Maternal vaccines: Safe for mom and baby

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

In the last few weeks, I’ve noticed an old friend from high school, a mother of an infant, consistently posting anti-vaccine content to her social media. Her posts, which were initially mere reflections, have transformed into full-on conspiracy theories about the safety of the COVID-19 vaccines and cast doubts about to the speed of their approval.

At first, I bypassed these posts, not wanting to create tension with an old friend. However, as they became more inflammatory, I realized that she was essentially spreading falsehoods about vaccines. As a public health advocate, I decided to reach out and offer my perspective. I assured my friend that vaccines have gone through rigorous testing and approval by multiple regulatory bodies in order to be deemed safe for widespread use.

She argued that she went through her entire pregnancy without being vaccinated and that she felt mask-wearing and proper hygiene would offer sufficient protection, ending her thoughts with, “maybe I’m crazy, because I think with this big push, that maybe there’s something else in it that the public doesn’t know about.” While my friend may need more and better information to convince her of the benefits of getting vaccinated, it’s important to know what the science says about vaccine safety for expectant or new mothers.

Per the  *Centers for Disease Control and Prevention (CDC) guidance, vaccines are an extremely safe and effective method of avoiding communicable diseases. Certain *vaccines for pregnant people not only help the mother stay healthy, but the antibodies developed in response to the vaccine penetrate the placenta and offer protection to the unborn child as well. If you are pregnant or planning on becoming pregnant, the specific vaccines you should receive depend on your age, lifestyle, medical conditions, and other factors. You should consult your doctor for the most up to date information.

The *CDC recommends that pregnant women receive two vaccines during the gestational period, the inactivated flu (injection) vaccine, and the tetanus, diphtheria, and pertussis or Tdap vaccine. Vaccines that are not recommended during pregnancy include the nasal influenza vaccine, the human papillomavirus (HPV), measles, mumps, and rubella (MMR), and Varicella (chickenpox) vaccines. Some travel vaccines, such as yellow fever, typhoid fever, and Japanese encephalitis are not recommended during pregnancy, but can be administered based on a health provider’s advice.

Vaccines also offer immense protections via lactation. With exception to live virus vaccines like smallpox and yellow fever, most vaccines provide safety to new moms and babies during pregnancy and postpartum via lactation. There is also evidence that breastfed babies respond better to routine pediatric immunizations than those on formula. The CDC has provided a chart of vaccines that are safe for use in lactation.

An even more convincing case for maternal vaccines are the protections offered against COVID-19.  Data  shows that pregnant people are more vulnerable to severe illness with COVID-19. *COVID-19 complications during pregnancy include hospitalization, intensive care, or the use of a ventilator or special equipment to breathe, or illness that results in death. Additionally, pregnant people with COVID-19 are at increased risk of adverse pregnancy outcomes, such as preterm birth.

The CDC has found the *COVID-19 vaccine to be safe for pregnant and lactating people. The CDC and Food and Drug Administration (FDA) have safety monitoring systems in place to gather data regarding adverse reactions to vaccines. Currently, neither the mRNA (Pfizer and Moderna) nor the viral vector (Johnson & Johnson) COVID-19 vaccines have demonstrated adverse outcomes and have been deemed safe for use in pregnant populations. While more data are needed to assess potential adverse reactions in pregnant individuals before or early in pregnancy, the agencies have vowed to closely monitor that information.

Expectant and new mothers are often faced with a host of difficult decisions about their own health and the health of their babies. Adding to the uncertainty brought on by COVID-19, it’s understandable that people are apprehensive. Through compassionate and non-judgmental conversations, we can help encourage vaccine confidence. Even though my friend seems adamant in her stance, I still see an opportunity to turn the tide. There are so many great resources to help address these concerns, like these ones by the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians. It’s up to everyday immunization advocates like you and me to quell concerns related to vaccine safety to ensure our friends and loved ones are safe.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

June 10 testimony before FDA’s Vaccines and Related Biological Products Advisory Committee

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

Washington, DC—Today, June 10, 2021, NCL’s Associate Director of Health Policy Nissa Shaffi, testified before the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, about the ongoing rollout of COVID-19 vaccines for pediatric populations. Her testimony appears below:

Arnold Monto, M.D., Acting 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-0458; for Vaccines and Related Biological Products Advisory Committee

Good afternoon. My name is Nissa Shaffi, and I am representing the National Consumers League (NCL). I have no conflicts of interests regarding today’s remarks.

The National Consumers League was founded in 1899, by the renowned social reformer Florence Kelley. General Secretary Kelley’s support of vaccinations played a key part in mitigating a critical smallpox outbreak towards the end of the 19th century, and her stalwart advocacy for immunizations has informed NCL’s bedrock principles for vaccine education, confidence, and safety.

122 years later, we are honored to persist in our pursuit to advance vaccines as vital public health interventions, and we extend our gratitude to the Vaccines and Related Biological Products Advisory Committee for the opportunity to present comment during this public hearing session.

Emergency Use Authorization (EUA)

NCL appreciates that the FDA recognizes that Emergency Use Authorization is not intended to replace the rigor of full approval, and that randomized clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment.

The diligent review and public engagement that went into the EUA process for the COVID-19 vaccines currently available have helped our nation reach key milestones in immunizations.

As our adult populations have benefitted from these critical public health efforts, we are energized to extend that momentum towards our youngest citizens. Through our education and outreach of consumers, we support FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine via an EUA to help prevent the spread of the virus in pediatric populations.

Safety and Effectiveness

We have great trust in the FDA’s safety monitoring systems and call on the Agency to perform ongoing post-market surveillance to ensure the vaccine’s continued safety and efficacy.

As we’ve observed with recent vaccine safety concerns, consumers rely heavily on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine. We call on the FDA to continue to sustain its robust interagency collaboration as we endeavor to vaccinate the nation.

Pediatric Population Vaccine Uptake

Although children are at a lower risk of COVID-19 compared to adults, and tend to experience milder symptoms, pediatric populations now account for 22% of new COVID cases, compared to 3% last year. As with adults, children and adolescents with underlying chronic health conditions are at higher risk for COVID-19-related hospitalization and death.

The absence of a vaccine for pediatric populations will lead to continuing transmission that will consistently put children at risk for infection.

Furthermore, vaccine uptake for routine pediatric immunizations have declined dramatically during the pandemic. It is essential for public health officials, advocates, and parents to ensure that children are up to date with their vaccines, and that children eligible for the COVID-19 vaccine receive their shots. Data shows that the COVID-19 vaccine currently available for children ages 12-15 is safe and effective, and has been recommended to be co-administered along with routine pediatric vaccinations.

Health Disparities

While COVID-19 has impacted the entire country, it has largely devastated communities of color. Children of color, specifically Black and Hispanic youth, have been especially vulnerable. This has been even more apparent with the prevalence of Multisystem inflammatory syndrome in children, a rare but serious COVID-19-associated condition, that has been observed in children 1- 14 years of age, 64% of which were reported to be Black or Hispanic.

To achieve meaningful herd immunity, we will need to ensure that children have access to a safe and effective COVID-19 vaccine, and also consider the unique disparities that children of color experience in the face of the pandemic.

Thank you to the Committee 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

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 concerned as Senate bill puts consumers at risk from unregulated CBD

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

Washington, DC—On May 19, Senators introduced the Hemp Access and Consumer Safety Act (S. 1698) which directs the U.S. Food and Drug Administration (FDA) to regulate hemp-derived cannabidiol (CBD) products as dietary ingredients or supplements. The National Consumers League (NCL) has long been concerned about the risks posed to consumers by unapproved cannabis-derived products. There is little research on the health and safety of CBD products, and as such the NCL does not support any legislation that would bypass the FDA’s regulatory authority and rigorous scientific review.

Currently, manufacturers and distributors of products containing CBD can petition the FDA for review and approval of a new ingredient as a dietary supplement (21 U.S.C. 350b). This approval process requires manufacturers and distributors to submit scientific data showing that the product is generally regarded as safe (GRAS). “Not only is there insufficient data to designate CBD products as GRAS, the FDA needs further data to determine safe dosage and concentration levels in order to set manufacturing and labeling requirements that ensure consumer safety,” said Jeanette Contreras, NCL Director of Health Policy.

As demonstrated in a white paper published by NCL, companies selling CBD products often focus their research efforts on weak and inexpensive studies, and then use the results for marketing purposes. “Current studies have not enhanced our scientific understanding of CBD, and policymakers should focus on incentivizing further clinical studies to bring new proven medical treatments to patients,” said Contreras. By mandating the FDA to regulate CBD as a dietary ingredient, S. 1698 would only further incentivize CBD manufacturers to forego rigorous clinical trials and the development of FDA-approved medicines. Easier approval as a dietary supplement will disincentivize real scientific research into any potential health benefits or risks of CBD products.

Under S. 1698, CBD manufacturers that make unwarranted claims of treating medical issues will seek expedited approval for their products as dietary supplements, rather than as drugs. We should be encouraging the development of new cannabis-derived medicines that have gone through the rigorous processes of randomized controlled trials and FDA approval. Considering the lack of existing research on CBD, this bill classifying CBD products as dietary supplements would irresponsibly lead to increased consumption of these products and limit the future development of cannabis-derived FDA approved treatments—while putting consumers at risk.

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About the National Consumers League

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.

AAPI Heritage Month: The ‘Model Minority Myth’ and its negative impact on health disparities

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

The month of May marks Asian American Pacific Islander (AAPI) Heritage Month, a time where we celebrate, honor, and reflect upon the vast contributions members of the AAPI community have made to our collective society. The AAPI community comprises more than 23 million individuals with origins from 20+ countries, who speak more than 200 languages or dialects, and it is the fastest growing subset of the population.

The AAPI community is one that harbors complex cultural and historical narratives, and varied generational traumas, such as colonialism, war, and the trials of immigration. The AAPI community’s resilience against these factors, while commendable, has contributed to the myth of the “Model Minority,” and has led to a host of social and health inequities. The model minority myth is one rooted in “positive” stereotypes. It is the assumption that deems AAPI individuals as docile, over-achieving, high-earning, and well-educated—denoting AAPI individuals as exemplars to other communities of color. While at face value these qualities are considered desirable, they tend to relegate an astoundingly diverse community to a monolith, resulting in a detrimental impact on their overall wellbeing.

Due to these unrealistic cultural standards, AAPI consumers face a host of internal and external barriers when interacting with the healthcare system, and are often deterred from seeking necessary care. According to a 2019 Substance Abuse and Mental Health Services Administration (SAMHSA) study, AAPIs have the lowest help-seeking rate for mental health services than any racial or ethnic group. Cultural identity, faith, stigma, and fear contribute to lower utilization of mental health services. Other systemic barriers such as disparities in access to culturally competent care also influence underutilization.

AAPIs are also the only racial or ethnic group for whom cancer is the leading cause of death. Despite facing a confluence of cancer risks, due to unique exposures and environmental factors, AAPIs are screened significantly less for cancers compared to other Americans. Because the model minority myth implies that AAPIs are “better off,” screening, public health, and cultural needs are often masked.

This is best demonstrated by the case of Susan Shinagawa, a leading Asian American breast cancer activist and cancer survivor, whose multiple attempts to obtain screening for a suspected lump in her breast was denied, due to the belief that “Asian women don’t get breast cancer.”

The pandemic has illuminated disparities experienced by AAPIs, such as being overrepresented among frontline healthcare workers, increasing risk of exposure to COVID-19. As a result, case fatality among AAPI healthcare workers is three times greater than their white counterparts. AAPIs also tend to live in multigenerational households, more than other minorities, where 29 percent of AAPI households consist of two or more generational families, further increasing risk of household transmission. Approximately 30 percent of AAPIs have limited English proficiency, augmenting overall barriers to care and government relief resources. This disparity has been especially cumbersome for AAPI consumers seeking telehealth, an integral part of our lives throughout the pandemic, where 50 percent of AAPIs with limited English proficiency were less likely to utilize telehealth than individuals with English proficiency.

One way to dispel the model minority myth and encourage greater health equity for AAPI consumers, is to disaggregate racial and ethnicity data in research studies. Disaggregation of data simply means breaking data into smaller, more precise segments. For example, recent United States census data reveal that AAPIs were less likely overall to live in poverty. However, when that data is disaggregated, it shows that Hmong, Bhutanese, and Burmese Americans experience higher incidence of poverty, in contrast to the greater AAPI community. Disaggregating data not only paints a more accurate picture regarding the different social and demographic characteristics that impact varied health statuses within the community, it influences proper allocation of community resources.

Disaggregation of data can only also happen when there is a prioritization of AAPI participants in research. The most illuminating example of this is highlighted by a 2019 study, which revealed that in the past 26 years, only 0.17 percent of the National Institute of Health’s (NIH) budget was allocated to research focused on the AAPI community. These gaps in funding have led to a paucity in data necessary for public health officials and policy makers to meaningfully address AAPI-specific health disparities. A lack of representation in research impacts how AAPI consumers seek, access, and utilize healthcare. It also impacts the greater community public health goals, impacting health equity for everyone.

Greater investments in culturally competent care, AAPI-focused research, and preventive services, such as screening and early intervention, can help improve overall health outcomes for AAPI consumers. The National Consumers League commends the Biden-Harris Administration’s efforts, such as the COVID-19 Hate Crimes Act and the establishment of a *subcommittee on Structural Drivers of Health Inequity and Xenophobia, which aim to ensure the federal government’s response to COVID-19 mitigates anti-Asian xenophobia and bias. These measures are critical in addressing structural inequities experienced by the AAPI community, enhancing community health outcomes as a whole.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

NCL supports the Protecting Seniors through Immunizations Act of 2021

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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) is delighted to support the Protecting Seniors through Immunizations Act of 2021 (H.R. 1978/S. 912), introduced by Senators Mazie Hirono (D-HI), Tim Scott (R-SC), Sheldon Whitehouse (D-RI), and Shelley Moore Capito (R-WV), and Representatives Ann Kuster (D-NH) and Larry Bucshon (R-IN). The bill would expand access to immunizations for seniors by eliminating cost sharing for vaccines covered under Medicare Part D.

The legislation would eliminate out-of-pocket costs for all vaccines recommended by Centers for Disease Control and Prevention (CDC) and covered under Medicare Part D. This would apply to crucial immunizations such as the Shingles and tetanus, diphtheria, and pertussis, or Tdap, vaccines, along with future vaccinations. Currently all CDC recommended vaccines are covered with no out-of-pocket costs under private insurance, Medicaid, and Medicare Part B. Unfortunately, Medicare beneficiaries must often pay out-of-pocket costs of up to $160 for vaccines covered under Part D.

“As healthcare costs continue to skyrocket, policymakers should support legislation that eliminates financial barriers for Medicare beneficiaries to get their CDC recommended vaccines,” said NCL Director of Health Policy Jeanette Contreras. “Research shows that higher cost-sharing means fewer seniors will elect to receive their vaccines. By eliminating out-of-pocket costs for immunizations, older Americans will be better protected from vaccine preventable illnesses.”

More than 50,000 American adults die from vaccine-preventable diseases every year. Among other provisions, this bill would increase education about vaccines for Medicare beneficiaries and would authorize a study to find ways to boost adult vaccination rates. These steps are important at a time when misinformation regarding vaccine safety is spreading rampantly throughout society. Improving access to and utilization of vaccinations will enhance overall health outcomes and help to address existing racial and socioeconomic health disparities.

“Vaccines are amongst the most effective public health measures at our disposal. Routine immunizations can prevent diseases that have the potential to cause severe disease and wreak havoc on our most vulnerable communities,” said Contreras. “We urge Congress to pass the Protecting Seniors Through Immunization Act, to ensure greater equity in access to vaccines, in turn protecting the most vulnerable members in society from unnecessary and easily preventable illness and death.”

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About the National Consumers League

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

Como detectar el COVID-19 en casa

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By NCL Director of Health Policy Jeanette Contreras

Tras la efectiva campaña de vacunación, las pruebas de detección serán claves para seguir evitando contagios del coronavirus y resumir a la normalidad. Reconociendo que estamos en buen camino para controlar la pandemia del coronavirus, los estados están eliminando las restricciones de la cuarentena. Pero el 11 de mayo, el director de la Organización Mundial de la Salud (WHO, por sus siglas en inglés) nos alerta que seguimos en una situación peligrosa porque los estudios de la variante que se ha propagado en la India indican que esta se transmite más fácilmente y provoca una enfermedad más grave.

Expertos de salud siguen cuantificando y analizando los casos positivos para vigilar las variantes. Una recomendación importante es seguir administrando las pruebas de detección de COVID-19 aunque las personas sean asintomáticas. En abril, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) autorizó varias pruebas de uso personal que detectan el COVID-19 y que se pueden comprar en las tiendas y farmacias como CVS, Walgreens y Walmart sin receta médica .

Para los fines de mayo esperamos ver estas pruebas caseras disponibles en todo el país. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) *ofrecen consejos sobre cómo usar un kit de recolección y realizarse la prueba en casa. Todas funcionan igual: toma el espécimen de tu nariz o de saliva, envíala al laboratorio por correo, y recibirás los resultados por el internet en un par de días.

Como todavía falta vacunar a los niños menores de 12 años, a las personas que por su religión no han sido vacunados, y personas con enfermedades graves que no se les permite vacunarse, los expertos de salud pública temen no poder eliminar el coronavirus por completo. Una de cada tres personas en el EE. UU. no confía en la vacuna. Y si la mayoría de la población no se vacuna, el COVID-19 será endémica en nuestro país. Solo el país de Israel ha logrado llegar a la inmunidad de grupo- incluso jóvenes de 16 años de edad se han vacunado.

Con acceso a estas pruebas personales, organizaciones y empleadores pueden comprar cantidades de kits de recolección para uso en sus comunidades. Las *escuelas y lugares de trabajo ya están estableciendo programas de pruebas para detectar el COVID-19 rápidamente. Para proteger los más vulnerables en nuestras comunidades, todos los casos positivos se deben reportar al departamento de salud del condado en donde vives y al estado para iniciar un rastreo de contactos. Es importante saber dónde se inició el contagiado y con quien ha tenido contacto cercano las personas infectadas.

Aunque el CDC afirma que *las personas con la vacuna completa que no presentan síntomas del COVID-19 no necesitan hacerse la prueba de detección después de haber estado expuestas a una persona contagiada con el COVID-19, es muy posible que personas que quieran viajar tengan que mostrar una prueba de detección negativa para entrar a otro estado o país. Mientras que no haya un pasaporte de vacunas, muchos países requirieran que los visitantes demuestren una prueba de COVID-19 negativa para ingresar a su territorio. El CDC tiene un *planificador de viajes que las personas pueden utilizar para buscar información sobre el COVID-19 en las comunidades estatales, locales, territoriales y tribales que atraviesen en ruta a sus destinos.

La facilidad de obtener pruebas caseras nos ayudar a detener la propagación del COVID-19 e identificar los orígenes de contagio. Poder hacer un seguimiento de contactos en las comunidades afectadas no solo puede prevenir enfermedad, pero también controlar la evolución de nuevas variantes del COVID-19. La conveniencia de poder hacerse la prueba del coronavirus desde la comodidad de la casa y sin receta de un doctor significa tener un mejor control del bienestar de cada persona en nuestras comunidades.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

The decline in COVID-19 testing nationwide could derail pandemic response wins

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

COVID-19 testing has been a critical component of the nation’s pandemic response, as health officials monitored the virus’s progression and set policies that supported back-to-school and return-to-work initiatives. Increased testing capacity has enabled our most essential industry sectors to resume activities that continue to carry us through the pandemic. However, as vaccines become more accessible and we surpass initial goals for population-wide immunizations, testing has declined by 35 percent daily since mid-January.

Testing provides a reliable snapshot into the virus’s trajectory that allows for proper allocation of vital resources (e.g., supplies, personal protective equipment (PPE), and medical equipment) and essential personnel. Data from testing rates are also critical for vaccine manufacturers, as they evaluate how the virus is mutating and further efficacy of the vaccine. The uptick in vaccinations, while incredibly promising, may have induced an inflated sense of security and diminished caution towards the virus. However, in the midst of rising variants, the decline in testing may very well be the Trojan horse that derails national efforts to combat the virus.

Testing has also declined in part due to a shift in focus to getting vaccinated. While vaccines are equally important, we need adequate COVID-19 testing for public health surveillance purposes. There needs to be sufficient capacity and public health messaging in place to encourage individuals who have potentially been exposed to SARS-CoV-2, or coronavirus, to get tested immediately.

Dr. Nasia Safdar, Medical Director for Infection Prevention at UW Health, states “we are seeing a decline in testing,” she said. “If we see the numbers continue to decline sharply, at some point then it may not be worthwhile to do widespread testing, but we’re certainly not there yet.” Without these measures, our healthcare system will be rendered unequipped to deal with dormant and emerging threats, like potential outbreaks and continuous mutations of the virus.

There are a couple of strategies that could help us get a hold on precipitous testing rates. It is estimated that a national program for universal mass testing for unvaccinated people would cost a few billion dollars a week—an amount that still presents a cost-benefit when considering potential shutdowns. The American Rescue Plan has appropriated $50 billion for expanded testing, which could help the situation significantly.

Another aspect of the problem is a lack of testing sites. With so many resources currently devoted to expanding vaccination sites at pharmacies and hospitals, people need places to get tested. Greater corporate involvement in the response could be a potential avenue for increasing capacity.

Finally, the Food and Drug Administration (FDA) is working to advance development and approval for over-the-counter (OTC) and point-of-care (POC) tests. Obtaining a greater number of FDA-approved OTC and POC COVID-19 tests could help address issues with logistics and access, and would give schools, workplaces, and communities more options for reliable and accurate screening.

The pandemic is far from over and experts predict that COVID-19 will likely be endemic, meaning it will be detected regularly, even if within small pockets of the population. We need all possible public health interventions at our disposal to ensure that we can effectively limit the spread of the virus and preserve ongoing plans to reopen the economy so that we can start the process to sustainably reintegrate back into society.

Dr. Safdar further emphasized, “the vaccines are great as they are, they’re not 100 percent. There will be a certain number of people that will…contract the illness despite having been vaccinated. It might be a milder condition which is very welcome news, but nonetheless, to make a diagnosis and figure out what treatment is required, you have to get a test.” Testing continues to be a simple, yet powerfully effective measure to prevent the massive spread of COVID-19 and we must persist in our efforts towards early detection.

NCL statement regarding efforts to ban menthol tobacco products

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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) commends the Food and Drug Administration (FDA) for its efforts to ban menthol cigarettes and flavored cigars. The FDA states it will work to keep menthol flavored tobacco products off the market by enforcing a potential ban against manufacturers, distributors, wholesalers, importers, and retailers. The ban on menthol-flavored tobacco products is a historic measure to address health disparities present in vulnerable communities as a result of unfair marketing practices.

Menthol cigarettes continue to be heavily advertised, widely available, and priced cheaper in Black communities. Tobacco manufacturers have long deployed tactics that lure and entice young people with their menthol-flavored tobacco products, consequently contributing to a gateway for children to initiate cigarette smoking.

“For generations, tobacco companies have disproportionately targeted communities of color with advertisements of highly addictive menthol flavored tobacco products”, said NCL Executive Director, Sally Greenberg. The sales resulting from these predatory marketing practices have ravaged vulnerable communities, particularly African American youth. We applaud this Administration’s effort to protect consumers, particularly from the most marginalized areas of society, from the adverse effects of menthol-flavored tobacco products.

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About the National Consumers League

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.

Consumer group urges FDA and CDC to remain vigilant in enforcing hand sanitizer standards

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April 27, 2021

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

Washington, DC—This week, the National Consumers League (NCL) wrote a letter to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), urging them to remain vigilant on the enforcement of proper manufacturing and distribution of hand sanitizers as we continue to fight the COVID-19 pandemic.

During the initial surge in demand for hand sanitizers, the federal government relaxed certain regulations in order to get over-the-counter products into consumers’ hands. The combination of a need for an immediate ramp-up of hand sanitizer distribution and reduced oversight led to a concerning trend of what NCL believes is a case of mislabeling — and unfortunately misleading — information regarding hand hygiene products.

While local and small businesses stepping up to produce products for their communities is admirable, hastily manufactured hand sanitizer operations have resulted in lower efficacy rates, with even some reports of products being made with dangerous ingredients. As a result, the FDA has currently identified 230 hand sanitizer products marketed in 2020 as unsafe or ineffective.

NCL commends the FDA and the CDC for their ongoing efforts to keep the American people safe. But the fight against this virus is far from over, and under-regulated hand sanitizer production and distribution will only prolong this public health crisis.

The following statement is attributable to NCL Executive Director Sally Greenberg:

“For more than a century, the National Consumers League has fought for access to quality products, honest labeling, and safe, effective medicines for American consumers and workers. And leaving this growing issue alone would be a disservice to the many people NCL has worked so hard to protect.”

NCL urges the FDA and the CDC to enforce the law and hold accountable those businesses engaged in the production and distribution of poorly manufactured and dangerous hand sanitizer products.

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About the National Consumers League

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 supports permanently lifting restrictions on access to mifepristone

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April 26, 2021

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) applauds the U.S. Food and Drug Administration (FDA) for moving to increase access to the abortion pill, mifepristone. As of April 12, the FDA will temporarily allow mifepristone to be dispensed by mail for the duration of the COVID-19 public health emergency. Patients are now able to obtain a safe and effective abortion pill through a telemedicine consult, without risking exposure to COVID-19 with an in-person visit.

Though mifepristone has been used in the United States for more than 20 years to safely and effectively end early pregnancies and treat early miscarriage, the FDA has placed particular restrictions on mifepristone when it’s used for pregnancy termination. Unlike other medications, patients can only obtain the abortion pill directly from a certified medical provider who has a prescriber agreement with the drug manufacturer.

In the early months of the pandemic, the American College of Obstetricians and Gynecologists (ACOG) and other provider groups filed a lawsuit that challenged these restrictions and subsequently won the suit to temporarily lift the restrictions to abortion care during the pandemic.

“This was a win for women’s health, but more importantly for women who live in rural and medically underserved communities who rely on telemedicine for their health care,” said NCL Executive Director Sally Greenberg.

The win, however, was short-lived. In January 2021, the Supreme Court ruled in favor of an appeal by the Trump Administration that put an end to the temporary lift, effectively restricting patient access to medication abortion care.

On April 11, Acting FDA Commissioner Janet Woodcock, sent a letter to ACOG and the Society for Maternal-Fetal Medicine (SMFM), stating that the FDA reviewed recent evidence and found that using telemedicine to provide abortion pills would not increase risks and would help patients avoid potential exposure to COVID-19.

“While we welcome this temporary change, we urge the FDA to continue to review the evidence and scientific data and permanently lift unnecessary restrictions beyond the public health emergency. If it’s safe enough to prescribe through telemedicine during COVID, then it is clearly safe enough to use beyond COVID,” said Greenberg. “We hope the FDA will consider the vast health and socioeconomic benefits that increased access to medically safe abortion via telemedicine would pose for women who rely on this essential reproductive service.”

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About the National Consumers League

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.