It is time to give Medicare beneficiaries effective obesity care

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

“What we’ve got here is a failure to communicate.”

As one of the most recognized quotes of all time, this line from the 1967 movie, Cool Hand Luke, originally addressed the struggle of a person’s will over government control.

Now the line is applicable to another and equally intractable struggle: ending outdated Medicare rules that leave millions of seniors with diagnosed obesity – particularly members of Black and Latino communities – vulnerable to disability, disease and premature death due to lack of access to the full range of treatment options.

The struggle is not new. As documented in a 2010 report from the US Surgeon General, the prevalence of obesity began to increase sharply in the 1980s and by the 1990s, public health leaders were calling obesity a national emergency. Now, the obesity rate among adult Americans exceeds 40 percent but is even higher among communities of color: virtually half of African Americans (49.6 percent) and 44.8 percent of Hispanics are living with obesity. Moreover, because obesity is directly linked to over 230 medical conditions, the disease is responsible for an estimated 400,000 deaths a year, costing the nation over $1.72 trillion annually in direct and indirect health costs.

Confronting this growing crisis, in 2012, the United States Preventive Services Task Force (USPSTF) issued guidelines recommending screening all U.S. adults aged 18 and above for overweight and obesity and encouraging clinicians to treat or refer adults with obesity for treatment. Then, in 2013, the American Medical Association officially recognized obesity as “a disease state” on a par with other serious chronic diseases, like type 2 diabetes and hypertension, so healthcare professionals (HCPs) would be motivated to diagnose, counsel and treat obesity. These actions were the impetus for most private insurers, state health plans and state Medicaid programs to cover obesity care to some degree. Moreover, the Office of Personnel Management, which oversees health coverage for federal employees, now requires that insurers cover the full range of obesity treatment options, including intensive behavioral therapy (IBT), prescription weight loss drugs, and bariatric surgery. Additionally. Tri-Care, which covers military personnel and their families, and the Veterans Administration cover AOMs for adults who do not achieve weight loss goals through diet and exercise alone.

This leaves the Medicare program, which today represents the biggest obstacle impeding access to quality obesity care. Outdated Medicare Part B policy places undue restrictions on intensive behavioral therapy by allowing only primary care providers to deliver IBT and severely restricting the physical locations where this care can occur. Equally troubling, new FDA-approved anti-obesity medications (AOMs) are excluded from Medicare coverage based on a statutory prohibition tracing back to the start of the Part D program. This was in 2003 when fen-phen (the drug combination of fenfluramine and phentermine) controversy raised questions about the safety of weight loss drugs, leading the Centers for Medicare and Medicaid Services (CMS) to classify these medicines as “cosmetic” treatments not eligible for coverage, just like hair loss drugs and cold and flu treatments.

But obesity medicine has improved substantially since 2003. Due to the latest science on obesity as a serious chronic disease, there have been major advances in drug development, including new anti-obesity medications that achieve meaningful weight loss. Yet, while science has moved forward, CMS policy is stuck in the past.

To change this situation, advocates have gone to both Congress and CMS for help. In Congress, public health and aging organizations have been working to pass bipartisan legislation called the Treat and Reduce Obesity Act (TROA) that would end the exclusion under Medicare Part D prohibiting coverage for AOMs and change Medicare Part B rules to permit all qualified health practitioners to provide Intensive Behavioral Therapy (IBT) to Medicare beneficiaries. With CMS, advocates have written to and met with key staffers on several occasions, urging the agency to use its inherent authority to allow flexibility to include drugs under Part D that might otherwise be excluded. One key argument is that CMS has already done this on multiple occasions, ending exclusions for treatments for AIDS wasting and other medical conditions when it is urgent to do so.   And yet, ten years have passed since AMA classified obesity as a chronic disease with no action from either Congress or CMS. In Congress, TROA did not receive a floor vote in the House of Representatives in 2022 despite having 154 co-sponsors and widespread support from medical societies, public health organizations and the aging community. Similarly, CMS has kept the exclusion on coverage for anti-obesity medications, even though the Biden Administration has asked for ways to address systemic racial inequity and obesity is a throughline to better health outcomes.

To start a dialogue that could lead to meaningful action, the National Consumers League and the National Council on Aging decided to change the dynamic. In September 2022, our organizations sent an urgent letter to CMS Administrator Chiquita Brooks-LaSure requesting a meeting so we could speak to her directly on behalf of  about 18 million traditional Medicare beneficiaries whose diagnosis of obesity puts them at risk of other serious conditions. Our letter was well received and on January 17, this meeting took place.

Recognizing that there has been a “failure to communicate” the urgency of the moment, our purpose was to put a human face on seniors with obesity and to convey that bureaucracy and intransigence cannot be the reason that 18 million older adults are denied effective obesity care. As such, we asked Administrator Brooks-LaSure to end the impasse in Part D coverage of FDA-approved AOMs by making access to obesity treatment an agency priority. This action could be the catalyst empowering CMS staff to think differently about obesity and be more open to interpreting the statutory exclusion provision in a way that would permit coverage for anti-obesity medications.

It is too soon to know what the outcome of the meeting will be. We opened a door and pledged to maintain a frank and constructive dialogue with Administrator Brooks-LaSure and staff she designates on the needs of Medicare beneficiaries living with obesity. Our hope is to elevate obesity as a priority for CMS policy and to work with CMS and other stakeholders to remove the access barriers that keep too many Americans from seeking obesity care.

Celebrating the life of the brilliant Rev. Dr. Martin Luther King, Jr.

Sally Greenberg

By Sally Greenberg, Chief Executive Officer

Each year, I savor the MLK Jr. weekend and holiday because it gives me time to reflect on the impact that Dr. King had. And here in Washington, DC, there’s an annual march along the boulevard named for King that snakes through Ward 8, a largely African American community, with lots of inspiring speeches, marching bands, Double Dutch jump rope jumping, and health fairs along the route. I try never to miss it and today’s march did not disappoint!

King was a towering figure who spoke to all of us as Americans about injustice, racial and otherwise. I loved that he refused to be discouraged by poverty and discrimination, telling his followers “out of the mountain of despair, a stone of hope.”

My “shot in the arm” when I start to get down about my work is King’s famous command “We shall overcome because the arc of the moral universe is long, but it bends toward justice.”

MLK weekend is also a time for reckoning about how racial injustice took root in America—beginning with the enslavement of 12 million Africans in 1619 and continued over hundreds of years, and its debilitating effects throughout generations.

Personally, I’m constantly learning new facts about the many forms racial discrimination has been embedded in our culture. I recently attended a program held in the affluent Friendship Heights section of Washington, DC. A series of posters were displayed in the window of a PEPCO substation describing how the city fathers in the 1920s decided to tear down an entire black neighborhood, uprooting blocks of homes that made up a thriving middle class community in Tenleytown right off Wisconsin Avenue.

These elected officials and members of the business community made plans to build a junior high school and a high school next door for white students. They bulldozed black homes whose children had long attended their neighborhood school, albeit a segregated school. So up went Alice Deal Junior High and Wilson High School. The school for black students closed and the black families, now without homes, moved out. Where they went is a mystery but probably to another part of town. Students at Wilson High, now called Jackson Reed, did the research for this project.

I was so surprised to be learning this history for the first time because 20 years ago, my son attended both schools, and I served as co-President of Alice Deal Middle School. No one had ever discussed this history until now.

Which tells us that we need to have these discussions.

The exhibit showed me that redlining was—and no doubt is—alive and well, and that white leaders, either through malice or indifference, thought nothing of destroying cohesive, vibrant African American communities in hundreds of cities throughout the United States. In doing so, they destroyed the fabric of these communities, their family ties, their civic life, and their children’s futures. These histories must not be forgotten.

What can we do to right the wrongs?

There is no way to compensate the African American community for slavery, for Jim Crow, or pervasive redlining and discrimination. But the bill HR 40, introduced in the House of Representatives for decades, would set up a commission to study the issue of reparations to African Americans. It sounds complicated, but compensation for past wrongs has been doled out many times.  Reparations were paid to Jewish victims of the Holocaust by Germany, to Native Americans in Alaska, to Japanese families interned during WWII, to 911 victims and their families from a taxpayer funded account.

NCL strongly supports HR 40.

While we hope that HR 40 sees the light of day in Congress, in the meantime, let’s not sweep US history under the rug. We can’t heal as a country until we confront the legacy of slavery and the persistent discrimination that followed emancipation. What happened in Washington, DC’s Tenleytown neighborhood in the 1920s is part of that legacy. I’m still learning and hope others are open to learning as well, and in the famous words of Dr. King: “The arc of the moral universe is long, but it bends toward justice.”

Nancy Glick

Alcohol labeling: We’re in it to win it

Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

For historians, 2003 will be remembered as the year that the space shuttle Columbia crashed, scientists finished sequencing the human genome, and the U.S. launched war against Iraq.

But 2003 also marks an important milestone for American consumers. In December of that year, three national consumer organizations – the National Consumers League (NCL), Center for Science in the Public Interest (CSPI), and the Consumer Federation of America (CFA) – first petitioned the federal government to require an easy to read, standardized “Alcohol Facts” label on all beer, wine and distilled spirits products. This sparked a 19-year battle that is finally paying off for the estimated 67 percent of Americans[1] who drink alcoholic beverages.

In 2003, the Nutrition Facts label on processed foods and non-alcoholic beverages had been in use for almost a decade (1994) and many consumers said they frequently or almost always read the label. Thus, public acceptance and use of the Nutrition Facts label created built-in public support for an Alcohol Facts label. In fact, polling NCL commissioned in both 2005 and 2007 showed overwhelming public support for comprehensive alcohol labeling. Now, polling consistently shows that 75 percent of Americans think alcoholic beverages should have standardized alcohol content labels and 72 percent say this labeling will encourage responsible alcohol use.

Even more significantly, not knowing what is in a beer, wine or distilled spirits drink increases the risk for overconsumption of alcohol, a serious and costly public health problem. According to the latest research findings, alcohol is a source of empty calories that contribute to obesity,[2] and can impact blood sugar control in people with diabetes.[3] Additionally, alcohol is a roadway killer accounting for about 30 percent of all traffic crash fatalities in the U.S.,[4] and excessive drinking increases the risk of liver disease, hypertension, cardiovascular disease, alcohol use disorders, certain cancers and severe injuries.[5] Consequently, an estimated 140,000 people in the United States die annually from alcohol- related causes,[6] which is why the cost of excessive alcohol use reached $249 billion in 2010 and is likely higher today..[7]

Based on this documented evidence, the 2003 petition, which was also signed by 73 nutrition/public health organizations and experts, called for a label that gives consumers the needed information to make responsible drinking decisions, such as the serving size, amount of alcohol and calories per serving, the percent alcohol by volume, and the number of standard drinks per container. And yet, the lead federal agency that regulates alcoholic beverages – the Alcohol and Tobacco Tax and Trade Bureau (TTB) – deliberated but failed to take meaningful action for almost two decades.

The arcane process started in 2005 with an advance notice of proposed rulemaking, which produced over 19,000 public comments. In 2006, TTB issued another notice of proposed rulemaking on allergen labeling followed by a notice in 2007 on alcohol and nutrition labeling. Unfortunately, however, TTB allowed these proposed rules to languish, ultimately deciding in 2013 to issue a voluntary rule allowing companies to decide what nutrition and calorie information to disclose – and what to keep hidden. Not surprisingly, many manufacturers opted out of TTB’s program so most alcoholic beverage products on the market remain unlabeled or carry incomplete information.

Even with these setbacks, the consumer community kept up the pressure on TTB because the need for alcohol labeling has only increased. This became apparent during the COVID-19 pandemic when a 2020 RAND study charted a 14 percent increase in alcohol consumption among adults over age 30 in one year.[8] Another national study found that excessive (binge) drinking increased by 21 percent during the pandemic, with the potential for 8,000 additional deaths from alcohol-related liver disease by 2040.[9]

And then, the sand started to shift. Also related to the pandemic, consumer demand skyrocketed for hard ciders, some types of beers, wine coolers and the other low-alcohol drinks sold in supermarkets and convenience stores and what consumers saw were complete alcohol labels on these products. This is because low-alcohol drinks fall under the purview of the Food and Drug Administration, not TTB. Armed with this evidence, NCL leaders met online with Department of Treasury and TTB officials in June 2021 and put TTB in the uncomfortable position of having to explain why often the same manufacturers who must put a standardized content label on brands regulated by FDA don’t bother to do so when their products are under TTB’s jurisdiction.

Not long after this meeting, the Treasury Department conducted its own review and on February 9, 2022, issued a report, Competition in the Markets for Beer, Wine and Spirits, that advanced the importance of labeling information to foster competition within the beverage alcohol industry. The report contains several recommendations, including the recommendation that “TTB should revive or initiate rulemaking proposing ingredient labeling and mandatory information on alcohol content, nutritional content, and appropriate serving sizes.”

This was encouraging news, so NCL doubled down, combining forces with CSPI and the Consumer Federation of America to get TTB to mandate alcohol labeling across the board. Recognizing that public pressure alone will not ensure success, the organizations turned to Congress, hosting briefings for lead staffers of the House and Senate appropriations committees with jurisdiction over TTB’s budget and sending a joint letter to key Congressional leaders from 23 consumer, health/nutrition, and alcohol policy organizations about the need for mandatory alcohol labeling. This led to report language in the draft House and Senate 2023 appropriations bills that encourages TTB to initiate a final rulemaking.

The last step was filing a lawsuit against TTB in the United States District Court for the District of Columbia on October 3, 2022, asking the court to direct TTB to grant or deny the 2003 petition within 60 days. The lawsuit was a gamble, but it worked: on November 17, 2022, TTB accepted the 2003 petition and committed to publish three rulemakings covering mandatory nutrient and alcohol content labeling, mandatory allergen labeling, and mandatory ingredient labeling within the next year.

However, this is not the end of the story. The proposed rules will be accompanied by open public comment periods where we can anticipate that segments of the alcohol industry will be aggressive in fighting robust consumer labeling.  Therefore, NCL will also be actively engaging a wide range of stakeholders to weigh in on behalf of consumers so the American public to have access to standardized and complete labeling information on beer, wine and distilled spirits. It has taken 19 years to get to this point, but our message is clear: alcohol labeling is long past due, consumers overwhelmingly want to see it, and we will stay in the fight until alcohol labeling is a reality.

[1] Gallup. Alcohol & Drinking. July 2022

[2] U.S. Department of Agriculture and U.S Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9Th Edition. December 2020.

[3] Emanuele NV, et al. Consequences of Alcohol Use in Diabetics. Alcohol Health Res World. 1998; 22(3): 211–219.

[4] National Highway Traffic Safety Administration. Risky Drunk and Drugged Driving Statistics.

[5] U.S. Centers for Disease Control and Prevention. Alcohol and Public Health. Last reviewed April 14, 2022. https://www.cdc.gov/alcohol/fact-sheets/alcohol-use.htm

[6] U.S. Centers for Disease and Control Prevention. Deaths from Excessive Alcohol Use in the U.S. Page last reviewed April 14, 2021. https://www.cdc.gov/alcohol/features/excessive-alcohol-deaths.html . Accessed June 2, 2022.

[7] U.S. Centers for Disease Control and Prevention. Alcohol and Public Health. Page last reviewed April 14, 2022. https://www.cdc.gov/alcohol/features/excessive-drinking.html. Accessed June 2, 2022.

[8] Pollard MS, et al. Changes in Adult Alcohol Use and Consequences During the COVID-19 Pandemic in the US. JAMA Netw Open. 2020;3(9):e2022942.

[9] Julien J, et al. Effect of increased alcohol consumption during COVID-19 pandemic on alcohol-associated lover disease: A modeling study. Hepatology. Vol. 75; Issue 6; June 2022; 1480-1490.

Promising new therapies are giving hope to Alzheimer’s patients and families, so why limit access?

Sally Greenberg

By Sally Greenberg, Executive Director

For years, Alzheimer’s patients, families, and caregivers have battled a condition with no treatment options. This year alone, an estimated 6.5 million Americans age 65 and older are living with Alzheimer’s.

The good news is, we’ve recently seen remarkable progress in the fight against Alzheimer’s disease as innovative treatments demonstrated the ability to halt disease progression in a major clinical trial and proved to curb cognitive decline. These therapies targeting the buildup of amyloid beta plaque in the brain (one of the telltale signs of Alzheimer’s) have shown promise for so many patients and families facing this fatal diagnosis.

The first such therapy was approved by the U.S. Food and Drug Administration (FDA) in June of last year. This should give us all hope for a brighter future, but this progress may be moot if regulatory barriers hinder patient access.

Rather than ensure broad coverage through the Medicare program – as is the case for nearly every other type of drug that receives FDA approval – the Centers for Medicare and Medicaid (CMS) decided this spring to restrict access to these new Alzheimer’s treatments only to patients participating in approved clinical trials. This puts severe limitations on coverage for an entire class of innovative Alzheimer’s disease treatments, with CMS in direct conflict with the FDA, whose medical experts approved the drug as safe and effective.

In fact, this puts the FDA’s entire accelerated approval pathway in the crossfire, sounding an alarm to millions of patients hoping for medical breakthroughs.

No one is arguing the therapy is a miracle cure, but that’s not how new therapies tend to work. History has shown that when it comes to serious conditions with high unmet medical needs, even small improvements are critical.

Accelerated approval first surfaced during the AIDS crisis, when HIV was a death sentence and there were no treatments. AIDS advocates demanded something – anything — despite minimal benefits “because we have nothing now and no hope.” The first AIDS treatments in the 1980s were grueling regimens with serious side effects, but they had to start somewhere. Today, as medicines have evolved, HIV-positive patients require one pill a day and can live with the disease.

The same is true for Duchenne’s Muscular Dystrophy, a terminal disease that lands young boys in wheelchairs often before they reach 10 years old. Approval of the first drug to treat Duchenne’s met significant controversy in 2016 because it was minimally effective. Yet, the FDA approved it because these patients had no hope. Today there are five treatment options for the disease that slows down the progression and buys time.

And in 2001, a game-changing therapy for chronic myeloid leukemia received approval; the treatment helped to spur innovation in what became targeted therapies for cancers.

The science and medical ecosystem will continue to naturally progress, moving us from zero treatment options to medicines that mitigate symptoms, to treatments that halt disease progression, and eventually, cures. This is true in the Alzheimer’s space, but by limiting access to an entire class of Alzheimer’s treatments, CMS is putting future scientific breakthroughs at risk and creating a ripple effect throughout the entire healthcare system. This new promising drug class will only be available to those with the financial wherewithal to pay thousands of dollars out of their own pockets.

With this precedent, any drug that emerges from the rigorous development pipeline could be deemed too expensive or too early in the discovery phase. CMS acting as the final arbiter on what new treatments will be made available and overriding the scientific judgment of FDA experts should concern all of us.

As we look ahead toward a new Congress, our lawmakers can and should put pressure on CMS to keep pace with the science and give hope to Alzheimer’s patients and families.

Guest Blog: Urgent push to get the Senate to pass the Pregnant Workers Fairness Act by end of year

By Robin Strongin

Pregnancy discrimination in the workplace is real and it’s dangerous.  But, if the Senate acts quickly, it can pass S. 4431, the Pregnant Workers Fairness Act (PWFA) which provides reasonable accommodations for pregnant and postpartum workers.

The legislation, which has already passed in the House, enjoys strong bipartisan support and has garnered wide-ranging support from business associations, the US Chamber of Commerce, labor unions, faith organizations, civil rights organizations, maternal health groups, and others.  The US Conference of Catholic Bishops has stated that “These and other efforts to protect pregnant workers and new mothers should be applauded as they demonstrate a respect for life, family, and the dignity of workers.”

NCL stands with these organizations in urging the Senate to pass the legislation.  Pregnancy discrimination in the workplace is not only medically dangerous, but disruption to a woman’s career hurts her earning power and has implications for the labor supply.  More than 85 percent of women will become mothers at some point in their working lives, the majority of whom cannot afford not to work.

Despite passage of the federal Pregnancy Discrimination Act (PDA) of 1978, employer bias against pregnant women still exists, especially when it comes to employers providing reasonable accommodations to pregnant workers.

In early February 2022, the Bipartisan Policy Center and Morning Consult conducted a survey of 2,200 adults on the prevalence of pregnancy discrimination in the workplace. The survey found that “pregnancy discrimination is common across race, incomes, and other demographics, causing fear about informing employers about a pregnancy and leading many pregnant workers to consider a career change. These trends are particularly elevated among younger women and those who are currently working.”

Key Results:

  • Nearly 1 in 4 (23%) mothers have considered leaving their jobs due to a lack of reasonable accommodations or fear of discrimination from an employer during a pregnancy.
  • 1 in 5 mothers (20%) say they have experienced pregnancy discrimination in the workplace.
  • Adults are witnessing pregnancy discrimination in their workplaces.
  • Over 1 in 5 mothers have been afraid to tell an employer about a pregnancy.
  • A comparable portion of adults report that their partner or spouse has experienced pregnancy discrimination at work.

In their November 10, 2022 letter to the Senate Majority and Minority Leaders, urging swift passage of the Senate bill, the bipartisan members underscored what pregnancy discrimination looks like, and the terrible toll it takes:  …”a warehouse employee in Tennessee who suffered a miscarriage after lifting heavy boxes and being denied light duty; a retail worker in Kansas who was fired because she needed to carry a water bottle to stay hydrated, and a hardware assembler in Ohio who was terminated after her doctor recommended she not lift more than 20 pounds.”

Advocates are raising the alarm: if the Senate doesn’t enact the bill by the end of this year, opposition from Republicans over a lack of religious exemptions could jeopardize the passage of the legislation as Republicans take over the House.

The bill that passed the House did so with a strong bipartisan vote of 315 – 101.  And the Senate bill enjoys strong bipartisanship as well, according to Senate HELP Chair, Patty Murray (D-WASH), who is working across the aisle to get it passed.

If a stand-alone vote in the Senate doesn’t materialize, backers of the bill are considering its inclusion in the year-end spending package. Sen. Bill Cassidy (R-LA) warned, “The clock is ticking… This is a bipartisan bill that’s pro-mothers, pro-healthy pregnancies, and pro-workers,”…”Let’s get it through the Senate by the end of the year.”

Food safety tips this holiday season

By Ryan Barhoush, Food and Nutrition Program Associate

As we are gearing up for this upcoming holiday season, food safety  is something important to keep in mind. If this is your first time or even your 20th being the Thanksgiving head chef, it is always good to review some simple safety tips in the kitchen. There is nothing worse than getting your relatives sick…unless that is the only way to get your uncle to stop talking about politics at the table. Just kidding, of course. Here are some food safety recommendations from National Consumers League for Turkey Day tomorrow. Happy Holidays!

Roasting a Turkey this year? Don’t be intimidated but keep these ideas in mind.

  • Keep poultry separated from other items in the fridge.
  • If brining a turkey, make sure it is properly secured or in a cooler away from your other food items. Be careful of spillage or drippings from contaminating other items.
  • If thawing a frozen turkey in the fridge, allow about 24 hours for each 4 to 5 pounds of Turkey
  • Never thaw a turkey by just laying it out on the counter, this could lead to bacteria growth, even if it is frozen.
  • You can thaw in cold water, keep it in a bag to prevent contamination, and change the water every 30 minutes. It takes about 30 minutes per pound to defrost a frozen turkey.
  • Remember to wash your hands before and after handling the turkey. Every time!
  • Use separate cutting boards and scrub with warm, soapy water after use.
  • Use a thermometer and make sure your turkey has an internal temperature of 165 degrees.

Frying a turkey? Don’t be scared but be aware of the risks!

  • Never leave oil unattended, even a small amount of oil reaching a lit flame can cause a large fire.
  • Make sure your turkey is dry and completely thawed! Pat dry the inside and the outside of the turkey. Any kind of moisture can cause combustion when in contact with oil.
  • Do not overfill the fryer with oil. Pre-test the oil levels with something in the same weight range as your turkey.
  • Always fry a turkey outside, away from the house, and on level surfaces.
  • Keep children and animals away from the fryer, even after use, as oil can remain hot for hours.
  • Remember that the sides and handles will be dangerously hot.
  • Have an all-purpose fire extinguisher nearby.

Besides the turkey, here are few more things to keep your eye on in the kitchen.

  • Be mindful of the “danger zone”. Bacteria and germs can grow rapidly between 40 and 140 degrees.
  • Keep warm food with warm food and cold food with cold food!
  • Don’t leave out any food past two hours
  • Don’t put warm leftovers away in the fridge
  • Follow these steps and enjoy a safe and Happy Thanksgiving!
Nancy Glick

At last: FDA is updating the definition of a “healthy” food

Nancy GlickBy Nancy Glick, Director of Food and Nutrition Policy

It is rare when new regulations from the Food and Drug Administration (FDA) warrant a song. But borrowing a phrase from Sam Cooke, FDA’s recent proposed rule changing the meaning of the term “healthy” has been a long time coming – 28 years to be exact. Yet, as the song goes “a change is gonna come.”

Why is this a good thing? Simply put, the term “healthy” is out-of-date, both with the state of nutrition science today and with the latest Dietary Guidelines for Americans, recommendations from experts on what to eat and drink to meet nutrient needs, promote health, and prevent disease.

Going back to 1994 when FDA’s old definition of “healthy” went into effect, the agency focused on individual nutrients in a food, not the actual foods we eat. Accordingly, foods now qualify as “healthy” if they are low in total fat, saturated fat, cholesterol and sodium and must contain a significant amount of fiber and at least two additional beneficial nutrients such as vitamins A, C, D, calcium, iron, protein, or potassium. This covers about 5 percent of foods, including white bread, highly sweetened yogurt, and sugary cereals.

The problem is that many healthy foods do not qualify for the use of a “healthy” claim based on FDA’s outdated standards. This includes avocados, nuts, seeds, olive oil, and salmon because they are high in fats now known to be heart healthy. And right now, plain, non-carbonated water and plain, carbonated water cannot be labeled as “healthy,” which makes no sense.

These absurdities have been apparent to consumer organizations for decades, but the impetus for change was the introduction of the KIND bar in 2015. KIND advertised its bars as healthy because they contain whole foods like nuts and grains, but because the nuts have more fat than what FDA now allows for a “healthy” claim, the agency sent a warning letter about the use of the claim.  When KIND responded with a Citizen Petition that documented the healthfulness of nuts, FDA permitted KIND to use the term “healthy” and issued a proposed rule change in 2016, signaling its intention to revise the definition.

At the same time, nutrition science has evolved over 28 years. Not only is it clear that not all fats and carbohydrates are the same but getting the nutrients needed for a healthy diet result from making food choices based on healthy dietary patterns. This understanding is especially noteworthy because more than 80 percent of Americans consume too much added sugars, saturated fat and sodium but aren’t eating enough vegetables, fruit and dairy, according to the Dietary Guidelines for America, 2020-2025.

Based on these developments, FDA’s proposed rule will do away with counting individual nutrients in a food. Instead, FDA’s plan is to define the term “healthy” on food packaging based on two criteria:

  1. The product must contain a certain “meaningful amount” of food from at least one of the food groups recommended by the Dietary Guidelines, such as fruits, vegetables, or dairy; and
  2. The food must stay within specified limits for certain ingredients, such as saturated fat, sodium and added sugar, based on a percent of the Daily Value (DV) of the nutrient. This includes a limit for sodium of 230 milligrams (mg) per day, or 10 percent of DV per serving – an important action by itself since Americans on average consume 50 percent more sodium per day than is recommended in the Dietary Guidelines.

The proposed rule is also consistent with recent changes to the Nutrition Facts label. For example, the Nutrition Facts label must now declare added sugars to help people maintain healthy dietary practices.

Applying these criteria, a cereal could only carry a “healthy” claim if contained ¾ ounces of whole grains and no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars. This would disqualify almost all breakfast cereals now marketed to children.

To help make the new “healthy” claim meaningful for consumers, the FDA is also researching a symbol that food manufacturers can use on the front of the package. The symbol would act as a quick signal that the food contributes to a healthy dietary pattern and is part of a labeling system the National Consumers League has long supported.

FDA’s proposed rule addresses several of NCL’s food policy issues. For many years, we have been pressing for a new definition of the term “healthy” that aligns with the latest nutrition science and we support a “Traffic Light” symbol to depict “healthy” foods on the front of the package. We also have been at the forefront in pressing for ways to lower excess sodium in the diet.

But while we believe FDA’s plan is a significant step forward for consumers, there are still some shortcomings. Although the Dietary Guidelines call on consumers to limit calories from added sugars and fats, FDA’s proposed rule fails to consider calorie limits.

Moreover, the new rules won’t stop “healthy” products from being loaded with artificial colors and will have the unintended consequence of incentivizing food processors to replace natural sugar with questionable artificial sweeteners and sugar alcohols without disclosing these ingredients. Even as NCL has advocated for a modernized definition of the term “healthy,” we have been supporting a Citizen Petition to ensure transparent labeling of substitute sweeteners, which have surged in use by more than 300 percent in the last five years and can produce digestive effects. The Citizen Petition asks FDA to add the term “sweetener” in parentheses after the name of all non-nutritive sweeteners in the ingredient list, and for children’s food and beverages, to indicate the type and quantity of non-nutritive sweeteners, in milligrams per serving, on the front of food packages.

FDA published its proposed rule, Food Labeling: Nutrient Content Claims; Definition of Term “Healthy,” in the Federal Register on September 29, 2022, and is encouraging anyone interested in the topic to submit written comments by December 22. NCL plans to use this opportunity to ensure the consumer’s voice is heard and to offer solutions that will advance better food and beverage choices. We all have a stake in labeling claims that are science-based and ensure that consumers have access to more complete, accurate, and up-to-date information about the foods they consume and serve their families.

Sunshine in Litigation Act introduced in the District of Columbia

By Sally Greenberg, NCL Executive Director

Here in the District of Columbia, we have a chance to stop the problem of secret settlements with the introduction of the DC Sunshine in Litigation Act (SILA).

The bill, which is scheduled for a hearing before Councilmember Allen’s Judiciary Committee on December 8, would require DC judges to consider public health and safety before granting a protective order, sealing court records, or approving a settlement agreement. Introduced by consumer champion and DC Councilmember Mary Cheh, the bill will ensure that injuries caused by dangerous or unhealthy products do not any longer get sealed away from the public through legal settlements.

As Councilmember Cheh said in her letter to the Council:

“This presumption in favor of public access is especially important in cases that have implications for individuals beyond the parties to litigation—in particular, cases that involve defective products or dangerous environmental conditions that pose a risk to the general public. Unfortunately, it has become increasingly common in cases like these for parties to undermine the public interest, often with a court’s endorsement, either through sweeping confidentiality clauses in settlement agreements or through protective orders issued by the court.

“Court-sanctioned secrecy in such cases can be a matter of life and death. Perhaps the clearest example of this comes from the high-profile litigation related to the opioid epidemic. As early as 2001, individuals and governments began filing lawsuits alleging that opioid manufacturers had misled doctors about the dangers of prescription opioids. However, because judges in these cases required that court records remain under seal, the compelling evidence of the manufacturers’ wrongdoing and of the dangers of opioids uncovered by the litigants was kept from the public for over a decade.”

This issue of secret settlements has a long and sordid history. Typically, a consumer sues a manufacturer for an injury or death that has resulted from a defect in one of the manufacturer’s products. The victim is suing a large corporation that can spend huge sums of money defending the lawsuit and delaying its resolution. Facing a formidable opponent and mounting medical bills, plaintiffs are discouraged from continuing and often seek to settle the litigation. In exchange for monetary damages, the victim is often forced to agree to a provision that prohibits him or her from revealing information disclosed during the case. While the plaintiff gets a respectable award and the defendant can keep damaging information from being publicized, the public remains unaware of critical health and safety information that could save lives.

Bipartisan federal SILA bills have been introduced since the 1990s, with Senator Herb Kohl (D-WI), now retired, being the prime champion, but sadly, none became law. So, we are left to legislate this important consumer protection matter on the state level.

The witnesses who testified before Congress in past years have developed a strong set of stories that underscores the importance of getting these bills passed. A shameful litany of products that have caused injury and death exists but without public scrutiny, the company continues to market and sell the product and keeps the hazards secret. At the hearings in 1990 and 1994, Congress heard testimony about silicone breast implants, adverse reactions to a prescription pain killer, “park to reverse” problems in pick-up trucks, defective heart valves, dangers from side-saddle gas tanks, playground equipment, IUD birth control devices, tires, and portable cribs.

Fast forward to 2011, the Senate Judiciary Committee hearing included many such stories of dangerous products whose hazards remained a secret, including the following.

  • Phenylpropanolamine – Known as PPA, in 1996 caused a seven-year-old boy in Washington State to suffer a sudden stroke and fell into a coma hours after taking an over-the-counter medicine to treat an ear infection. After three years in a coma, he died. The child’s mother sued the manufacturer of the medicine alleging that the stroke was induced by PPA, an ingredient with deadly potential side effects, which has since been banned by the Food and Drug Administration (FDA). Unknown to the public, similar lawsuits in state and Federal courts had previously been filed against the drug manufacturer, but were settled secretly, with the lawyers and plaintiffs subject to restrictive confidentiality orders.
  • Silicone breast implants – Information about the hazards of silicone breast implants was discovered during litigation as early as 1984, but because of a protective order that was issued when the case settled, the information remained hidden from the public and the FDA. It was not until several years and tens of thousands of victims later that the public learned of potentially grave risks posed by the implants.
  • “Park-to-reverse”’ malfunction – For many years, one car company was aware of problems associated with “park-to-reverse”’ malfunction in its pick-up trucks and quietly settled cases stemming from this alleged defect. It was not until years later that the company made a minimal effort to notify original owners by sending stickers alerting them that there was a problem. The stickers made no mention of the potential risks of severe injury or death. Unfortunately, 2.7 million of these truck owners did not receive the warning. One victim was Tom Schmidt. His parents Leonard and Arleen Schmidt testified before the Subcommittee on Courts and Administrative Practice. During their lawsuit they learned that the company had known about the problem as early as 1970 and had quietly settled cases with strict protective orders concealing information about the problem.
  • Bjork-Shiley heart valve – Over the course of several years, Bjork-Shiley heart valves were linked to 248 deaths. The manufacturer insisted on secrecy agreements when settling dozens of lawsuits before the FDA finally removed the valves from the market. The Subcommittee on Courts and Administrative Practice heard testimony from Fredrick Barbee about how court-endorsed secrecy prevented him and his wife from learning about the potential heart valve malfunction and prevented her from getting the appropriate and life-saving treatment she needed when her valve malfunctioned.
  • Dalkon Shield – In 1974, the FDA suspended use of the Dalkon Shield, a popular intrauterine birth control device. The device was linked to 11 deaths and 209 cases of spontaneous abortion. Prior to the FDA’s action, the maker of the device had settled numerous cases with strict confidentiality agreements. The manufacturer even attempted to include agreements with the plaintiffs’ lawyers that would have prohibited them from taking another Dalkon Shield related case.
  • Side-saddle gas tanks – Over the course of several years, one car company quietly settled more than 200 cases brought by victims of fiery truck crashes involving the automaker’s side-mounted gas tanks before the defect became known. It was not until 1993, when General Motors sued Ralph Nader and the Center for Auto Safety for defamation, that lawyers discovered records showing that GM had been sued in approximately 245 individual gas tank pick-up truck cases. The earliest cases had been filed as far back as 1973. Almost all cases were settled and almost all the settlements required the plaintiffs to keep the information secret.
  • Playground equipment – Miracle Recreation Company manufactured and sold a piece of playground equipment called Bounce Around the World. Dozens of lawsuits were brought against the company alleging that it was dangerous and caused serious injuries to young children, including severed limbs and crushed bones. For 13 years, the public and regulatory agencies remained in the dark about the potentially crippling equipment because the company insisted on settling lawsuits conditioned by confidentiality agreements. Approximately 80 children between the ages of four and five were seriously injured before the CPSC learned about the magnitude of the danger and the company recalled the merry-go-round
  • Collapsing decks – On June 16, 2015, shortly after midnight, five Irish J-1 visa students and one Irish-American died and seven others were injured after a balcony on which they were standing collapsed. The group was celebrating a 21st birthday party in Berkeley, California. One of those injured died of her injuries later that year. Building inspectors later found that the wooden supports holding up the balcony had been eaten away by dry rot, even though the structure was less than 10 years old. It subsequently emerged that the contractors who built the complex, Segue Construction of Pleasanton, California, had paid $26.5 million in settlements for previous defect cases, but that this information had not been available to the state construction licensing authority or to clients.

What needs to be done

Time is of the essence in getting this bill enacted in the District of Columbia. Residents of DC will not know what hazards are lurking out there until this bill passes!

Business interests have typically opposed these bills in other states and in Congress. They claim that the Sunshine in Litigation legislation will slow down the courts, discourage settlements, and launch fights over production of documents. In fact, AK, FL, LA, MT, NV, NC, OR, SC, TX, VA, and WA, have all adopted some form of SILA laws and there has been no such collapse of the legal process.

As Councilmember Cheh noted in her letter introducing the bill, “according to the legal advocacy organization Public Justice, there is no evidence that these anti-secrecy laws have discouraged settlements, exposed proprietary interests or trade secrets, or imposed burdens on the courts.”

We look forward to the December 8 hearing and having residents of the District come forward to tell members of the City Council how especially important the Sunshine in Litigation Act is to their families and communities.

Debt cancellation is not Biden’s only aid to borrowers

By Eden Iscil, Public Policy Associate

If you’ve got student loans like I do, you were probably waiting on President Biden’s student debt cancellation since January 6, 2021. And in late August, President Biden delivered on this promise and announced up to $20,000 in relief for borrowers. While the one-time debt relief has dominated headlines (and rightfully so), Biden’s Department of Education (ED) has implemented a few other noteworthy changes to the federal student loan system—reforms that could save thousands of dollars for millions of borrowers.

Here is a brief (and non-exhaustive) overview of recent modifications to US student loan infrastructure that consumers should keep in mind.

One-Time Debt Cancellation

The application for one-time debt relief is live and can be accessed at https://studentaid.gov/debt-relief/application. The process is 100% free and it takes less than five minutes to complete. This is the only website to which consumers should be providing information to receive debt cancellation. Filers do not need to go digging for old forms, IDs, or income receipts as the only information the application requires is name, date of birth, email, and Social Security number. The ED may contact select borrowers to verify eligibility or request further information, but unless you are contacted, you are good.

Borrowers who earn less than $125,000 a year are eligible for up to $10,000 in debt relief on federally held student loans. This amount increases to $20,000 in cancellation for Pell Grant recipients. Student loans eligible for cancellation must be held by the federal government and disbursed on or before June 30, 2022.

Student loans eligible for Biden’s debt cancellation include:

· Federal Direct Loans (including Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans, Direct parent PLUS Loans, and Direct Consolidated Loans)

· Federal Family Education Loans (FFEL) held by ED

· Federal Perkins Loans held by ED

· FFEL and/or Perkins loans that were privately held but the borrower applied for these loans to be consolidated into a US ED consolidation loan before September 29, 2022

Student loans not eligible for the federal, one-time debt cancellation include:

· FFEL loans not held by ED

· Perkins Loans not held by ED

· Federal loans that were consolidated into a commercial loan

· Student loans held by a private lender

· Student loans held by a state government

Refunds for Loan Payments Made During the Pandemic

If you had paid off your federal loan balance after the pandemic began, you can request a refund for those payments to receive your debt relief. This should be done before applying for the debt cancellation. Also, this should only be done if you paid off your entire balance and would otherwise be unable to claim debt relief. If you still have an outstanding balance equal to or greater than the amount of debt cancellation you are eligible for, you likely do not want to request a refund for your payments.

To get your money back, call your loan servicer directly to ask for a refund on payments you made since March 13, 2020. You should figure out the specific amount of money you are requesting back before contacting your servicer. Additionally, you should have your payment confirmations and receipts nearby throughout this process to ensure that you get a refund for every payment that you want refunded. Then, you should apply for the one-time debt cancellation.

Will Debt Relief Be Taxed?

The one-time debt relief will not be taxed by the federal government, thanks to a provision within the 2021 American Rescue Plan. States, however, can tax debt cancellation as income. This is something that a small number of states have weirdly said they intend to do, while a handful of others may also end up taxing their residents on debt relief by failing to pass legislation in time to exempt the debt cancellation. Most states though will not tax the relief for borrowers.

Federal Payment Pause Ending

President Biden coupled the sweet with the sour by announcing the end of the federal payment pause on student loans alongside the debt cancellation. Since early 2020, student borrowers have not had to pay a cent toward their federal student loans. Now, that payment pause (AKA administrative forbearance) is set to expire on December 31, 2022, it is unclear what the impact will be of an added monthly expense to tens of millions of borrowers (especially as recession worries grow). The two-and-a-half-year pause made clear that these payments are not necessary—Biden, there’s still time to change your mind!

A New Income-Driven Repayment Plan

While receiving a significantly lesser share of the headlines, the new income-driven repayment (IDR) plan will have a significant impact. As opposed to standard repayment plans, which are calculated only from the principal loan balance, the interest rate, and the length of repayment, ED’s IDR plans put a cap on a borrower’s monthly payments proportional to the borrower’s income. Although a few IDR plans have been available for some time, President Biden’s newly announced IDR plan includes enhanced provisions to help prevent debt from becoming unmanageable.

The new IDR plan will place a payment cap at 5% of a borrower’s discretionary income (half of the previous 10%). Additionally, it will raise the threshold for non-discretionary income to 225% of the federal poverty level (the equivalent of $15/hr); borrowers earning less than this amount will not have to make a monthly payment. Furthermore, borrowers with original loan balances of $12,000 or less will have their debt wiped out in 10 years of enrollment in this IDR plan. Lastly, if monthly payments are made, the ED will cover the added interest, ensuring that borrowers’ outstanding balance does not grow, even if their monthly payment is $0 due to their income level.

To enroll in the new IDR plan when it becomes available, or to switch to any of the four existing ones, visit https://studentaid.gov/idr/.

Fresh Start for Borrowers in Default

When the federal payment pause ends on December 31, 2022, the federal government will open their Fresh Start program for one year, allowing borrowers who were previously in default to enter repayment in good standing. The program will not require anything like a lump sum payment or consolidation, but it will remove the many penalties associated with default, such as wage garnishment and the denial of further student aid.

More details on how to enroll when this program opens on January 1, 2023 can be found at https://studentaid.gov/freshstart.

Support for labor unions on the rise

By Sally Greenberg, NCL Executive Director

The good news is in: 71 percent of Americans support labor unions. This is an all-time high and so encouraging as America celebrates our federal Labor Day holiday.

I’ve had some interesting labor experiences this past week while visiting my sister Jane in Minneapolis. Wednesday, we went by Starbucks and saw that it was closed due to striking workers. We cheered them on and went across to Caribou coffee for our drinks. Then a mailer showed up at Jane’s house addressed to her son, who is a Minnesota school teacher. It read “Stop Funding Racism with Your Union Dues.”

Hmmm, I thought, this is curious. Union dues to fund racism? Sounds fishy to me.

The flyer featured a photo of young African American woman holding teaching materials and said, “Your union really negotiated a contract that undermines the Civil Rights Act.”

I started to dig deeper and learned that the union has negotiated terms that guarantee a diverse work in Minnesota. That is what this group is calling “racism” – racism against white folks apparently. The mailer’s return address was from the “Freedom Foundation,Cincinnati OH”. At the bottom it says “CancelUnionDues.com”.

Yup, you guessed it – it’s a full-on attack on teachers’ unions, which I learned from reading an interview this week with AFT president Randi Weingarten. As part of an on ongoing attack on teachers by the right, this flyer was directed at the Minneapolis Federation of Teachers.

As for the Freedom Foundation mailer, the Maryland State Education Association has this to say about them:  The Freedom Foundation [is funded by] conservative donors, including the billionaire brothers Charles and David Koch, that supports conservative and libertarian organizations.

“When educators are aware of who’s funding [these anti-union campaigns], and what their agendas are, then the charade of these emails falls away pretty quickly,” said Adam Mendelson, a spokesperson for the Maryland State Education Association.

For a shot in the arm about labor rising, I recommend both President Weingarten’s Labor Day blog post along with AFL-CIO President Liz Shuler’s remarks to the Federation of International Football Associations titled Don’t Leave Workers Behind. Young people are excited about organizing unions – they get it – and we must be there to support them.