Legislation is needed to close the environmental health gaps in the Polluters Pay Principle

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By Eric Feigen, NCL Health Policy Intern

Today, more than 40% of Americans live in communities with unhealthy levels of air pollution and every year, millions of deaths and chronic illnesses have been found to be directly caused by various pollutant types. This represents the human cost inherent in environmental degradation. Despite this, policy-makers and regulatory agencies continue to ignore public health consequences when crafting legislation designed to address environmental issues nationwide.

The current approach towards addressing both climate change and environmental damage is rooted in the Polluters Pay Principle (PPP). This commonly accepted practice dictates that those who pollute are responsible for not only abatement costs, but also compensating those adversely affected by their actions. From the Clean Air Act to the more recent Inflation Reduction Act, PPP is the fundamental framework for the majority of environmental legislation in the U.S.

The core mechanism used in PPP is cost-benefit-analysis. Due to the fact that polluters receive a benefit from polluting, in the form of profits, they must correspondingly compensate individuals for the negative externality their pollution creates. For example, paying for a water treatment plant in order to ensure a safe water supply for a community.

One of the most significant externalities of pollution is long-term health conditions. High levels of particle air pollutants are linked to a variety of health issues including asthma, cancer, infant mortality, and premature death. However, as previously mentioned, while 40% of Americans live in places with failing grades in air quality, not all of these individuals have asthma. This illustrates the uncertainty inherent in including the costs to humans’ health in the PPP’s cost benefit analysis. Using this logic, Michigan v. EPA set the precedent for omitting the negative impact polluters have on health from PPP-based calculations.

The Public Health Air Quality Act is one solution to the uncertainty dilemma surrounding pollutants and chronic health conditions. This is because the Act sets thresholds for pollutant levels at the point where the pollutant becomes harmful to human health. In essence, while previous legislation has made polluters pay for the right to pollute, the standards in this legislation will prohibit contamination after the air quality reaches a dangerous level. Furthermore, the Act will also mandate new air pollution monitoring programs and allow the EPA to follow the “precautionary principle”, which errors on the side of safety when determining what levels of pollution may be harmful to humans.

Another arena where PPP must be supplemented is equity. While designed to reduce environmental damage nationwide, PPP fails to address how pollution disproportionately harms Black and Brown communities. An example of this is exposure to PM 2.5, an air pollutant responsible for upwards of 85,000 deaths a year. A recent study highlights that while the Clean Air Act has led to a nationwide decrease PM 2.5 related health conditions, the number of deaths this pollutant causes in communities of color has remained constant.

Climate change and environmental degradation are just as much a public health issue as they are an environmental one. Policy-makers have the obligation to create legislation to supplement PPP policies to mitigate the harm polluters inflict on public health and ensure an equitable approach to environmental regulation and cleanup.

 

My path from strawberry and blueberry fields to college

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By Alma Hernandez, NCL Child Labor Coalition Summer 2022 Intern

Alma attends the University of South Florida, where she is pursuing a Bachelor of Science in Public Health.

Alma Hernandez (far right) is joined by fellow National Migrant and Seasonal Head Start Association  farmworker youth interns Jose Velasquez Castellano and Gizela Gaspar. NCL CLC Coordinator Reid Maki is also in the photo.

Imagine being a five-year-old child – happy and carefree. The age where you either attend pre-K or start kindergarten. But can you imagine a five-year-old working in farm fields in hot 90-degree humid weather with her parents? I was that child. I wore a long-sleeved shirt, jeans, closed-toed shoes, and a hat to protect me from the hot sun. At five years old, I was unaware of how difficult agricultural labor is. My mom had enrolled me at the Redlands Christian Migrant Association (RCMA), a Migrant and Seasonal Head Start program, but she also wanted to teach me to value my education.

My mother’s life lesson started during the weekend after I did not want to wake up for school. My mother remembers that I was full of confidence when asked if I wanted to go to work with her and my father. However, I did not know what was in store for me.

Arriving at the fields around 7:30 am, I first saw endless rows of strawberry fields. I felt enthusiastic. My task: collect as many bright red strawberries as I could and place them in my pink Halloween bucket. After filling my bucket, I would give the strawberries to one of my parents. Around 12, I felt the heat. It was around 90 degrees. The humidity made it feel worse. I felt like I was in 100-degree weather; I did not like that at all and wanted to go home. I was already tired and asked if we could leave. My mom said no; I had to stay until they finished. And so I kept working.

I do not recall what happened the rest of the time I was there, but I remember what happened afterward. I went home and sat on the stairs of the house with a red face, a headache, and clothes covered in dirt, and reflected on the decision I had made to join my parents in the strawberry fields. I went inside. I was so tired that I ignored dinner and skipped a shower and went straight to bed just to wake up the next day, to repeat another day of long, hard work. My parents had me help them one more day; and convinced that my lesson was learned, they let stay home where, in the next few years, I could help take care of younger siblings when my parents could not find childcare.

Although my work in the strawberry fields was short-lived, I have much more experience harvesting blueberries. I started working on blueberry farms when I was 12 years old and worked every summer until I was 16. The blueberry season starts in the summer after school ends in Florida.

My family and I would leave Florida near the end of June and start the 17-hour drive to Michigan. Unlike the strawberry season, I liked picking blueberries because I did not have to bend down low to the ground all day; blueberry plants grow higher. My job was to fill up my six buckets. Once they were all filled, I would carry all the buckets to place them into plastic containers and have them weighed. On average, six buckets would be 42 to 45 pounds, and depending on who we were working for, the average pay was 0.45 to 0.55 cents a pound. I had to pick as many pounds as I could. On good days, I would be able to pick 200 pounds or more; on many other days, I would pick less.

The clothing I wore was also the same: long sleeves, jeans, closed toes shoes, and a hat to protect myself from the sun. The weather in Michigan is not as humid as it is in Florida; usually, it was in the mid-80s to low 90-degrees however it was still hot being there all day. We would go in each morning at 8:30 or later depending on how wet the blueberry plants were and leave the fields around 8 or 9 at night.

I did not like going to a new school in Michigan every September just to leave in late October and return to Florida and start school. The curriculum was very different; I would excel quickly in Michigan since what I was learning I had already studied in Florida. But I also did not like how every time I would go to a new school, I’d be the “new girl,” struggling to make friends but knowing I would soon be migrating. “What is the point?” I would wonder. So I always kept to myself and only spoke when I was spoken to, and to this day I still do.

I also did not like the “what did you do during the summer?” question on the first day of school when I returned to Florida because all I did was work all summer and had no fun. Work caused my parents to miss many school functions that other parents would attend. Sometimes, it felt like a lack of support, but I understood that this type of work was their only way to generate income to provide for the family.

This summer, after four years away, I came back to Michigan with my family for the blueberry harvest one more time. Now that I am 20 and reflecting on my family’s agricultural experience, I appreciate my parents for what they have done for my siblings and me. They wake up early every day, go to work, come home to cook, and still spend a little bit of time with my younger siblings. I help around as much as I can because I know they cannot do everything on their own, especially now that they are getting older. I know they are tired and have no rest days. But thanks to them, I am the first person in my family to go to college and serve as an example to my siblings which proves to them that there is a reason for our parent’s sacrifices.

Gun violence is a public health problem

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By Eric Feigen, NCL Health Policy Summer 2022 Intern

We live in a nation where children fear for their lives at school, racially motivated killings are pervasive, and mass shootings have become commonplace. The United States is in the midst of a gun violence epidemic. One promising avenue that could help address this crisis involves approaching gun violence from a public health perspective. By developing strategies aimed at protecting the health and safety of people and communities, we can develop a policy framework for reducing incidences of gun violence and suicide.

Of the 24,897 people who have died from gun violence in 2022, 13,530 people have lost their lives to suicide. To compound this loss, National Institutes of Health (NIH) estimates that 45 percent of people who take their own lives visit their primary care physicians within a month of their death. Many Americans are reaching out for support. However, due to the inaccessibility of mental health services, people cannot receive the help they desperately need. According to the American Psychological Association, in 2018, 39 percent of people could not afford the cost of receiving mental health services. Even for those with healthcare coverage, 26 percent choose to forgo treatment because their copays are too high.

There are a wide range of public health policies that could be implemented to remedy this issue. The first task is improving accessibility. A survey by the Health Resources and Services Administration indicates that the demand for mental health services far exceeds the number of professionals in the field and some primary care professionals receive no training in suicide assessment or management. In addition, many Americans have to travel immense distances to receive mental health treatment. The pandemic has illustrated the effectiveness of telehealth as a solution to this issue, however programs such as fellowships, outreach seminars, and more must be put into place to increase the number of health professionals in the field.

Gun violence in America is also an equity issue, disproportionately affecting communities of color. This has created a cycle of violence which places children at an increased risk for gun violence exposure earlier in life. A NIH study indicates that the prevalence of gun violence during childhood increases interactions with firearms later in life to a medium to large effect. This leads to the second policy issue that must be addressed: improving access to quality mental health services in order to break cycles of violence.

To accomplish this, policies designed to incentivize and increase the number of psychiatric practitioners of color must be put into effect. Not only do Black and Brown mental health professionals have a better understanding of the challenges their communities face, but studies indicate that white mental health workers often misdiagnose minority patients leading to counterproductive treatment. In 2019, racial/ethnic minorities made up only 17 percent of the psychologist workforce, illustrating how marginalized communities have disproportionately less access to quality mental health services in comparison to their white counterparts.

The social determinants of health; healthcare, housing, economic mobility, and more are inescapably linked to the root causes of gun violence. In addition to those listed above, policy solutions include:

  • Expanding healthcare coverage to include mental health services
  • Tightening regulations on opioids and other dangerous prescription drugs to create safe and healthy environments
  • Including safeguards against measures intended to limit an individual’s right to treatment such as the lack of affordability of clinically prescribed medication
  • Ensuring that for those currently receiving effective treatment, their medication is not switched to a less effective alternative just because it is cheaper
  • Expanding Extreme Risk Protection Order laws
  • Promoting health equity as those facing adverse health conditions are at higher risk for experiencing violence. This includes increasing access to:
  • vaccines, including COVID-19
  • treatment for chronic conditions, such as diabetes
  • healthy fresh foods and vegetables
  • Increasing research devoted to tackling gun violence as an investment in national public health

While many forms of gun control legislation have been written off as politically impossible, there are other solutions Congress can enact to mitigate the gun epidemic. Approaching the issue from a public health perspective is an effective avenue policymakers can take for ensuring that the gun-related tragedies, which now seem omnipresent in America, harm fewer people in the future.

My Juneteenth federal holiday didn’t turn out the way I hoped. It was even better!

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By Sally Greenberg, NCL Executive Director

This week we celebrated the Juneteenth federal holiday and one that the National Consumers League will continue to honor into the future.

Juneteenth marks the date in 1865 when a union general and his soldiers rode into Galveston, Texas to tell the enslaved community that they had been emancipated from slavery; the plantation owners didn’t bother to give them the news.

At last, these Texans were free human beings.

Sadly, this happened two years after the 1863 signing of the Emancipation Proclamation by President Abraham Lincoln.

Fast forward to June 20, 2022. While watching the Today Show, I saw a 95-year-old inspiration named Miss Opal Lee, appropriately from Texas, who made it her life’s work to make Juneteenth a federal holiday. The piece featured Miss Opal’s photos from her childhood when she had celebrated Juneteenth in Texas.

Most of the U.S. didn’t know about the importance of this date, but, in Texas, the black community has been honoring Juneteenth for decades – with parades and music and traditional foods. The Today Show clip featured Miss Opal in 2021 when President Joe Biden signed the bill creating the federal holiday; she is standing next to him surrounded by members of Congress.

This heroic former schoolteacher was nominated for a Nobel Prize. Not only did she march to Washington with more than one million signatures to get Juneteenth recognized, but she created a food bank out of her kitchen that has grown into a huge warehouse. She launched a farm to feed thousands in the community.

I was in awe of this incredible woman and was so grateful to learn about her role in the adoption of this federal holiday.

Later that day, I was looking forward to celebrating local events around D.C., and headed down to the National Museum of African American of History and Culture. Sadly, I couldn’t get in because the museum had sold out of timed passes. I was so disappointed.

On the ride home from the museum, I happened to see horses being put back into a trailer by African American men dressed as union soldiers. I stopped and got out to see what was happening; they told me this was the end of a parade from 14th street down to Howard University.

Then they said, “Miss Opal came too.”

“Miss Opal?”, I asked. Was this Miss Opal the same amazing lady who made it her life’s work to make Juneteenth a federal holiday?

“That is her over there,” they told me.  I asked if I could meet her – it turned out she was in a car near the food trucks. She rolled down her window and we talked for a few minutes about how she made Juneteenth happen. I shook her hand and thanked her for being a true American hero; for finally getting this most important federal holiday on the calendar; for teaching school and; for her incredibly uplifting spirit. She was just as inspiring in person. I hope I have her energy and spirit when I’m 95 years old!  She invited me to come down and see her in Fort Worth, which I might just do!

Serendipity in Washington, D.C.

Juneteenth didn’t turn out like I thought it would, but I feel so honored to have met this towering figure in American history. Go Miss Opal Lee!

Dispatches from Durban: May 15-20, 2022

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Reflections on the 5th Global Conference on the elimination of child labour in Durban, South Africa: May 15-20, 2022

Reid Maki is the director of child labor advocacy at the National Consumers League and he coordinates the Child Labor Coalition.

The recently-concluded week-long “5th Global Conference on the Elimination of Child Labour” in Durban, South Africa was convened against the backdrop of the announcement last July of an alarming rise in child labor numbers after two decades of steady and significant declines in global child labor totals.

The global conference, which typically comes about every four years, brought together an estimated 1,000 delegates from foreign governments and small number of representatives of NGOs. It also brought together for the first time at one of the quadrennial child labor conferences dozens of participant youth advocates as well as a number of child labor victims and survivors.

The conference had the difficult mission of righting the ship and trying to reverse the rising child labor numbers, which seem destined to rise further as the COVID pandemic’s impact will continue to be felt for years. Sadly, the pandemic threw 1.6 million children out of school, often for prolonged periods and some of those children entered work and may never return to school.

We would first like to thank the South Africa government for the herculean task of organizing a global conference during a still raging pandemic, all against a backdrop of devastating floods in April that savaged the provinces of KwaZulu-Natal and Easter Cape and killed nearly 500 people, destroyed 4,000 homes and displaced 40,000 people.

As the conference opened, Guy Ryder, the Director General of the International Labour Organization, which helped advise the government of South Africa on the organization of the conference, suggested that the rise in 8 million child laborers from 152 million to 160 million likely represented complacency and a loss of focus by global governments on the child labor problem and must be rectified. He noted increases in child labor impacting children under age 11 and urged delegates to redouble their efforts. “We need to increase our efforts, and pay particular attention to child labor in agriculture,” said Ryder, who added that child labor advocacy is threatened by a “perfect storm” created by COVID’s enduring impact, rising food insecurity, and debt crises that are expected to impact 60 nations in the coming years.

South Africa’s president Cyril Ramamphosa delivered a stirring welcome. He noted that his country’s embrace of child rights is not just a matter of principle. “The assertion of the rights of children was a direct response to the deprivation, discrimination and deliberate neglect that had been visited on the black children of this county by successive colonial apartheid administrations,” said Ramamphosa. “Child labor perpetuate the cycle of poverty, denying young people the education they need to improve their circumstances. It condemns communities to forms of economic activity and labor that limit any prospect of advancement or progress.”

Nobel Peace Prize laureate Kailash Satyarthi noted the particular challenge that the sub-Saharan African region is facing with the highest rates of child labor and one in five children are in child labor.

Satyarthi urged listeners to embrace the idea that every single child can be protected from child labor. “Let us march from exploitation to education,” he urged, calling for children to have a “fair share” of resources. The amount needed to ensure all children have access to needed resources is only $53 billion – not much considering the wealth of many nations, said Satyarthi who also noted that the G7, which is about to meet on June 26th, has never focused attention collectively on child labor. “This needs to change,” he urged.

The conference opened with a pledge by European Union (EU) Commissioner Jutta Urpilainen that the EU will create a new $10 million euro initiative to reduce child labor in agriculture. Child labor must return to the political agenda, she urged.

The six-day conference, attended by 1,0000 delegates in person and an estimated 7,000 online, according to organizers, featured workshops and side events, and included three meetings every other day by separate groups of employers, workers, and governments. Readers can find a conference agenda here with video links to many sessions.

Twenty-four side events focused on many related topics including child labor in supply chains, a decent work agenda, youth-led activism, small-scale mining, livelihoods skills development, African priorities, partnership in Latin America to end child labor, due diligence legislation, data and research needs, labor inspections, artisanal fisheries and aquaculture, and a child-labor-free zone in Ghana. For a complete list and to view specific side events, please go to agenda, scroll each day’s offerings and click links to the videos.

Attendees learned a lot about specific intervention efforts, and the struggles many nations are engaged in, including Malawi, which has recently been hit by two cyclones and where there is a shortage of 50,000 schools – less than half of the children have access to education, said the nation’s Education Minister Agnes Nyalongje. She pleaded for international help, noting that 12 years of sustained aid could create generational change in Malawi and fix its troubled education system.

It’s difficult to summarize the hundreds of hours of content but readers may get a sense from the CLC’s twitter stream which included four to five dozen original tweets at @ChildLaborCLC.

The conference’s concluding “Call to Action” document emphasizes the need for urgent action, because “the consequences of the COVID-19 pandemic, armed conflicts, and food, humanitarian and environmental crises threaten to reverse years of progress against child labour”. The document includes commitments in six different areas:

  • Make decent work a reality for adults and youth above the minimum age for work by accelerating multi-stakeholder efforts to eliminate child labour, with priority given to the worst forms of child labour.
  • End child labour in agriculture.
  • Strengthen the prevention and elimination of child labour, including its worst forms, forced labour, modern slavery and trafficking in persons, and the protection of survivors through data-driven and survivor-informed policy and programmatic responses.
  • Realize children’s right to education and ensuring universal access to free, compulsory, quality, equitable and inclusive education and training.
  • Achieving universal access to social protection.
  • Increasing financing and international cooperation for the elimination of child labour and forced labour.

As is often the case at conferences, many of the side conversations are of great interest. We had many great conversations with Simon Steyne, who recently retired from the International Labour Organization but continues his child labor advocacy. Simon is campaigning to bring about a child-labor-in-agriculture conference in the coming year. With 70 percent of global child labor in agriculture and rising child labor rates, a focus on agriculture at this time is absolutely essential, Steyne argued.

What might have been improved at the conference? It seems that a relatively small number of Civil Society participants were invited to the conference, included few from the Americas and Asia. The pandemic and travel distances certainly impacted in-person attendance. And we know a lot of NGO participants were able to join online. We hope that a broader spectrum of Civil Society is invited to future global child labor conferences. NGO delegates often possess in-the-field, grass roots knowledge lacked by government and employer groups and NGO presence is a key element in the fight to reverse accelerating incidence of child labor.

The Civil Society advocates and experts who were there enhanced the conference greatly, mostly through the two dozen side events. We were delighted to be joined at the conference by CLC members Bank Information Center and GoodWeave, which organized the side event “Child Labour Free Supply Chains: Tackling Root Causes from Maker to Market” — included panelist Thea Lee, the deputy undersecretary for International Affairs at the U.S. Department of Labor, who was ubiquitous at the conference. CLC-member Action Against Child Exploitation (ACE) also presented a side event: “Promoting an Integrated Area-based Approach to the Elimination of Child Labour: A Case of the Child Labour Free Zone in Ghana,” with Yuka Iwatsuki, president of ACE among the panelists.

In addition to thanking our gracious South African hosts and the ILO for its organizing role, the CLC also wishes to express appreciation to our valued partners the Global March Against Child Labour and the Kailash Satyarthi Children’s Foundation for enhancing the conference significantly through organizing side events and bringing the voices of youth advocates to Durban.

Tara Banjara. 17, was among the youth advocates who appeared as a panelist. Tara said she is from a community in India where there are no schools and “no one had an idea about what education is.” She was four and half when she went to work on roads with her mother. They cleaned garbage and rubble out of potholes. The work was exhausting and difficult and went on till she was rescued by Bachpan Bachao Andolan’s Bal Ashram.

Today, Tara is the first girl to complete grade 12 exams in her entire family. She asked attendance participants gathered in Durban and the thousands on line: “Is this our fault that if we are born in a small village, we do not have the right to live our childhood with freedom?” She asked.

“We want freedom. We want the right to education,” Tara said, sharing her dream of becoming a police officer some day and working at the grassroots level to ensure that all children have equal rights and freedom. In one of the conference’s emotional high points, Tara asked attendees to stand and make a pledge: “Let us all pledge to create a world where every child is free from slavery; every child gets an education and an opportunity to fulfill their dreams.”

Jeanette Contreras portrait

Leaders in Congress support safe OTC hearing aid standards

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By NCL Director of Health Policy Jeanette Contreras

Mild to moderate hearing loss is a difficult reality that millions of Americans struggle with, which is why the availability of over-the-counter (OTC) hearing aids is exciting for those who are impacted by hearing loss. While making OTC hearing aids more accessible is a promising step for consumers, we at NCL would be remiss if we didn’t underscore our concerns around the Food and Drug Administration’s (FDA) proposed OTC hearing regulations as they currently exist.

In December of last year, NCL was one of hundreds of organizations who submitted a comment to FDA’s public docket on the issue; and last month we submitted a letter voicing our concerns to the FDA that was supported by 29 not-for-profit, public health organizations across the country. These organizations collectively represent the concerns of millions of consumers, patients, and individuals impacted by hearing loss.

We want to reiterate our enthusiasm for OTC hearing aids, but as the gold standard of safety in our country, it is imperative that the FDA make sure these devices are safe for consumers and do not worsen a problem they are intended to mitigate. As written, the draft regulations would allow for a maximum sound output level of 120 dBA – equivalent to the volume of a chainsaw or fire engine siren. This is concerning, as exposure to sounds at 120 dB can be dangerous in as little as nine seconds according to the CDC. This is why NCL, along with other leading consumer and healthcare voices, encourage the FDA to follow the recommendations of hearing care professionals, including the American Academy of Otolaryngology–Head and Neck Surgery that recommend a maximum output of 110 dB and a gain limit of 25 dB. Without a limit on gain, OTC hearing aids users will be able to amplify sounds to dangerous levels, and far beyond what Congress authorized when it said these devices must be limited to adults with moderate hearing loss or less.

The safety parameters we are recommending would in no way compromise the efficacy of OTC hearing aids intended for individuals with perceived mild to moderate hearing loss. In fact, a recent study concluded that commercially-available hearing aids programmed according to parameters typical of those used for individuals with mild to moderate hearing loss yield effective output and gain levels and are within the recommended limits specified by leading hearing care organizations and medical experts.

Importantly, the FDA has already cleared several hearing aids for adults with perceived mild to moderate hearing loss that were found to be safe and highly effective during clinical trials. While these devices were authorized under a different category of hearing aids, these devices limit the maximum output to 115 dB or below and gain to 30 dB or less, lower than the amplification limits currently proposed by the FDA. At the very least, the FDA should incorporate these amplification limits in the final OTC hearing aid regulation.

Finally, as we await finalized guidance from the FDA, we applaud leaders in Congress who are standing behind consumers in supporting safe and effective amplification limits. Last month, Congresswoman Betty McCollum (D-MN) and Congresswoman Rosa DeLauro (D-CT) sent a letter to the FDA echoing their safety concerns. The letter states, “[The proposed rule] hurts consumers and patients in two ways. First, it means individuals suffering from greater levels of hearing loss could put off a needed visit with a licensed hearing professional. Doing so could lead to worsening their existing symptoms, delaying an accurate diagnosis and treatment, and even creating irreparable damage to their hearing. Secondly, it means those with perceived mild-to-moderate hearing loss would be exposed to harmful levels of noise that could result in further damage to their long-term hearing. In order to avoid these concerns, FDA should impose a gain limit of 25 dB and an overall output limit of 110 dB.”

Similar to the countless other experts that have also weighed in, we believe that establishing safe amplification limits would not reduce the efficacy of these devices or limit the advancement of innovative technologies. We thank Congresswomen McCollum and DeLauro for being a voice for consumers and patients on this important issue. To learn more about gain and output and how to protect yourself from hearing loss, check out our infographic.

Jeanette Contreras portrait

How to protect consumers from PBM greed

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By NCL Director of Health Policy Jeanette Contreras

The rising cost of health care is a sore point for all consumers and nowhere is it more glaring than at the pharmacy counter. However, consumers are largely unaware that Pharmacy Benefit Managers – or PBMs – are the middlemen working behind the scenes with very little competition and accountability. There are now just three PBMs that account for about 77% of all equivalent prescription claims. This lack of competition allows PBMs to easily manipulate the price and make it impossible for consumers to get a fair deal.

There is plenty of blame to go around when it comes to the rising cost of prescription drugs. But PBMs ultimately control which medicines we get (and don’t get) and how much we pay out of pocket for them. That’s exactly why the Federal Trade Commission (FTC)– whose mission is to protect consumers and competition – has requested public comments on the ways these large, middlemen companies are affecting drug affordability and access.

I recently led a discussion with key experts to discuss this issue. NCL’s Executive Director Sally Greenberg, Former FTC Policy Director David Balto, and HIV + Hepatitis Policy Institute Executive Director Carl Schmid, shared their insights with us.

David Balto explained, “There are three things needed for a market to really function effectively – you need to have choice (competition); second, transparency – that is you know what you’re getting and what the benefit of the bargain is; and third, that there’s no conflict of interest. In the PBM market, PBMs fail on all three grounds.”

PBMs initially came into existence to streamline how consumers get their medicines and were intended to lower costs. However, as Sally Greenberg pointed out, “The fact that PBMs have the influence and decision-making authority they do should be concerning for all consumers. PBMs have the power to negotiate discounts with drug manufacturers, they work with insurance companies to determine which drugs will ultimately be covered, and they work with pharmacists to reimburse them for dispensing drugs. All along the way, they’ve found ways to profit – and all along the way this impedes the savings that should be going to consumers.”

Carl Schmid shared more about how this impacts patients, “We’re now seeing the creation of specialty drugs or specialty tier (on formularies). This is a term created totally by the PBMs…now it’s just any new drug – all HIV drugs, all Hepatitis drugs, all cancer drugs – they’re all specialty drugs these days and they put them in the highest tier. And this not only creates higher out-of-pocket costs for patients, but it’s also discriminatory.”

These unfair PBM practices lead to unnecessarily high out-of-pocket costs for prescriptions while PBMs continue to find ways to game the system to their benefit. The FTC wants to hear from consumers and patients who have been negatively impacted by these PBM practices.

Watch the full discussion here to learn more about the PBM problem. Then share your story with the FTC here.

NCL Briefing: measuring the 340B program’s impact on charitable care and operating profits for covered entities

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Join the National Consumers League for a panel discussion with experts from Health Capital Group, the Community Oncology Alliance, and Johns Hopkins on this new white paper, which analyzes 340B’s impact on hospital profit margins and charitable care spending and attempts to quantify the amount of program benefits accruing to covered entities, contract pharmacies and patients.

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Breyault and Amazon’s Alyssa Betz discuss policing fake reviews and counterfeits

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By NCL Staff

 

This week, John Breyault, our Vice President of Public Policy, Telecommunications, and Fraud, sat down with Amazon’s Director of Public Policy, Alyssa Betz. On this episode of NCL’s We Can Do This! podcast, Alyssa and John discussed fake reviews, Amazon’s product liability, and more. This has been the latest collaboration between Amazon and NCL in our partnership towards improving consumer safety and online experiences.  

Fake Reviews 

With users increasingly relying on user reviews to make buying decisions, having access to trustworthy reviews is critical for consumers. Last month, Amazon sued a group of review brokers who were allegedly paying for fake reviews at large scale. In addition to discussing the suit, Betz outlined some of the steps they have taken to ensure that user reviews are trustworthy and accurately reflect consumers’ experiences. 

Counterfeits 

Given the vast number of products sold through nearly two million sellers worldwide, Amazon has an enormous responsibility to ensure consumer safety. Alyssa discussed some of the measures Amazon has taken to reduce criminals’ ability to operate on their platform, including investing over $700 million and employing more than ten thousand people to protect its store from fraud and abuse, including counterfeit products.

To hear the full episode, including John and Alyssa’s conversation about product liability and how to spot those phony Amazon delivery phishing texts, click here. 

If you have received suspicious communications or packages claiming to be from Amazon, you can find Amazon’s support page here. 

Nancy Glick

Consumers need accurate product names and labeling of plant-based meat products

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Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

With mounting information that plant-based diets are generally better for people’s health and the environment, many consumers are giving “meatless meats” a try.

About two-thirds of Americans consumed “plant-based meat alternatives” – or PBMAs – in the past year, with 20 percent eating them at least weekly, according to an August 2021 survey from the International Food Information Council (IFIC).[1] As a result, current estimates put the market for PBMAs at $1.4 billion – up from $962 million in 2019[2] –and a Bloomberg Intelligence Report predicts a 500 percent increase in global sales of plant-based foods globally by 2030.[3]

It is easy to understand consumers’ excitement about meatless products that closely resemble the look, feel and taste of burgers, sausages, deli meat and other products made from beef, pork, chicken, eggs and seafood. Polling shows consumers’ top reason for buying these products is the perceived healthfulness of PBMAs. The most sought-after benefits consumers cite are heart health and a good source of high quality and complete protein.

Yet, the reality is that plant-based meat products vary in their formulations, nutritional content and can be high in saturated fat and sodium. These products are often packaged in the same way as their animal protein counterparts and routinely sold next to the meat section in supermarkets. Thus, consumers need clarity in labeling to ensure product names, descriptions and packaging are not misleading and consumers have the qualifying terms to make informed decisions.

As the agency that regulates plant-based foods in the US, the Food and Drug Administration shares this viewpoint. Later this year, FDA will issue draft guidance on the labeling of plant-based milks and plant-based alternatives to “animal-derived foods” (meats) under the umbrella of the agency’s Nutrition Innovation Strategy. The strategy addresses the need for FDA to modernize its regulatory approach for new categories of foods, like PBMAs, developed through the latest technologies.

In developing its draft labeling guidance, FDA has sought information on a range of issues related to labeling, including whether consumers understand terms like “milk” when used in the name of plant-based alternatives and are aware of the nutritional differences between traditional meat and dairy products and their plant-based substitutes. In response, the agency has received thousands of comments from industry groups, manufacturers, academic institutions and professional societies offering their viewpoints. However, the National Consumers League contends that the consumer’s voice must be articulated and heard. Unless the information needs of consumers are clearly defined, FDA’s goal of labeling for transparency and clarity will not be realized.

To provide the consumer perspective, especially regarding decisions about plant-based meat alternatives, in November 2021 NCL and the Academy of Nutrition and Dietetics (AND) convened a panel of experts to assess consumers’ needs for accurate naming, labeling and claims on the package of PBMAs. Comprising regulatory specialists, market researchers, consumer advocates and food industry leaders, the panel also addressed how some key principles laid out in FDA’s Nutrition Innovation Strategy – a common nomenclature, accurate naming and labeling, and elements that assure honesty and fair dealing — can be applied to improve consumer understanding, perception, and decision-making of PBMA products.

In the near future, NCL will issue a full report of the findings of the expert panel and the implications for consumer education efforts and public policy. However, the need to articulate the consumer perspective on labeling PBMAs shouldn’t wait. Therefore, NCL has translated the consensus from the expert panel into a blueprint for FDA and the food industry.

The following are the seven priorities for labeling, naming and marketing plant-based meats alternatives that are in the best interest of consumers:

  1. Establish a definition for the category of “plant-based meat alternatives” that will unite all stakeholders
    Today, many brands, companies and organizations define the term “plant-based” differently and there is not collective agreement on definition of a “meat alternative.” Since these terms represent an entire class of food products, FDA guidance should define what constitutes a “plant-based meat alternative” to promote consistency in labeling across the category.
  2. Ensure brand names are not deceptive
    NCL’s position is it is a deceptive practice to use brand names for PBMAs that suggest a product contains meat, seafood or eggs when none is present or is better/healthier than the traditional animal protein product. Even when the label states the product contains no meat or eggs, consumers are influenced by the brand name, especially if the packaging and content on the website, social media platforms and in ads shows pictures and iconography of animals or the type of meat. 
  3. Require that labels on PBMAs are standardized and clarify the protein source

For labels of PBMAs to be transparent, the naming and labeling of PBMAs must be uniform and consistent and ensure that consumers can readily identify the protein source. Accordingly, FDA should require that all labels and advertisements for PBMAs must:

  • Use a common name that links the protein source and the form, such as “soy burger.”
  • Make clear that the product contains some animal protein in addition to plant-based proteins like soy. Qualifying terms can include “plant-based” and “made from plants.”
  • Make clear when the PBMA contains no meat. These terms can include vegan,” “meatless,” “vegetarian,” “veggie,” and “veggie-based” as well as “plant-based” and “made from plants.”
  • Place the phrase “contains no meat,” “contains no poultry,” or “contains no eggs” on the principal display panel of vegan PBMAs near the common name and in letters at least the same size and prominence as shown in the product’s common name.
  • Not use pictures, icons or vignettes on the packaging, in marketing materials or in advertising that suggests nutrition superiority or that the product is the same as the comparable meat product.
  1. Regulate health/nutrition claims for PBMAs
    Consistent with how FDA regulates the health claims allowed on traditional food products, FDA must make clear in its guidance that nutrition/health claims must undergo review by the FDA through a petition process and there must be significant scientific agreement that the claim is supported by available scientific evidence.
  2. Ensure website, social media, and advertising content for PBMAs conforms to what is on the product label

The guidance must make clear that FDA considers websites and social media to be an extension of the product label, meaning the claims and information that PBMA manufacturers put online must conform what FDA allows on the label.

  1. Address the nutritional composition of the PBMAs in FDA guidance
    In Canada, regulation of PBMAs includes nutritionally required amounts of vitamins and mineral nutrients that must be added to the PBMA product and a minimum limit of total protein content, among other requirements. While NCL supports this approach, FDA should at least recommend levels of key vitamins and nutrients in its guidance and address concerns, such as allergenicity with labeling requirements to flag known allergens, such as soy.
  2. Educate consumers about the nutritional composition of plant-based protein alternatives

It is in the public interest for FDA and the US Department of Agriculture – along with nutrition societies – to conduct education programs that explain the nutritional composition of plant-based protein food products. This will allow consumers to make informed decisions based on science-based information.

Plant-based meat alternatives are a popular and valued part of our food supply. That is why the public needs regulatory policies that ensure the labels on these products are accurate, complete, and provide the qualifiers necessary for consumers to understand what they are purchasing.

[1] International Food Information Council. “Consumption Trends, Preferred Names and Perceptions of Plant-Based Meat Alternatives. November 3, 2021.

[2] Good Food Institute. US retail market data for the plant-based industry. Accessible at: https://gfi.org/marketresearch/

[3] Fortune. Plant-based food sales are expected to increase fivefold by 2030. August 11, 2021. Accessible at: https://fortune.com/2021/08/11/plant-based-food-sales-meat-dairy-alternatives-increase-by-2030/