrooms, would soon holdarguments via video conference? The Supreme Court itself has famously never allowed live broadcasts of arguments (a subject of considerable debate). But with arguments moving to the phone, the Court will now allow the public to listen in real time.

As one would expect, the rollout of these sudden changes has not been entirely smooth. In many courts, things have gone well, with only “momentary audio hiccups and minor glitches.” But in March, a D.C. Circuit judge was dropped from an argument and missed several minutes. Last week, a Florida judge complained of lawyers making court appearances shirtless or in pajamas. One Australian barrister described remote court hearings as follows: “The judge couldn’t see anyone; lines dropped out regularly; witnesses didn’t know where to go; … subpoenaed material could not be accessed by anyone; feedback made it impossible to proceed.”

Some of these problems are silly—in the grand scheme of things, we have bigger worries than appropriate Zoom dress codes. But others have the potential to fundamentally impact proceedings—possibly affecting parties’ due process rights. This blog post briefly explores some of the issues that COVID-19 has brought to the forefront, with a particular focus on administrative processes. (For a comprehensive listing of the ways in which different federal administrative agencies are holding their hearings, see this great blog post from the Yale Journal on Regulation).

 Remote Hearings—An Overview

Remote proceedings are not exactly new. Even before the pandemic took hold, CourtCall—a company that facilitates remote appearances—had hosted six million such appearances since 1996. Many courts have long allowed certain remote appearances (sometimes requiring the consent of the parties, sometimes not). According to the Administrative Conference of the United States (ACUS), some agencies already conducted thousands of video hearings a year even before the pandemic. Still, until recently, such appearances were the exception, not the norm. And the use of remote technologies has generated controversy, even before its sudden widespread adoption.

Problems with Remote Hearings

Some people have expressed skepticism about the use of remote hearings, emerging in part from evidentiary concerns. As the BBC recently reported, video calls can make it “harder to process non-verbal cues like facial expressions, the tone and pitch of the voice, and body language.” That BBC story also referred to a 2014 study which found that even a 1.2 second transmission delay on a videoconferencing system “made people perceive the responder as less friendly or focused.” These effects can matter, considering the importance of perception and non-verbal cues in courtrooms. Additionally, one 1996 study in the University of Michigan Journal of Law Reform (before the advent of video technology) found that “parties to telephone hearings are less likely to exercise their rights to submit evidence through witnesses and documents than are parties to in-person hearings.”

Remote hearings can be particularly problematic in immigration hearings, which often involve language interpretation and the recounting of traumatic events. In early March—even before COVID-19 closures began—immigration courts in Texas began a pilot program to hold more hearings for unaccompanied children over videoconference, attempting to reduce a backlog of cases. One immigration attorney, forced by the virus to work with clients remotely, described the difficulty of doing so: “[w]e’re asking kids to open up and talk about the most personal and traumatic experiences of their lives and not even be making direct eye contact with them.” Remote hearings can affect the outcome of cases; a 2017 Government Accountability Office (GAO) study found that video hearings caused difficulties with language interpretation and affected immigration judges’ assessments of respondents’ credibility. A study in the Northwestern University Law Review found that respondents in video hearings were more likely to be deported. The American Immigration Lawyers Association opposes the use of video hearings for immigration for these reasons.

Problems with remote hearings also arise in settings that require public participation—like rulemakings and permit applications. In Minnesota, for instance, the state Pollution Control Agency (MPCA) recently delayed publication of a proposed Clean Cars rule, recognizing the importance of in-person comment and“ensuring that the public has opportunity to participate in the rule-making process.” At the same time, the MPCA moved forward with public meetings about Clean Water Act permits for the controversial Line 3 pipeline project, holding the meetings over the phone. More than 1,600 people called into the meetings, but only 400 were able to speak due to high volume. Some local organizers collected video comments, attempting to put a face to the public input, and called for the agency to hold in-person meetings once the pandemic has passed.

Finally, depending on the circumstances, remote hearings can also run afoul of specific public process requirements and open meeting laws. Lawyers in New Jersey, for instance, have highlighted a number of legal concerns arising from virtual land use board hearings. Laws about when and how meetings may be held electronically vary state to state; and amidst the pandemic, governors and legislatures have taken varying steps to clarify that authority. In Minnesota, the state legislature amended the open meeting law to account for the pandemic, expanding the circumstances under which meetings may be held remotely.

Benefits of Remote Hearings

Despite all of these problems, some lawyers have actually long advocated for an increase in virtual hearings. One common argument is that online hearings can help improve access to justice, addressing backlogs of millions of cases in some courts and agencies. Some argue that our current legal process is built more around “serving a place than serving justice.” One paper surveyed a number of other reasons why remote hearings may help in some contexts. Remote hearings can help in international cases or cases where the parties and witnesses live far apart; they can help with safety and security for parties, witnesses, and judges; they can help alleviate scheduling issues; and they can help in cases where traveling to court presents a significant burden for an individual, perhaps for economic reasons or due to a disability. (For a thorough summary of some of the ways in which technology—not just remote hearings—can help improve access to justice, see this 2012 article in the Harvard Journal of Law & Technology). 

Further, while some arguments against remote hearings focus on the importance of non-verbal cues in proceedings, others have disputed that importance. Some research has pointed out that there can be as much pseudoscience as science in attempts to interpret witness behavior. Some have questioned whether witness demeanor is even useful at all for assessing credibility. And while non-verbal cues can and do shape judge and jury reactions, this may not always be a good thing—reactions to certain behaviors can be shaped by implicit bias, furthering racial and other disparities. More research is likely needed on whether these disparities are exacerbated or lessened by different types of virtual hearings.

Finally, remote court hearings can create significant cost savings. For example, according to ACUS, the Social Security Administration’s Office of Disability Adjudication and Review saved $59 million in 2010 from using video hearings. These savings matter to people who have to navigate the legal system. A 2014 NPR investigation found, for example, that “the costs of the criminal justice system in the United States are paid increasingly by the defendants and offenders.” Many defendants are required to pay hundreds or thousands of dollars in court costs, even for constitutionally required services. Reducing court costs could help lower fees, reducing the burden on low-income parties. Additionally, law firms are saving money from virtual hearings too, potentially reducing the cost of legal services and improving access to representation down the road.

The potential for improved access and reduced costs from virtual hearings is promising, but comes with an important caution. As British lawyer Richard Atkinson wrote for The Guardian in 2012: “A more efficient justice system is possible, but the government needs to recognise that speed does not always equate to efficiency and efficiency should never be promoted over justice.”

Looking Forward

 As the effects of social distancing wear on, many of us look forward to the day when we can finally go “back to normal.” Without question, it will be a happy day when we can be with our loved ones, our friends, and our coworkers again. Lawyers will also be happy to return to the office, meet with clients in person, and advocate in real courtrooms.

At the same time, questions about remote hearings will not go away. Looking backward, some litigators will likely contest whether certain remote hearings conducted during COVID-19 were permissible. Looking forward, others will use our social distancing experience to argue that we should expand or reduce the use of remote hearings in the future.

There are no universal answers to these questions—the appropriateness of remote hearings depends on the applicable laws and the context of the case. In some cases, remote hearings can adversely affect parties’ rights; in others, they can actually improve access to justice. As one English judge wrote recently, “[i]t remains the obligation of all involved and at all stages of the hearing, to continue to evaluate whether fairness to all the parties is being achieved. Fairness cannot be sacrificed to convenience.” Our task, in these unprecedented times, is to move forward as best and as fairly we can—and to learn from these new experiences to better inform our approach to technology in the courtroom in the future.


Will the Vaping Industry Go Up in Smoke?

Stephen Wood, MJLST Staffer

It’s no secret that vaping has become increasingly popular. The number of users has increased from 7 million in 2011 to 41 million as of 2018. The total market is now worth an estimated $19.3 billion. Less clear is the future of industry regulation in light of the recent respiratory illnesses linked to vaping. On September 24, 2019, the Centers for Disease Control and Prevention reported that vaping was attributed to 805 illnesses and 12 deaths. Pressure is building on the industry’s major players. In the last week, we have seen the cancellation of a merger between two of the largest tobacco companies, Altria and Philip Morris, and the release of the CEO of Juul, Kevin Burns.

However, the respiratory illnesses associated with vaping haven’t been linked to a specific product, and it is unclear what the long-term effects of vaping are. Because of this uncertainty, some states have implemented blanket restrictions on the sale of vaping products, President Trump has proposed new regulations, and the CDC has issued warnings regarding their safety. This is blindsiding the industry, which has been free from regulation by the FDA until recently.

Vaping devices, also known as electronic nicotine delivery systems (ENDS), became subject to the FDA’s regulatory scheme for all tobacco products on August 8, 2016. The Deeming Rule placed ENDS in the same category of products as cigarettes and other traditional tobacco products, which have been regulated under the Family Smoking Prevention and Tobacco Control Act since 2009. For this reason, the minimum age for purchasing ENDS is 18 years old, and the marketing, manufacturing, and distribution of ENDS is heavily regulated.

Juul, in particular, has come under fire for its marketing strategies. Among other claims, many lawsuits allege that the company specifically targeted minors through its use of social media and distribution of enticing flavors. These practices have also been the focal point of the recent surge of state regulations, which “are filling what many see as a regulatory void caused by federal inaction.” For example, in Michigan, Governor Gretchen Whitmer implemented an emergency ban, limiting the sale of vaping products to those which are tobacco flavored. New York did the same but exempted menthol from the ban. Massachusetts, notably, implemented a four-month emergency ban on all products. President Trump’s proposed ban, on the other hand, would be limited to flavored products.

If President Trump’s proposal is adopted, the industry would see an estimated 80% loss in sales. It will be interesting to see what the regulatory landscape looks like once the smoke clears.

 


New Year, New Chinese Intellectual Property System

Sherrie Holdman, MJLST Staffer 

Since the beginning of the new year, China has implemented various new Intellectual Property (“IP”) changes. Three major changes are particularly critical for promoting an enhanced IP system in China.

The first change is the establishment of a new IP appellate court. On October 26, 2018, China’s National People’s Congress (NPC) Standing Committee issued the Decision on Several Issues Concerning the Litigation Procedures in Patent and Other Intellectual Property Cases. On December 3, 2018, in a plenary session of the Judicial Committee of the Supreme Court chaired by Chief Justice Zhou Qiang, the Committee passed the Supreme Court Guidance Re Intellectual Property Tribunal. The official IP court was finally launched in January 2019. The new body is expected to hear appeals from both civil and administrative matters. According to Chief Justice Zhou Qiang, handing civil and administrative patent appeals to the new IP court will help unify adjudications related to patent validity and infringement, improve the efficiency and quality of court proceedings, and thus improve judicial protection of IP rights. The protection of IP rights has been a key issue of the trade war between the United States and China. China has been criticized for its lax IP protection for many years. The new IP court seems to come as a trade negotiation of the two countries.

Another change is China’s new policy on IP enforcement. On December 4, 2018, the National Development and Reform Commission, along with 37 government departments, released a Chinese interagency Cooperation Memorandum of Understanding. The goal of the Memorandum was to punish entities who seriously violate the patent law, including acts such as repeated patent infringement, non-compliance with the patent law, and serious illegal patent agency conduct. Like the new IP court, this policy seems to be another negotiation between the United States and China. Indeed, the policy was released days after the meeting of United States President Donald Trump and Chinese leader Xi Jinping at a summit in Argentina. The policy took a further step to enhance the IP protection in China.

The third change is the Fourth Amendment of the Chinese Patent Law. On December 5, 2018, the latest Draft of the Chinese Patent Law was presented to China’s State Council in a meeting chaired by Premier Li Keqiang. The new Amendment aimed to strengthen the protection of patent rights holder’s legitimate rights and interests, stimulate innovations, and promulgate legislations to effectively protect patent rights. Specifically, the Draft aimed to increase the penalties for IP infringement, to increase the amount of compensation and fines for willful infringement and counterfeiting patents, and thus increase the infringement cost in order to deter illegal acts. Particularly, the Draft proposed to raise the minimum fine to 100,000 RMB and the maximum fine to 5 million RMB. The Draft also stated that an infringer shall be cooperative in an infringement lawsuit. The Draft further set forth that network service providers shall bear joint liability for not stopping infringement in a timely manner. The Draft provided an incentive mechanism for employee inventors so that they could equitably share profits from inventions invented by the employees in the course of their employment.. Further, the Draft introduced a patent term extension system for innovative drugs, strengthened public information systems, and proposed to make basic patent data available in the China National Intellectual Property Administration (“CNIPA”) website. In order to foster patent dissemination and utilization, the Draft provided national and local authorities to increase public patent services and introduced an open patent license system. In addition, the Draft introduced a domestic priority of six months for design applications, extended patent term for design patents to fifteen years, and extended the time period for priority document submission for patents/utility models applications. The Draft Amendments were released for public comment from January 4, 2019 to February 3, 2019. The final rule is expected to come out soon this year.

It remains to be seen how these changes would improve China’s IP system. Nevertheless, the impact of these changes should not be underestimated. China is known as a big market for technology and business. However, foreign investors have been hesitate to invest in China due to China’s lax patent protection. With these changes aiming to establish an enhanced IP system, China is expected to build a friendly commercial environment to foreign inventors and investors, continue to improve domestic innovations, and encourage collaborations between foreign corporations with local companies. For instance, it has been said that these changes would attract global pharmaceuticals and tech companies to China because an enhanced IP system would enable foreign companies to uphold their IP in specialist courts, which is a great reassurance for foreign investors and inventors.


Health Supplements: The “Wild West” of FDA Regulations

Gabe Branco, MJLST Staffer 

At some point, we all have taken a multivitamin and/or some type of dietary supplement. They are hard to miss in most stores such as Target or Wal-Mart.  The bright colored packaging and unfulfilling promises of “losing weight quickly” without dieting or “building muscle” without working out catches everybody’s attention. Most people assume that these products, ironically labeled “health” or “dietary” supplements, must be safe to ingest due to placing them in the same category as a “drug,” or because they deem the supplement to be “natural.” However, the reason people are mistaken is because the Food and Drug Administration (“FDA”) chooses to differentiate “health” products from “drugs.”

Under the FDA’s current regulatory scheme, “health” supplements are treated more like special foods than drugs. Drugs are considered unsafe until proven safe through clinical trials. These trials must be done on all drugs, even those that are sold without a required prescription. The trials must show that the drug is both safe and effective for the specified use. Once the drug is approved, manufacturers are subject to carefully monitored conditions and packaging requirements. The packaging requirement includes conditions the drug has been proven to treat, known side effects, contraindications, and unsafe interactions with other drugs. After the drug has been manufactured and released to the public for consumption, the FDA follows up on any adverse effects consumers and their doctors report, along with any adverse effects reported by the manufacturer.

“Dietary” supplements, on the other hand, are seen as safe until proven unsafe, a stark contrast to their drug counterpart. The Dietary Supplement Health and Education Act (DSHEA) defines “dietary” supplements as a category of food. As such, “dietary” supplements do not undergo the rigorous pre-manufacturing and post-manufacturing approval and monitoring process that drugs do. DSHEA prohibits supplements from containing anything that may have “a significant or unreasonable risk of illness or injury” when the supplement is used as directed on the label, or with regular use if there are no directions. While the regulation makes clear these supplements should not significantly or unreasonably expose the public to increased risk of harm, DSHEA fails to enforce the regulation with any preventative measures.

DSHEA effectively allows manufacturers to print any statement they wish on “dietary” supplement labels, so long as it is followed by the phrase “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. This practice is troublesome because the statement may suggest or claim outright that the “dietary” supplement treats symptoms or results in an outlandish outcome if taken. Even with the FDA warning, consumers would have little to no reason to assume that supplements placed on shelves everywhere could contain none of the listed ingredients or unknown ingredients that can cause adverse health effects.

The FDA has the authority to stop any production of “dietary” supplement if it is shown there is an increased risk of harm to the public. However, this only occurs after the release of the supplement and subsequent adverse effects impact consumers. Due to the lack of pre-manufacturing testing requirements, many “dietary” supplements contain germs, pesticides, or toxic heavy metals that may adversely impact consumers. In addition, many “dietary” supplements either do not contain what is listed on the label, contain more or less of what is listed on the label, or even contain ingredients not listed on the label. This issue could also stem from parties other than the manufacturers and sellers. Without any regulations pre-manufacturing, many suppliers of ingredients may mix or substitute the ingredients sold to manufacturers with less expensive or tainted filler ingredients.

These issues become problematic when an ingredient the FDA would deem a “drug” finds its way into a “dietary supplement.” Many male enhancers or muscle building “dietary” supplements have been found to contain substances much like Viagra or Cialis, which are regulated as “drugs.” In addition, certain weight loss supplements have been found to contain sibutraimine, which has been banned in the United States. All of these supplements were recalled by the FDA in a reactionary manner. However, in most instances a “dietary” supplement may contain a drug that has little to no known effects. Having little to no known effects makes it more difficult to detect if a “dietary” supplement indeed contains a drug, and if it then must undergo the more rigorous FDA drug requirements. By providing manufacturers and sellers a pathway to produce categorical “drugs” and distribute them to the public without undergoing the rigorous FDA drug testing processes, DSHEA potentially does more deregulation than regulation.

FDA regulations concerning “dietary” supplements should be as stringent as regulations governing drugs. The simplest solution would be to implement the same pre-manufacturing and post-manufacturing procedures that are required of “drug” manufacturers into the “dietary” supplement realm. Doing so would fulfill DSHEA’s requirement that the “dietary” supplements do not cause a significant or unreasonable increase in risk of injury or illness. Additionally, this would allow the FDA to regulate “drugs” to its fullest potential.


FDA’s Nutrition Innovation Strategy: The Right to Remain Silent on Added Sugars

Christina Petsoulis, MJLST Staffer 

As of 2017, obesity rates in the United States reached 38.9%.  It is without a doubt that poor diet is a major contributing factor to obesity prevalence. More specifically, diets consisting of convenience foods containing high amounts of added sugar serve as significant exposures leading to obesity and other comorbidities. A recent study reported that sugar was added to 66% of packaged foods.

While the sugar industry is quick to blame lack of physical activity for America’s obesity rates, research is clear that diets high in refined sugar increase the risk of obesity, cardiovascular disease, diabetes, fatty liver disease, cognitive decline and some cancers.

Though the linkages between food and obesity have been well established in scientific literature for some time, it is not until now that the Food and Drug Administration (FDA) has seriously recognized the importance of diet quality in chronic disease prevention.

On March 29, 2018, FDA commissioner, Dr. Scott Gotlieb, announced the Nutrition Innovation Strategy (NIS). Some of the key elements highlighted in the NIS include: modernizing claims, modernizing ingredient labels, modernizing standards of identity, implementing the nutrition facts label and menu labeling, and reducing sodium. The agency stated that it would be “committed to finding new ways to reduce the burden of chronic disease through improved nutrition.”

Gotlieb’s press release introducing the initiative seems to take a different perspective despite the agency’s intended goal.

In Gotlieb’s statement, he started by explaining the critical importance of a healthy diet in human health. He first introduced the importance of informed consumer choice as it relates to transparent labeling, then dove into the issue of “standards of identity.” Using milk as a key example, he explained that plant-based alternatives to cow’s milk, such as soy and almond-based beverages, labeled as “milk” create major public health concerns, including cases of kwashiorkor (protein deficiency disorder), and rickets (vitamin D deficiency disorder). He then went on to cite a case where a child was diagnosed with rickets as a result of parents assuming a soy-based beverage they fed their child contained the same nutritional qualities as cow’s milk. While the issue of standards of identity is relevant to public health nutrition in the context of protein deficiency and other forms of malnutrition, these issues have little relevance to obesity, or any other chronic disease for that matter.

It is surprising to see that Gotlieb’s press release does not highlight any of the important factors contributing to obesity in light of the initiative’s supposed goals.  The worry, of course, is that the FDA is tip-toeing around food-industry players and, namely, the sugar industry in efforts to avoid conflict. The sugar industry is known for its aggressive efforts to shift blame for obesity on poor diet to lack of physical activity and poor consumer choice. For example, it was recently discovered that the sugar industry paid Harvard scientists to produce favorable results in their nutrition research on sugar’s role in heart disease.

While FDA has addressed the issue of sugar content through “added sugars” labeling requirements finalized in May 2016, little has been done to address sugar content in packaged foods. Serious efforts need to be taken to reduce sugar content in foods on the market to address the obesity epidemic