National Consumers League weighs in on FDA’s OTC Hearing Aid Rule, encourages consumers to consult with medical professionals

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August 17, 2022

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

Washington, DC – Today, the U.S. Food and Drug Administration (FDA) issued its final rule enabling access to over-the-counter hearing aids for consumers with perceived mild to moderate hearing loss. National Consumers League (NCL) strongly supports expanding access to and affordability of hearing aids. NCL is encouraged by the positive impact these policy changes will have on increasing access to life-altering hearing aids. “We hope this means that more people will proactively assess their hearing loss and seek the help they need for their hearing health needs” said Sally Greenberg, Executive Director of NCL.

At the same time, while OTC hearing aids are a promising first step in achieving that goal, NCL remains concerned about potential consumer safety issues surrounding the use of OTC hearing aids without consultation of a trained, medical professional. NCL strongly encourages consumers to first consult with a medical professional before treating their perceived hearing loss with a hearing aid, including those that will be sold OTC.

Safety is the cornerstone of NCL’s mission. This is why NCL, along with 90 leading healthcare and consumer organizations, weighed in during the public comment period and via a group letter to FDA urging the agency to adopt lower the maximum outputs for OTC devices and establish a limit on gain. This limit has been recommended by leading hearing health professional organizations to ensure consumer safety. FDA ultimately lowered the maximum outputs in the final rule but decided against establishing a gain limitation. While we are pleased that the FDA recognized the need to lower the maximum outputs, we believe these devices could have been safer by limiting the amount of gain, as recommended by hearing care professionals. The lack of a gain limit, coupled with excessive amplification of sound for prolonged periods of time, may put some consumers at risk of experiencing increased hearing loss.

Because hearing loss is a medical condition that is unique to each individual, it should be addressed in consultation with a hearing care professional. With OTC hearing aids expected to be in stores as early as mid-October, NCL encourages consumers to purchase hearing aids in consultation with a professional who can help them fully understand the nature of their hearing loss, if any exists at all, and ensure that the treatment plan is appropriate for their needs, including the potential use of OTC hearing aids.

If consumers experience any adverse events or complications related to the use of OTC hearing aids, including worsening hearing after using such a device, NCL encourages consumers to report these events to the FDA. Instructions for reporting adverse events, are available at https://www.fda.gov/safety/medwatch, or by calling (800) FDA-1088.

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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 strongly supports FDA’s proposal to ban menthol

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August 3, 2022

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

Washington, DC – The National Consumers League filed comments today with the Food and Drug Administration (FDA) in support of the agency’s proposal to ban menthol products.

“We commend the FDA’s actions, though we believe the ban on menthol cigarettes in the United States should have been implemented years ago,” said Sally Greenberg, Executive Director of NCL. “Nevertheless, this ban on menthol will save hundreds of thousands of lives and will have especially important positive benefits for African Americans because tobacco companies have relentlessly marketed menthol cigarettes to African Americans for decades.”

NCL recently recorded a podcast with the African American Tobacco Control Leadership Council, the country’s leading public health education and advocacy organization taking on Big Tobacco to save Black lives. The podcast can be found here: https://nclnet.org/menthol-cigarettes-going-up-in-smoke/

NCL also noted that the United States is an outlier among nations of the world in its proposal to ban menthol just now. The EU implemented a ban for its 28 member countries in 2020.

“Menthol enhances the addictive effects of nicotine in the brain,” said Greenberg. “The tobacco industry knew this and yet continued to market the product to Americans, especially targeting African Americans. Menthol is associated with progression to regular cigarette smoking in youth and young adults.”

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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.

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 Director of Health Policy testifies at Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights on how consolidation in the marketplace harms consumers

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June 16, 2022

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

Washington, D.C. – On Wednesday, June 15, 2022, the National Consumers League’s Director of Health Policy Jeanette Contreras provided oral testimony to the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights on how consolidation in the marketplace harms consumers.

In her testimony, Ms. Contreras discussed the importance of consumers having choices for safe goods and services at a fair price, a core principle of NCL’s advocacy work. Touching on several issues impacting consumers in the U.S. – such as the infant formula shortage, consolidation of the airline industry, primary ticketing market for live events, and the unfair business practices of pharmacy benefit managers (PBMs) – Ms. Contreras reiterated the need for competition in the marketplace and enacting stronger antitrust laws, all of which help protect U.S. consumers.

Her testimony appears below.

June 15, 2022

Good afternoon Chairwoman Klobuchar, Ranking Member Lee, and members of the Subcommittee. My name is Jeanette Contreras. I am the Director of Health Policy at the National Consumers League. I appreciate the opportunity to testify remotely today- due to COVID.

Founded in 1899, NCL is America’s oldest consumer advocacy organization. A core principle of our advocacy is that the marketplace should encourage competition to guarantee that consumers have choices for safe goods and services at a fair price. Monopolies harm competition, leaving consumers with fewer options at higher prices. Monopolistic practices are especially harmful when they occur in the health care arena, where they can exacerbate health disparities.

We share the concerns of new parents regarding the recent shortage of infant formula. Our hearts go out to those parents who have lost babies or whose infants suffered devastating health consequences from contaminated formula. At NCL, we believe all goods and services sold to consumers should be safe and meet all legal requirements- including regulatory guidelines set forth by the FDA.

NCL applauds the FDA and the Administration for adopting a multifaceted approach to increase the supply of infant formula, including temporarily allowing foreign manufacturers to sell their products in the U.S. Additionally, we believe invoking the Defense Production Act to prioritize getting needed inputs to infant formula manufacturers was sound policy. These measures are helping to solve the immediate logistical problem of getting formula onto store shelves across the country.

While addressing the immediate formula shortage is most urgent, we are also troubled that it took the FDA almost four months to act on a whistleblower complaint sent to the agency. This complaint should have received immediate attention given the gravity of the allegations against the Abbott facility. We support a full investigation and, if warranted, bringing criminal and civil charges against those who falsified data. NCL also recommends that the U.S. create a single food safety agency and dedicate an office to overseeing the safety and supply of infant formula.

It should concern every American that one manufacturer controls 40% of the U.S. infant formula market. Only three companies — Abbott, Mead Johnson, and Nestle — control 98% of the industry.

Consolidation in the infant formula industry is a major contributor to the current crisis, but it is only one of many cases where market concentration in recent decades has limited competition and harmed consumers.

For example, NCL continues to raise concerns about the consolidation of the airline industry. Due to weak enforcement of existing antitrust laws, from 2005 to 2015, the number of major U.S. airlines declined from nine to four. And today they control more than 80 percent of the domestic U.S. market.

Our antitrust laws have also failed to protect consumers who attend live events. After merging with Ticketmaster in 2010, Live Nation Entertainment controls roughly 80% of the primary ticketing market in the U.S. As anyone who has purchased tickets recently can attest, this has led to an increase in add-fees and the basic price of tickets.

Stronger antitrust enforcement would be especially beneficial for curtailing anti-competitive conduct in the health care industry, where we’ve seen consolidation lead to higher costs for consumers without an increase in quality or access to care. We are pleased that the Biden administration is looking into how hospital prices increase after acquisitions. We are also hopeful that the ongoing review of DOJ & FTC merger enforcement guidelines will result in more action by those agencies.

NCL also applauds the recent FTC decision to open an investigation into the unfair business practices of pharmacy benefit managers or PBMs. NCL works tirelessly to raise awareness of the outsized role that PBMs play in driving up prescription drug prices for consumers. According to a recent report, the three biggest PBMs controlled roughly 77% of all U.S. prescription drug claims in 2020. And a recent Senate Finance Committee report found some PBMs are getting a 70% rebate on insulin, while out-of-pocket costs for this life-saving medication continue to rise.

These cases are just a few examples of how monopolies and anti-competitive practices have become a problem for consumers. To ensure crises like today’s formula shortage do not happen again, market consolidation must be addressed so that the temporary shutdown of a single factory does not result in the collapse of an entire supply chain.

Whether it is baby formula, airline travel, live event tickets, or pharmaceutical sales, the lack of competition is having increasingly negative impacts on consumer welfare and requires urgent action.

Chairwoman Klobuchar, Ranking Member Lee, thank you for holding today’s hearing and inviting NCL to speak about this important issue. I look forward to answering your questions.

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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 issues recommendations to avoid another baby formula shortage

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May 19, 2022

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

Washington, D.C. – The National Consumers League shares the very real concerns of new parents regarding the recent shortage of infant formula. Our hearts also go out to parents who have lost babies due to contaminated powdered formula and those whose infants suffered devastating health consequences from the contaminated product.

We appreciate the FDA’s multifaceted approach to increase infant formula supply, including allowing foreign manufacturers of baby formula to sell their products in the U.S. Additionally, the Biden Administration has implemented the Defense Production Act, which will be important in increasing production by requiring suppliers to prioritize getting needed inputs to the infant formula manufacturers. Initiating the DPA also allows the Administration to use Department of Defense contracts with commercial cargo lines to speed the transport of foreign products into the U.S. and onto store shelves across the country. These actions are critical steps in combatting this formula shortage issue.  We applaud Congress for supporting emergency legislation to address the formula shortage.

However, while addressing the shortage is the most pressing issue, first and foremost, the responsibility lies with the Abbott facility in Michigan whose reckless actions set events into motion. Abbott failed to follow safety protocols, falsified documents to the FDA and then shipped contaminated formula exposing our most vulnerable little consumers to foodborne illnesses. Those actions triggered an FDA investigation and subsequent recall, leading to the current shortage.

We are also troubled that the FDA, for its part, took almost two months to act on the whistleblower complaint sent to the agency in October 2021. That report cited unsanitary conditions, contamination of formula, and serious allegations against company officials at the Abbott Facility in Michigan. This complaint should have received immediate attention given the vulnerability of infants, whose immune systems are just developing. This plant is also responsible for producing a great deal of the formula sold to federal WIC program. (The Special Supplemental Nutrition Program for Women, Infants, and Children). We think both civil and criminal charges are in order. The shortage demands that the FDA source infant formula from countries already approved for importing formula. It’s also time to create a single food safety agency and create an office to oversee the safety and supply of infant formula.

A summary of NCL’s recommendations include:

  1. Immediate sourcing of infant formula from countries that are already approved to import the product
  2. Opening the Abbott plant once the FDA can reach an agreement with the company to ensure production of infant formula will be under strictest safety and quality control.
  3. A full investigation of the Abbott facility, and criminal and civil charges brought against those who falsified data or knowingly allowed the shipment of contaminated formula
  4. Expansion of the number of companies making infant formula
  5. Creation of a single food safety agency and appointment of a baby formula safety and supply chain expert

Infants are our most vulnerable and precious consumers and they rely on us to protect them. We have let them down and safety provisions must be put in place to ensure that this never happens again. NCL stands ready to work with Congress, consumers, businesses, and the FDA to ensure the safety of infant formula is never compromised again.

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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.

 

After 80 years, the FDA updates food-safety regulations – National Consumers League

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food.jpgBy Ali Schklair, Linda Golodner Food Safety & Nutrition Fellow 

In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (FD&C). Regulated by the FDA, the law set safety standards for the manufacturing and distribution of food, drugs, and cosmetics. But, our food (drug and cosmetic) system has changed dramatically since the 1930s. 

Today, most of our raw and processed foods come from industrial farms. The popularity of frozen and prepackaged foods has skyrocketed. And imported foods account for 15 percent of the US food supply, including almost 50 percent of fresh fruit and 20 percent of fresh vegetables. While everything from farming practices to eating habits has evolved since the 1930s, the FDA has followed the same safety standards implemented almost a century ago.

The Food Safety Modernization Act (FSMA), which was first enacted in 2011, is a breakthrough for food safety in the US.  On Thursday, September 10th, 2015, the final preventive control rules for human and animal food were released. These rules are a critical piece of FSMA’s prevention-based approach to improving food safety. Additional rules addressing produce safety and food imports are expected to be finalized and released by the end of October. Once all rules are in effect, the US will have a food safety oversight system that requires producers and processors to take preemptive action against the growth and spread of pathogens.

A focus on prevention reflects how food policy and public health frameworks have shifted in America. Instead of relying on reactive interventions, today, health initiatives focus on identifying and preventing hazards before they reach the public. Prevention strategies are used to address public health problems like the flu, obesity, lung cancer, and now foodborne illness.

But, FSMA will only be successful in carrying out these preventive measures if the FDA has access to adequate funding. Currently, the House and Senate appropriations bills for the 2016 fiscal year do not meet funding needs. The Food Safety Modernization Act has the potential to overhaul our current food safety regulatory system, which will hopefully lead to less food contamination and less foodborne illnesses. However, without sufficient funding, we could be stuck with the same antiquated system for another eighty years.