Articles by mjlst

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

May 7, 2017
Biotechnology, Drug Policy, Ethics

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

May 3, 2017
Internet, Regulatory

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

April 30, 2017
Environment, EPA, Healthcare, Healthcare Reform

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

April 30, 2017
FDA, Food and Agriculture, Regulatory

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

What’s in That? the Dilemma of Artificial Flavor, Natural Flavor & Artificial Color

April 30, 2017
FDA, Food and Agriculture, Regulatory

Zach Berger, MJLST Executive Editor

[1] 21 C.F.R. 182.1–.99

Fore! Golf Ball Fragments Found in Frozen Hash Browns

April 24, 2017
Uncategorized

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

April 19, 2017
International Law, Regulatory, Weapon Law

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

April 18, 2017
FDA, First Amendment, Food and Agriculture, Litigation

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

April 12, 2017
Financial Law, Internet, Regulatory, Securities Law

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.

As Clear as Milk: Misleading Milk Marketing?

April 11, 2017
FDA, Food and Agriculture, Litigation

MJLST Guest Blogger, Tommy Tobin

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

Milk and cookies are one of the quintessential American comfort food combinations. Even so, considerable controversy has arisen out of products being labeled and sold as “milk.” I guess that’s just the way the cookie crumbles.

“Milk” has a precise regulatory definition under 21 C.F.R. § 131.110. Inter alia, “milk” is “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” Leave it to the C.F.R. to make food sound delicious.

The Eleventh Circuit recently decided that a “skim milk” product could be sold as such. The Circuit’s March 20, 2017 decision in Ocheesee Creamery LLC v. Putnam examined whether a Florida statute barred the business from labeling its product “skim milk” if it did not contain Vitamin A. The court below had upheld that law, and the dairy appealed claiming infringement of its free speech rights. Using dictionary definitions and common sense, the panel ruled that the dairy’s use of the words “skim milk” to describe its skim milk would not mislead consumers.

As consumers walk around the grocery store, they may see other products labeled “milk.” As the AP declared, “fake milk” is one of America’s latest food fights. In addition to milk from cows, consumers may see products labeled as “milk” that are derived from almonds, soy, coconuts, or rice. Would consumers actually get confused between these “milk” products and cow milk? The Northern District of California said no.

In a 2013 decision in Ang v. Whitewave Foods Co., consumers brought suit asserting, inter alia, that products like “soymilk,” “almond milk,” and “coconut milk” represented fraudulent business practices and false advertising as they did not come from cows. The court found the claim utterly ridiculous, finding that the descriptions accurately described the nature of the products. The opinion reasoned that “it is simply implausible that a reasonable consumer would mistake a product like soymilk or almond milk with dairy milk from a cow. The first words in the products’ names should be obvious enough to even the least discerning of consumers.”

In 2015, the Northern District of California revisited whether “soymilk” would mislead a reasonable consumer. In Gitson v. Trader Joe’s, the federal court examined whether advertising a product as “soymilk” would violate the Federal Food, Drug and Cosmetic Act. The court first examined whether the use of “soymilk” was false or misleading, finding that the “reasonable consumer (indeed, even the least sophisticated consumer) does not think soymilk comes from a cow.” Second, the court analyzed whether “soymilk” ran afoul of the regulatory definition of “milk” discussed above. The court concluded that Trader Joe’s did not attempt to pass off its soymilk as “milk,” that is the soymilk was not purported to come from a cow.

While many might find the courtroom melee over milk to be melodrama, figuring out what’s in a name is more than making a mountain out of a molehill. It may matter to companies’ bottom lines.

From mayonnaise to margarine, food fights over standards of identity are likely to increase given the rate of innovation in the food industry and its creative marketers, according to the Food+Bev Law Blog. As noted there, “what you call a food clearly influences consumers’ opinions and purchasing decisions.” Time will tell how companies and consumers react to evolving identities and innovation throughout the food industry.

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