The National Consumers League commends the FDA’s decision to ban JUUL e-cigarettes

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June 27, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— NCL applauds the FDA’s decision to ban JUUL e-cigarettes and believes that this is a significant first step towards curtailing the ongoing vaping epidemic. After a blistering and aggressive social media campaign in 2017, JUUL emerged at the forefront of the e-cigarette industry. Targeted advertisement towards youth and the production of fruit flavored nicotine pods highlighted the company’s flagrant disregard for public health and safety. JUUL is a central contributor to the rising rates of nicotine addiction in youth, according to the FDA. The FDA did its job in banning the company’s further advertising and sale of vaping products.

A large increase in the use of e-cigarettes among youth has occurred in recent years. Research indicates that vaping among high school students rose from 2.4 percent in 2019 to 26.5 percent in 2020 – a 1000 percent increase. Eight out of ten teenagers use flavored products and an estimated 59 percent of high school and 54 percent of middle school students who vape prefer JUUL as their brand of choice. As a consumer watchdog, NCL finds JUUL’s deliberate youth-targeted marketing and lack of health transparency shocking. This has led to our children purchasing their products without fully understanding the risk vaping poses to their health.

The FDA’s assessment of the data JUUL provided for their application to sell their products was that it was “insufficient and conflicting”. The agency also expressed concern about the potential toxicological risks of JUUL products. The adverse effects of e-cigarette usage are known. The immediate side effects include, but are not limited to, shortness of breath, headaches, dizziness, and coughing. Long-term, the vaporization of e-cigarette juice pushes ultrafine particles deep into the lungs. This can lead to damaged lung tissue, respiratory issues, reproductive complications, and harm adolescent neurodevelopment.

It is clear that the vaping epidemic jeopardizes consumers’ health and must be addressed. According to the CDC, tobacco product use is the leading cause of preventable disease, disability, and death in the United States. As an organization dedicated to advocating for consumer health and safety, NCL believes that the FDA’s JUUL ban will help mitigate this public health crisis, but for the sake of our children, regulatory agencies and policy-makers must continue to push forward in addressing this issue.

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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 denounces today’s SCOTUS ruling overturning Roe v. Wade

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June 24, 2022

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, (202) 207-2831

Washington, DC— Almost 50 years since the Supreme Court ruling in 1973, Roe v. Wade, which guaranteed a woman’s constitutional right to an abortion, the protections provided by Roe were overturned today by the Supreme Court of the United States (SCOTUS). The ruling is a devastating blow to women, girls, and their families who have long fought for equal access to reproductive health services – health services which includes access to safe abortion, says the National Consumers League (NCL).

“Many women will suffer and will suffer unnecessarily from this egregious ruling by SCOTUS,” says Sally Greenberg, Executive Director of NCL. “This decision is an attack on poor women or low-income woman, who represent 75% of abortion patients,” according to the Guttmacher Institute, a research group that supports abortion rights.

The final opinion is strikingly similar to the draft that was leaked in May of this year and authored by Justice Samuel Alito. In the opinion, Alito writes, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

In the wake of this June 24 ruling, 26 states are expected to ban all or nearly all abortions.

Justice Clarence Thomas, in his concurring opinion overturning Roe v. Wade, laid out a vision that fomented fears about what other rights could disappear: the same rationale that the Supreme Court used to declare there was no right to abortion, he said, should also be used to overturn cases establishing rights to contraception, same-sex consensual relations and same-sex marriage.

In their joint dissent, the three liberal justices of the court, argued that the ruling will affect “countless life decisions.” They also noted that, “It says that from the very moment of fertilization, a woman has no rights to speak of.”

“NCL applauds responses from many employers, including JPMorgan Chase, which is clarifying its health care benefits in the wake of the Supreme Court overturning Roe v. Wade on Friday, saying that abortion has long been a covered service for the bank and starting in July will be included under the company’s health care travel benefit,” says Greenberg. “We applaud Levi Strauss & Co — the 169-year-old jean company — stands strongly against restricting access to abortion and said it will continue to protect employees — making sure they have access to the care they need regardless of where they live.

NCL also thanks officials in many states and the District of Columbia that have pledged to provide abortion access and safe havens including New Hampshire, Michigan, New York governors along with New York Attorney General Letitia James and DC Mayor Muriel Bowser.

In his address to the nation today, President Joe Biden expressed his disappointment over the SCOTUS ruling: “This is a sad day for the country in my view, but it doesn’t mean the fight is over.” He also added that his administration will use all its appropriate lawful powers and that “Congress must act.” He went on to say, “with your vote, you can act.”

NCL believes that women’s reproductive rights is fundamental and must be protected; this radical decision by the Supreme Court is vastly out of step with American public opinion and a disastrous for women’s rights and freedoms.  We will continue to advocate for federal, state and local protections for women across the country, in keeping with NCL’s long history of championing the rights of women and children, especially those among us who are most vulnerable.

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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 provided oral testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of new pneumococcal vaccine recommendations for adults 65 years of age and older

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June 22, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— On June 22, 2022, NCL’s Health Policy Associate Milena Berhane provided oral testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of new pneumococcal vaccine recommendations for adults 65 years of age and older. NCL comments appear below.

Thank you, Dr. Lee. My name is Milena Berhane, and today I am representing the National Consumers League. Since NCL’s founding in 1899 by social reformer Florence Kelley, we have advocated for the critical role immunizations play in the preservation and improvement of public health. We extend our gratitude to this Committee for the opportunity to present public comments.

According to the National Foundation for Infectious Diseases (NFID), pneumococcal disease is a leading cause of serious illness throughout the world. In the US, nearly 50,000 people die each year from pneumonia. The death rate is even higher in those age 65 years and older. Vaccination is a critical public health measure for preventing disease, hospitalizations, and death, so it is critical that access to the pneumococcal vaccine is expanded.

We are concerned about the lack of clarity surrounding the current ACIP recommendations regarding the pneumococcal vaccine, for adults ages 65 years of age and older. It is critical that the recommendations for this age groups are clear, so that patients and providers are better able to understand who should receive which vaccine, and when. The pneumococcal vaccine will continue to be a safe and effective measure in protecting Americans from disease, and it is imperative that older adults are able to receive them.

Having clear recommendations for adults 65 years of age and older is also critical in addressing health equity issues, especially among older Black and Latinx populations that already face issues in lacking access to health care. Pneumococcal vaccine uptake needs to increase in these populations so that currently existing health disparities are not further exacerbated. Therefore, in order to promote health equity among all older adults and increase vaccination rates, it is critical that clear recommendations are provided for this age group.

The National Consumers League recognizes the extreme importance of immunizations in protecting the health and safety of all Americans, and will continue its efforts to increase vaccine confidence and uptake across lifespan. We look forward to the upcoming recommendations by this committee regarding the pneumococcal vaccine for older adults.

Thank you.

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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 backs the Pregnant Workers Fairness Act to curtail workplace discrimination

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June 21, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League (NCL) believes it is imperative that the Pregnant Workers Fairness Act (H.R. 1065), introduced by Representative Jerrold Nadler (NY-10), is enacted by Congress. In the uphill battle for equity in the workplace, NCL views H.R. 1065 as essential to protecting pregnant workers against unjustly losing their jobs and ensuring they receive pregnancy and post-partum accommodations to stay healthy.

Despite the steady decline of births in the United States since 2016, the number of federal pregnancy discrimination cases filed has steadily risen 67% from 2016-2020; and lawsuits are projected to set a new annual record this year. Workers lose approximately two thirds of the cases filed due to gaps in the current legal framework. H.R. 1065 will close loopholes in the Pregnancy Discrimination Act which requires pregnant workers to demonstrate that other workers are benefiting from comparatively similar accommodations before gaining approval from their employe

Women of color are more likely to work in physically demanding jobs, which also places the baby at  increased risk for preterm birth, low-birth weight, preeclampsia, birth defects, and more. While these health problems can be severe, long-term, and even deadly, studies illustrate how low-cost and basic accommodations for pregnant and postpartum workers can significantly reduce their risk. These include providing access to a chair to decrease time spent standing and basic accommodations for breastfeeding parents, such as a private space and additional break time to pump.

NCL strongly supports H.R. 1065. It will ask employers to provide reasonable accommodations for workers affected by medical conditions relating to pregnancy and childbirth. This will not only reduce health-related risks, but also improve workers’ economic security by safeguarding their jobs, income, health insurance, their baby’s health and more. Furthermore, by directly targeting discriminatory employment practices, H.R. 1065 represents a strong step in addressing sexism and racism in the workplace.

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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.

How did my medicine get here? Behind the scenes of the healthcare supply chain

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Many of us take for granted that our medicines are available at the pharmacy whenever needed. Despite the disruptions of the pandemic, U.S. healthcare supply chains remained incredibly resilient, safe and reliable.

Read more

The National Consumers League applauds the FTC’s decision to investigate PBMs

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June 14, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— NCL is deeply concerned by the lack of transparency and accountability surrounding pharmacy benefit managers (PBMs). The pervasive power of PBMs in the pharmaceutical industry has raised out-of-pocket costs for consumers and made it more difficult for them to receive essential medical treatment. NCL believes that the FTC’s investigation into PBMs represents a significant first step to addressing these issues.

The PBM system was originally intended to work on behalf of employers, health plans, labor unions, and states, to negotiate with drug manufacturers and process prescription drug claims. However, as their power and influence in the market has grown, there are major concerns that PBMs have increasingly prioritized profits, with consumers paying the price.

With the highest profit rates of any corporations in the prescription drug supply chain, PBMs have pocketed more than $450 billion in revenue in 2020, a stark $150 billion increase from eight years ago.  More concerning is that now, just three PBMs account for approximately 77 percent of all equivalent prescription claims.

PBMs often demand that drug companies provide them “rebates” or discounts to offer medicines as part of a drug benefit plan. While implemented to lower consumers’ out-of-pocket costs, these theoretical consumer savings seem to be nonexistent. In addition, to increase profits, PBMs intentionally steer consumers to higher-priced drugs, regardless of patient and treatment considerations.

As the most prominent PBMs have vertically integrated with the largest health insurance companies, they are employing monopolistic-like practices to increase prescription prices, limit consumer choice, and stifle market competition. NCL is encouraged that the FTC is taking preliminary action to hold PBMs accountable. In addition to this investigation, policy-makers and the FTC must continue to address the lack of regulatory oversight with the utmost urgency.

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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 supports the HELP Copays Act to make prescription drugs more affordable for consumers

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June 2, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League (NCL) is pleased to support the HELP Copays Act (H.R. 5801), introduced by Representatives Donald McEachin (VA-04) and Rodney Davis (IL-13). NCL stands with other aligned stakeholder groups, as part of the All Copays Count Coalition (ACCC), to protect patients from increased out-of-pocket medical costs and ensure that essential and life-saving drugs are readily accessible for all consumers.

NCL’s support of the Help Copays Act follows our organization’s long history of ensuring access to health care and a fair marketplace for consumers in the United States. Across the nation, the cost of drugs vital to patients’ health and wellbeing are unaffordable for many families. This has made co-pay assistance including discounts, coupon cards, vouchers, donations, and more, a key tool for enabling people to pay for their prescriptions. However, recent policies, mainly copay accumulator adjustment programs instituted by health insurance and pharmacy benefit managers (PBMs), block these contributions from patients’ deductibles and out-of-pocket maximums, resulting in more costs for consumers.

The pandemic has only exacerbated consumers’ struggles to afford the medical treatment they need. A recent report by HIV and HEP Policy Institute, discusses how the average family cannot afford to cover the deductibles of their employer-sponsored health plans. The Help Copays Act will require these health insurance plans to count all forms of co-pay assistance towards patients’ out-of-pocket maximums, making essential drugs and treatments more affordable.

NCL supports H.R. 5801 as a solution to reducing the barriers that prevent our nation’s most vulnerable from receiving the medicines they need to maintain and improve health outcomes. According to a survey conducted by the National Hemophilia Foundation, 80 percent of voters support this bipartisan effort to ensure that copay assistance counts towards patients’ deductibles. NCL strongly urges policy-makers to fulfill their obligation to their constituents and support The Help Copays Act as this legislation is an important step in improving access to health care and establishing a fair marketplace for all 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.

 

2022 Script Your Future Medication Adherence Team Challenge Winners

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The eleventh annual Script Your Future contest saw participation by 24 schools in 11 states and directly counseled nearly 7,000 patients nationwide

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

May 13, 2022

Washington, DC —Today, the National Consumers League (NCL) and its partners announced the winners of the eleventh annual Script Your Future Medication Adherence Team Challenge, a competition designed to engage pharmacy students and faculty across the nation by encouraging teams to develop creative initiatives to raise public awareness about the importance of medication adherence, vaccine confidence, and safe drug disposal.

This year’s winners are Wilkes University, Temple University, Western University, Northeast Ohio Medical University (NEOMED), University of Pittsburgh, and Touro University California.

The 2022 Script Your Future Team Challenge is an awareness campaign coordinated by NCL with support from its partners and the Challenge sponsors—Eli Lilly, Deterra, the American Association of Colleges of Pharmacy (AACP), the American Pharmacists Association (APhA), and the National Community Pharmacists Association (NCPA).

The Team Challenge was first established in 2011 to nurture adherence-minded values in future generations of professionals entering the workplace.

In 2022, our Team Challenge student health professionals spread messaging on the importance of medication adherence, vaccine confidence, and a new health topic: safe drug disposal. This year, over 1,000 future healthcare professionals and volunteers from across 11 states participated in the Team Challenge.

2021 Medication Adherence Team Challenge Winners

This year’s winners, selected from dozens of applications and 24 participating educational institutions, are listed below.

National Award Winner: Wilkes University Nesbitt School of Pharmacy – PA

Wilkes University is a fourth-time participant of the Script Your Future Team Challenge, and a first-time winner of the National Award! During the 2022 Team Challenge, students on the Wilkes team successfully collaborated with Highmark Health pharmacists to create a medication adherence questionnaire that was circulated to patients. They also creatively used social media, including TikTok and YouTube, to spread messages about the importance of medication adherence, vaccine confidence, and safe drug disposal. These messages got over 58,000 views. Students were also able to vaccinate patients for COVID-19 (boosters), Shingles, and Influenza. The Wilkes team was able to directly counsel 1,184 patients, and reached 49,313 people through their outreach efforts.

 

National Award Winner: Temple University School of Pharmacy – PA

Temple University is also a first-time winner of the Script Your Future National Award! This year, Temple students of pharmacy collaborated with health and community organizations in Philadelphia, including Temple University Hospital, and its affiliated clinics as well as the places where people live their lives such as local community pharmacies, parks, churches, charitable organizations, and schools. For example, Temple’s team worked with Dispose Rx to spread messages about the importance of safe drug disposal in North Philadelphia. This team also worked with the Children’s Mission to serve people who have no or unstable housing, and counseled them on their medications along with conducting blood pressure checks. Temple students directly counseled 234 patients, and reached over 400 patients through their activities.

 

Health Disparities/Underserved Focus Award Winner: Northeast Ohio Medical University School of Pharmacy – OH

The Northeast Ohio Medical University School of Pharmacy (NEOMED) team is this year’s winner of the Script Your Future Health Disparities Award! NEOMED’s team focused on reaching low-income and homeless individuals, the elderly, and refugees. NEOMED students worked with the Center for Families and Children, IKON Health Foundation, and Rose Centers for Aging Well to reach these underserved populations. Through their efforts, the NEOMED team vaccinated 456 patients, directly counseled 1,323 patients, reached 1,923 patients, and distributed and donated 3,254 resources.

 

Media Outreach Award Winner: Western University School of Health Sciences, College of Pharmacy – CA

This year’s winner of the Media Outreach Award is Western University College of Pharmacy! This team implemented creative uses of traditional and social media to spread messaging related to medication adherence, vaccine confidence, cardiovascular disease, diabetes, interprofessional collaboration, antimicrobial resistance, and safe drug storage & disposal. They created a brand-new podcast series that aimed to provide information on these topics, and made them available on multiple media platforms including Spotify, Apple Podcasts, Google Podcasts, and their website. The podcast series can be found here. Across all of these platforms, Western University’s team was able to get 1,203 views.

 

Creative Interprofessional Team Event Award Winner: University of Pittsburgh School of Pharmacy – PA

University of Pittsburgh’s pharmacy students demonstrated great interprofessional collaborations with other health professional students at their university. Their team included students from the University of Pittsburgh’s School of Dental Medicine, School of Health and Rehabilitation Sciences, School of Medicine, School of Nursing, and School of Social Work. Their multi-disciplinary intervention with different health professional students helped to bring multiple perspectives and skills sets together to bridge gaps in expertise when counseling patients. Their interprofessional team documented over 1,800 unique patient encounters at community pharmacy sites, including patients with disease states like hypertension, diabetes, and dyslipidemia to transplant and neurologic disorders.

 

Technology Innovation Focused Award: Touro University California, College of Pharmacy – CA

Touro University’s pharmacy students implemented creative uses of technology to increase messaging for medication adherence. They created a digital medication adherence wallet card, to help patients keep track of their medications in a more convenient way. Given that technology is so widely used today, this was a great effort by the students. They did mention an important issue, that there are people who do not have internet access, so these digital cards were given in complement with the physical wallet cards.

2022 School

Congratulations to the winners of the 2022 Script Your Future Medication Adherence Team Challenge!

 

A word from NCL and one of our generous Script Your Future sponsors

“The Script Your Future program has been a great way to engage future health professionals and spread messages about the importance of medication adherence, vaccine confidence, and now, safe drug disposal. As we are still combatting the COVID-19 pandemic, it is important to keep patients on top of their health care needs, and participants of this program have been a part of these efforts. This year, we had over 1,000 participants conduct community outreach activities, and NCL continues to be impressed by the impact these students have on their respective communities across the country.”

  • NCL Executive Director, Sally Greenberg

 

“Student pharmacists have been important contributors to the outreach to communities, especially throughout the pandemic. Medication adherence, vaccine access, and substance use prevention are critically important priorities and AACP appreciates NCL’s commitment to this recognition program.”

  • American Association of Colleges of Pharmacy (AACP) Executive Vice President and CEO, Lucinda L. Maine, PhD, RPh

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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 applauds FDA proposal to ban menthol cigarettes

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May 4, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, D.C. – The National Consumers League (NCL) applauds the Food and Drug Administration’s (FDA) proposed rule to ban menthol cigarettes and flavored cigars. This long overdue ban is a critical public health measure that is expected to save the hundreds of thousands of lives lost to lung cancer, and other smoking-related morbidities. The tobacco industry has had a long history of aggressive marketing of menthol cigarettes to Black smokers. Today, 85% of Black smokers use menthol cigarettes compared to 29% of all white smokers.

While consumers know that tobacco use is the number one cause of cancer and a preventable death in the U.S, it is a very addictive product and the industry knows that and capitalizes on it. The tobacco industry continues to prey on children with the lure of flavored tobacco products to ensure that young people become addicted. Flavored cigars are especially popular with Black and Latino teenagers.

The FDA’s proposed rule to ban flavored cigars and menthol cigarettes is not just important for preventing our young people from using tobacco; it will help to address a wide range of health disparities within the Black community.

The public will have the opportunity to comment on the proposed rule from now until July 5, 2022. We urge consumers to share their views with the FDA during this open comment period. Smokers interested in quitting should also visit smokefree.gov or call 1-800-QUIT-NOW to learn about cessation services available in their state.

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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

Leaders in Congress support safe OTC hearing aid standards

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By NCL Director of Health Policy Jeanette Contreras

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

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

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

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

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

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

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