NCL urges caution following HHS drug importation announcement

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December 20, 2019

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)urges caution in light of this week’s announcement on drug importation from the Department of Health and Human Services. Our primary concerns are that this proposed new rule will put the public at greater risk of counterfeit drugs while not clearly passing on any cost savings on to consumer.

NCL recently launched the Fake Rx Action Center in conjunction with our site Fraud.org, which aims to educate consumers on the risks posed by counterfeit medicines, and how to spot, avoid, and report them should consumers come across any fakes. Counterfeit medicines have already claimed lives across the country, and this proposal further endangers consumer health by undermining the security of the American pharmaceutical supply chain.

Opening the door for states, pharmacies, and distributors to obtain medications beyond U.S. borders means that consumers could more easily fall prey to bad actors from around the globe when being provided medications that have originated outside of the U.S. regulated manufacturing and distribution supply chain. As the World Health Organization has noted regarding the broader counterfeit issue, patients may end up with medications that have the wrong active ingredient, the wrong amount of active ingredient, no active ingredient, or dangerous added ingredients. While we will continue to advocate for access to affordable drugs, it is not clear from the regulations that any potential cost savings from obtaining medications outside the U.S. borders will be passed on to individual consumers. The goal of lowering prices for consumers without a clear assurance of out of pocket cost savings in these regulations is not worth increasing the risk of harm to consumers by exposing them to medications that may not meet the clear standards of U.S. law.

Our organization has put consumers first for more than 100 years. It is our belief that there are safer and more effective ways to provide access to necessary prescription medications than to expose Americans to potentially deadly counterfeits originating outside the United States.

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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.

Capitol Hill briefing alerts lawmakers to public health ramifications of CBD proliferation

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Lawmakers need to be aware of the threats to public health posed by the proliferation of unregulated, untested CBD products currently widely available in the marketplace. There is a great deal of work to be done in Washington to better understand the healing potential of CBD, while also protecting consumers from the dangers of what is currently an anything-goes market environment.

That was the compelling message participants took from a congressional staff briefing last week on “The Future of Cannabis as a Drug.” Expert speakers, including National Consumers League Executive Director Sally Greenberg, issued a two-pronged call for action: to intensify clinical research into new medical treatments containing CBD, while encouraging the Food and Drug Administration (FDA) to proactively regulate non-medical, over-the-counter CBD products that are frequently mislabeled and contain potentially harmful ingredients.

The briefing featured opening remarks by U.S. Representatives Scott Peters (D-CA) and Cathy McMorris Rodgers (R-WA) and was moderated by Ron Manderscheid, Executive Director of the National Association of County Behavioral Health and Developmental Disability Directors and the National Association for Rural Mental Health. “We would like to have more understanding and more confidence in CBD products,” Rep. Peters explained. “You should know what you’re getting”.

Attendees received eye-opening data about the ways in which readily-available CBD products—sold in the form of oils, lotions, food additives, and more—have the potential to make consumers ill. Few realize, for example, that an independent study found 70 percent of the top-selling CBD products contain substances such as pesticides, arsenic, and toxic mold.

NCL’s Greenberg previewed upcoming academic research that will place a spotlight on the questionable science being utilized by CBD and cannabis companies, often in partnership with academia, to lend legitimacy to these products and short-cut the regulatory approval process. “Not only are these products untested, but they are inaccurately labeled,” said Greenberg. “We want FDA to do what it’s supposed to do, and what we as consumers expect it to do.”

NCL launched Consumers for Safe CBD to warn the public of the potential health and safety risks associated with unregulated and unlawfully marketed CBD products.

Susan Audino, a board member of the Center for Research on Environmental Medicine in Maryland, shared her findings on the lack of quality controls currently in the CBD marketplace and how product marketing is accelerating faster than the science used to substantiate claims of enhanced health and well-being. “We even trust McDonald’s to inform us of the number of calories in a Big Mac,” said Audino. “When it comes to cannabis, we are not afforded that same safety and assurance.”

James Werline, a pharmacist and the father of a daughter with a severe form of epilepsy, spoke to the promise and importance of CBD-related research. The only CBD medication currently approved by the FDA is used to prevent seizures caused by rare forms of childhood epilepsy. Angelique Lee-Rowley, Vice President, Global Chief Ethics and Compliance Officer at Greenwich Biosciences, discussed the importance of clinical research into new CBD treatments and shed light on the restrictions pharmaceutical companies have in educating consumers on product efficacy versus the retail and online marketers who have few boundaries in the claims they can make.

“We are on the verge of a major breakthrough,” said Rep. McMorris Rogers. “We want to be encouraging those breakthroughs. I am committed to helping with those developments.”

The briefing served to alert congressional staff to the seriousness of this issue. By 2022, the CBD marketplace is expected to reach $1.8 billion in sales, more than triple what it was just four years earlier. As the commerce expands, so do—without adequate consumer protections—the threats to health and safety.

Letter to Congress: NCL calls for safe CBD

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December 10, 2019

Dear Member of Congress,

For more than 120 years, the National Consumers League has pursued the values of access to quality products, honest labeling, and safe, effective medicines for America’s consumers. We write to you today about a growing public health concern affecting millions of Americans in every state and congressional district across the country. Unregulated, untested cannabidiol (CBD), an extract of the hemp plant, has infiltrated the market in a dizzying range of products. These products pose a significant threat to consumers.

The CBD market is one of the fastest growing retail segments in the nation. By 2022, Americans are expected to purchase approximately $1.8 billion worth of these products, triple the amount since last year. CBD, however, continues to raise questions and concerns for consumers.

CBD products are not currently tested or evaluated for safety and efficacy, nor required to meet similar safety standards as the tube of toothpaste we buy at the grocery store. CBD products are too often deceptively labeled and may contain contaminants that can harm consumers. *Independent testing of the 240 top-selling CBD products found that 70 percent were contaminated with substances including lead, arsenic, herbicides, pesticides, and toxic mold.

*New public opinion research conducted by Greenberg Quinlan Rosner finds that voters overwhelmingly – an 83 percent majority – support allowing the Food and Drug Administration (FDA) to evaluate and regulate CBD products. The research found that ensuring the safety and effectiveness of CBD grows even stronger among those who have used CBD products or describe themselves as very familiar with them. When asked about illness resulting from vaping CBD, 83 percent of respondent expressed concern, with nearly half, 48 percent, being very concerned.

This is why NCL created Consumers for Safe CBD in partnership with Consumer Federation of America (CFA) and Community Anti-Drug Coalitions of America (CADCA) to encourage the FDA to take strong, effective, and prompt action to protect the public from the potential harms posed by unregulated, untested CBD.

As Executive Director of NCL, I hope you will lend your voice in calling for the FDA to take immediate action to protect consumers from potentially harmful CBD products and pursue four common-sense objectives:

1. WARN THE PUBLIC OF THE DANGERS OF THE CBD MARKET

The public should be warned regarding the dangers of unapproved, untested CBD products. Clearly, as verified by the explosive growth in sales, the public is not appropriately informed about the potential dangers of unapproved, untested CBD products that contain harmful contaminants and may not have the ingredients listed on product labels. Resources should be devoted to a national informational campaign that warns consumers of these dangers. There is a growing interest in CBD products, but the marketplace is largely an unregulated “wild west,” and consumers literally often have no way of knowing what is contained in the products they are purchasing.

2. ENFORCE EXISTING REGULATIONS REGARDING LABELING (INGREDIENTS, RISKS, ETC.)

The FDA should curtail the proliferation of potentially dangerous, unapproved CBD products by using its existing legal authority. The FDA should use its authority to penalize manufacturers, marketers, and distributors of CBD products that: 1) make medical claims that cannot be scientifically verified, 2) market products to minors, 3) sell products that contain higher or lower-than-advertised levels of CBD and/or THC, or harmful ingredients and 4) sell products that have inaccurate labels. Swift and strong enforcement can serve as an effective deterrent effect against the future marketing of unapproved, potentially harmful CBD products.

3. DETERMINE SAFE LEVELS OF THC/CBD TO BE ALLOWED IN CBD PRODUCTS

Clear differentiation between medicines and consumer products should be established, including firm parameters as to CBD levels that can be safely included in a particular product. The FDA should establish a firm, enforceable ceiling on the potency of CBD that can be contained in an individual product and require safe packaging practices, similar to the child-proof cap closures on prescription medicines. All products should include a 1-800 phone number to allow concerned consumers to call the manufacturer to make specific inquiries about the product.

4. ENCOURAGE ROBUST CLINICAL RESEARCH INTO THE POTENTIAL OF CBD TO IMPROVE HEALTH AND LIVES

The FDA should incentivize CBD research, clinical trials, and the creation of new CBD treatments that are thoroughly vetted through the proven FDA process. CBD has the potential to improve lives, but with little research and clinical data, the risk is currently greater than the reward. We should encourage research to ensure that CBD reaches its full potential.

Your constituents should be protected from the potential dangers related to CBD products. This does not require the creation of new laws or regulations, but rather that the FDA simply use its existing authority to protect public safety. The agency has already sent more than 50 warning letters to CBD product manufacturers making egregious health claims about their products’ ability to treat cancer and other serious illnesses. It recently advised women who are pregnant or breastfeeding to avoid using any CBD products, citing a number of health and safety risks. But these efforts need to be stepped up. We hope you will join us in asking the FDA to erect stronger safeguards, including safe concentration limits, around a rapidly growing, but unregulated, industry that is already causing harm to consumers.

If you or your staff has any questions, please reach out to our Director of Health Policy Patricia Kelmar at patriciak@nclnet.org or 202-207-2824.

Thank you for your consideration.

Sally Greenberg
Executive Director
National Consumers League

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

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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 announces new action center to help patients steer clear of deadly counterfeit drug websites

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December 5, 2019

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), America’s pioneering consumer advocacy organization, today launched Fraud.org/FakeRx, a new digital consumer education campaign to address the growing global crisis of harmful counterfeit medications. The World Health Organization estimates that one in every 10 medical products circulating in developed countries is either substandard or fake, and nearly $83 billion in counterfeit drugs are sold annually. Counterfeit drugs can be, at best, a waste of money and, at worst, fatal.  The Partnership for Safe Medicines has found counterfeit pills made with fentanyl in 48 states, with deaths attributed in 33.

“Counterfeit drugs are everywhere, and they are dangerous. Going to the Internet to buy medicines is a bad idea if you don’t know how to protect yourself from illegal pharmacies selling counterfeit drugs. Consumers do not realize how common counterfeits are; our campaign aims to provide the tools and resources to help consumers steer clear of illegal products and protect themselves and their families,” said NCL Executive Director Sally Greenberg. “NCL is launching Fraud.org/FakeRx to serve as a hub for reliable information for consumers and law enforcement.  Our action center helps consumers learn how to spot the red flags of counterfeit drugs and report issues to law enforcement.”

With the growth of Internet sales of medications, the problem of illegal pharmacies hawking counterfeit drugs is a growing risk to consumers. Visitors to Fraud.org/FakeRx can arm themselves with information to:

  • Reduce the chances they’ll encounter counterfeit drugs and shop safely for medications online
  • Learn to spot harmful counterfeit drugs if they do; and
  • Report counterfeit drugs and the websites offering them to the authorities fighting the problem.

“Criminals posing as legitimate online pharmacies are a serious threat to our nation’s drug supply and to unsuspecting consumers who purchase contaminated or potentially deadly counterfeit medications,” said George Karavetsos, former director of the U.S. Food and Drug Administration’s Office of Criminal Investigations. “Policymakers, regulators, and manufacturers have clear roles for doing their part to protect our drug supply, but having informed consumers is essential to shutting down this illegal online market. This campaign gives consumers the tools they need to stay safe and keep criminals from lining their pockets with consumers’ money.”

NCL has worked with victims of suspected and confirmed counterfeit drugs to capture their experiences and report them to authorities. Two mothers who each lost their adult children to tainted counterfeit medications have lent their stories to the new campaign in hopes of helping others avoid falling to the same fate.

“I lost my son, Jerome, himself a loving big brother and father of three beautiful children, to a counterfeit drug laced with fentanyl. It took one single pill to take Jerome away from us,” said Natasha Butler, whose son was one of a wave of victims of counterfeit drug deaths in Sacramento in 2016. “We had no idea that these dangerous drugs, manufactured to look exactly like the real thing, are out there and could be the last drug someone ever takes. Anyone who takes medication or fills prescriptions needs to be aware of the risks of counterfeits, and that where you get drugs is so crucial for your safety and health. Everyone should visit Fraud.org/FakeRx to learn about the risks and how to avoid being the next victim.”

 “On June 11, 2018 my phone rang at 7:24 am. The voice on the other line told me that my beautiful daughter, Ashley, was dead. Ashley had been given a counterfeit pill laced with fentanyl. I was told by the coroner that she probably died instantly,” said Andrea Thomas, a Colorado mother who, since her daughter’s death from a counterfeit drug, co-founded Voices for Awareness Foundation. “The deadly pill Ashley took looked just like her normal medication. This is an epidemic in our country that I previously knew nothing about. It is time to take action. The National Consumers League’s new resources for consumers will help spread awareness and will make a difference to many.”

To hear from additional victims who know the issue firsthand, visit the new Fraud.org/FakeRx. The site also includes tips for consumers about ways to save on prescription drugs without increasing their risks of purchasing counterfeits. 

NCL thanks its partners for providing support for the new campaign: Allergan, Celgene, Eli Lilly, Gilead Sciences, Pfizer, and PhRMA.

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About the National Consumers League (NCL)

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

NCL statement on nomination of Hahn to head FDA

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December 3, 2019

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), the nation’s pioneering consumer advocacy organization, welcomes Dr. Stephen Hahn’s nomination to lead the Food and Drug Administration (FDA). The statement below is attributed to Sally Greenberg, NCL executive director:

“Dr. Hahn is a veteran doctor and cancer researcher who served as chair of radiation oncology at the University of Pennsylvania School of Medicine and most recently as chief operating officer and medical executive at MD Anderson in Houston. He holds rare dual board certifications in both medical oncology and radiation oncology and has authored more than 200 academic works. He also brings a wealth of experience supervising and facilitating clinical trials. In an era where science is under attack, Dr. Hahn brings a welcome commitment to evidence-based medicine, science, and research. The FDA is the gold standard across the globe for ensuring the highest standards of safety and efficacy of medications and devices, and for the safety of our food supply. Consumers are being barraged by a plethora of untested products claiming health and safety. The FDA needs a strong leader who will bring an evidence-backed approach to protecting consumers and ensuring a clear pipeline for new therapies that are tested for safety and efficacy and hold true promise for treatments and cures.

“If confirmed, we look forward to working with Dr. Hahn to improve consumer protections in a number of areas, including regulation in the CBD product marketplace, addressing the clear health hazards of e-cigarettes, especially to underage users, and fully implementing the Food Safety and Modernization Act to reduce foodborne illness, which kills an estimated 3,000 people each year. We need a well-funded FDA that can offer a pipeline for medications to treat diseases while protecting the public from unsafe products, including drugs, devices, and foodborne illness.”

Greenberg is a board member of the Reagan Udall Foundation, created by Congress, to support the work of the FDA.

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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 statement on FDA action regarding CBD

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November 29, 2019

Leading consumer advocate urges ‘buyer beware’ as busiest shopping season of the year gets underway

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

Washington, DC—Sally Greenberg, executive director of the National Consumers League and a convening partner of Consumers for Safe CBD, today released the following statement in response to FDA’s recent action regarding CBD:

“The decision by the FDA to send 15 new warning letters and remind consumers of potential harm caused by untested and illegal CBD is a step forward in keeping millions of Americans safe. While regular communication from the FDA is helpful, it’s critical that we pursue tangible actions that will lead to broad awareness and prevent the sale of harmful CBD products in a marketplace that is growing by the day. This includes enforcing existing regulations regarding labeling and ingredients, as well as setting safe concentration levels. We cannot wake up a year from now and wish that we had done something when there are practical and achievable solutions right in front of us. Our recent polling shows that 83 percent of registered voters support regulating CBD. We need the gold standard that the FDA provides now more than ever.

“Today marks the start of the busiest shopping season of the year. As consumers head to stores and browse the Internet for deals, we are urging buyer beware when it comes to CBD products. The risk of not getting what you pay for and, even worse, putting one’s own health in jeopardy is far too great. Until the FDA steps in with its stamp of approval, we have no choice but to warn consumers to avoid unregulated CBD products and encourage family and friends to do the same.

“The National Consumers League and Consumers for Safe CBD will continue to work with advocates, policymakers and other stakeholders to ensure that we keep people safe, provide a much-needed sense of clarity and put the interests of the consumer first.”

Learn more about the CBD Myths and Facts HERE.

Learn more about what could be in CBD products HERE.

See what others are saying about CBD HERE.

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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.

CBD is not the cure for whatever ails you

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Unless you’ve been living under a rock, you’ve surely seen the dozens of ‘miraculous’ CBD products available today. Health food stores, pet supply stores, gas stations, and even your neighborhood pharmacy and grocery stores are carrying a plethora of CBD-infused products. CBD is included in everything from lotions and oils, beauty products, pet treats, and “tampons.” You can buy CBD-infused workout clothing and even take CBD yoga classes.

CBD, or cannabidiol, is a compound found in cannabis and derived from the hemp plant. After the passage of the Farm Bill, CBD is now legal and CBD products are marketed as having little or no THC, the primary psychoactive element in marijuana. However, under the bill, these products may lawfully contain as much as 0.3 percent THC, which is enough to produce intoxication or a positive result on a drug test, which has led to many workers unwittingly losing their jobs.

Sales of products containing CBD have exploded in recent years. In 2018, Americans purchased $500 million in products containing CBD. By 2022, that amount is expected to more than triple to reach $1.8 billion nationwide.

Consumers, take note! Illegal marketing of these products include unsubstantiated health claims as innocuous as offering “a higher sense of well-being” to the extreme claims of therapeutic benefits such as treating Alzheimer’s and Parkinson’s disease, schizophrenia, or AIDS. 

Our concern is that most CBD products on the shelves today fail to meet the safety standards we have come to expect:

  • Most have not been scientifically tested for safety and efficacy.
  • CBD product labels aren’t accurate in lists of ingredients and potency.
  • The purity and potency of ingredients in most CBD products have not been verified by reliable third parties.

Without these safeguards, consumers may be using these products or offering them to their children and pets with blindfolds on.

Exaggerated claims of unproven benefits are nothing new, but with the legalization of CBD, there’s a new explosion of untested products that demand attention from regulators. CBD could be key to the development of many new treatments and therapies. One indication is the success of the first FDA-approved drug containing CBD in controlling two types of rare, childhood-onset seizures. However, without better regulation and enforcement, unsafe dosages of CBD and the use of adulterated products make for a minefield of consumer caveat emptor.

Clinical studies have demonstrated potential risks of CBD, including liver toxicity, fatigue, and harmful interactions with other drugs. The Food and Drug Administration (FDA) has recently begun to take action. In October, it issued a strongly worded advisory discouraging pregnant and breastfeeding mothers from using CBD products. It also recently warned a Florida company that was illegally selling unapproved products containing CBD online with unsubstantiated claims that the products treat teething pain and earaches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), among other conditions or diseases. We welcome that action by the FDA, and we want to see it doing more.

Advocates recognize the dangers for consumers and we are mobilizing. Earlier this month, National Consumers League (NCL) staff presented at a roundtable discussion of consumers and other partners about FDA’s authority to protect consumers via product testing and regulation of product marketing. The discussion allowed further sharing of information and identified opportunities to bring commonsense changes to the marketplace.

Consumers need access to good information about CBD, how to understand concentration levels in products, and the products’ risks. The FDA should take a more active role as a regulatory agency overseeing products that make health benefit claims. Our regulators should help consumers understand the difference between FDA-approved medicines and consumer products, including a definition of a safe level of CBD.

We welcome the potential that CBD has to offer new therapies and treatments, but the products in the marketplace must be safe and proven effective with hard science. NCL is committed to doing its part to help protect and educate consumers.

Why won’t New York’s governor Cuomo ban a nasty pesticide that harms children?

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Reid Maki is the director of child labor advocacy at the National Consumers League and he coordinates the Child Labor Coalition.

Something really curious is happening in New York State. In June, the New York Assembly passed a bill to ban the nasty pesticide chlorpyrifos, which damages the development of children. But that’s not the weird part.

What’s surprising is that Governor Andrew Cuomo has not signed the bill, despite the fact that the NY Attorney General Letitia James joined five other attorneys general in suing the Trump Administration’s federal Environmental Protection Agency because it overturned an Obama Administration ban on the pesticide.

“Chlorpyrifos is extremely dangerous, especially to the health of our children,” said Attorney General Letitia James. “Yet, the Trump Administration continues to ignore both the science and law, by allowing this toxic pesticide to contaminate food at unsafe levels. If the Trump EPA won’t do its job and protect the health and safety of New Yorkers, my office will take them to court and force them to fulfill their responsibilities.”

The other states that joined the suit are Washington, Maryland, Vermont, Massachusetts, and California—the latter is the country’s largest agricultural producer (measured by cash receipts) and has decided to remove chlorpyrifos from the market in 2020. 

Studies have also linked chlorpyrifos to autism, cancer, Parkinson’s disease, reduced IQ, loss of working memory, attention deficit disorders, and delayed motor development.

Nationally, home use was banned in 2001 because of its impact on children’s developing brains. In 2018, Hawaii became the first state to enact a complete ban on its use, which includes farms.

Chlorpyrifos is also thought to damage male reproductive organs to the point that it can make men sterile.

Since food safety authorities determined that there was no safe exposure level to chlorpyrifos—that any trace of the pesticide was too dangerous—the European Union is expected to ban entry of food products contaminated with the pesticide next year.

In August, the National Consumers League (NCL) and the Child Labor Coalition (CLC), which NCL co-chairs, joined 80+ groups—including many from New York—on a letter, urging Governor Cuomo to sign the chlorpyrifos ban. We were naïve enough to think he would.

With an avalanche of data suggesting it is too dangerous to use and his own attorney general suing over its use, why has Cuomo seemingly decided not to ban the pesticide? We can only guess. In July, the governor signed landmark legislation to protect farmworkers from labor abuses, ensure equitable housing and working conditions, and grant them collective bargaining, overtime pay, unemployment compensation and other benefits.

Farmworkers are some of the most exploited workers in America, and we applaud the governor for doing the right thing, but he seems to be taking the position that—having done something farm owners didn’t like—he shouldn’t sign the chlorpyrifos ban because they won’t like that either. The farmers see the pesticide as an effective tool to help them grow crops.

The problem is that chlorpyrifos doesn’t just harm those who eat farm produce; It harms the very people that produce crops—the farmers and the farmworkers and the children of both.

Should giving farmworker labor rights mean that it’s okay to endanger their fertility and cause their children to suffer developmental delays or autism? And from the farmers’ perspective, shouldn’t their children be protected from those afflictions? The governor shouldn’t be striving to protect some of the people some of the time, but should protect all of the people all of the time.