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National Consumers League response to the Request for Information regarding FDA regulation of CBD

August 25, 2023

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, 202-823-8442

Washington, D.C. – On August 17, the National Consumers League responded to the Request for Information regarding FDA-Regulation of CBD.

In 2019, in response to the proliferation of unreviewed and untested CBD products, NCL identified the need for greater education among consumers about CBD and better enforcement of regulations in the CBD marketplace. NCL created Consumers for Safe CBD to address the need, champion the rights of consumers, and call on government and industry to do better – to ensure safety and promote a pathway for new products through clinically tested scientific research. Since then, action has been taken on the state and federal levels to increase access to cannabinoids beyond CBD. In response, NCL expanded our educational campaign and established Cannabis Consumer Watch.” 

The full letter can be found 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 nclnet.org.

Safety in question: The alarming disparities between cannabis product health claims and research, and the magnified risks for women

By Health Policy Intern Grace Lassila

July 27, 2023

When I started my National Consumers League (NCL) internship in May 2023, I quickly dove into NCL’s health policy work. NCL is leading on several efforts to protect consumers –one area of focus that stood out to me is their work in the cannabis policy space. NCL is a founding member of Cannabis Consumer Watch (CCW), which educates consumers on cannabinoids, their effects, the risks related to the unregulated marketplace, and the ways policymakers and regulators can help protect consumers. NCL is also a part of the Collaborative for Cannabinoid Science and Safety (CCSS), which also works to educate people about cannabinoids and policy in the interest of public health.

CCW’s “test your cannabis knowledge” quiz was shocking for me. Going into the quiz, I was fairly confident about my knowledge, but as I started getting wrong answer after wrong answer, I realized I had no idea that not only are these products under-researched, but they may pose serious public health risks for consumers. Products can be sold, without having gained FDA approval, making false claims about their medicinal abilities.  And side effects are not adequately researched or revealed to consumers.

One particularly concerning aspect of the cannabis marketplace is that while CBD or Delta-8 or other cannabis products are often marketed to women, there is a concerning lack of research into the safety of these products for women. Historically, misogyny and sex discrimination have made women’s health severely under-researched and underfunded. More research on diseases, disorders, and medication is conducted on men, not women. Women are misdiagnosed far greater than men are, and experience dangerous health outcomes because of it (Greenhalgh). And without sufficient research and data on women’s health, it is incredibly difficult for legislators to write policy (Adams). Overall, for women’s health to improve, more resources need to be devoted to this issue.

Despite cannabis companies’ marketing efforts that claim their products can help with anything from menstrual cycle-related pain to morning sickness, there is little insight into the effects of cannabis or cannabis derivatives on women, pregnant people, nursing parents, and newborns. What we do know is that the risks are very real – a recent study found that THC use during pregnancy was linked to changes in fetal development and several studies have shown that CBD can be transferred to a baby via breast milk. The FDA strongly advises against THC or CBD usage while pregnant or breastfeeding. And, given the evidence currently available, I would caution any women from using these products for medical benefit.

The lack of regulation, as well as research, is very concerning. Because the FDA currently does not regulate these products, consumers have no way of knowing whether the dosage, ingredients, or claims on the label are accurate and no way of knowing whether or not they are contaminated. Though some products may acknowledge they are ‘Not Approved by FDA,’ many consumers may not see this fine print – and assume that anything they can buy at their local grocery store must be safe for consumption. While the risks of an unregulated cannabis marketplace affects all consumers, women who need medical health and relief and turn to cannabis products may be more at risk.

The good news is that in January of this year, the FDA recognized this grey area for regulation – particularly for CBD – and stated that CBD would not be regulated as a food and dietary supplement anymore, because of the unknown safety risks, and requesting that Congress act quickly to protect public health and the consumers involved.

While cannabis products are often marketed as a miracle drug, they are not. While there may be some health benefits, without comprehensive research and regulation of these products, the risks outweigh the potential good. Consumers remain responsible for making their health decisions, and women in particular should be vigilant. The FDA is heading in the right direction but more must be done to protect consumers – and women in particular. I encourage you to learn more about a safe path forward here and help NCL raise awareness of this important issue.

Sources:

Adams, Katie. “Women’s Health Is Suffering Due to Lack of Research and Funding, Experts Say.” MedCity News, 9 Dec. 2022, medcitynews.com/2022/12/womens-health-is-suffering-due-to-lack-of-research-and-funding-experts-say/#:~:text=Women’s%20health%20has%20been%20historically,healthcare%20conference%20in%20Washington%2C%20D.C.

Eversheds Sutherland. “FDA Says ‘No’ to CBD: Now What?” FDA Says “No” to CBD: Now What? – Eversheds Sutherland, us.eversheds-sutherland.com/mobile/NewsCommentary/Legal-Alerts/256713/FDA-says-no-to-CBD-Now-what#:~:text=Since%202018%2C%20the%20FDA%20has,%2Dapproved%20drug%20(Epidiolex). Accessed 6 July 2023.

Greenhalgh, Ally. “Medicine and Misogyny: The Misdiagnosis of Women.” Confluence, 5 Dec. 2022, confluence.gallatin.nyu.edu/sections/research/medicine-and-misogyny-the-misdiagnosis-of-women.

Grinspoon, Peter. “Cannabidiol (CBD): What We Know and What We Don’t.” Harvard Health, 24 Sept. 2021, www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476.

“What You Should Know about Using CBD When Pregnant or Breastfeeding.” U.S. Food and Drug Administration, www.fda.gov/consumers/consumer-updates/what-you-should-know-about-using-cannabis-including-cbd-when-pregnant-or-breastfeeding#:~:text=FDA%20strongly%20advises%20against%20the,during%20pregnancy%20or%20while%20breastfeeding.&text=Cannabis%20and%20Cannabis-derived%20products,products%20appearing%20all%20the%20time. Accessed 6 July 2023.

Meet the winners of this year’s Script Your Future Medication Adherence Team Challenge

The 2020 Medication Adherence Team Challenge is part of the national Script Your Future public awareness campaign coordinated by NCL with support from its partners and the Challenge sponsors—the American Association of Colleges of Pharmacy (AACP), the National Association of Chain Drug Stores (NACDS) Foundation, the National Community Pharmacists Association (NCPA) and the American Pharmacists Association (APhA).

Medication non-adherence can lead to devastating health outcomes. Research shows that nearly one in five prescriptions go unfilled and half of all patients with chronic illnesses do not take their medication as prescribed. Improved medication adherence leads to better health outcomes and reduced total healthcare costs, and it was for these reasons that NCL launched the Script Your Future awareness campaign in 2011.

The Team Challenge was established to extend campaign messages into medical and other schools of health professions, and to nurture adherence-minded values in future generations of professionals entering the workplace. Each year, top performing teams are honored with a National Award for overall outstanding team achievement, or a Focused Award, which recognizes outstanding team achievement in the specific areas of health disparity/under-represented community outreach, media/communications outreach, or creative interprofessional team event. This year, we introduced a new focused award category, with the inclusion of a Technology Innovation Focused Award – a category that evaluates creative outreach with a focus on technology-based interventions.

In 2020, our Team Challenge student health professionals were met with unique challenges as they navigated the historic COVID-19 pandemic, which resulted in school closures, event cancelations, and a host of other obstacles. To adhere to social distancing guidelines, our dedicated teams pivoted their campaigns and made an impact in other ways. This year, the Team Challenge observed engagement from nearly 2,900 future healthcare professionals and volunteers, who all together hosted over 250 events in 14 states. Collectively, the teams directly counseled close to 12,000 patients and introduced Script Your Future messaging to over 430,000 consumers, nationwide.  Since the Team Challenge began in 2011, more than 21, 000 future healthcare professionals have directly counseled nearly 87,000 patients and nearly 26 million consumers.

The recognized schools, selected from dozens of applications and 82 participating educational institutions, are listed below.

National Award | University of the Sciences: Philadelphia College of Pharmacy, PA

University of the Sciences (USciences) interdisciplinary medication adherence outreach centered around individuals across all ages, from children to older adults. USciences’ team structure included students of pharmacy, occupational and physical therapies, medicine, and social work. Throughout the Team Challenge, USciences directly counseled 455 patients, reaching a total of 805 people. During their outreach, USciences introduced a new campaign theme – “A future of ______ begins with me”, to personalize medication adherence through each patient interaction. USciences’ campaign also placed a great emphasis on addressing racial disparities, reducing stigma surrounding mental health, and tangential issues like vaccine confidence and proper nutrition.

National Award Finalists

The following schools were named Finalists under the National Award category:
Pacific University School of Pharmacy, West Virginia University School of Pharmacy, Western University College of Pharmacy, Northeast Ohio Medical University (NEOMED), University of Charleston School of Pharmacy, Touro University College of Pharmacy, St. Louis College of Pharmacy.

Rookie Award | Howard University College of Pharmacy – Washington, DC

NCL is thrilled to announce that DC HBCU, Howard University College of Pharmacy, was the recipient of the 2020 Rookie Award. Howard University’s team included students of pharmacy, medicine, social work, and dentistry. Howard University’s target population included homeless or displaced minorities, children and parents, and adults with behavioral issues. The team tailored its disease focus to diabetes and heart disease, as they are chronic conditions that plague the region. Throughout the Challenge, Howard University directly counseled close to 400 patients and reached over 1,000 people with the help of 169 students and volunteers and distributed nearly 1,000 Script Your Future medication adherence resources.

Rookie Award Finalist: University of Arizona College of Pharmacy– AZ

The University of Arizona College of Pharmacy in Tucson, AZ also made a strong showing in the Team Challenge as a first-time competitor.

Focused Awards

Health Disparities Community Outreach Award | St. Louis College of Pharmacy – MO

Pharmacy students from St. Louis College of Pharmacy and nursing students from St. Louis University, joined forces to strategically and intentionally identify their target population – residents of a region of St. Louis known as the “Delmar Divide.” St. Louis College of Pharmacy chose this target population due to the stark disparities observed in the residents directly north and south of the Delmar Divide. For their outreach, St. Louis College of Pharmacy focused their interventions on communities north of the Delmar Divide, which predominantly consists of people of color of lower socioeconomic means. The team chose to focus on chronic conditions like diabetes and hypertension. Together, 60 students and volunteers directly counseled 350 patients and reached nearly 400 people. Through numerous events and newly fostered community partnerships, St. Louis College of Pharmacy disseminated nearly 400 Script Your Future medication adherence resources within the community.

Communication and Media Outreach Award | Lake Erie College of Osteopathic Medicine School of Pharmacy (LECOM) – PA & FL

To illustrate the diversity of their team, LECOM pharmacy and medical students from campuses based in PA and FL produced a public service announcement (PSA) spoken in eight languages, to help amplify the value of medication adherence to numerous populations. The PSA garnered over 2,800 views. LECOM employed social media platforms like Facebook, Instagram, Twitter, and LECOM’s Pulse Newsletter, to help disseminate Script Your Future medication adherence messaging. LECOM students also wrote an original book to present heart health information to the children entitled “Mr. Pumper and the Heart Valves”, which was read to third grade elementary students. Throughout the Challenge, 293 students and volunteers directly counseled over 500 patients, reaching over 1,200 patients, and disseminated over 730 Script Your Future resources in their community.

Creative Inter-Professional Team Event Award | University of Pittsburgh School of Pharmacy – PA

The University of Pittsburgh School of Pharmacy partnered with the Schools of medicine, dentistry, social work, nursing, dietetics, and rehabilitation sciences, to organize a team of over 300 students and volunteers to execute their medication adherence outreach. University of Pittsburgh harnessed the interdisciplinary nature of their team to build a campaign serving older adults in their community, from a holistic treatment perspective. The team addressed issues like hypertension, social isolation, and food insecurity. Throughout the Challenge, University of Pittsburgh directly counseled over 130 patients and reached over 2,200 patients.

Technology Innovation Award| Western University College of Pharmacy – CA

Western University College of Pharmacy made an impressive debut for the inaugural inclusion of the Technology Innovation Award. To foster medication adherence, the team created a dedicated website that directed patients to resources relating to disease areas like COPD, pneumonia, heart failure, and diabetes. The website was geared towards patients recently discharged following a hospital stay and contained features like medication and post-discharge appointment reminders and medication adherence-related infographics in multiple languages.

Advocating for emergency air transport coverage

This spring, NCL sent a letter to the CEOs of Cigna, Aetna, and UnitedHealth Group, urging them to enter into productive negotiations with air medical service providers to ensure coverage of emergency air medical transportation. The ask came as the COVID-19 pandemic spread across the country, making air medical services even more essential, particularly in rural America.

“We are increasingly concerned about emergency air medical access during this crisis, and believe this life-saving care should be covered by every insurance plan,” said NCL Associate Director of Health Policy Nissa Shaffi.

“We are asking that insurers review the robustness of their coverage policies and immediately enter into network negotiations with air medical providers so that this critical service is covered, and patients are never left with a bill they cannot pay.”

At-home vision assessments no replacement for in-office visits

With COVID-19 keeping many of us at home, companies claiming to offer at-home vision tests are ramping up their marketing, despite the fact that there is no U.S. Food and Drug Administration-approved at-home device that people can use to self-conduct a vision assessment, let alone a full eye examination. These devices aren’t even proven to provide an accurate vision prescription. NCL has long recommended an annual, in-person eye exam as part of consumers’ annual health and wellness routines.

“Consumers need to be wary of products that mistakenly claim that their at-home devices can provide an eye exam or a vision prescription and should instead consult their eye doctors who are available to help provide safe solutions,” said NCL Associate Director of Health Policy Nissa Shaffi.

Sorting through bogus health claims

Across the United States, people are rising to the historic health needs and challenges posed by coronavirus, with healthcare workers on the frontlines risking their lives, and businesses pivoting to manufacture much-needed medical and protective supplies.

But deep concerns about the health implications—what happens to people who contract the disease from a health and financial perspective—are top of mind for many of us. And a cynical minority has seized on the crisis to employ unscrupulous, and frankly dangerous, marketing tactics to promote bogus products claiming to protect users against the coronavirus or provide relief for those infected—as well as peddling downright phony coronavirus testing products.

“These false claims touting unproven medical benefits are nothing more than craven attempts to take advantage of fearful consumers,” said NCL Executive Director Sally Greenberg.

“Moreover, they spread misinformation among consumers anxiously seeking ways to stay safe and healthy amidst the coronavirus crisis.”

In an op-ed in The Hill published in May, Greenberg noted that a number of CBD manufacturers and stores are falsely promoting unproven medical benefits of CBD products.

A CBD store in Portland, OR, for example, was recently ordered by the office of the state’s attorney general to take down signs claiming that its products could boost immunity against COVID-19.

“False claims such as this are particularly dangerous as consumers anxiously attempt to stay safe and healthy amidst the coronavirus crisis,” said Greenberg. “The need for science-backed treatments is significant and we must ensure products are tested and regulated for safety.”

Contrary to claims being made by CBD marketers that products containing cannabidiol can help those suffering from coronavirus, recent studies have actually found potential harmful side effects of cannabis products on infected coronavirus patients. Aurelius Data cautions the public against the potential harmful side effects that can come from consuming cannabis products with Tetrahydrocannabinol (THC) if a patient is infected with COVID-19. And studies have shown that many unregulated CBD products have been found to contain THC, though the labels may not disclose this.

“In these uncertain times, we urge consumers to continue to take precautions,” said Greenberg. “We urge everyone to follow CDC guidelines for COVID-19, practice safe social distancing, and at the same time avoid THC products and all untested, unregulated CBD products to help keep your family, friends, and communities safe.”

The overlooked epidemic: COVID-19 and its relationship to opioids

By NCL Health Policy intern Talia Zitner

The coronavirus pandemic isn’t the only major public health crisis plaguing America. As the country struggles to contain COVID-19, the pandemic has seen a corollary rise in incidents of opioid usage and overdose. A major disruption in the way people suffering from opioid addiction receive treatment may ultimately prove critical to understanding how the opioid epidemic is directly affected by the coronavirus.

When lawmakers passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act in March, opioid treatment centers were not eligible to receive any of the $50 billion in funding that was allocated for Medicare providers. As a result, these essential centers—often under-supported and understaffed—saw their workforce getting ill or leaving to care for loved ones. Additionally, job loss and illness have left those already at risk of opioid addiction more vulnerable to relapse and death.

A key problem is the patient’s ability to get a prescription for addiction-managing drugs. Many centers rightly offer only one pill a day to their patients, but as the pandemic has forced the need for physical distancing and lack of physical contact, it has become increasingly difficult for people to get their medication. Long lines and hours-long wait times dissuade patients from getting their daily dosage. Few patients qualify for more than one dose per day, and few doctors are authorized to prescribe larger amounts of opioid managing medication.

Sadly, the coronavirus pandemic has overshadowed the opioid epidemic that continues to haunt millions of Americans. During this difficult time, the government should focus on the risk of opioid abuse and overdose and put more money into treatment programs and centers. Without support, more people will succumb to opioid addiction, lack of access to treatment, and death, further burdening the health care system.

Talia is a Washington, DC native and a rising sophomore at Wesleyan University, where she is studying English. Beyond health policy, Talia’s interests are in journalism, law, and social justice.