Jeanette Contreras portrait

La tercera vacuna trae esperanza

By NCL Director of Health Policy Jeanette Contreras

La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) acaba de aprobar una autorización de uso de emergencia para la vacuna de Johnson & Johnson, la tercera vacuna para combatir el coronavirus en EEUU. Aunque parece que no es tan efectiva como las otras dos, la vacuna de Johnson & Johnson ofrece una protección de 85 por ciento contra casos severos de COVID-19 y 100 por ciento de eficacia para evitar hospitalización y mortalidad, a causa del COVID-19. Con solo una dosis, esta vacuna ofrece protección de 72 por ciento contra el COVID-19 que ultimadamente ayuda controlar la pandemia en la población y alcanzar un nivel de inmunidad necesaria para regresar a la vida normal.

Una ventaja enorme de esta vacuna en términos de administración, es que se puede mantener en refrigeración normal por meses. Las otras vacunas requieren mantenimiento de temperatura súper baja en refrigeradores industriales que solo se encuentran en hospitales grandes. La vacuna de Johnson & Johnson es ideal para distribuir a comunidades rurales y en clínicas comunitarias. La aprobación de esta tercera vacuna, aumenta la disponibilidad y nos da esperanza de poder vacunar a más personas, más rápido con solo una dosis.

Sabemos que la comunidad Latina sufre de una taza de contagio más alta que otros grupos. Latinos constituyen una gran cantidad de empleados en trabajos esenciales con alto riesgo de contagio, como en la producción de comida y en puestos de trabajo de pequeños negocios. Mientras muchos esperan vacunarse, otros tendrán dudas o miedo de vacunarse. La campaña Depende De Ti nos asegura que es normal tener preguntas y ofrece información y respuestas en Español para educar a la comunidad latina.

Campañas educativas como esta son necesaria para combatir información falsa y mitos que circulan en las redes sociales. Se escuchan mitos que las vacunas en general hacen daño o que alteran o cambian el ADN. Sin embargo, está comprobado científicamente por siglos que las vacunas han salvado vidas y nos han protegido. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) tiene una página dedicada a información para derribar los mitos más frecuentes acerca de estas vacunas.

Para alentar a la población a vacunarse, muchas empresas grandes están ofreciendo tiempo pagado o incentivos financieros a los empleados que se vacunan. Por ejemplo, supermercados como Publix les da $125 y Kroger les da $100 a empleados cuando reciben la vacuna completa. Dollar General les aumenta cuatro horas de pago normal a los que se vacunan.

Gracias a la autorización de la nueva vacuna, Presidente Biden afirma que para el fin de mayo habrá vacunas para todos los adultos en EEUU. Las personas que deciden vacunarse, pueden buscar información confiable en el recurso de Telemundo – PlanificaTuVacuna.com para verificar la elegibilidad de acuerdo a las ordenes de cada estado.

Jeanette Contreras portrait

Vaccine recommendations for those who recovered from COVID-19

By NCL Director of Health Policy Jeanette Contreras

As the United States prepares for the release of a third COVID-19 vaccine, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meets to discuss further implementation considerations that will inform guidance for the vaccine rollout. At its March 1 meeting, ACIP dedicated a portion of the discussion to whether those who’ve recovered from the virus should still be vaccinated.

To date, there are more than 28 million confirmed cases of COVID-19, and experts estimate that the true number of individuals infected, yet not clinically confirmed, to be triple that amount, pushing the total prevalence to approximately 100 million. A recent study by the National Institutes of Health (NIH) indicates that those who’ve recovered will have a certain amount of natural immunity to the virus for up to eight months after infection, which is in line with the findings of a major British study published in early February, in which 88 percent of participants who previously tested positive for COVID-19 still had antibodies after six months.

Considering that the demand is greater than the supply, it is a difficult task to make recommendations for the equitable distribution of vaccines. For example, Spain issued recommendations that patients wait six months after diagnosis to get vaccinated if an individual is under age 55 with no major health complications. People over 55, or those with health risks that make them vulnerable to reinfection, are exempt from this delay and encouraged to be vaccinated.

Additionally, early studies are showing that immunity in individuals who had recovered and received one shot may be equal to or even exceed those not infected who had received two doses. According to the University of Maryland School of Medicine, a single dose of the Moderna or Pfizer mRNA vaccines would elicit an immune system response sufficient to provide comparable immunity to two doses in a non-infected person. On February 12, France became the first country to issue guidance recommending that people who have already recovered from COVID-19 only need to receive one dose of a vaccine, between 3 and 6 months after their infection.

Early research like this is informing public health policies in other countries. But the United States is known all over the world for its scientific rigor and reliance on randomized clinical trial data as a gold standard. In a recent blog, NIH Director Dr. Francis Collins reassures us that, should other studies support these early results, the experts at the Food and Drug Administration (FDA) and CDC will certainly consider whether one dose is enough.

The implementation of a one-dose vaccine would help to increase supply, however, the emergence of COVID-19 variants presents new challenges for curbing this pandemic. Current CDC guidance states that even if you’ve recovered from COVID-19, you should get vaccinated. Arming yourself with a vaccine will keep you and your family safe, and ultimately help to stave off new COVID-19 variants.

NCL testimony before FDA on Janssen Biotech COVID-19 vaccine

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

February 26, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the FDA’s Vaccines and Related Biological Products Advisory Committee at the Center for Biologics Evaluation and Research. Read her testimony.

Hana El Sahly, M.D., Chair
Vaccines and Related Biological Products Advisory Committee
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993

RE: Docket No. FDA-2021-N-0173; for Vaccines and Related Biological Products Advisory Committee

Good Afternoon. I am Nissa Shaffi, present today on behalf of the National Consumers League. I have no conflicts of interest to disclose. Our organization extends its gratitude to the Vaccines and Related Biological Products Advisory Committee, for the opportunity to amplify consumer voices regarding the Janssen Biotech COVID-19 vaccine.

For over 120 years, NCL has championed efforts to increase vaccine education, safety, and access for consumers. As consumer advocates, we thank the Food and Drug Administration for their commitment to fostering public trust throughout the development and approval of a vaccine for COVID-19. We have been encouraged by the transparency and opportunities for engagement afforded to the public during this process.

Emergency Use Authorization (EUA)

Consumers are relying on the FDA more than ever for guidance pertaining to treatments for COVID-19, and preserving their confidence in the Agency is of vital importance at this time. Emergency Use Authorization, while not intended to replace randomized clinical trials, has been a critical component to the nation’s pandemic strategy. NCL appreciates the FDA’s recognition of clinical trials as vital to demonstrating the safety and efficacy of a treatment.

Safety and Effectiveness

We are encouraged by reports indicating that the Janssen Biotech vaccine has proven to be effective against hospitalizations and deaths from COVID-19. The added benefit of another vaccine is to decrease virus mutation. Presently, three, far more contagious, variants of COVID-19 spread and could hamper efforts to quell the virus. We are reassured that the Janssen vaccine has demonstrated efficacy against certain variants. As new data is collected, we call on the FDA to perform post-market surveillance to monitor ongoing efficacy.

Health Equity

Vaccine hesitancy and social determinants of health remain critical obstacles in the vaccine rollout process. The Janssen Biotech single-shot vaccine has the potential to increase access for hard-to-reach communities, bringing us closer to herd immunity. This week, we marked a grim milestone, as half a million Americans have now perished from this relentless virus. Amidst this loss, the continued development of vaccines for COVID-19 has provided the nation with much-needed hope and respite.

As the Committee deliberates on the Janssen Biotech COVID-19 vaccine, we request the Agency to also consider the benefit its release would have for historically disadvantaged communities, for which this vaccine would be logistically more accessible than the prior two vaccines.

Thank you to the Committee for your consideration of our views. Through our consumer education work, NCL will continue to support FDA in its efforts to develop a safe, effective, and expedited pathway towards a vaccine for COVID-19.

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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NCL testimony before CDC’s Advisory Committee on Immunization Practices highlights Hep. B vaccine disparities

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

February 24, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices today. Read her testimony.

José R. Romero, MD, FAAP, Chair
Advisory Committee on Immunization Practices
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop A27
Atlanta, GA 30329-4027

RE: Docket No. CDC-2021-0008; Advisory Committee on Immunization Practices (ACIP)

Good Afternoon. I am Nissa Shaffi and I will be presenting public comment on behalf of the National Consumers League. For over 120 years, NCL has championed vaccine education and access for consumers who depend on these lifesaving medical interventions. We extend our gratitude to the Advisory Committee on Immunization Practices for the opportunity to serve as a voice for consumers.

NCL remains committed to educating consumers on the value and safety of immunizations. During the COVID-19 pandemic immunization rates have dropped drastically, which means that our work is needed more than ever. Even under ordinary circumstances, vaccines are underutilized in adult populations, especially among racial and ethnic minority communities.

Health disparities contribute largely to the burden for Hepatitis B infection, with Asian/Pacific islanders and non-Hispanic black communities having the highest rates of HBV-related death. Despite vaccine recommendations, there is an estimated prevalence for chronic HBV infection in the US of nearly 1.6 million persons (range 1.2–2.5 million).

NCL is concerned that the updated guidance for those over 60 years of age with diabetes getting vaccinated only upon shared decision making with their providers will not address the health disparities that persist. The populations at greatest risk for HepB infection are those that are more likely to lack access to health care and not have a primary care medical home. NCL would like to see the CDC support a large-scale education and outreach campaign to raise awareness of the risk of HepB in older adults and call for increased HepB screening in high-risk communities across the country.

NCL similarly shared its disappointment in response to ACIP’s 2019 recommendations for the pneumococcal vaccine to be administered for those over 65 years of age with shared decision making based on the rationale that childhood vaccinations had dramatically reduced the spread of this disease. However, pneumococcal disease continues to result in an estimated 150,000 hospitalizations per year. And adults over age 65 remain at increased risk for pneumococcal disease.

In light of the drop in childhood immunizations induced by the pandemic, the CDC may want to issue caution statements to providers that herd immunity may have diminished compared to years prior for many of the diseases we target with the most commonly recommended vaccines. As a commitment to our advocacy, NCL continues to reaffirm that vaccines save lives and will continue to support increased immunizations for preventable diseases.

In closing, we encourage ACIP to maintain effective public messaging and strong vaccine recommendations to instill vaccine confidence, so that the American public feels safe and informed in their decisions to vaccinate across the lifespan.

Thank you for your consideration of our views on this important public health issue.

 

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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Welcoming FDA’s call for better science, more research on CBD

In 2019, in response to the growing retail market of untested, unapproved cannabidiol (CBD) products, NCL identified the need for greater consumer education and increased regulation at the federal level. NCL and its partners — Consumer Federation of America and the Community Anti-Drug Coalitions of America — created Consumers for Safe CBD to help raise awareness of the unregulated CBD marketplace, champion the rights of consumers, and call on government and industry to do more to protect consumers. This year, we will continue to work with key stakeholders to encourage safe CBD food and beverage products and promote a pathway for new therapeutic products through clinically-tested scientific research.

We’ve come a long way since our launch, and FDA is making progress. Newly former FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy recently called for better science, more data, and increased testing to determine the risks and benefits associated with CBD. We are encouraged by the commitments outlined in the FDA statement and look forward to continued collaboration with the Biden Administration and the new leadership at the agency to make the CBD marketplace fair, safe, and healthy for consumers.

Read more about the FDA’s comments on the Consumers for Safe CBD here and sign up for CBD updates from our Consumers for Safe CBD campaign here.

Letter to Congress: NCL calls for confirmation of Becerra as Health Secretary

January 22, 2021

Dear Chairman Grassley and Ranking Member Wyden:

The National Consumers League (NCL) is America’s pioneering consumer advocacy organization, representing consumers and workers on marketplace and workplace issues since our founding in 1899. NCL has long advocated for equitable access to affordable quality health care for all. Today, NCL continues to work tirelessly to ensure the nation’s COVID-19 response meets the needs of the communities hardest hit by the pandemic.

As such, we call on the Senate to act expeditiously to confirm the appointment of Attorney General Xavier Becerra to serve as Secretary of the U.S. Department of Health and Human Services (HHS). AG Becerra’s appointment to Secretary of HHS is welcomed by advocates across the health care spectrum. As a nation in the midst of a public health crisis, there has never been a more critical time for bipartisanship. AG Becerra’s speedy confirmation would be a positive step forward to setting aside political ideology and working across the aisle to serve the American people.

AG Becerra is a proven champion for increasing access to health care in low-income minority communities, which are being disproportionately affected by the coronavirus. As Attorney General of California, AG Becerra’s stalwart leadership helped to preserve key consumer health care protections enacted by the Affordable Care Act. We anticipate that Attorney General Becerra will lead the HHS pandemic response with the same health equity and social justice principles he’s employed throughout his career.

NCL strongly supports the nomination of Attorney General Xavier Becerra as the next HHS Secretary and urges this Committee to report his nomination favorably to the Senate. NCL is encouraged this Committee has already begun the nomination process by sending its initial questionnaire to the nominee, and hopes this is an indicator that the diligent work to confirm AG Becerra’s appointment to HHS will commence without delay.

Sincerely,

Sally Greenberg
Executive Director
National Consumers League

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

National Consumers League applauds Congress for surprise billing protections for consumers

For immediate release: December 22, 2020

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC – The National Consumers League welcomes the inclusion of long-needed surprise billing protections in the COVID Relief Omnibus Spending Bill.

Surprise billing happens when a patient’s insurance doesn’t cover a procedure provided by an out-of-network physician, something patients don’t know or realize when they get a procedure. An estimated one in five emergency visits and one in six inpatient admissions will trigger a surprise bill, which can run into the thousands of dollars.

Medical debt disproportionately drives people into bankruptcy. Bill collectors and hospitals often layer on fees, interest, and penalties, driving the original costs way up. A 2019 study published in the American Journal of Public Health found that 530,000 bankruptcies filed annually are because of debt accrued as a result of treatment for medical illness.

This statement is attributable to NCL Executive Director Sally Greenberg:

“We greatly appreciate the bipartisan leadership of Senators Maggie Hassan (D-NH) and Bill Cassidy (R-LA) in getting the surprise billing language over the finish line. We also thank House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Senate Health Committee Chairman Lamar Alexander (R-TN), and Ranking Member Patty Murray (D-WA) for their early leadership on this issue. This is a shining example of working across the aisle for the betterment of consumers.

Consumers can breathe a huge sigh of relief because under the bill—including the cost of an air ambulance—consumers will be ‘held harmless’ when exposed to out-of-network costs. Once this bill is law, consumers can expect that fees charged will be far more affordable and predictable at in-network rates. We are grateful to Congress for recognizing surprise billing as a predatory practice from which consumers need protection. The committee leadership not only helped to pass a bill but launched an investigation.

After two years of debate and discussion on how health care providers and health plans will negotiate these extra costs, it was agreed that patients should be taken out of the middle of dispute resolution processes. Now, we finally have a workable system for protecting consumers.”

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Jeanette Contreras portrait

2021 rings in new health care protections for consumers

By NCL Director of Health Policy Jeanette Contreras

Surprise medical bills occur when patients unknowingly receive care from a provider who is not in their health insurance plan’s network. As the first COVID-19 vaccinations are administered, Congress has passed landmark legislation to ensure consumers needn’t worry about surprise medical bills from emergency medical services.

The passage of this legislation couldn’t come soon enough, as more than 476,000 Americans hospitalized with the coronavirus have already incurred exorbitant medical debt from COVID-19 treatment. Now, thankfully, 2020 will come to a close with renewed optimism in the American health care system.

This new law will also protect consumers from surprise billing from out-of-network ambulance and air ambulance trips, which can amount to tens of thousands of dollars in medical bills. Most patients are conscientious consumers, careful to find a doctor that accepts their insurance before making an appointment. However, in the case of an emergency, a patient faces the possibility of receiving care from an out-of-network doctor in an out-of-network hospital.

As Congress debated legislative fixes to surprise billing, the Administration showed political will toward finding a solution with the issuance of Executive Order 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients First, which includes principles on surprise billing. In a July 2020 report addressing surprise billing, the U.S. Department of Health and Human Services (HHS) further urged Congress to act, recognizing that 41 percent of insured adults nationwide were surprised by a medical bill in the past two years.

Following Executive Order 13877, HHS finalized a set of regulations to address price transparency for consumers. The first rule set to take effect on January 1, 2021, requires hospitals to publicly list standard charges for the items and services that they provide. The second rule, set to take effect in 2022, demands similar transparency from most health plans and issuers of health insurance coverage. These regulations offer consumers more control over their health care spending and better information as they shop and compare health coverage options for themselves and their families.

The new HHS regulations, coupled with the surprise billing legislation, amount to the greatest consumer protections in America’s health care system since the Affordable Care Act. Consumers with health insurance should not have to worry about surprise medical bills—especially during a pandemic. The health care system will be a little more consumer-friendly in 2021, which is good news for all of us.

NCL testified before CDC committee on COVID-19 vaccine recommendations

For immediate release: December 22, 2020

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC – The National Consumers League (NCL) testified before the Centers for Disease Control and Disease Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) this weekend on the equitable distribution of the Moderna vaccine and recommendations for consumer education on vaccine safety. In its testimony, NCL applauds the transparency and access afforded to the public throughout the COVID-19 vaccine approval process.

Equitable distribution:

NCL is encouraged that the Food and Drug Administration (FDA) has approved the Moderna vaccine and that the U.S. government will lead distribution efforts. Due to its ease of transport and storage, the Moderna vaccine stands to readily ship to rural and hard to reach communities. NCL calls on federal health officials at the helm of distribution to facilitate access to the Moderna vaccine to medically underserved areas.

Safety and efficacy:

NCL expressed its trust in the FDA and CDC’s robust inter-agency collaboration to continue ongoing, post-market surveillance of adverse events among recipients of the COVID-19 vaccine and to inform consumers of any additional safety recommendations. NCL urged the CDC to educate consumers about potential reactions and side effects, as this transparency will further encourage the compliance necessary to achieve herd immunity. The vaccine is expected to induce flu-like symptoms after the initial dose and this may deter some patients from getting their second dose if they aren’t warned about what to anticipate.

Vaccine adherence:

NCL encouraged the CDC to conduct culturally competent and inclusive public messaging about vaccine safety to ensure that communities of color and persons with limited English proficiency are informed and feel empowered in their decisions to vaccinate. Adding to the complexity of administering the vaccine, public health officials will need to ensure the completion of two doses in a series. This stands to create additional challenges because evidence has shown that when a vaccine involves multiple doses, nearly 50 percent of patients fail to return for a second dose.

Equitable allocation:

NCL applauds ACIP’s recommendations to prioritize vaccinations for health care workers and long-term care facility residents in Phase 1a. Now that there are two approved vaccines, NCL calls on ACIP to prioritize recommendations to vaccinate the approximately 87 million non-healthcare essential workers unable to work from home—such as bus drivers and grocery workers—who are at higher risk of exposure. Racial and ethnic minorities make up more than 40 percent of the essential workforce and are the backbone of many essential industries. The pandemic has illustrated that low-income minority communities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death.

Persons who recovered from COVID-19:

Lastly, over 18 million individuals in the U.S. have been infected with the coronavirus. It is expected that individuals who recover will acquire some natural immunity to COVID-19. Individuals who recover from the coronavirus want to know if they are protected from reinfection and for how long. We call on the CDC to expedite developing vaccine recommendations for persons who’ve recovered from COVID-19.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

NCL statement on White House pressure to approve COVID-19 vaccine

For immediate release: December 11, 2020

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC – In just a matter of days, we could potentially have an FDA-approved COVID-19 vaccine ready for rollout. Now more than ever, the public needs to see the evidence of a transparent and deliberate process to ensure the safety of a vaccine. NCL has actively participated in the vaccine approval process, testifying before the Centers for Disease Control and Prevention and the Food and Drug Administration’s (FDA) vaccine advisory committees to ensure that the nation’s most vulnerable consumers are considered at each step of the approval process. The race to a vaccine is a critical one, consumers should not be discouraged by the careful deliberation of the States’ vaccine approval process, but should instead be encouraged that the U.S. is following deliberate, well-established protocol to vet and review the data. 

NCL is amongst the stakeholder groups advocating for increased scrutiny of the data, particularly citing reports from the U.K. about adverse reactions to the Pfizer vaccine among people with severe allergies. We expect that the FDA will be aware of these concerns and call on the agency to perform ongoing post-market surveillance to ensure public safety. Consumers should rely on continuous guidance regarding potential adverse events, as this will be critical to ensuring vaccine confidence. 

NCL has continually recognized the integrity of the career-scientists at the FDA who are entrusted with ensuring the safety of the U.S. drug supply and applaud their demonstrated commitment to fostering public trust throughout the COVID-19 vaccine development, evaluation, and approval processWe have great confidence in the FDA’s rigorous approval methods and trust that the agency will issue an Emergency Use Authorization only after careful consideration of the available safety and efficacy data.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.