Category: Blog

Amidst an unprecedented U.S. environmentalist movement in the 1970s, Congress enacted groundbreaking legislation to protect the public health and welfare: The Safe Drinking Water Act (“SDWA” or “Act”). Officially signed into law by President Ford in 1974, the SDWA was revolutionary at the time, providing a national “comprehensive regulatory framework” for overseeing the drinking water supply of the country at large. The Act delegates authority to the Environmental Protection Agency (“EPA”) to set standards for drinking water safety and quality. Importantly, the SDWA expressly allows for states to monitor their own compliance with EPA standards, rather than the federal government. The Act requires a two-step process: (1) EPA establishes a maximum contaminant level goal (“MCLG”), creating a strict health-based goal, and then (2) as provided by Section 1412(b)(4)(B), EPA sets a maximum contaminant level (“MCL”), creating the enforceable standard. This is the standard states are required to meet for certain listed contaminants—a list requiring review and revision every six years. 

Though the United States is a leading country in water safety, as much as half of some state populations still drink unregulated water from small systems that slip through the cracks of the regulatory protections enforced by the Act. This is because the SDWA regulates only public water sources, defined narrowly as that providing drinking water regularly to a minimum of 25 people or through 15 service connections for at least 60 days per year. Moreover, state enforcement of the SDWA has also been the subject of much criticism. In 2015, nearly 77 million Americans resided in areas with water systems in violation of the SDWA’s safety standards; however, because the statute requires self-regulation by the states and municipalities themselves, these violations were underreported, leaving many consumers unaware that their drinking water may be substandard. Maybe more concerning is that “nine out of ten violations of the SDWA are not subject to disciplinary or corrective action,” again, likely due to the Act assigning states the burden of regulating themselves.

A more modern concern about the SDWA is that it only regulates an outdated list of contaminants. For example, “PFAS,” broadly known as “forever chemicals,” are harmful human-made substances that are incredibly resilient and persist in the environment over long periods of time. PFAS can be found in a broad range of consumer products, from food to cookware, and even diapers. Thus, it is no surprise that the chemicals have been detected in U.S. air, water, soil, and the bloodstream of the many Americans. Research shows PFAS exposure can be toxic at relatively low concentrations and may result in adverse health effects, such as cancer or developmental delays to unborn children. A recent government study estimates more than half of our tap water across America could contain these toxins. Yet, the public drinking water containing PFAS meets legal standards unless and until EPA explicitly sets an MCL for the contaminant.

Fortunately, in 2021 EPA proposed a rule now in its final stage of approval. The rule includes the authorization to regulate certain PFAS in drinking water by establishing the MCLG and determining the MCL states will be required to enforce. EPA intends to implement the final rule in 2024. Still, for decades there has been effectively no government intervention nor industry regulation on how these toxic chemicals are used. Further, Americans will continue to drink tainted water until the new MCL is officially established–a process that has taken three years and counting. While the SDWA has created a consistent set of rules that still serve as a fundamental standard for ensuring public water safety, its effectiveness and practicality is tarnished by complexities. First, approximately 12% of the US population depends on federally unregulated private wells for drinking water because the scope of the Act is too slim. Second, per the Act, Americans are only protected by an underinclusive list of contaminants that EPA has established MCLs for, which shockingly only requires review once every six years. In sum, Congress should take action to rework the specifics of the SDWA so that it is more inclusive in terms of its scope of what water is regulated, how the federal government oversees state enforcement, as well updating which contaminants are subject to MCLs.

On September 09, 2021, President Biden issued Executive Order 14,042 (“the Order”). In the Order, President Biden required all executive agencies to include a clause in their contracts stating both contractors and subcontractors would “obey COVID-19 safety guidance issued by the Safer Federal Workforce Task Force.”  On September 24, 2021, the Task Force issued its guidance, which required all contractors and covered employees be vaccinated against COVID-19.

With the World Health Organization rescinding its classification of COVID-19 as a global health emergency in May 2023, you may be wondering why we are discussing the Order. Well, this was not the first global pandemic, and it will not be the last. The first pandemics emerged once hunter-gatherer tribes settled in larger communities, as the formation of these communities, as well as increased agriculture and war, made it easier than ever for diseases to spread. The first recorded pandemic, the Athenian Plague, occurred in 430 BC Athens, and experts predict that there is a 47-57% probability that the world will experience another deadly pandemic before 2050.

Circuit courts around the country are split on whether Executive Order 14,042 was constitutional, with the most recent circuit, the Ninth Circuit, ruling that the Order could stand. In the Order, President Biden asserted power stemming from the Federal Property and Administrative Services Act of 1949 (also known as the “Procurement Act”). The Act was originally signed into law to “increase the efficiency and economy of Federal government operations with regard to the procurement, utilization and disposal of property.” Since its codification, Presidents have used the Procurement Act to require contractors to use immigration status verification systems and to establish paid sick leave for federal contractors.

            The Procurement Act notes that, “[t]he President may prescribe policies and directives that the President considers necessary to carry out this subtitle. The policies must be consistent with this subtitle.” Two Circuits have analyzed this language and created tests to determine whether Presidential orders are consistent with the Procurement Act’s requirements. The Fourth Circuit, in Liberty Mutual Insurance Company v. Friedman, introduced the reasonably-related test, which states that there must be a finding that the executive order’s policies are “reasonably related to the Procurement Act’s purpose.” The D.C. Circuit, in American Federation of Labor and Congress of Industrial Organizations v. Kahn, introduced the sufficiently close-nexus test, which states that the executive order issued must have a sufficiently close nexus to the Procurement Act and the statutory goals of economy and efficiency.

            What we learn from the two tests is that the President’s order must relate back to the Procurement Act’s goals of economy and efficiency in contracting; however, when the next pandemic hits and the Supreme Court has to decide which test to apply when analyzing an Executive Order passed under power granted from the Procurement Act, which test should they choose (granted they do not create their own)? The Court should adopt the D.C. Circuit’s “sufficiently-close nexus” test; all though this test can sometimes be interpreted more leniently than the Fourth Circuit’s “reasonably-related” test, the “sufficiently-close nexus” test’s language and standards are more stringent. When handling health law policy, typically reserved for the states, and vaccinations that could impact millions of people, the Executive branch should be able to decide whether to issue an executive order; however, it should require a serious and sufficient justification.

            The U.S. Public Health Emergency (PHE) that began at the start of the COVID-19 pandemic concluded on May 11, 2023, ending the temporary policies started in response to the pandemic. These changes have affected the American public in different ways. For those with Medicare, over-the-counter COVID-19 tests are no longer free, and coverage regarding COVID-19 testing and treatment will change depending on the insurance plan. Another change that comes with the termination of the PHE is that COVID-19 vaccines and boosters will continue to be free, but only until the federal stockpile lasts. While these changes might seem obvious as COVID is not as prominent as it once used to be, there are some changes that have negatively impacted underserving a community’s way beyond COVID-19 coverage.

            One of these changes includes Medicaid redeterminations restarting. Continued Medicaid enrollment ended March 31, 2023, and states have restarted Medicaid and Children’s Health Insurance Program (CHIP) edibility reviews. Some patients that usually do not qualify for Medicaid, did qualify during the PHE period. This means that these patients have the dreadful task of finding and transitioning to another type of insurance. Unfortunately, the only insurance option was Medicaid for some of these patients, as they could not afford anything else.

            A direct consequence of the end of the PHE will be the looming loss of Medicaid eligibility for the millions of Americans who come from low-income households. There could be as many as eighteen million enrollees without coverage as a result of the new eligibility requirements. The U.S. Department of Health and Human Services predicts that people of color will lose coverage because of administrative barriers, not because they don’t qualify in many instances. 

The end of PHE will affect more Black and Hispanic communities since they are twice as likely to be Medicaid recipients. This sudden cut in coverage will only worsen an already failing healthcare system for people of color; this is because the cut in coverage will reduce access to screenings and preventive care for chronic diseases that are more common in people of color, overload already overburdened hospitals with emergency care, and cripple low-income families with medical debt.

 To avoid or lessen all of these inequalities in the healthcare system, states must act as soon as possible. For example, states can market campaigns to encourage citizens to sign up for alternative care that has COVID-19 benefits, as well as communicate with Medicare enrollees so that they at least know their coverage is coming to an end. The state of Colorado has already taken a proactive approach to healthcare insurance by opening enrollment for a program called OmniSalud that assists undocumented residents and individuals with protections through the Deferred Action for Childhood Arrivals program in obtaining affordable healthcare insurance. Communities that lack these kinds of programs should follow suit and protect their most vulnerable residents.

  It is an overstatement to say that COVID has ended when it has not. It is important to remember that moving out of an emergency state does not mean the impact on vulnerable communities has concluded. It is imperative that states enact policies that prevent the worsening of COVID-induced inequities in the most vulnerable communities.

Spooky season is upon us, but what do you do when you get the kind of jump scare you do not want?  On October 4^th, Walmart shopper Veronica allegedly experienced exactly that when she opened a package of Reese’s cups to find that mealworms and maggots had breached the batch. In the PSA video that Veronica posted to TikTok, she opened several Reese’s Cups on camera, demonstrating that she didn’t plant the worms herself. Comments on the video pose several questions: could it be last year’s leftover candy? Could there have been a packaging defect? The latter, of course, leads to the inevitable question: is this a Walmart problem, a Hershey problem, or will this become a mass consumer problem?

Calls for a product defect recall against Reese’s Peanut Butter Cups circulated the internet for the first time in 2014, when two men posted a video on Twitter alleging similar circumstances as Veronica’s. The same year, Fact-Checker David Mikkelson pointed out the indeterminable veracity of the video. Global insect-eating enthusiasts, on the other hand, find no problem mixing a little protein with their candy. In Bon Appetite magazine’s 2014 publication, Larry Peterman discloses not only that his company, Hotlix, creates exclusively insect-filled candies, but also that the Food and Drug Administration told him that he doesn’t have to clip the stingers off scorpions before adding them to lollipops! This, however, does not distract from the reality that in the average consumer’s preferred candy-to-insect ratio, there is such a thing as much too much, and the FDA is inclined to agree.

The FDA’s stance on insect contamination in food is that in order to be permissible, it must also be “natural or unavoidable.” The natural and unavoidable ratio of insect-to-chocolate is on average sixty or more fragments to 100 grams of chocolate, introduced or unfiltered during the processing stage of production. That’s more than a hundred bug fragments in every Hershey’s Candy Bar—and that’s before it even hits the shelves. Yet, these candy bars are still considered safe for consumption. Meanwhile, Trader Joe’s has pulled almond cookies and broccoli cheddar soup off the shelves due to insect contamination possibly too high for even the apparently insect-loving FDA. Most consumers are also unsurprised to find wasp heads in figs, as they play an essential role in pollination. So, could the line between “too much” and “much too much” be drawn depending on expectations? And what do consumers do when confronted with creepy-crawly tricks in their Halloween treats this October 31^st?

Products liability may have an answer. The Civil Jury Instructions for products liability offer a consumer expectations test, which states that in order to prove a product is defective—or, in this case, too defective to eat—”a plaintiff must prove that the product failed to perform as safely as an ordinary user or consumer of the product would expect when used in an intended or reasonably foreseeable manner, including reasonably foreseeable misuse.” Thus, companies like Walmart and Hershey may not be liable if candy is improperly stored, is beyond its expiration, or contains maggots. In a case arising from Texas, plaintiff Peables Fowls experienced a shock upon finding maggots in the Almond Joy she purchased and popped into her mouth while sitting in the Walmart parking lot. Not only did she launch herself from the truck, but she also left it in reverse and nearly lost her car to oncoming traffic. Upon review of Ms. Fowls’ tort case, The District Court found that a vendor has no duty to inspect or test a product manufactured by another for latent defects like maggots or mealworms. On a wider scope, companies may conduct food recalls voluntarily or the FDA may request a recall. So, between FDA regulations, company candidness, and products liability, the message to candy consumers this Halloween seems be: if you don’t want to risk getting tricked, the safest bet is to avoid the treat.

In a bold move, California Governor Gavin Newsom recently enacted legislation banning four commonly used additives, including Red Dye No. 3. As the Golden State takes this proactive stance to protect public health, the Food and Drug Administration (FDA) is facing pressure to take similar action on a national scale.

            The four additives at issue in the legislation, which are all commonly used in United States food and beverage production, are brominated vegetable oil, potassium bromate, propylparaben, and Red No. 3. Red No. 3 is a dye used for coloring in foods such as Nerds, Peeps, and many Halloween treats.

            The bill put forth by Governor Newsom, titled The California Food Safety Act, prohibits the use of these four additives in California beginning in 2027. Newsom notes that the four additives in the bill “are already banned in various other countries;” Newsom also cited the  European Union’s near-complete ban on Red No. 3. By delaying the bill’s implementation until 2027, Newsom stated in the bill that he intends to give brands significant time to revise their recipes to avoid these harmful chemicals. Newsom also pressured the FDA to review and establish updated national safety levels for these additives.

            Given the pressure from Governor Newsom and consumer advocacy groups to ban the use of Red No. 3 and other additives in foods, the FDA may take action. The definition of food additives in the Federal Food, Drug, and Cosmetic (FD&C) Act contains a provision for the use of ingredients that are “Generally Recognized as Safe” (GRAS) without pre-market approval from the FDA. There is no GRAS exception for Red No. 3 and other color additives, as they are not included in the definition of food additives. Instead, Red No. 3 and other synthetic dyes are subject to a formal FDA certification process based on safety and purpose to be listed. Should the FDA wish to reverse its certification and ban the use of Red No. 3 for all purposes, it could easily do so via the same regulatory action it took to restrict its use in 1990.

The FDA restricted Red No. 3 in 1990 by banning its use in cosmetics and externally applied drugs, citing their own studies that determined that FD&C Red No. 3 is an animal carcinogen. By banning Red No. 3 from being used in cosmetics and externally applied drugs but not banning its use in food, the FDA implicitly stated that Red No. 3 was somehow safe enough to be ingested, despite not being safe enough to be applied to the skin.

The FDA still has not banned the dye from being used in foods, despite its website reading, “The FDA does not approve the use of a color additive that is found to induce cancer in people or animals.” This language stems from the Delaney Clause of the FD&C Act, which forbids any additives in food shown to be carcinogenic in any species of animal or in humans. Despite their studies determining it to be carcinogenic, the FDA currently allows Red No. 3 to be used in food and drugs. This policy contradicts the Delaney Clause and the FDA’s stance of not approving carcinogenic color additives.

            California can use its economic strength to influence the FDA’s decision-making regarding the fate of Red No. 3. Because California contributes significantly more to the U.S. GDP than any other state, corporations heavily consider California’s regulations. The FDA should proactively promote a state of uniformity by banning Red No. 3 nationwide because national food companies currently using Red No. 3 will likely have to adjust their formulas to accommodate California law anyway.

In addition to its influence on corporations, the California Food Safety Act could serve as model legislation for other states seeking to ban additives including Red No. 3. This would lead to an industry-wide state of disarray, where every state allows its own different set of additives. The FDA can and should prevent this chaos by implementing a national ban on Red No. 3.

            It’s been more than a year since the passage of the Inflation Reduction Act (IRA), which made over $393 million in investments towards reinforcing existing energy infrastructure, furthering R&D on clean energy sources, and strengthening the Internal Revenue Service’s collections efficacy. One of the IRA’s blockbuster provisions has increasingly made waves in the news and courthouses nationwide: the Medicare Drug Price Negotiation Program. Before the IRA’s enactment, the Health and Human Services (HHS) Secretary was prohibited from involvement in negotiations between pharmacies, drug manufacturers, and prescription drug plan sponsors under the “noninterference” clause. The IRA inserted an exception to the clause that now mandates the Secretary to negotiate prices directly with manufacturers for a select number of expensive “single-source” branded drugs or biologics without generic or biosimilar counterparts.

In response to the Program, drug companies and trade groups have filed ten complaints across seven federal forums around the country (Astellas dropped their complaint as their drug did not appear on the first round of negotiations). The plaintiffs include Merck, U.S. Chamber of Commerce (through its Dayton chapter), BMS, PhRMA, Janssen, Boehringer, AstraZeneca, Novartis, and Novo Nordisk. Interestingly, the root of many of the plaintiffs’ novel constitutional claims are the consequences if any of the ten manufacturers choose not to participate in the Program.

All manufacturers of the first ten branded drugs up for negotiation were required to begin the negotiations by October 1, 2023. Any manufacturer that fails to negotiate with Centers for Medicare & Medicaid Services (CMS) will be required to either pay an excise tax amounting up to 95% of the medication’s sales or cease its participation altogether in Medicare and Medicaid. Since Medicare held a 30% share of U.S. retail prescription drug spending in 2017, nonparticipation or nonagreement to the negotiations would be a huge deal for several manufacturers.

While it is too early to tell whether the courts will validate some of the constitutional claims, we at least know that there is some skepticism regarding some of the plaintiffs’ due process arguments: such is so in the U.S. Chamber of Commerce complaint. In a disappointment to the Chamber and its members, Judge Michael J. Newman not only denied the Chamber’s motion for a preliminary injunction on the program but expressed disapproval of their due process claims, one of which is that the negotiated prices were confiscatory and thus violated the Fifth Amendment. Judge Newman stated that the negotiated prices were not confiscatory because participation in Medicare was voluntary for drug manufacturers, whether it was a wise business sense or not. Given that the order also cites plenty of Sixth Circuit precedent supporting the notion that participation in Medicare is voluntary, it will be interesting to see whether this impacts other constitutional arguments throughout the litigation’s lifecycle. This is especially so since the present Supreme Court is exceedingly suspicious of Fifth Amendment violation matters.

            The Chamber of Commerce suit is just the tip of the Medicare Negotiations Program litigation iceberg. There are also First, Fifth, and Eight Amendment concerns raised by many of the plaintiffs’ complaints (e.g. the 95% excise tax can be considered an “excessive fine” under Eighth Amendment). Some even expect the disagreement across the circuits to result in a fast track to the Supreme Court, which casts much uncertainty on the legal survival of a program that would yield $98.5 billion in savings for Medicare over ten years – only time will tell.