Category: Blog

The War on Sugar

Every few decades there is a shift in diet culture. Currently, we are experiencing the war on sugar as consumers become increasingly aware of the growing overconsumption of sugar and the risks associated with it. As a result, high-intensity sweeteners are now a common alternative to ordinary sugar that make up little to no calories when added to food or drink, creating desirability for those attempting a calorie deficit. These sweeteners are frequently used in beverages or foods marketed as “diet” or “sugar-free.” Research from 2019 shows a whopping two-thirds of Americans were attempting to limit their sugar intake. In efforts to keep up with these trends, the food industry had to begin adjusting the contents of their products while adhering to the Food and Drug Administration’s (“FDA”) regulations.

Among the high-intensity sweeteners on the market are saccharin and aspartame. Both are chemical formulas used as food additives to produce an intensely sweet flavor without the calories of sugar; notably, aspartame is 200 times sweeter than sugar. Both saccharin and aspartame are currently approved and regulated by the FDA. High-intensity sweeteners are regulated as a food additive, unless its use is generally recognized as safe (such as stevia leaf). Before a food additive can be used in food and marketed as such, it must undergo premarket review and obtain approval by the FDA. During the premarket review of the current high-intensity sweeteners permitted for use, the FDA established an acceptable daily intake level (“ADI”) for each of the sweeteners. The FDA has included a chart on its website showing the number of tabletop sweetener packets a 132 pound individual would need to consume to reach the ADI: 75 packets of aspartame and 45 packets of saccharin. The FDA also claims that even for consumers whose daily consumption of a sweetener is high, it generally does not present safety concerns if it is still less than the ADI.

Yet, the question remains for consumers conscious about their health but with a persistent sweet tooth: should I be choosing products with sugar or artificial sweetener? This complex question is best answered by comparing Diet Coca-Cola (“Diet Coke”) to regular Coca-Cola (“Coke”). Diet Coke contains artificial high-intensity sweeteners, including aspartame, while regular Coke contains traditional sugar in the form of high fructose corn syrup. However, high consumption of both Diet Coke and regular Coke may be linked to a higher risk of heart disease and other health problems. The question is not “which version of sweetener is better for you,” but “which version of sweetener is less bad for you.” A can of Coke contains 39g of sugar, which amounts to about 7 teaspoons of sugar. The FDA suggests a Daily Value of 50 grams per day for added sugars based on a 2,000 calorie daily diet. Thus, drinking a Coke will make up 78% of one’s suggested daily added sugar intake. Contrary to what many believe, Diet Coke (although containing 0g of sugar) may still present similar health issues as regular coke, such as a spike in blood sugar caused by its artificial sweeteners. Spikes in blood sugar have been linked to heart problems, type-2 diabetes, weight gain and the other various health problems commonly associated with traditional sugar intake.

Overall, the convoluted truth is that western diet trends heavily influence how products are presented in the media and then marketed to the public. Evidently, there is a surprising lack of concrete scientific evidence to heavily sway individuals in one direction or another in terms of choosing high-intensity sweeteners over classic sugar. Remarkably, the one consensus is that neither of the two are particularly “good” for health as both are addictive and stimulate the brain in a similar fashion. In sum, moderation is key as consuming excess amounts of either sugar or artificial sweeteners can be cause for concern. It is important not to blindly follow the intentional marketing of “diet” or “zero sugar” products without doing further research on what exactly is replacing that sweet flavor. But, to avoid the issue altogether, perhaps opt for a sparkling water sweetened naturally with fruits instead of deciding between a diet or regular Coke.

Accountability for Privacy Violations in Mobile Health Apps: Flo Health and the Health Breach Notification Rule

Digital privacy concerns were raised once again following the overturn of Roe v. Wade in June 2022. These concerns were exacerbated when messages sent via Facebook Messenger discussing a medication-induced abortion were the basis for further search warrants that were used to prosecute a mother and daughter in Nebraska. As exemplified in the Nebraska case, tech companies must comply with search warrants issued by courts, sewing privacy concerns particularly in period tracking app users. Following the overturn of Roe v. Wade, menstruating people were encouraged to delete period tracking apps all together, but data experts warned that deleting the apps alone may not protect users.

Privacy concerns are not new to period tracking apps. Flo Health is a period tracking app, used by more than 100 million users, with a history of privacy concerns. From 2016 to 2019, Flo Health promised users to keep their health data private yet released identifiable health information to third party applications, including Facebook’s analytics division. In 2020, the Federal Trade Commission (FTC) filed a complaint against Flo Health alleging that the app had misled users about how their health information was stored and used. Flo had been sharing user data with third party firms under app event names such as “R_Pregancy_Week_Chosen,” explicitly communicating their health information. Flo Health reached a settlement with the FTC in 2021. Flo Health is just one example of how mobile apps struggle with privacy compliance.

While the Health Insurance Portability and Accountability Act (“HIPAA”) applies to many institutions who store personal health records, its application to mobile health apps, such as Flo Health, can be complicated.  The FTC has released an interactive tool for mobile health app developers to determine if certain regulations apply to their app. One such regulation is the Health Breach Notification Rule (“HBN”). The HBN was enacted in 2009, but, as of 2021, the FTC has never brought  an action to enforce it.  The HBN was enacted to ensure accountability when entities not covered by HIPAA compromise consumers’ sensitive health information.  The regulation requires subjected entities to inform users and the FTC of any breach of security of unsecured personal health records. A breach of security is considered any acquisition of identifiable health records that is not authorized by the consumer.

While the FTC did not charge Flo Health with a violation of HBN, two Commissioners released a joint statement arguing that its application was warranted in the case. Commissioners Rohit Chopra and Rebecca Kelly Slaughter argue that Flo Health shared user data with Facebook and other entitles, without obtaining the user’s authorization to do so. The Commissioners seek enforcement of the HBN as a way to, “induce firms to take greater care in collecting and monetizing our most sensitive information.” The FTC has also published further guidance for mobile health app developers that store sensitive health information. The guidance includes minimizing data collected, storing it in a de-identified form, and limiting operating systems’ access to the data.

Despite this guidance, Flo Health, and apps like it, still store detailed, identifiable information about their users, including personal notes left by the user. However some progress has been made as Flo Health released an “anonymous mode” after the overturn of Roe v. Wade in June, allowing users remove their name, email address, and technical identifiers. However, a user’s privacy and control over their health information should not be an afterthought only brought about by changes in case law, especially when regulations already exist to hold entities accountable for releasing sensitive information without the user’s authorization.

The ACT for ALS: No More Bad Breaks

“For the past two weeks you have been reading about a bad break. Yet today I consider myself the luckiest man on the face of the earth.” Lou Gehrig spoke to a Yankee Stadium crowd of 61, 808 on July 4, 1939 following the publicization of his amyotrophic lateral sclerosis (“ALS”) diagnosis. As a result of Gehrig’s diagnosis and subsequent retirement from baseball, ALS became a well-known disease thanks to the man who considered it to be “a bad break.”

For approximately 20,000 Americans currently living with ALS, the disease is more than “a bad break.” For those with ALS, they must live with the progressive loss of control over their bodies. Voluntary movements such as walking, talking, breathing, and chewing become difficult. The nerve cells that control these voluntary movements are attacked and killed by the disease. As it progresses, ALS weakens and paralyzes the muscles, eventually leading to death. There are currently no cures for ALS.

In response to ALS and other neurodegenerative diseases, President Biden signed the “Accelerating Access to Critical Therapies for ALS Act” (ACT for ALS) into law on December 23, 2021. The ACT for ALS requires that the Food and Drug Administration (“the FDA”) publish and implement a 5-year action to foster drug development and facilitate access to investigational drugs for ALS and other rare neurodegenerative diseases.” Additionally, the ACT for ALS also requires the FDA to award grants or contracts to public and private entities to fund research and developments of interventions meant to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in children and adults.

The action plan that FDA developed per ACT for ALS outlines that FDA will engage in the following: establish the FDA Rare Neurodegenerative Diseases Task Force (FY 22), establish the Public-Private Partnership for Rare Neurodegenerative Diseases (FY 22), develop disease-specific science strategies (FY 22 – FY 26), and leverage ongoing FDA regulatory science efforts. The science strategies FDA developed for ALS addresses current obstacles and challenges to the development of ALS drugs.

On September 29, 2022, FDA approved the new drug Relyvrio (sodium phenylbutyrate/taurursodiol) for treatment of ALS. The drug causes a slower rate of decline and a longer overall survival for patients. It can be taken orally or through a feeding tube alongside a snack or meal. The drug’s efficacy was demonstrated in a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients received either Relyvrio or a placebo, with those receiving the drug experiencing a slower rate of decline than those who received the placebo.

The ACT for ALS appears to be doing its job: spurring more treatment options for patients with ALS and more development for therapies for neurodegenerative diseases. For those experiencing “a bad break,” there is now more hope for the future as more research is incentivized to find treatments for ALS and other rare neurodegenerative diseases.

Hungry for Change: The Biden Administration Takes Steps Toward Ending Hunger by 2030

According to the United States Department of Agriculture (USDA), more than 33 million Americans, including five million children, are considered food insecure. The United States Department of Health and Human Services (HHS) defines food insecurity as a household-level economic and social condition of limited or uncertain access to adequate food. While food insecurity does not necessarily cause hunger, hunger is a possible outcome of food insecurity. Adults who are food insecure may be at an increased risk for a variety of negative health outcomes and health disparities. For example, a study found that food-insecure adults may be at an increased risk for obesity. Another study found higher rates of chronic disease in low-income, food-insecure adults between the ages of 18 and 65. Food-insecure children may also be at an increased risk for a variety of negative health outcomes, including obesity. They also face a higher risk of developmental problems compared with food-secure children. In addition, reduced frequency, quality, variety, and quantity of consumed foods may have a negative effect on children’s mental health.

In an effort to address this issue, President Joe Biden hosted the White House Conference on Hunger, Nutrition, and Health and announced over $8 billion in hunger and nutrition commitments. It was only the second-ever conference of its kind and the first in over fifty years. The last time this conference took place was in 1969, under President Richard Nixon. The Nixon-era conference was a pivotal moment that led to the creation of the big programs underpinning the United States hunger response, such as food stamps and the Women, Infant, and Children program (WIC), which provides child nutrition assistance among other things. The Biden administration used this as an opportunity to lay out its plan to improve the nation’s health. This plan includes pushing for Congress to permanently extend the child tax credit, raise the minimum wage, and expand nutrition assistance programs to help reduce hunger rates. This ties to an ambitious goal the president set in May—ending hunger in the United States by 2030.

The $8 billion in commitments comes from some of the largest corporations in America’s private sector—Google, Tyson Foods, Walgreens—and includes $4 billion that will be dedicated by philanthropies that are focused on expanding access to healthy food. Additionally, there will be a focus on expanding nutrition research and encouraging the food industry to lower sodium and sugar. However, some of the most ambitious proposals require Congressional action. Thus, the partisan split threatens the president’s success.

Furthermore, the conference comes at a time of steep inflation and the end of pandemic benefits that staved off hunger rates. While the expanded child tax credit that was part of the American Rescue Plan of 2021succeeded in reducing poverty and hunger in the United States, Democrats were unable to make that measure permanent in the Inflation Reduction Act that they passed this year. Now, lines at food banks keep getting longer, food prices are rising at their fastest rate in four decades and fears of a recession that could result in higher unemployment rates are growing.

Unfortunately, while the Biden-Harris administration’s strategy includes many great ideas, it also seems to let the food industry off the hook and fails to adequately address the impact that racism, gender inequality, and the climate crisis on food insecurity. Though the conference served as a good first step toward future investments and policy changes around combatting food insecurity, there is still a long road ahead and the administration must do more to achieve its goal of ending hunger by 2030.

Baked Brie, Peanut Butter & Baby Formula: Explaining the Major Food Recalls of 2022

On September 30, 2022, the Food and Drug Administration (“FDA”) issued a food safety alert after two kinds of cheese were linked to a listeria outbreak. The cheeses in question? Brie, baked brie, and camembert cheeses made by Old Europe Cheese, Inc. The products were sold under 25 different brand names in major retail stores such as Safeway, Whole Foods, and Trader Joe’s both nationwide and in Mexico. 

The recalled products consist of a wide variety of cheeses, ranging from double crème wedges to cranberry baked brie. However, it is far from the first grocery recall that has happened this year. A study conducted by Agruss Law Firm found that in 2022 alone, salmonella and listeria outbreaks led to 49 food and beverage recalls from the FDA, representing 37.4% of all food product recalls. It is a considerable increase compared to 33.3% in 2021 and consists of more than 45% of recalls this past year. 

In addition, more than a fifth of grocery recalls this year came from peanut butter products contaminated with salmonella. On May 20, the FDA released a statement announcing the voluntary recall of nearly 50 Jif products for potential salmonella contamination. The recall also affected products distributed in international markets including countries such as Canada, Thailand, and Honduras. An epidemiological review conducted by the Center for Disease Control and Prevention (“CDC”) examined a multistate outbreak of salmonella senftenberg infections. In a joint investigation between the FDA and CDC, the CDC found that out of ten people interviewed, all ten consumed peanut butter and nine out of ten people ate Jif peanut butter products before they became sick. In total, 21 people from 17 states fell ill and four people were hospitalized. Using a process known as Whole Genome Sequencing (WGS) analysis, the FDA discovered that the outbreak was linked to Jif products produced at the J.M. Smucker Company facility in Lexington, Kentucky. Jif then issued a report describing a machinery breach that allowed puddles of water to come into contact with peanut roasting equipment. Plant officials also discovered past incidents of salmonella found at the facility and a report obtained by Axios indicated that the issue may have been considered a routine error or ignored by the company altogether. 

However, food recalls this year weren’t limited to cheese and peanut butter. The number of recalled products during the first quarter of 2022 was also the highest figure in a decade due to a large recall of baby formula. This past February, the FDA published a company announcement concerning a voluntary recall of powder formulas produced in a plant owned by Abbott Nutrition. In total, the announcement stated that four infants from three different states contracted a cronobacter sakazakii infection after consuming powdered formula, resulting in two deaths. The FDA’s inspection of the plant revealed that key production areas, including the machinery and floor of the packaging room, tested positive for cronobacter. And similar to the Jif plant, FDA inspectors discovered a water leak dripping from the valves, leading to standing water on the floor and near the floor scrubber. The FDA also found that the company failed to identify the root causes of the cronobacter complaints and that employees in contact with the infant formula did not sanitize their shoes or wear proper protective gear while working. 

Many of the issues stemming from recent food recalls can be traced back to supply chain issues and a lack of corporate oversight. While the passage of the Food Safety Modernization Act (FSMA) in 2011 gave the FDA greater authority in responding to food safety complaints, the regulations remain at odds with the increased industrialization and expansion of facilities. However, an increase in food recalls does not necessarily mean an increase in food-borne illnesses or contamination. Since the FSMA allows companies to recall products as a precaution, it enables the FDA to prevent health threats before they begin. As a result, it is important to keep in mind how these recalls can affect consumers of all ages and socioeconomic backgrounds, and to consider how the legal system can provide remedies to resolve issues in safety regulations and corporate oversight.

The Future of IUDs in a Post-Dobbs World

The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which eliminated the federal right to abortion has produced more questions than answers. It not only created uncertainty around the future of abortion accessibility and legality, but also around birth control and contraceptives. As states begin to test the new limits of what overturning Roe v. Wade truly means – a difficult question presents itself: Will states extend abortion restrictions to limit certain types of contraceptives?

One type of contraception stands out as particularly at-risk: Intrauterine devices (“IUDs”). Laws based on the viewpoint that “life begins at fertilization” are particularly ripe for a broad and far-reaching interpretation that could eventually include banning this type of contraception.

The concept that a fetus is considered an unborn child is not new. However, the idea of fetal personhood has taken on new meaning and is helping drive exceptionally restrictive anti-abortion measures. These measures are likely to move beyond, or at least test the limits of, what is traditionally considered abortion.

IUDs are generally known as a preventative form of birth control, blocking fertilization and sometimes ovulation. However, they can also prevent implantation of a fertilized egg; this is the scenario in which IUDs enter a gray area in states that define life as beginning at fertilization.

In Kentucky, which has one of the most restrictive abortion bans in the country, the statute currently provides an exemption for contraceptives. However, it’s easy to see how a strict interpretation of the statute’s key definitions could result in the exclusion of contraceptives in the future. For example, the Kentucky statute defines an “unborn human being” as beginning at fertilization, yet it concludes by stating that “nothing in this section may be construed to prohibit…a contraceptive measure.” The language of the statute contradicts itself: It clearly exempts contraceptives from the ban, but key terms have been defined in a way that suggests they should not be exempt.

Meanwhile, in statutes that do not state an exemption for contraceptives that inhibit fertilization, IUDs are an open question. The legality of these contraceptives will likely be determined by the courts, or through clarifying language in amended statutes. Legislators in Missouri, Idaho, and Louisiana, among others, have already declared that life begins at fertilization. Missouri’s statute is one of the most restrictive; there are no exceptions for rape or incest. Confusion about the terms of Missouri’s statute were almost immediate. A hospital system in Kansas City stopped providing emergency contraception as soon as the state’s trigger ban took effect, and only resumed providing it upon clarification from the governor that contraceptives were exempt from the ban.

The lack of clarity and consistency in terminology poses a barrage of questions for pregnant individuals, families, doctors, and insurance providers. Legislatures will either have to continue refining and updating statutes as confusion arises, or the courts will become the interpreters, inserting precision into vague and potentially conflicting statutory language.

Legislators could argue that their intention is to only ban abortion procedures, as evidenced by the current carve-outs for contraceptives. However, in light of the other types of exemptions up for debate, the underlying intent warrants skepticism. Other exemptions in question include whether to allow abortion procedures in cases of rape, incest, and non-viable pregnancies, which suggests that the objective is to impose increasingly stringent restrictions. As these questions arise state-by-state, in legislatures that are constantly prescribing more restrictive measures, it is hard to imagine that definitive clarifications are coming anytime soon.