Snortable Chocolate Fails the Smell Test, But What Exactly Is It?

Tommy Tobin, MJLST Guest Blogger

 

Snorting chocolate does not sound like a good idea. In fact, it sounds downright crazy. Enter the aptly named “Coco Loko.”

As reported by the AP, Coco Loko is a cocktail of cacao powder and common energy-drink ingredients, such as guarana and taurine. Marketed by a company called Legal Lean, the product makes several bold claims and promises, including feelings similar to ecstasy and “a steady rush of euphoric energy that is great for party goers to dance the night away without a crash.” Oddly, that promised effect is juxtaposed with promises of “calm focus” and “natural relaxation.”

Legal Lean advises users to “consume responsibly.” Warnings include the all too familiar boilerplate that product statements have not been evaluated by FDA and that the products are not intended to diagnose or treat any disease. A notable product warning also advises potential customers that Coco Loko is “not recommended for children or pregnant women.” Legal Lean also notes that the product “may impair your ability to drive a car or operate machinery, and may cause health problems.” It is certainly helpful that the company recognizes that snorting a chocolate concoction up one’s nose may result in health issues and is warning potential consumers accordingly. Self magazine summarized the situation succinctly: “If it sounds like a bad idea to snort what basically amounts to glorified hot chocolate mix, you’re right.”

As the Huffington Post recently put it, “snortable chocolate exists now, for some reason.” The mere fact that this product exists raises myriad questions, not least of which is what the product actually is and how it will be regulated.

According to ABC News, FDA is currently weighing whether the product falls within its jurisdiction and is currently “not prepared to issue a determination regarding whether and how this product is subject to FDA jurisdiction at this time. In reaching that decision, FDA will need to evaluate the product labeling, marketing information, and/or any other information pertaining to the product’s intended use.”

While the intricacies of regulatory classifications are enough to make one crazy, Coco Loko’s regulatory future remains to be seen. As the administrative law bloodhounds at FDA continue their work sniffing out the proper classification for this product, here are some preliminary thoughts.

 

Is Coco Loko a Food?

Strictly speaking, probably not. The statutory definition of food, 21 U.S.C. § 321 (f), is not tremendously helpful here. The statute’s most applicable definition defines “food” as an article used for food or drink for man or other animals. Snorting something through one’s nose is not generally how most people consume their food or drink, especially as the nose is woefully devoid of taste buds.

Legal Lean may argue that an alternative use of the product is as a hot chocolate mix. Presumably, the Coco Loko powder could be used as a drink when dissolved in hot water. Even so, the company markets the product as “infused raw cacao snuff.”

The product’s marketing as “snuff” is highly suggestive that the company does not consider that the product is meant to be food, given that “snuff” is taken through the nose. Put differently, the company may huff and puff that the product is a “food,” but in the end, the stuff is “snuff” by their own admission.

 

Is it a Drug?

Possibly. Coco Loko is likely not a “drug” under 21 U.S.C. § 321 (g). One applicable definition of “drug” includes items “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Such an intention is expressly disclaimed by the makers of Coco Loko.

Another definition of “drug” applies to “articles (other than food) intended to affect the structure or any function of the body of man or other animals,” with a carve-out for foods and dietary supplements. Coco Loko does promise a rush of serotonin and endorphins, as well as “increased overall happiness.”

The structure or function claims made by Coco Loko could make it a “drug” if it is found to be neither a food nor dietary supplement. Put another way, the product appears to be an inhaled stimulant, and regulators could plausibly put it in the category of “drug” given the claims the product is making, in the case that the product does not fit in other categories.

 

Is it a Dietary Supplement?

It depends. Regulators could label Coco Loko as a “dietary supplement” under 21 U.S.C. § 321 (ff). Just as the definition of “food” was quite broad, so too is the statutory definition of “dietary supplements,” which helpfully notes that the term:

 

1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”

 

Given the inclusion of cacao in the product, a colorable claim could be that Coco Loko contains a dietary substance used by man to supplement the diet. That said, is someone actually supplementing their diet by inhaling through their nose? Not being a doctor myself, I can only surmise that the snorted chocolate may have a circuitous path from the nose to one’s stomach—if it ends up there at all.

More on the nose, US News & World Report notes that the product’s label includes B vitamins, ginkgo biloba, blood flow-improving amino acid L-Arginine, as well as energy drink staples guarana and taurine. So, it would seem that Coco Loko would meet the vitamin and amino acid test.

Other aspects of the “dietary supplement” definition in 21 U.S.C. § 321 (ff) include that the item must not represent itself for use as a conventional food or as a sole item of a meal or the diet. “Dietary supplements” must also be labeled as such. If its labeling does not call it a “dietary supplement,” Coco Loko cannot be a “dietary supplement.” According to Ars Technica, Legal Lean is already marketing Coco Loko as a “dietary supplement.”

Incorporated by reference into the § 321 (ff) definition of “dietary supplements” is the requirement that the product be intended for ingestion under 21 U.S.C. § 350 (c)(1)(B). That section requires products be “intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form.” While Coco Loko is a powder, it is unlikely that it is “ingested” in the typical meaning of that term. The statutory provision also provides an alternative definition for items “not intended for ingestion in such a form” that are otherwise “not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.” Both incorporated definitions are predicated on “ingestion,” and Coco Loko’s method of intake is unlikely to fit the plain meaning of “ingestion.”

By analogy, a suppository also bypasses the mouth when they are taken into the body. Even so, suppositories generally go into one end of the alimentary canal—rather than the sinuses or the lungs. Moreover, neither suppositories nor this inhaled chocolate are “ingested.” No less an authority than the Oxford English Dictionary includes a definition of “ingest” that equates ingestion with the introduction of material into the stomach or mouth.

Coco Loko faces an uphill battle getting a “dietary supplement” label given that is probably not “ingested” or intended for ingestion. According to the FDA Law Blog, “FDA has consistently taken the position that articles not intended for ingestion do not qualify as dietary supplements.” In the end, FDA may find that “ingestion” is distinct from insufflation, or the act of breathing something into the body.

Even if Coco Loko is labeled as a “dietary supplement” and met other aspects of the § 321 (ff) definition, the Secretary of Health and Human Services, pursuant to 21 U.S.C. § 342 (f), could conceivably find that it presents a “significant or unreasonable risk of illness or injury.” While unlikely, the Secretary has the authority to declare a dietary supplement so unsafe that it poses “an imminent hazard to public health or safety.” That said, do not hold your breath for such a declaration—if you do, it’d be harder to inhale the chocolate.

 

Concluding Thoughts

While the safety and propriety of snorting crystalline chocolate powder through one’s nostrils is up for debate, FDA is hard at work sniffing out the proper regulatory classification of Coco Loko.

My preliminary thought is that Coco Loko might be labeled a “dietary supplement,” given its ingredients. On the other hand, its method of delivery—through the nasal passage—is not one typically seen in dietary supplements and is unlikely to fit the “intended for ingestion” prong of the incorporated statutory definition.

Alternatively, FDA may label the product a “drug,” especially with its “structure or function” claims. Either way, if you think I’m going to go snort chocolate anytime soon—you’re loko.


U of M Asserts Sovereign Immunity Prevents USPTO from Invalidating Its Patents

Prof. Richard Stern, MJLST Guest Blogger

The University of Minnesota owns a number of patents on cell phone signal processing technology that was invented by Professor Georgios Giannakis of U of M’s Department of Electrical and Computer Engineering and his colleagues. The U of M claims that AT&T, Sprint, T-Mobile, and Cellco Partnership (a joint venture between Verizon and Vodaphone, doing business as Verizon Wireless) are infringing five of these patents, and in 2014 it sued the companies in Minnesota federal district court for patent infringement. The U of M is “a great research university,” President Eric Kaler said, and “must vigorously protect our faculty, [their] discoveries and the overall interests of our university.” (The U collects about $40 million annually in royalties from licensing and the commercialization of faculty work.) Apparently, the cell phone carriers infringed the patents by utilizing Ericsson radio chips that code signals for wireless transmission and practicing patented methods the chips performed.

 

The case was assigned to Chief Judge John R. Tunheim in Minneapolis, who denied the defendants’ motion to dismiss the case for defective pleading, in September 2015. He did reject the U’s claim, however, that the defendants engaged in “willful blindness” in infringing the patents. Judge Tunheim said that the U “alleges no actions that would constitute deliberate avoidance of knowledge” that they were infringing, although they did know of the patents and they “actively entice[d] their customers through advertising, marketing and sales activity to use [their] infringing products.”

 

Ericsson, the wireless carriers’ equipment supplier, then acted to protect its defendant customers against the U by intervening in the Minnesota infringement suit. Ericsson then filed inter partes review (IPR) proceedings in the USPTO to invalidate the U of M patents on which the U was suing the carriers. An IPR is a new type of administrative proceeding that the recent America Invents Act established to provide a swifter and supposedly cheaper way for small companies to resist demands by trolls that they pay patent tribute. Instead of engaging in district court litigation, an aggrieved party can seek an IPR before the USPTO, which then employs its patent expertise to determine whether the patents it issued are invalid, and (if so) consequently relieving the aggrieved party from infringement liability (an invalid patent cannot be infringed).

 

Here is where the complications set in. The 11th Amendment preserves state sovereign immunity against suit—“The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States . . . .” Thus, when a patent owner sued a Florida state agency that provided college tuition payment plans, for patent infringement, the Supreme Court held the law subjecting states to infringement liability unconstitutional under the 11th Amendment. Florida Prepaid Postsecondary Ed. Expense Bd. v. College Savings Bank, 527 U.S. 627 (1999). Accordingly, in two January 2017 IPR cases, the USPTO held that the 11th Amendment required it not to allow proceedings before it against Maryland and Florida. Neochord, Inc. v. Univ. of Maryland, Baltimore and Harpoon Medical, Inc., IPR2016-00208 (May 23, 2017), http://www.ptablitigationblog.com/wp-content/uploads/2017/06/IPR2016-00208.pdf; Covidien LP v. University of Florida Research Found. Inc., IPR2016-01274 (Jan. 25, 2017), http://www.finnegan.com/files/upload/LES_Insights_Column/2017/CovidienvUFIPRNos20160126476.pdf. Although waiver was urged, the USPTO said it was inapplicable because the 11th Amendment is jurisdictional—it deprived the tribunal of any jurisdiction to act, so that jurisdiction could be considered at any time. Waiver requires an affirmative act of invoking federal jurisdiction in the relevant tribunal, and that had not occurred.

 

Ericsson argued, in support of its claim that there was jurisdiction to hear its IPR challenges, that the U had waived its 11th Amendment immunity by suing Ericsson’s customers in the Minnesota district court. Ericsson said that the U “has consented to jurisdiction,” when it sued Ericsson’s customers in the district court, because by filing lawsuits against Ericsson’s customers, “it could surely anticipate” that Ericsson would bring an IPR case at the USPTO to invalidate the patents asserted against its customers for using its products. The U has now urged the USPTO to dismiss Ericsson’s IPR cases, insisting that it has not waived its sovereign immunity by suing the phone carriers—not Ericsson, a third party to the U’s patent infringement suits.

 

The U argues that the law is clear that a waiver must be personal, i.e., filing a lawsuit or counterclaims in the same action and in the same forum. Thus, in Regents of Univ. of New Mexico v. Knight, 321 F.3d 1111, 1125 (Fed. Cir. 2003), the Federal Circuit held that it would be unfair to let New Mexico sue in federal court to enforce a right to ownership of patents arising from contracts “and, at the same time, to claim immunity from liability [in the same case] for royalties or other compensation arising from those same contracts and conduct.” The court added, “Moreover, because a state as plaintiff can surely anticipate that a defendant will have to file any compulsory counterclaims [in the same case] or be forever barred from doing so, it is not unreasonable to view the state as having consented to such counterclaims.” Id. at 1126. On the other hand, the Federal Circuit has held that “a state that files a [patent infringement] lawsuit in one district court does not waive its immunity in a related [invalidity declaratory judgment] lawsuit filed by a party in another district court.” Board of Regents of the Univ. of Wis. Sys. v. Phoenix Int’l Software, Inc., 653 F.3d 448, 462 (7th Cir. 2011) (citing Tegic Communications Corp. v. Board of Regents of the Univ. of Texas Sys., 458 F.3d 1335, 1342 (Fed. Cir. 2006)).

 

In the Tegic case, in which UT sued Tegic’s customers for patent infringement in Texas, the Federal Circuit held that UT waived its immunity against a declaratory judgment counterclaim in Texas. But UT did not waive immunity against the separate declaratory judgment action that Tegic wanted to bring in Washington (where Tegic resided). The court said that if Tegic wanted to litigate patent validity, it could intervene in the Texas case and subject itself to infringement liability if the patent was valid and infringed. This is consistent with the Supreme Court’s concept in the College Savings Bank that the 11th Amendment is more about where a state is willing to be sued than whether it can be sued—for example, most states allow suits against them in their own courts of general jurisdiction. (But they don’t want to be sued in another jurisdiction.)

 

Based on this case law, the U argued: “IPR petitions are [not] counterclaims nor adjudicated in the same forum—they are a different action brought in a different forum.” Further, “a state that files an infringement action does not waive its immunity from a different action challenging the patent in a different forum.” The USPTO had said previously that it was not passing on what would happen if the patentee did file a patent infringement suit, as U of M did here. Furthermore, Ericsson did intervene in the Minnesota district court patent infringement suit, as the Tegic court said the equipment seller should if it wanted to challenge validity. But the Minnesota district court has stayed the federal patent action (at Ericsson’s request) to await the result in the IPR case, as district courts usually do in order to let the experts in the USPTO resolve the patent issues for them. (Presumably, the court will vacate its stay if the IPR case is dismissed.)

 

The U quoted the Federal Circuit opinion in Tegic that insisted that Tegic could not show that adjudication of its claim of invalidity was “not available in the Texas action,” and the U then argued, “Similarly, Ericsson cannot show that adjudication of invalidity counterclaims is not available in the Minnesota court,” where the U has (constructively) waived its immunity. There is a serious conflict here between the respective policies of the 11th Amendment that states should not be subjected to forums not of their choice and of the America Invents Act that a cheap, fast, expert determination of patent validity should be available in lieu of litigation in courts. Like the College Savings Bank case, this case may well end up in the Supreme Court. One important issue, not raised or resolved so far, is whether Congress may constitutionally impose, as a condition of the statutory right to acquire the benefit of a patent, and thus make as an integral element of the patent right, that the patent is subject to validity determination in IPR proceedings. Or would the 11th Amendment make that an unconstitutional condition on a benefit, as applied to a state, rather than a legitimate part of the statutory definition of a patent right?


Happy Mother’s Day to all the Moms!: Law, Science, Technology and Beagles

Angela Fralish, MJLST Guest Blogger

Beagles are well-known as a quintessential family dog because they love humans and listen to their owners (most of the time). What is less known, is that those same traits are the primary reasons they are used in 95% of canine medical experimentation. Although, beagles are not biologically comparable to humans, they are compliant people-pleasers, making them ideal subjects for scientific experiments.

This reality is a hard pill to swallow for animal lovers and scientists alike. To scientists, research beagles are a necessary evil decreasing the pain and suffering of humans. To advocates, beagles are victims of unspeakable cruelty.

One law bridges the divide between these opposing views to help the beagles. The Beagle Freedom Bill, created by the Beagle Freedom Project (BFP), forges a compromise between animal rights lawyers, scientists and medical technologists. The Bill asks that ”tax-payer funded laboratories offer up the “experimentally-spent” dogs and cats for public adoption through rescue organizations.” In other words, once the beagle is no longer used for research, the dog is given a home instead of euthanasia. Minnesota was the first state to sign the Bill into law in 2014, and since then, 5 more states have joined. Currently, 5 additional states are considering adopting this law as well.

In addition to legislative measures, the BFP has found other ways to help research beagles. They have created new technology such as the Cruelty-Cutter app which helps shoppers easily scan products for humane animal testing, and sued the USDA demanding restoration of scrubbed animal records. The Beagle Freedom Project is a leader in animal science law and a great example of how lawyers, scientists and technologists can work together for the greater good of both humans and animals.

Scientists are working to replace this “necessary evil” as well. According to Dr. Teresa Arora’s article Substitute of Animals in Drug Research: An Approach Towards Fulfillment of 4Rs, research methods are being developed that are “superior to using animals to learn about human disease or predict the safety of new drugs [and include] stem cells, microdosing, DNA chips, microfluidics chips, human tissue, new imaging technologies, and post-marketing drug surveillance.” There is even a Center for Alternatives to Animal Testing at John Hopkins University and the NC3R in the UK.

For an employee of medical research looking to carve out meaning in their every day workweek, helping research animals through new collaborative measures is one way to answer the call. As a lawyer, scientists or technologist, you can help develop policy, arbitrate between groups, hold violators accountable, assist in medical technology development, vote for the Beagle Freedom Bill or adopt a research beagle. According to Congressman Earl Blumenauer, “members of Congress are realizing that protecting animals is not just the right thing to do, it’s also developing to become potent politically.” Congress will need help understanding the relationship between animal models and science in order to make improvements. That help will come from people who work in these fields on a daily basis.

The Beagle Freedom Bill highlights the plight of animals languishing in labs and promotes cruelty-free lifestyle choices everyone can make. Now that BFP has opened the door, it is time for all of us to show a little gratitude to the beagles for their sacrifice in advancing medical science such as chemotherapy and insulin. We can do this in our own unique ways, and although we can’t change the world for all beagles, for some beagles, we can change the world.

As Mahatma Ghandi stated, “The greatness of a nation and its moral progress can be judged by the way its animals are treated.” I hope ours is one of progress.


Say Goodbye to Net Neutrality: Why FCC Protection of the Open Internet Is Over

Kristin McGaver, MJLST Guest Blogger

[Editor’s Note: Ms. McGaver’s blog topic serves as a nice preview for two articles being published in this Spring’s Issue 18.2, one on the FCC generally by researchers Brent Skorup and Joe Kane, and one on the Open Internet Order more specifically by MJLST Staffer Paul Gaus.]

Net neutrality is a complex issue at the forefront of many current online regulation debates. In these debates, it is often unclear what the concept of “net neutrality” actually entails, what parties and actors it affects, and how many different approaches to its regulation exist. Nevertheless, Ajit Pai—newly appointed chairman of the United States Federal Communications Commission (“FCC”)—thinks, “the issue is pretty simple.” Pai is openly opposed to net neutrality and has publicly expressed his intent not to enforce current FCC regulations pertaining to the issue with his recently acquired position of power. This is troubling to many net neutrality supporters. Open Internet advocates are rightfully concerned that Pai will hinder recent success for the advancement and protection of net neutrality achieved under former President Obama, resulting in the FCC’s 2015 “Protecting and Promoting the Open Internet” Regulation. With Pai at the FCC helm, net neutrality policy in the United States (“US”) is noticeably in flux. Thus, even though official policies protecting net neutrality exist on the books, the circumstances surrounding their enforcement and longevity leave much gray area to be explored, chiseled out, and set into stone.

Net neutrality is the idea that all Internet traffic should be treated equally. Yet, since 2003 when Tim Wu coined the term, scholars and commentators cannot agree on a standard definition since that very definition is at the base of a multi-layered over-arching debate. In the US, the most recent FCC articulation of net neutrality is defined by three principles—“no blocking, no throttling and no paid prioriti[z]ation.” These principles mean that ISPs should not be allowed to charge companies or websites higher rates for speedier connections or charge the user higher amounts for specific services. The new “bright-line” rules forbid ISPs from restricting access, tampering with Internet traffic, or favoring certain kinds of traffic via the use of “fast lanes.” Markedly, one thing the 2015 Regulation did not completely forbid is “zero-rating” or “the practice of allowing customers to consume content from certain platforms without it counting towards their data plan cap”—a practice many see as violating net neutrality. Even with this and other exceptions, the 2015 Regulation’s passing was not met without resistance: Republican Senator Ted Cruz from Texas tweeted that the 2015 Regulation was “Obamacare for the Internet.”

Additionally, net neutrality supporters and the FCC majority did not have long to bask in their success after the 2015 Regulation’s approval. The United States Telecom Association and Alamo Broadband quickly challenged it in a lawsuit. Because the new regulation re-classified ISPs as common carriers and therefore subject to the FCC’s authority, Telecom claimed that the FCC was overreaching, harming businesses, and impeding innovation in the field. Fortunately for the FCC, the United States Court of Appeals for the District of Columbia upheld the 2015 Regulation in a 2–to–1 decision.

Yet, the waves are far from settling for the FCC and net neutrality supporters in the US. Following the D.C. Circuit’s 2016 decision, American company AT&T and other members of the cable and telecom industry signaled an intent to continue the challenge, potentially all the way to the Supreme Court. More importantly, the lead dissenter to the 2015 Regulation is now chairman of the FCC. In his first few months as Chairman, Ajit Pai declined to comment on whether the FCC plans to enforce the 2015 Regulation. Pai’s “no comment” does not look promising for net neutrality or for those hoping the US will maintain its intent to protect the open Internet as was articulated in the 2015 Regulation.

Although the 2015 Regulation remains on the books, the likelihood that it is carefully enforced, or really enforced at all, is pretty low. This leaves a total lack of accountability for breaching ISPs. Achieving a policy that is not entirely spineless is admittedly complicated in the context of an Internet that is constantly evolving and a market that is increasingly dominated by just a few ISPs. But, effective policies are not impossible, as evidenced by success in the European Union and several of their member states in setting policies that protect and promote net neutrality. It is clear from these examples that effective net neutrality regulation in the online context requires setting, maintaining, and enforcing official articulations of policy. However, with a clear signal from the FCC chairman to back away from the enforcement of a set policy, it will be as if no regulation exists at all.


Perpetuating Inequality and Illness Through Environmental Injustice

Nick Redmond, MJLST Staffer

In Sidney D. Watson’s Lessons from Ferguson and Beyond, published in issue 1 of MJLST’s 18th volume, the author focuses on issues of inherent racial bias in access to health care for African Americans, and how the Affordable Care Act may be able to help. The author “explores the structural, institutional, and interpersonal biases that operate in the health care system and that exacerbate Black/white health disparities.” The article’s focus on health care in particular is a critical component of inequality in the U.S., but it also only briefly touches on another important piece of the disparity puzzle: environmental justice. Conversations about environmental justice have taken place in multiple contexts, and in many ways serve to emphasize the multiple facets of racial disparity in the U.S., including police violence, access to health care, access to education, and other issues which are all influenced by the accessibility and the dangers of our built environment.

Such systemic inequalities can include access to public transportation and competitive employment, but they can also be problems of proximity to coal plants or petroleum refineries or even a lack of proximity to public natural spaces for healthy recreation. Lack of access to safe, clean, and enjoyable public parks, for instance, can serve to exacerbate the prevalence of diabetes and obesity, and even take a toll on the mental health of residents trapped in concrete jungles (which the article refers to as “social determinants” of poor health). Though there is some indication that environmental factors can harm neighborhoods regardless of income, industrial zones and polluted environments tend to lie just around the corner from low-income neighborhoods and disproportionately affect those who live there, primarily communities of color.

Often the result of urban development plans, housing prices, and even exclusionary zoning, issues of environmental justice are an insidious form of inequality that are often on the periphery of our national political conversations, if addressed at all. Indeed, the U.S. Environmental Protection Agency’s Office of Civil rights (established in 1993) has not once made a formal finding of discrimination, despite President Bill Clinton’s executive order which made it the duty of federal agencies to consider environmental justice in their actions. When the primary federal agency tasked with ensuring access to environmental justice appears to be asleep at the wheel, what recourse do communities have? The answer, it seems, is depressingly little.

A high profile example in our current discourse, environmental justice appears to have failed Flint, Michigan, and it seems likely that the issue won’t be resolved any time soon. Other examples like Columbus, Mississippi and Anniston, Alabama, are becoming more and more prevalent at a disturbingly high rate. Impoverished people with little political or legal recourse struggle against the might of the booming natural gas industry and new advances in hydraulic fracturing, and as water runs out these communities will be the first to feel the squeeze of rising food prices and access to the most essential resource on the planet.

At risk of sounding apocalyptic, there is some hope. National groups like the NRDC or the ACLU have long litigated these issues with success, and more local or regional groups like the Minnesota Center for Environmental Advocacy or the Southern Environmental Law Center have made enormous impacts for communities of color and the public at large. But as Sidney Watson states at the end of her article: “[w]e need to talk about race, health, and health care. We need to take action to reduce and eliminate racial inequities in health care.” These same sentiments apply to our built environment and the communities that we have pushed to the periphery to take the brunt of the harmful effects of our dirty technologies and waste. Few people would choose to live near a coal plant; those who are forced to do so are often trapped in an endless cycle of illness, poverty, and segregation.


What’s in that? The Dilemma of Artificial Flavor, Natural Flavor & Artificial Color

Zach Berger, MJLST Executive Editor

By law, most food is required to display nutritional information; if a product bears nutrient content or health messages, it must comply with specific requirements. However, as questioned by J.C. Horvath in volume 13 of MJLST, do these requirements really help consumers? For example, how often do you see “contains artificial flavor” or something similar listed on your groceries? The use of the non-descriptive descriptor phrases such as “artificial flavor,” “natural flavor,” and ‘artificial color” are common on food labels, yet do not help the average consumer. These phrases can substitute for over 3900 different food additives. The difference between artificial and natural flavors is much more technical than meaningful as both contain chemicals. The distinction comes from the source of the chemicals. In reality, there is little difference between the two, as both are made in a laboratory by a trained professional, a “flavorist,” who blends appropriate chemicals together in the right proportions.

The Food and Drug Administration (FDA) does regulate these additives, but once a substance is Generally Recognized as Safe (GRAS) it may be added to anything without further testing for any unexpected chemical interactions with other ingredients. Examples of ingredients that fall under GRAS[1] range from beef tallow, lard, and gelatin to ambergris a “waxy substance generated in the digestive system of and regurgitated by sperm whales” and Lcystine, “a dough conditioner often derived from duck feathers or human hair.” Basically, these non-descriptive descriptors don’t tell the consumer anything useful, so companies allowed to use these stand-ins?

The Food industry is generally reluctant about releasing all of its ingredients in order to prevent competitors from easily replicating their product. However, “the information that would actually be useful to consumers tends to be categorical information. Things such as whether or not the product conflicts with dietary restrictions or contains artificial hormones or genetically engineered products. The goal of food labeling is clarity for the consumer and the use of the non-descriptive descriptor phrases are anything but clear; for the average consumer, they may as well not even be on the packaging. To make labeling more informative, Horvath recommended “FDA-mandated universal allergen warnings and front-of-pack labels to better educate consumers.” Whatever the solution is, it is time to end the use of non-descriptive descriptors.

[1] 21 C.F.R. 182.1–.99


Fore! Golf Ball Fragments Found in Frozen Hash Browns

By Guest Blogger Tommy Tobin

While golfing at the local links may be a popular pastime for many Americans, consumers don’t expect that golf balls will appear alongside their sausage links on the breakfast plate.

In one of the most unusual food recalls in recent memory, consumers in multiple states are warned that their frozen hash browns may contain golf ball fragments. According to the voluntary recall notice, the potatoes used for these products may have inadvertently been harvested with golf balls.

As hard as the idea may be to swallow, consumption of golf balls or their fragments is not advisable. Golf balls aren’t even a good source of iron as they’re made of resin and rubber. McCain Foods USA warns that consumption of golf ball fragments “may pose a choking hazard or other physical injury to the mouth.”

The affected products were distributed after January 19, 2017 with the production code date B170119. They were sold in two pound bags of Southern Style frozen hash browns under two different labels: Roundy’s and Harris Teeter. The Roundy’s-branded products were shipped to multiple supermarket chains in Illinois and Wisconsin. The Harris Teeter brand “Southern Style” products were shipped to Delaware, Florida, Georgia, Virginia, North Carolina, South Carolina, Maryland, and the District of Columbia.

The recall notice urges consumers in possession of the affected product “not to consume them” and directs consumers to either throw the product away or return it to the store of purchase. No injuries have yet been reported with regard to this recall.

As the Washington Post recently noted, people enjoy hash browns in numerous different ways, with chefs and home cooks each “adding their own special ingredients, although never golf balls.”


Autonomous Weapon Systems: Legal Responsibility for the Terminator

Ethan Konschuh, MJLST Staffer

While technological progress has been the hallmark of the twenty-first century, the rise has been especially drastic in weapons technology.  As combatants in armed conflicts rely more and more heavily on automated systems pursuing such goals as safety, efficiency, and effectiveness on the battlefield, international law governing the use of force in armed conflicts is under threat of becoming outdated.

International law governing the application of force in conflicts is premised on notions of control.  Humans have traditionally been the masters of their weapons: “A sword never kills anybody; it is a tool in a killer’s hand.”  However, as automation in weapons increases, this relationship is becoming tenuous- so much so that some believe that there is not enough control to levy responsibility on anyone for the consequences of the use of these weapons.  These actors are calling for a preemptive ban on this technology to avoid the possibility of the offloading of moral responsibility for war crimes.  Others, however, believe that there are frameworks available that can prevent this gap in responsibility, and allow for the realization of the aforementioned benefits of using autonomous machines on the battlefield.

There are three general categories of policies proposed regarding the regulation of using these machines.  One has been proposed by Human Rights Watch (HRW), International Committee for Robot Arms Control (ICRAC), the International Committee of the Red Cross (ICRC), and other NGO’s and humanitarian organizations have called for a preemptive ban on all autonomous weapons technology, believing that human input should be a pre-requisite for any targeting or attacking decision.  The second regulatory regime has been espoused by, among others, the United Kingdom and Norther Ireland, who claim that there would be no military utility in employing autonomous weapon systems and agree they will never use them, effectively agreeing to a ban.  However, the way that they define autonomous weapon systems belies their conviction.  The definition put forth by these actors defines autonomous weapon systems in a way that effectively regulates nothing:

“The UK understands [an autonomous weapon system] to be one which is capable of understanding, interpreting and applying higher level intent and direction based on a precise understanding and appreciation of what a commander intends to do and why.  From this understanding, as well as a sophisticated perception of its environment and the context in which it is operation, such a system would decide to take – or abort – appropriate actions to bring about a desired end state, without human oversight, although a human may still be present.”

This definition sets the threshold of autonomy so high that there is no technology that currently exists, or will likely ever exist, that would within its purview.  The third policy framework was put forth by the United States Department of Defense.  This policy regulates fully autonomous weapon systems (no human action connected to targeting or attacking decisions), semi-autonomous weapon systems (weapon depends on humans to determine the type and category of targets to be engaged), and human-supervised autonomous weapon systems (weapon can target and attack, but a human can intervene if necessary).  This policy bans all fully autonomous weapon systems, but allows for weapons that can target and attack as long as there is human supervision, with the ability to intervene if necessary.

The debate surrounding how to regulate this type of weapons technology is continually gaining traction up in the face of advances approaching the threshold of autonomy.  I believe the U.S. policy is the best available policy to prevent the responsibility gap while preserving the benefits of using automated weapons technology, but others disagree.  Whichever policy is ultimately chosen, hopefully an international agreement is reached before it is too late, and your favorite sci-fi movies become all too realistic.


What’s Shaking? Sodium Warnings Upheld in NYC Restaurants

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This is the last in guest blogger Tommy Tobin’s latest series on Food and FDA law.  You can find the earlier posts here and here.]

New York’s intermediate appellate court recently upheld a salt shaker. In the February 10, 2017 decision, the court found that New York City could require chain restaurants to mark certain dishes with a “salt shaker” icon, warning consumers that the food contained considerable amounts of salt.

In June 2015, the City issued notice of its intent to require foodservice establishments to warn diners about high salt menu items. After considering over 90 comments and a public hearing, the city adopted its “Sodium Warning” Rule, effective December 1, 2015. In adopting the Rule, the City noted that cardiovascular disease was the leading cause of death in the City and that higher sodium intake was related to increased blood pressure. Further, New York City residents regularly consumed more than the daily recommended amount of sodium and restaurant food was a “primary source” of the salt in New Yorkers’ diets.

The Rule requires chain restaurants—defined as foodservice establishments with 15 or more locations that offered similar menu items—to note food items or meal combinations containing the daily recommended amount of sodium with a specific warning. The warning mandates that a salt shaker icon be placed next to applicable menu items. It also required the following language be displayed at the point of purchase, explaining that the icon “indicates that the sodium (salt) content of this item is higher than the total recommended limit (2300 mg). High sodium intake can increase blood pressure and risk of heart disease and stroke.” The Rule imposes a $200 penalty for non-compliance.

Writing for a unanimous five justice panel, Justice Gesmer ruled against the National Restaurant Association, which had as members more than half the chain restaurants that would be affected by the Rule. The Association challenged the Rule on three grounds, arguing that it violated the separation of powers, was preempted by federal law, and infringed upon its members’ First Amendment rights.

Regarding the separation of powers, the Association argued that City’s health department had exceeded its authority and encroached upon legislative functions in making the Rule. The court was explicit in rejecting the Association’s argument, finding that providing health-related information was the “least intrusive way” to influence citizens’ decision-making. The Rule provided further information to consumers regarding health risks and left it to the diners themselves to decide their dietary choices. The court found that the City has “always regulated” restaurants as necessary to promote public health and did not exceed its authority in adopting this Rule. The court also noted that the same chain restaurants are subject to the City’s calorie content warnings for high-calorie menu items

The Association further argued that the City’s Rule was preempted by federal law, which requires nutrition labeling on grocery store foods. The court rejected this argument as the federal law in question, the Nutritional Labeling and Education Act (NLEA), contained provisions excluding certain warnings and foods from its preemptive effects. Relying on 21 U.S.C. § 343(q) and Second Circuit’s decision in New York State Restaurant Association v. New York City Board of Health, 556 F.3d 114, 124 (2nd Cir. 2009), the court found that the NLEA permits states and localities to establish nutrition labeling for restaurant foods, provided that they are not identical to federal requirements.

The court also examined the appellant’s First Amendment arguments. The Rule would compel commercial speech by placing the salt warnings on menus. Applying the Second Circuit’s New York Restaurant Association, the court examined this compelled commercial speech requirement under a lenient rational basis test. The court found that City’s intended purpose to improve consumer knowledge of potential health risks of salty foods was reasonable. Moreover, the Rule’s applicability only to chain restaurants was not arbitrary or capricious; instead, it was based on health considerations and to facilitate compliance.

The Rule upheld by the court provides advocates new lessons on how to nudge consumers in making point-of-purchase decisions to promote public health. Given the prevalence of cardiovascular disease across the country, additional jurisdictions may consider adopting provisions similar to the “Sodium Warning” Rule. Time will tell how future salt warnings might shake out.

The case is National Restaurant Association v. New York City Department of Health and Mental Hygiene et al., No. 2629, — N.Y.S.3d —- (N.Y. App. Div. Feb. 10, 2017).


Why Equity-Based Crowdfunding Is Not Flourishing? — A Comparison Between the US and the UK

Tianxiang Zhou, MJLST Editor

While donation-based crowdfunding (giving money to enterprises or organizations they want to support) is flourishing on online platforms in the US, the equity-based crowdfunding (funding startup enterprises or organizations in return for equity) under the JOBS Act is still staggering as the requirements are proving impractical for most entrepreneurs.

Donation-based crowdfunding is dominating the major crowdfunding websites like Indiegogo, Kickstarter, etc. In March, 2017, Facebook announced that it will introduce a crowdfunding feature that will help users back causes such as education, medical needs, pet medical, crisis relief, personal emergencies and funerals. However, this new crowdfunding feature from Facebook has nothing to do with equity-based crowdfunding; it is only used for donation-based crowdfunding. As for the platforms specialized in crowdfunding,  equity-based crowdfunding projects are difficult to find. If you visit Kickstarter or Indiegogo, most of the crowdfunding projects that appear on the webpages are donation-based crowdfunding project. As of April 2, 2017, there are only four active crowdfunding opportunities appearing on the Indiegogo website that are available for investors. The website stated that “more than 200 (equity-based) projects funded in the past.” (The writer cannot find an equity-based crowdfunding opportunity on Kickstarter or a section to search equity-based crowdfunding opportunities.)

The reason why equity-based crowdfunding is not flourishing is easily apparent. As one article points out, the statutory requirements for Crowdfunding under the JOBS Act “effectively weigh it down to the point of making the crowdfunding exemption utterly useless.” The problems associated with obtaining funding for small businesses that the JOBS Act aims to resolve are still there with crowdfunding: for example, the crowdfunding must be done through a registered broker-dealer and the issuer have to file various disclosure statement including financial statement and annual reports. For smaller businesses, the costs to prepare such reports could be heavily burdensome for the business at their early stage.

Compared to crowdfunding requirements in the US, the UK rules are much easier for issuers to comply with. Financial Conduct Authority (FCA) introduced a set of regulations for the peer-to-peer sector in 2014. Before this, the P2P sector did not fall under any regulatory regime. After 2014, the UK government requires platforms to be licensed or to have regulated activities managed by authorized parties. If an investor is deemed a “non-sophisticated” investor constraints are placed on how much they are permitted to invest, in that they must not invest more than 10% of their net investable assets in investments sold via what are called investment-based crowdfunding platforms. Though the rules require communication of the offers and the language and clarity of description used to describe these offers and the awareness of the risk associated with them, much fewer disclosure obligations are required for the issuers such as the filing requirements of annual reports and financial statement.

As a result, the crowdfunding market in the UK is characterized as “less by exchanges that resemble charity, gift giving, and retail, and more by those of financial market exchange” compared with the US. On the UK-based crowdfunding website Crowdcude, there are 14 opening opportunities for investors as of April 2, 17, and there were 494 projects funded. In comparison, the US-based crowdfunding giant Indiegogo’s statement that “more than 200 projects funded in the past” is not very impressive considering the difference between the sizes of the UK’s economy and the US’ economy.

While entrepreneurs in the US are facing many obstacles in funding through equity-based crowdfunding, the UK crowdfunding websites are now providing more equity-based opportunities to the investors, and sometimes even more effective than government-lead programs. The Crowd Data Center publicized a report stating that seed crowdfunding in the UK is more effective in delivering 40% more funding in 2016 than the UK government funded Startup Loans scheme.

As for the concern that the equity-based fraud funding involves too much risk for “unsophisticated investors,” articles pointed out that in countries like UK and Australia where lightly regulated equity crowdfunding platforms welcomed all investors, there is “hardly any instances of fraud.” While the equity-crowdfunding JOBS Act has not failed to prove its efficiency, state laws are devising more options for the issuers with restrictions of SEC Rule 147. (see more from 1000 Days Late & $1 Million Short: The Rise and Rise of Intrastate Equity Crowdfunding). At the same time, the FCA stated that it will also revisit the rules on crowdfunding. It would be interesting to see how the crowdfunding rules will evolve in the future.