National Consumers League statement urging FDA to make patient-centered decision on only available treatment option for pregnant mothers at risk for recurrent preterm birth

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Oct. 7, 2020

Removing FDA-approved 17P could put countless pregnancies at risk even as COVID-19 adds new barriers for mothers with a history of spontaneous preterm birth

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 is urging the U.S. Food and Drug Administration (FDA) to protect patient access to the only approved treatment to reduce the risk of preterm birth in women with a history of spontaneous preterm birth, following this week’s proposal that all approved treatment options be withdrawn. We maintain that it is not in the best interests of patients, nor their healthcare providers, to deprive pregnant women of access—especially as there are no other approved treatment options—without considering alternative methods to better understand which patients benefit the most from 17P.

Hydroxyprogesterone caproate or “17P” has been the only available FDA-approved treatment option for nearly a decade to reduce the risk of recurrent preterm birth. Patients and the healthcare providers who serve them currently have access to one branded and five generic versions of the prescription product.

Since last year, the FDA has considered whether to remove FDA-approved formulations of 17P due to conflicting data from two clinical trials with notably different patient populations: one of which included a majority of African American women (59 percent) from the United States, and another where African American women represented 7 percent of a predominantly international patient population.

Despite the strengths of the original clinical trial and experiences of thousands of women to whom 17P was administered over the past decade, the strong safety profile of 17P, and the fact that 15 leading patient advocates and providers urged them to carefully consider all of the data and recognize the needs of women of color, the Center for Drug Evaluation and Research (CDER) within the FDA recently proposed that approval for all versions of 17P (branded, generics, and compounded for this indication) be withdrawn from the market.

CDER made this recommendation without meeting with advocates or providers who have personal experience of the positive impact 17P can have on the lives of mothers and babies at risk of being born prematurely.

We strongly urge CDER and the FDA to commit to a transparent and patient-centered process before making a decision about the fate of this vital treatment. Removal of 17P from the market would leave at-risk pregnant women and their providers without a recommended standard of care, and in the interim, extends a period of uncertainty that has already lasted too long.

Appreciating the importance of continued access to FDA-approved treatment options for at-risk pregnant women, including those that reduce their risk of early delivery, several months ago, we led a joint effort to urge the FDA to maintain and protect patient access to 17P. An array of leading consumer, women’s health, and maternal health organizations and thought-leading healthcare providers joined our efforts, together expressing serious concerns that a regulatory decision could be based on a single study that was largely conducted outside of the U.S., in a predominantly white population of women.

In our outreach to the FDA, we urged the agency to consider alternative ways to further evaluate and define the patient populations that most benefit from 17P, without depriving women of access. We regret to state that the agency did not respond to our letter, nor two separate requests to meet with stakeholders who have stood ready to discuss these concerns for months.

Moreover, the company that makes the branded version of 17P reported that it submitted a proposal to the FDA earlier this year with a plan to generate additional data and predictors of benefit in women with a history of recurrent preterm birth. Despite the company’s effort to proactively initiate the first part of a retrospective study, it has indicated that it was not provided an opportunity to discuss this research with the agency before its recent response.

While we recognize there is no single solution that will improve maternal and infant health outcomes, only one proven intervention exists to help pregnant women prevent recurrent preterm birth. Especially during this pandemic, pregnant women and their unborn babies are under extreme stress, yet providers have few therapeutic options to help at-risk mothers. There may be an increased risk of preterm birth and pregnancy loss among pregnant women with COVID-19, and even under normal circumstances, preterm birth places mothers and babies at significant risk—particularly among pregnant women of color.

Access to FDA-approved treatment options should not be compromised without substantial evidence that there is a lack of benefit in the appropriate population—which we don’t believe we have today. Instead, it is our belief that findings from a study where the majority of participants resided outside the U.S. in countries with different health systems and different rates of preterm birth shouldn’t be generalized and that it is reasonable to pursue real-world data sources to help us better understand the overall benefits in a patient population where there are no other options.

We believe it is possible for the FDA to continue to uphold its strong history of regulatory integrity while listening to perspectives from patient advocates and providers that are rooted in years of clinical use. What we can’t believe is the alternative, which leaves providers and pregnant women without a path forward in the middle of a pandemic.

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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 concerned Congress seeks to approve unreviewed CDB products

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Sept. 17, 2020

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

Washington, DC—On September 4, lawmakers introduced The Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2020 (HR 8179), which directs the U.S. Food and Drug Administration (FDA) to make hemp and hemp-derived CBD lawful as a dietary ingredient or dietary supplement. The National Consumers League (NCL) has long been concerned about the public health and safety risks posed by unapproved cannabis-derived products. NCL does not support legislation that seeks to bypass FDA’s authority and circumvent the scientific rigor of an FDA review.

Under current law, manufacturers and distributers of CBD products can already petition the FDA to review and approve a new ingredient for use as a dietary supplement (21 U.S.C. 350b). For FDA approval as a dietary supplement or new ingredient, manufacturers and distributors are required to submit scientific data, including any published studies, to provide a basis to conclude that a product is generally regarded as safe (GRAS). Unfortunately, there is a disconcerting lack of research and data about the safety of CBD products already in the market, whereby millions of consumers are using to self-treat serious and life-threatening ailments.

In response to the proliferation of unreviewed and untested CBD products in the market, NCL launched the Consumers for Safe CBD program to provide greater education to consumers about CBD. As demonstrated in a white paper published by NCL, cannabis companies tend to focus their research efforts on inexpensive, low-strength studies that are ultimately used for marketing purposes, not to enhance scientific knowledge or bring new proven therapies to patients. HR 1879 would further incentivize CBD manufacturers to forego the more rigorous and costly clinical trial process for developing an FDA-approved medicine.

NCL is concerned that CBD manufacturers and distributers making claims to treat certain medical issues will seek expedited approval of CBD products as a dietary supplement, instead of as a drug. Lawmakers should encourage the development of cannabis-based medicines that have undergone the rigor of randomized controlled clinical trials to learn more about how cannabis-derived therapies can both help and harm patients. This legislation seeks to fast-track the classification of CBD products as dietary supplements or ingredients without sufficient scientific data on their safety and efficacy, potentially placing consumers further at risk.

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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.

Mail-in and absentee voting during COVID-19

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By NCL Executive Assistant Adrienne Archer

The National Consumers League (NCL) wants consumers to know that voting by mail or absentee ballot during the COVID-19 pandemic is safe. Due to conflicting information being shared by the media, and federal, state and local governments, it can be difficult to determine how best to vote. During the COVID-19 pandemic, a voter should always focus on keeping themselves and their family safe and healthy. Whether voting by mail-in or absentee ballot, it’s important to have a plan. However, due to the variety of challenges posed by the pandemic, it might be difficult to keep up with the changes or updates to a state’s voting guidelines. Voters should contact their local elections office.

Many states and the District of Columbia have made it easier to vote early by mail or by absentee ballot. In the past, voters needed a reason why they couldn’t vote in person. National Conference of State Legislators (NCSL) has resources for on state laws governing voting across the U.S. To know exactly when to vote in your state, contact your local elections office. USA.gov also offers information on the time frames for early or absentee voting.

All states will offer a form of mail-in voting and some states will make it more accessible to vote than others. Some states are still crafting legislation to make it easier for people to vote by mail or absentee ballot. The New York state legislature passed three bills allowing voters to request an absentee ballot or mail-in ballot because of COVID-19 fears. One of the bills allows for absentee ballots to be postmarked as late as election day and still be counted.

Government officials have noted possible instances of voter fraud. Some states have voiced concerns that mail-in ballots can easily be stolen, altered, or forged. Voters worry that they will not receive their ballot in time to vote. Congress is worried that the increase in mail will overwhelm the United States Postal Service (USPS) and delay the delivery of ballots. To add to the problems, the U.S. Postmaster General has made budget cuts to the USPS, dismantled machines, collected mailboxes, and reduced mail services causing consumers to worry that the USPS will not be able to process the increase in mail. Disability advocates want to ensure that mail-in voting will not be more difficult for voters with disabilities to exercise their right to vote.

Voting by mail is a safe option: it increases the overall voter response in the election. Even with these challenges to voting, military members and older Americans have been always encouraged to vote absentee. The Centers for Disease Control and Prevention (CDC) has provided recommendations for people to handle mail-in ballots safely when they are received. In response to consumer requests, the USPS has created a website to help voters ensure that they can receive and return their ballot safely. Also, voters should remember that the main goal of voting during this pandemic is to safely cast their votes.

Americans voting from abroad, or in the military should be aware of the following: potential delays with sending and receiving mail, possible embassy closures due to COVID-19, and ensuring that their personal address is updated with his or her state. Americans abroad should request a ballot immediately from the Federal Voting Assistance Program’s website and check with their local U.S. polling place for instructions on receiving and returning the ballot. Most states permit Americans abroad to request a ballot via email with the caveat that a completed ballot should be returned by well before the November 3rd deadline via postal mail. Under Federal law, ballots should be requested by overseas military voters by September 19th (at least 45 days before the election). The Military Postal Agency has a list of recommended mailing dates. After individuals have returned their ballot, they should be sure to contact their local elections office to ensure that their ballot was received or if they have any questions.

Voting by mail has always been a good way to ensure access to those with disabilities. The American Civil Liberties Union has guidelines to improve accessibility to persons with disabilities. They suggest voters with a disability should receive ballots electronically so they can vote from the safety of their homes. Voters could indicate their candidate on the ballot by using accessibility features on his or her device. Then the ballot should be printed and mailed to his or her local polling place. Some states require witnesses or notarization on the ballot envelope. The American Civil Liberties Union (ACLU) wants to dispense with this requirement. Election poll workers should receive training on accessible voting options and how to respectfully interact with voters with a disability. Lastly, every state should raise awareness about accessible voting options.

In summary, to effectively vote by mail or absentee ballot during the COVID-19 pandemic, the National Consumers League suggests these steps:

  1. Create a plan for voting by mail or via absentee ballot.
  2. Check your local polling office to ensure that it has your correct mailing address and you are eligible to vote in the upcoming election.
  3. Request your absentee or mail-in ballot NOW, well before the deadline of October 3rd (45 days before the election) from your local polling office.
  4. If voting from abroad or in the military, allow for extra time to request and receive your ballot.
  5. If you have a disability, every state has in place accommodations so you may vote safely and effectively. If you have questions, please contact your local polling place early so they may be resolved.
  6. When you get your ballot, review the instructions for completing and returning it. If you have questions, contact your local polling office for guidance.
  7. Mail-in your ballot immediately, in advance of your state’s deadline, allowing for time for it to be reviewed and counted.

Above all, vote, vote, vote!

Jeanette Contreras portrait

FDA Emergency Use Authorizations and public trust for COVID-19 treatments

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By NCL Director of Health Policy Jeanette Contreras

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration (FDA). The FDA is charged with ensuring the safety, efficacy, and security of the drugs, biologic products, and medical devices needed to treat and prevent the spread of COVID-19. The agency has undergone scrutiny from the scientific community for issuing Emergency Use Authorization (EUA) for COVID-19 treatments and diagnostics that appeared to be politically motivated.

On August 23, the FDA issued an EUA for the use of an investigational convalescent plasma to treat patients with COVID-19, touting it as yet another achievement in the Administration’s fight against the pandemic. After just two days of backlash from the scientific community, FDA Commissioner Dr. Stephen Hahn, took to Twitter to concede his mistake, admitting that the criticism was justified. Commissioner Hahn stated that the EUA is not the final FDA approval and that the agency would revoke authorization if needed. Criticism included former FDA Commissioners who stand by randomized clinical trial as the gold standard for evidence-based medicine.

This renowned round of criticism has come not long after the FDA provided EUA for hydroxychloroquine in March which it revoked in July after further review proved that it lacked efficacy.

The Federal Food, Drug, and Cosmetic Act provides the FDA Commissioner with the authority to issue EUAs for unapproved medical products or unapproved uses of medical products in response to a public health emergency, such as the current pandemic. An EUA can be revoked when new evidence emerges and the risk no longer outweighs the benefit of the unapproved use of a drug or product, yet the Trump Administration claimed that it was revoked due to political reasons.

Since February, when the Department of Health and Human Services (HHS) declared the pandemic a public health emergency, the FDA has exercised its authority to issue hundreds of EUAs for diagnostic tests, personal protective equipment, ventilators, and other medical devices to combat COVID-19. In August alone, the FDA revoked EUAs for over 100 diagnostic tests, including antibody and rapid tests. The FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a drug, treatment, or product.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments, testing products, and safety recommendations. After witnessing the media controversy over EUAs for hydroxychloroquine and convalescent plasma, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs for political gain. The FDA, now more than ever, needs to reestablish public trust as it proceeds to fast track the approval of a COVID-19 vaccine.

Compromised access to the USPS could result in worsened health outcomes

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

Washington, DC—The National Consumers League (NCL), the nation’s pioneering consumer advocacy organization, is today expressing concern about recent cuts to funding for the United States Postal Service (USPS) and the impact this has on consumers’ access to critical lifesaving medications.

The USPS has already suffered setbacks due to deteriorating financial conditions, and most recently the significant delays caused by the COVID-19 pandemic. The vulnerable agency is now caught in the middle of political strife as the President ponders withholding funding for the USPS in upcoming COVID-19 relief legislation, in order to impede mail-in voting. The USPS is an essential service, and consumers rely on these services daily to pay their rent, receive wages and Social Security checks, and most importantly, receive prescription medications via mail-order pharmacies.

These developments have grave ramifications for older Americans, and particularly veterans, of whom 80 percent receive their medications through mail-order pharmacies, 90 percent of which are delivered via the USPS. The Department of Veterans Affairs (VA) proprietary mail-order pharmacy system, the Consolidated Mail Outpatient Pharmacy (CMOP), consists of a group of seven automated hub pharmacies. The CMOP processes nearly 500,000 prescriptions daily, and ships packages to more than 330,000 veterans each working day.

The VA has stated that changes in the USPS have delayed medication deliveries by 25 percent in the last year, and has experienced an influx of mail-order prescriptions as entry to VA facilities have been limited to curb the spread of COVID-19. Veterans in rural or remote areas often rely exclusively on mail-order prescriptions, and as older Americans are cautioned to quarantine and social distance throughout the pandemic, ensuring timely access to medication is ever more imperative. The VA is currently rushing to mitigate potential delays by temporarily converting its deliveries from USPS to UPS 2nd Day Air or FedEx. Additionally, the VA will set up a specialized USPS code, to help prioritize veteran prescription deliveries.

The VA has advised patients to request refills for their medications at least 10 days before their treatment course ends, to ensure timely delivery of medications. Disruptions in medication deliveries caused by a lack of funding to the USPS could drastically impact overall health outcomes and medication adherence. As the country navigates the COVID-19 pandemic, it is crucial that our most vulnerable have timely and adequate access to the medications they need to maintain their health and avert potential progression of disease.

The National Consumers League stands with the United States Postal Service workers, as they tirelessly work to provide essential services during these challenging times. We call on Congress to hold the Administration accountable to ensure that consumers maintain access to the essential USPS services on which they depend.

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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.

Be wary of bad hand sanitizers

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By NCL Executive Assistant Adrienne Archer

Hand sanitizers help protect and prevent the spread of COVID-19 when soap and water are not readily available. When the coronavirus first emerged, demand for hand sanitizers soared. Stores were unable to maintain ample inventory, resulting in rampant hoarding and price gouging. Essential workers that desperately needed hand sanitizer couldn’t get them, prompting some companies to start making sanitizers that originally did not produce them (i.e. distilleries, cosmetic companies, etc.)

Guidelines from the Centers for Disease Control and Prevention (CDC) require hand sanitizer to have at least 60 percent ethanol (ethyl alcohol) in order for it to be effective. The CDC does not encourage members of the public to make hand sanitizer for individual use.

The Food and Drug Administration (FDA) has observed a sharp increase in those that, in addition to ethanol, also contain methanol—an ingredient that can be toxic when absorbed through the skin and can be fatal when ingested. Children and adults ingesting certain sanitizers led to blindness, hospitalizations, and even death.

Extended exposure to methanol can cause nausea, vomiting, seizures, permanent blindness, or death. The FDA has also found sanitizers with 1-propanol are also harmful. Accidental ingestions can cause central nervous system depression or death. Consumers that may have been exposed to hand sanitizers containing methanol or 1-propanol should seek medical attention immediately.

The FDA recently updated its guidelines on temporary policies about testing hand sanitizers to determine methanol levels. As companies produce hand sanitizers, they should frequently test to ensure that methanol is not created as a byproduct of either ethanol or isopropyl alcohol. The testing should be performed by an FDA inspected lab to ensure that it has met current good manufacturing practice (CGMP) standards. CGMP ensures the proper design, monitoring, and control of manufacturing processes and facilities. If alcohol (ethanol) has been found to contain more than 630 parts per million of methanol, it is contaminated and should be disposed of in hazardous waste containers. This guidance serves to help state-licensed pharmacies and outsourcing facilities report any incidents. The FDA has guidelines for an additional deterrent formula of alcohol to prevent children from ingesting them.

Consumers should also be cautious of false claims that hand sanitizers provide prolonged protection against COVID-19. Carefully inspect any purchased hand sanitizers to see if methanol or 1-propanol is listed.

FDA maintains a current list of hand sanitizers that are not recommended. As consumers review the list, they should compare the manufacturer name, product name, and National Drug Code (NDC) # on the hand sanitizer. If you find a product on the list, dispose of it immediately in a hazardous waste container and NOT down the drain.

The FDA encourages health professionals, consumers, and patients to report adverse effects and problems to the FDA’s MedWatch Adverse Event Reporting Program. Questions can be emailed to COVID-19-HandSanitizers@FHA.nns.gov. The FDA has also created a quiz to test consumer’s knowledge about hand sanitizers and a Q&A section on hand sanitizers and COVID-19 to keep consumers informed.

‘Should I stay or should I go?’ How the pandemic has affected higher education

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By NCL Health Policy intern Talia Zitner

Every morning, I wake up with a new decision to make. Am I going back to campus? Or am I spending the Fall semester taking online classes from the comfort of my childhood bedroom? I’m a rising sophomore at Wesleyan University, and to add insult to injury, I’m also an incoming transfer student. My internal debate about going back to school is near-constant, and despite weighing the pros and cons of each, I still can’t seem to come to a comfortable conclusion.

Around the country, colleges and students are faced with this same, nearly impossible challenge. If schools can’t or won’t open in the fall, they risk closing forever without tuition money. If they do allow students to come back to campus, and an outbreak occurs, they put students, professors, faculty, staff, their families, and the greater community at risk. Students rely on colleges to be their home away from home, a place where they can work and learn in a structured, safe, and healthy environment, not to mention the social benefits.

Consequently, coming back to campus poses a serious financial and ethical question. Like anything else, college and higher education is a business. Consumers want to get the most for their money, and the colleges and universities need consumers to engage to have a sustainable business model. The pandemic has shifted the conversation in many areas of life, higher education included.

This issue is especially complicated because it can be broken down from multiple perspectives. For example, an economic point of view argues that colleges are only re-opening because they need the money. Like many other businesses, they stay open because they have no other choice. Without the money generated through tuition and other forms of revenue like donation and state funding, it would take years for schools to recover from the impact of COVID. But college is a substantial investment for families. Why should consumers be expected to pay full (or reduced) tuition for an experience that is more like a monastery than college? Will the investment really be worth it if schools are simply shut down again because of an outbreak at a campus party?

On the other hand, if students aren’t in school come fall semester, what else would they be doing? Most students are hard-pressed to find a job or internship that’s worth taking a semester off for in this environment. And time off may push back a student’s graduation time, putting them behind the rest of their peers. For very legitimate reasons, students want to come to campus and keep their college experience intact.

This seems to be where my own expectations fall. I have no idea if the situation will improve between now and the spring semester. To me, the only course of action is to enjoy the experience that I will have, even if it means wearing a mask.

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.

Understand the opioid epidemic and protect yourselves and loved ones

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Knowing the rights, risks and responsibilities of prescription opioid use is an important first step to addressing the opioid epidemic. Whether you are taking medication to treat pain, or have friends or family members who have been prescribed opioids, knowing the facts can help prevent misuse before it occurs.

NCL recently partnered with the Allied Against Opioid Abuse (AAOA) to create a new batch of resources to help educate consumers about prescription opioid safety. The new Consumer Toolkit includes educational materials to help reinforce the need for patients, caregivers, parents, and others to understand their rights, risks, and responsibilities associated with prescription opioid use.

Prescription opioids are medications prescribed by healthcare providers to treat moderate to severe pain for health conditions that cause ongoing discomfort as well as for pain following surgery or injury. Common prescription opioids include:

  • Oxycodone
  • Morphine
  • Hydrocodone
  • Oxymorphone
  • Codeine
  • Fentanyl

If you are not sure if your medicine is an opioid, check your prescription labels to look for generic names. The National Safety Council also provides a helpful chart of medicines that contain opioids. You should always ask your healthcare provider or pharmacist if you are not able to find the name or have questions.

Watch for risk factors associated with prescription opioids, including:

  • Mixing opioids with other medications, drugs, nutritional supplements or alcohol
  • Taking more than prescribed
  • Taking a high daily dose of opioids
  • Certain conditions such as depression, anxiety, post-traumatic stress disorder, HIV, sleep apnea, or liver or lung disease
  • Pregnancy
  • Older age
  • Family history of substance abuse

Let your doctor know if you or your loved ones have any of these risk factors before filling any opioid prescription.

“Opioid misuse often starts in the home, so safe storage and disposal are key to prevention,” said Sally Greenberg, executive director of NCL. “Make sure that prescription opioids are stored securely and remember to properly dispose of all unused prescription opioids as soon as possible.”

AAOA offers a safe disposal locator for you to find a place to safety get rid of your unused medications. Find details on safe disposal options here.

Consumers for Safe CBD is working to protect, educate Americans

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As America’s premier consumer advocacy organization, with a rich history of fighting to make the marketplace fair, safe, and healthy for consumers, NCL is hard at work on the most important issues in food and drug safety and to collaborate on improving consumer education.

In recent years, NCL has been observing the CBD, or cannabidiol, marketplace exploding, with products lining shelves of grocery stores, specialty shops—even gas stations. Products were appearing to make many claims or hint at miracle cures, and most consumers had no idea how or whether the products were being regulated. Who is making sure these tinctures, oils, gummies, and lotions are safe, and do they do what they claim?

This is why last year, NCL joined forces with the Consumer Federation of America and the Community Anti-Drug Coalitions of America, to create a national campaign called Consumers for Safe CBD.

NCL had identified a serious need for greater education among consumers about CBD, and that’s why Consumers for Safe CBD was created. Consumers for Safe CBD aims to help educate the public about the risks related to untested, unapproved CBD products on the market, champion the rights of consumers, and call on the U.S. Food and Drug Administration (FDA) and industry to do better to ensure safety and promote a pathway for new products through clinically tested scientific research.

“Cannabidiol, commonly referred to as CBD, is being used in a growing number of consumer products and is illegally sold in stores and on the Internet,” said NCL Executive Director Sally Greenberg. “We’re working to educate consumers and ensure accurate labeling, clear guidelines, and further research to protect against unknown and known risks of CBD products.”

NCL and its partners continue to raise awareness among consumers, policymakers, and regulators about the health risks associated with the unregulated CBD marketplace, in particular with the unproven health claims and often inaccurate labeling of products on the market today. Beyond the known health risks associated with unregulated CBD, there are a number of unscrupulous marketing tactics that prey on unsuspecting consumers. This includes false and dangerous claims that CBD has medical benefits that can prevent and stop the spread of the COVID-19.

By warning consumers about these false claims, participating in media interviews and publishing op-eds across the country, highlighting important research and reports, and sending letters to several retailers, state Attorneys General and Members of Congress, the campaign is working to protect consumers across the country from unapproved and potentially dangerous CBD products.

“We need to better understand the potential health benefits of CBD, but this can only be accomplished through clinical testing and scientifically validated methodologies,” said Greenberg. “We need the FDA to step up for consumers and for the public health.”

The time for action is now. CLICK HERE for more information about the Consumers for Safe CBD effort.

Reopening the economy prematurely has dire consequences for states

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By NCL Health Policy intern Talia Zitner

The past month has seen a serious surge in reported coronavirus cases in the United States. It seems the virus is going to be with us for a while. Of states where COVID is spiking, the majority are in the South, many of which had ambitious reopening plans that are now being reconsidered.

Three of these states—Texas, Florida, and Arizona—have current surges. All three pushed to reopen their economies early in an attempt to “return to normal.” The current deluge in cases that resulted was due to a lack of continuing stay-at-home order and a failure to require masks.

Texas officially started Phase 1 of its reopening plan on May 1, but—as of June 26—had to retract much of the opening that it had started. In total, Texas was only able to reopen the state for 55 days. As of July 27, Texas has seen an average of 8,089 new cases of the coronavirus over a seven-day period. Compared to cases in April, when there were 814, this is astounding. Texas Governor Greg Abbott (R) has since ordered everyone to start wearing face masks and has limited the size of public gatherings.

It does not appear that Texas will shut down again, however. As the governor said, “we need to refocus on slowing the spread, but this time we want to do it without closing down Texas again.” Although it is an issue of public health, the issuance of a statewide masking policy and the staggered re-opening of the economy has become a matter of contention across party lines. Some residents find the Governor’s actions to be inadequate, and others feel as if the newly implemented precautions impede their personal liberties.

Florida and Arizona are not faring much better. As of April, Florida had 1,027 cases reported. In July, it was 6,563. Florida started its reopening plan on May 4 and entered into Phase 2 on June 5. Clearly, cases have surged.

Earlier this week, Florida reported 8,892 new COVID-19 cases. Like Texas, there seems to be a mixed reaction among Florida representatives to slow the spread of the virus. Senator Rick Scott (R) has been vocal about his intentions for Florida, and it appears the state will not roll back any of its reopening course. As Senator Scott put it a couple of months ago, “wearing a mask is a choice you get to make.”

Like Texas and Florida, Arizona is hurting badly, with only 115 in April surging to 4,753 cases in July. Arizona’s stay-at-home order lasted until May 15, and was replaced by the new Stay Healthy, Return Smarter, Return Stronger Executive Order, on May 16. When Arizona first reopened, Governor Doug Ducey did not require residents to wear face masks, but as the case numbers increased, he allowed local governments to set their own masking policies. As of July 1, officials said that Arizona saw the highest rate of new cases in the entire country.

Many public officials are starting to realize opening too soon was foolhardy and has spread the virus. New revelations by scientists show the virus can actually be airborne, urging those to take indoor transmission more seriously. The virus is also proving to be more of a blood vessel disease than solely a respiratory one, which may lead to long-term impacts that doctors are still learning about.

There’s one takeaway here: following the example of states like Texas, Florida, and Arizona is not recommended. The more seriously states take this crisis the better, and the sooner the entire country will be able to move towards a newer, safer “normal”.

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.