2019

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.


The International Whaling Commission Sans Japan: What it Means for the Whales

Allie Jo Mitchell, MJLST Staffer

On December 25, 2018 Japan announced that it would withdraw from the International Convention for the Regulation of Whaling (“ICRW”) and leave the international whaling commission (“IWC”) in order to resume commercial whaling.  A statement by Japan’s Chief Cabinet Secretary explained that the decision to withdraw was based on the failure of the IWC to take into account all stated objectives of the ICRW, including the “orderly development of the whaling industry” and the creation of sustainable commercial whaling. Citing the cultural and economic significance commercial fishing has played in Japan, the country rested its decision on its determination that commercial whaling could resume without negatively impacting cetacean resources.

International condemnation over Japan’s decision was swift, with Greenpeace Japan questioning the health of Japan’s whaling stock and calling the decision “out of step with the international community, let alone the protection needed to safeguard the future of our oceans and these majestic creatures.” The UK’s environment secretary tweeted that “[t]he UK is strongly opposed to commercial whaling and will continue to fight for the protection and welfare of these majestic mammals” and a diplomat of Norway called the decision to break away from the global agreement “dangerous.” On January 14, 2019 the IWC issued a statement that it had received notification from Japan that it would withdraw from the ICRW in 2019.  Recognizing the role Japan had played, the chair of the IWC specifically mentioned the controversy surrounding commercial whaling within its member group, offering hope that the IWC would continue to work on a variety of issues in which there was common ground.  

Now that Japan has left the IWC, it will begin the commercial hunting of whales in July of 2019 within its territorial seas and exclusive economic zone that exists within 200 miles of Japan’s coasts. Japan will also remain an observer of the IWC and “continue to contribute to the science-based sustainable management of resources.” Importantly, without it’s permit to kill whales for research under the ICW, Japan will now cease the taking of whales in the high sea, including the Antarctic Ocean and the Southern Hemisphere, as required by international law. Japan had previously killed whales in the Antarctic Ocean under the auspicious guise of research. In fact, in 2014 the International Court of Justice found that Japan’s whale research program was violating the IWC’s moratorium on commercial whaling because Japan was using lethal methods where none were required. Despite this holding, in 2016 a Japanese “research” expedition in the Antarctic killed 333 whales (207 of which were pregnant) with the meat from the whales sold on the commercial market.

But what does all this really mean for the whales of the world? There are some positives that may come from Japan withdrawing from the IWC, but these could easily be outweighed by the negatives. Because Japan will have to limit its commercial whaling to 200 miles within Japanese coasts, whales outside of this region, particularly whales in the Antarctic and southern hemisphere, will be in luck. However, whales within Japan’s territorial sea and economic zone, where studies suggest stock levels are low, won’t fare so well.

Furthermore, Japan may not only shift its catch to Japanese waters but could actually increase the number of whales it kills each year with little to no oversight from the international community. This could severely impact whale species, both endangered and non-threatened, and deplete whale stocks within Japan’s territorial sea. As Astrid Fuchs, program lead of the Whale and Dolphin Conservation explained, “[t]he oversight that the IWC was having over Japan’s whaling will now be lost. We won’t know how many whales they are catching, we won’t know how they will report it. It might spell doom for some populations.”

Perhaps the greater danger lies in what Japan’s withdrawal from the IWC may signal to other countries. As Japan stated in its public announcement, “Japan hopes that more countries will share the same position to promote sustainable use of aquatic living resources based on scientific evidence, which will thereby be handed down to future generations.” Fuchs is worried about the precedent this might set, particularly in countries with an interest in commercial whaling and whale meat including South Korea and other Pacific and Caribbean island nation states.

On the bright side, decreasing interest and consumption of whale meat may play a bigger role in protecting whales from commercial hunting than Japan’s involvement with the IWC. Demand for whale meat is the lowest in Japan since WWII, with the average consumption of whale just one ounce per person a year. A recent poll also showed that only 11% of Japanese people strongly support the whaling industry. If the economics of commercial whaling are not as strong as imagined, commercial whaling my peter out on its own in Japan.

The world will likely have to wait and see what the real effect of Japan’s withdrawal from the IWC is on the health and vitality of whale species and whale stocks. In the meantime, there are a myriad of other human caused dangers to whales from bycatch, plastic pollution, noise pollution, oil & chemical pollution, marine traffic, and climate change. Humans have a history of driving whale species to extinction, wreaking havoc on whaling stocks, and threatening the very survival of whales for their personal use and consumption. Despite Japan’s withdrawal from the IWC, it will be necessary for all nations to look beyond commercial whaling and address the continual threats humans pose to whales and other marine life.


Election Security: US Lawmakers Concerned “Deepfake” Videos are the Next Stage of Information Warfare Ahead of 2020 Election

By: Jack Kall

The nation’s attention has turned to the 2020 election with the 2018 midterms in the rear view mirror. Accordingly, an increasing number of US lawmakers are concerned that a form of video manipulation known as “Deepfakes” will be the next stage of information warfare. In short, Deepfake videos are hyper-realistic manipulated videos made using artificial intelligence technology. The videos are often convincing enough that it can be difficult to even tell what has or has not been manipulated. To raise attention, BuzzFeed published this video of Barack Obama delivering a public service announcement regarding dangers of the technology—except it was actually Jordan Peele.

Election security is a more important issue for US voters in the wake of Russian-led election interference in the 2016 Presidential Election. A recent Pew Research poll found that 55% of Americans say they are not too (37%) or not at all (17%) confident that elections systems are secure from hacking and other technological threats. Republicans (59% at least somewhat confident in security) express greater confidence than Democrats (34%), which is a reversal of attitudes from 2016.

While the threat of deepfakes has not garnered the same attention as Russian interference and other forms of “Fake News,” some US legislators are beginning to vocalize concern. This past September, three members of the House of Representatives—including the new chair of the House Intelligence Committee Rep. Adam Schiff (D-CA)—sent a letter expressing concern that the “technology could soon be deployed by malicious foreign actors” to the Director of National Intelligence Dan Coates. Senator Marco Rubio (R-FL) also displayed concern for the technology at a Senate Intelligence Committee by describing a scenario in which a deepfake video is released just before an election and going viral before analysts could determine it was fake.

While concern is rising, there is still a shortage of solutions. In January 2019, House Democrats unveiled several election security measures, but lacked solutions for deepfakes. The same month, Brookings Institute released advice for campaigns to protect against deepfakes. It remains to be seen whether Brooking Institute’s advice to protect infrastructure, add two-factor authentication, film the candidate at speaking engagements, and replicate a classified environment—while important general advice—is enough to protect against this ever-evolving deepfake technology.


Renewable Energy vs. National Parks

By: Bethany Anderson

That’s what happened in Animal Welfare Institute v. Beech Ridge Energy LLC, where a wind energy facility was curtailed because it stood in the migration pathway of an endangered species—Indiana bats. The court allowed the facility to operate, but with significant constraints. For instance, though construction on those turbines already under construction could continue, Beech Ridge could operate only after it applied for and obtained an Incidental Take Permit (“ITP”), which would immunize Beech Ridge from certain ESA penalties for killing and injuring bats. Moreover, construction of additional turbines was conditioned on obtaining an ITP. Additionally, the Court ordered the Fish and Wildlife Service (“FWS”) to determine when Beech Ridge could actually operate after Beech Ridge obtained an ITP, taking into account the migration and hibernation patterns of the bats (see this report for a brief discussion on the aftermath of the Beech Ridge case).

In a similar energy against nature context, significant outcry (see this article) over oil and gas drilling in and around national parks arose in the last year. The Trump Administration opened up more public lands for mineral leasing, and directed agencies to revise or rescind rules that burden domestic energy development. Environmental groups lamented the endangerment of pristine public lands, darkness of wilderness night skies, quiet of natural soundscapes, and tech- and industry-free experiences many visitors crave. These are all legitimate concerns because the experiences, sounds, and sights preserved in our national parklands are preserved relatively unspoiled only in these limited corners of the country. The groups’ sentiment seems to be “let’s just drill somewhere else, okay? It’s a big country. Preservation uses claim few acres in the scheme of things.”

The recent outcry misses, however, concern over greener energy projects that also threaten wilderness and nature values. Like in Beech Ridge, there are two sometimes competing goals here. Renewables serve climate change goals, displacing carbon-emitting energy sources like coal, natural gas, and oil. National parklands preserve land and culture in their natural and historical state. What happens when green energy development requires a huge expanse of flat land exposed to sun year round? A solar facility one mile from Mojave National Preserve presents an example. Is such a land use plan any less invasive than drilling? Maybe it’s quieter and lower to the ground, and maybe it serves a goal that those in the nature fight can get behind better than oil and gas drilling. In this instance, the solar facility still a mile away and does not in any way reach into the park through something comparable to directional drilling. But the facility uses land that was previously untouched and is still potentially visible from parks. As another example, what happens when the only way to get offshore wind online is to construct a high-voltage transmission line across a historic park? Developers say alternative energy sources that replace closing coal plants require a transmission line crossing a historic trail. Opponents say the line undermines the historic atmosphere of the trail and surrounding park area, and may open the floodgates to more industrialization in historic and pristine areas. In the same way as oil and gas drilling, these developments undermine some of the wilderness and historic values park advocates fight for.

So how do we balance these seemingly competing values? National parks are to be preserved unimpaired for the enjoyment of present and future generations. That mandate may conflict with climate change-combatting green energy tech seeking the most effective locations for new facilities.

The 9B regulations (“regulations”) that govern nonfederal oil and gas rights in and around national parks are a framework from which to balance renewables with the preservation mandate. The regulations require a plan of operations, plans in case of spills or other emergencies, a security bond in case of harm to park resources, and eventual restoration of the land, returning it as close to its original status as possible after operations conclude. Renewables are likely more permanent than an oil or gas well, so space and distance restrictions will need to be stricter. But a similar plan of operations, with mitigation strategies and emergency contingencies, is a good start, especially since the regulations are already in place in one piece of the energy sector. As energy technology develops, it constantly brings novel challenges into the existing legal context. The 9B regulations provide a starting point for the ever-growing green energy versus preservation debate.


Corporate Cheat Codes: When Does Video Game Hype Become Securities Fraud?

By: Alex Karnopp

As production consolidates around a few key players, larger economic growth in the video game industry masks underlying corporate concerns of securities fraud. Last year, the video game industry reached an important milestone, earning the title of “world’s favorite form of entertainment.” In 2017, the video game industry generated $108.1 billion, more than TV, movies, and music. While other entertainment industries saw revenue decline, the game industry increased 10.7%. This drastic jump in revenue has made investors happy. In 2017, most companies producing hardware or software for the industry easily beat the broader market. NVIDIA, a popular graphic card producer, jumped up 80% over the year. Nintendo, similarly, saw an 86% increase. Even more drastically, Take-Two Interactive shot up 117%.

Red flags in the industry, however, indicate changes are needed to sustain growth. For one, production costs and technological innovations hinder profitability as games take longer and cost more to bring to market. Making matters worse, game fatigue remains high, meaning an audience remains focused on a game only for a small window. High development risk has led to a pattern of mergers and acquisitions – large, publicly traded companies either acquire publishing rights or development teams altogether to diversify holdings and increase profitability.

This consolidation has had interesting impacts on video game development. Publicly traded companies face tremendous pressure from investors to uphold profitability – to the frustration of developers. Developers are constantly faced with unrealistic deadlines from executives looking to maximize profit, ultimately leading to the release of low-quality games. As large game publishers learn to deal with the interplay between profit and content, they may also face legal consequences.

What may seem like “corporate optimism” to some, looks more like fraudulent misstatements to investors. In 2014, the “disastrous launch” of Battlefield 4 (which was rushed to hit the release of the PS4 and Xbox One) sent Electronic Art’s stock plummeting. As both executives and producers claimed the title would be a success, investors brought lawsuits, claiming they relied on these false statements. Similarly, the recent split between developer Bungie and Activision has led to rumors of lawsuits. Constant frustrations over sales and content finally led to a split, dropping Activision stock by more than 10%. Investors claim Activision committed federal securities law by failing to “disclose that the termination of Activision-Blizzard and Bungie Inc.’s partnership … was imminent.” As large, publicly traded publishers begin dealing with the effects of a consolidated market on content and profits, it will be interesting how courts interpret executive actions trying to mitigate missteps.


Tinder Shows Discrimination Can Take All Shapes In The Internet Age

Caleb Holtz, MJLST Staffer

On January 20th Tinder Inc., the company responsible for the popular dating mobile app, filed a proposed settlement agreement worth over $17 million. The settlement seeks to settle claims that Tinder charged older users more to use the app solely because of their age. Interestingly, while many people think of age discrimination against a group for being too old as being solely the concern of AARP members, this discrimination was against people over the age of 29. This is because of the relatively low threshold in California as to what can constitute age discrimination under California civil rights and consumer protection laws.

Discrimination is incredibly common in the Internet age, at least partially because it is so easy to do. Internet users develop a digital “fingerprint” over time and usage which follows them from website to website. Data contained within a digital “fingerprint” can contain information from “websites you visit, social platforms you use, searches you perform, and content you consume.” Digital fingerprinting is becoming even more common, as enterprising trackers have discovered a way to track users across multiple different browsing applications. When this information is combined with data users willfully give out on the internet, such as personal data on Facebook or Tinder, it is incredibly easy for companies to create a profile of all of the users relevant characteristics. From there it is easy to choose on what grounds to distinguish, or discriminate, users.

Discrimination in this manner is not always necessarily bad. On the most positive end of the spectrum, institutions like banks can use the information to discern if the wrong person is trying to access an account, based on the person’s digital fingerprint. More commonly, internet companies use the data to discriminate against users, controlling what they see and the price they are offered. A quintessential example of this practice was the study that found travel websites show higher prices to Mac users than PC users. Advocates of the practice argue that it allows companies to customize the user experience on an individual basis, allowing the user to see only what they want to see. They also say that it allows businesses to maximize efficiency, both in terms of maximizing profits and in terms of catering to the customer flow, which would therefore lead to a better user experience in the long run. To this point, the argument in favor of continuing this practice has generally won out, as it remains generally legal in the United States.

Opponents of the practice however say the costs outweigh the benefits. Many people, when shown just how much personal data follows them around the internet, will find the practice “creepy”. Opponents hope they can spread this general sentiment by showing more people just how much of their data is online without their explicit consent. This idea has support because, “despite its widespread use, price discrimination is largely happening without the knowledge of the general public, whose generally negative opinion of the practice has yet to be heard.”

More serious opponents move past the “creepiness” and into the legal and ethical issues that can pop up. As the Tinder case demonstrates, online discrimination can take an illegal form, violating state or federal law. Discrimination can also be much more malicious, allowing for companies looking for new employees to choose who even sees the job opening, based on factors like race, age, or gender. As Gillian B. White recently summarized nicely, “while it’s perfectly legal to advertise men’s clothing only to men, it’s completely illegal to advertise most jobs exclusively to that same group.” Now, as the Tinder case demonstrates, in certain scenarios it may be illegal to discriminate in pricing as well as job searches.

So what can be done about this, from a legal perspective? Currently in the United States the main price discrimination laws, the Sherman Antitrust Act, the Clayton Act, and the Robinson-Patman Act were created long before the advent of the internet, and allow for price discrimination as long as there is a “good faith reason”. (Part of the trouble Tinder ran into in litigation is a judge’s finding that there was not a good faith reason to discriminate as they were). There are also a plethora of discrimination in hiring laws which make certain discrimination by hiring employers illegal. Therefore the best current option may be for internet watchdog groups to keep a keen eye out for these practices and report what they come across.

As far as how the law can be changed, an interesting option exists elsewhere in the world. European Union data privacy laws may soon make some price discrimination illegal, or at the very least, significantly more transparent so users are aware of how their data is being used. Perhaps by similarly shining sunlight on the issue here in the states, consumers will begin forcing companies to change their practices.


Animal-product substitutes – does it really matter what we call them?

Nick Hankins, MJLST Staffer 

Fake meat is getting good, really good. The ImpossibleTM Burger 2.0, developed by Impossible Foods Inc., is a big upgrade from its 1.0 counterpart. The 1.0 has been referred to as a “good replacement for a bad burger” and compared to an “OK Sizzler steak” –not the type of reviews to make turncoats out of meateaters.  The 2.0, on the other hand, was hailed as “a triumph of food engineering,” “a burger that could truly wean people off their meat lust,” and (probably most flatteringly) “a well-massaged Kobe ribeye.” Importantly, the latest Impossible Burger has real meat qualities, it can be juicy and red in the middle along with a texture containing small chunks like real beef.

Aside from being an obviously capable meat substitute, the Impossible Burger has the potential to get people to eat less beef and that’s good news because beef isn’t exactly environmentally friendly. In fact, beef is responsible for 41% of livestock greenhouse gas emissions, which account for 14.5% of total global emissions. The UN Intergovernmental Panel on Climate Change report found that changing our diets (including eating less meat) could contribute 20% of the effort necessary to keep global temperatures from risings 2°C above pre-industrial levels. So switching out regular burgers for ImpossibleTM  ones might be one step in the right direction toward fighting global warming.

It turns out that not everyone is on board with meat substitution products, like the Impossible Burger. In February of last year, U.S. Cattlemen’s Association filed a petition with the U.S. Department of Agriculture calling for official definitions for the terms “beef” and “meat.” USCA argued, in its petition, that “[c]urrent labeling practices may cause consumer confusion in the market place.” However, it doesn’t look like this petition has gone very far. Unlike the U.S., France actually passed legislation that banned foods based largely on non-animal ingredients from being labeled as if they were. Recently, in response to lab grown meat (meat that is synthetically grown and not a vegetable substitution like the Impossible Burger) Terry Goodin, Indiana General Assembly representative, has put together a bill that aims to ensure that lab grown meat makers do not try to sell synthetic meat as the animal-grown original.

Manufacturers of meat alternatives argue that the ability to name their product after its meat analogue is important for branding their products to provide appropriate expectations to consumers. Names for animal product replacements like Soylent and “aquafaba” (a vegetable based egg replacement) simply don’t have the branding power to be super marketable. Considering that last year United States residents were projected to eat a record amount of meat, we might not want to bar meat alternatives from potential branding strategies just yet. In any case, it might not be worth a 20-year naming-rights battle, like the one currently being waged against dairy replacement products.


Virtual Reality in Education & the ADA: More Accessibility or Less Accessibility?

Yvie Yao, MJLST Staffer 

Imagine that students no longer need to go to a lab to have a lab experience or go to France to visit the Eiffel Tower. Though sounding impossible, edtech companies that integrate virtual reality (“VR”) technology into the classroom learning experience have enabled these activities.

Copenhagen-based company, Labster, plans to use VR to create virtual labs that will allow students to perform experiments and hone their skills in a risk-free environment. U.S.-based companies, like Nearpod and Alchemy Learning, can take students on virtual field trips to learn about everything from the Amazon rainforest to ancient Roman ruins.

While kids love VR technologies, edtech companies ought to be careful about creating content or products within legal boundaries. After edX’s settlement with the U.S. Department of Justice (“DOJ”), edtech companies may face increased scrutiny under the Americans with Disabilities Act (“ADA”). DOJ claimed that edX’s website, as well as the open online courses offered on its platform, were not fully accessible to individuals with disabilities, thus violating the ADA.

“Massive open online courses have the potential to increase access to high-quality education for people facing income, distance, and other barriers, but only if they are truly open to everyone” said Acting Assistant Attorney General Gupta.

The same can be said for VR applications in education. Courses with the aid of VR technology provide access to high-quality education for students facing different barriers. Yet, the technology itself is less accessible to individuals who are blind or have low vision, who are deaf or hard of hearing.

Title III of the ADA prohibits discrimination on the basis of disability by public accomodations, which include places of education and requires these places to take necessary steps to ensure individuals with disabilities are not treated differently. In the edX settlement, DOJ appeared to interpret edX itself as a place of education within the ADA’s definition of public accommodation. This has two implications. First, purely online educational entities without any physical location qualify as places of education. Second, other web-based education-related service providers might fit the definition of a place of education.

With the law in mind, edtech companies providing online learning content using VR that integrate the content into school curriculums, should be aware of the implications of the ADA and take necessary steps to provide auxiliary aids and services sufficient to enable disabled students to fully participate in the technology.


Virtual Reality in Education & the ADA: More Accessibility or Less Accessibility?

Yvie Yao, MJLST Staffer 

Imagine that students no longer need to go to a lab to have a lab experience or go to France to visit the Eiffel Tower. Though sounding impossible, edtech companies that integrate virtual reality (“VR”) technology into the classroom learning experience have enabled these activities.

Copenhagen-based company, Labster, plans to use VR to create virtual labs that will allow students to perform experiments and hone their skills in a risk-free environment. U.S.-based companies, like Nearpod and Alchemy Learning, can take students on virtual field trips to learn about everything from the Amazon rainforest to ancient Roman ruins.

While kids love VR technologies, edtech companies ought to be careful about creating content or products within legal boundaries. After edX’s settlement with the U.S. Department of Justice (“DOJ”), edtech companies may face increased scrutiny under the Americans with Disabilities Act (“ADA”). DOJ claimed that edX’s website, as well as the open online courses offered on its platform, were not fully accessible to individuals with disabilities, thus violating the ADA.

“Massive open online courses have the potential to increase access to high-quality education for people facing income, distance, and other barriers, but only if they are truly open to everyone” said Acting Assistant Attorney General Gupta.

The same can be said for VR applications in education. Courses with the aid of VR technology provide access to high-quality education for students facing different barriers. Yet, the technology itself is less accessible to individuals who are blind or have low vision, who are deaf or hard of hearing.

Title III of the ADA prohibits discrimination on the basis of disability by public accomodations, which include places of education and requires these places to take necessary steps to ensure individuals with disabilities are not treated differently. In the edX settlement, DOJ appeared to interpret edX itself as a place of education within the ADA’s definition of public accommodation. This has two implications. First, purely online educational entities without any physical location qualify as places of education. Second, other web-based education-related service providers might fit the definition of a place of education.

With the law in mind, edtech companies providing online learning content using VR that integrate the content into school curriculums, should be aware of the implications of the ADA and take necessary steps to provide auxiliary aids and services sufficient to enable disabled students to fully participate in the technology.