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FDA puts tobacco interests over kids

E-cigarette flavor guidance won't address growing youth epidemic

The U.S. Food and Drug Administration (FDA) released guidance on Jan. 2 that includes only a partial prohibition on flavors by allowing “vape shops” that sell open tank systems to continue to sell fruit, candy, mint, and menthol flavors that have hooked a new generation of tobacco users. 

The guidance will also continue to allow the sale of menthol flavored e-cigarettes in all locations, abandoning previous commitments by the Administration to clear the market of all e-cigarette flavors in response to a growing epidemic of youth use.

The guidance does not preempt strong, comprehensive state and local policies that regulate the sale of flavored tobacco products.

Data from the 2019 National Youth Tobacco Survey show youth use of e-cigarettes in high schools skyrocketed, with a 135% increase over the past two years. Survey results also show that 27.5% of high school students used e-cigarettes in the last 30 days. Nearly 64% used mint or menthol flavored e-cigarettes, only 2% less than fruit flavored products and significantly more than candy flavors.

A statement from Gary Reedy, CEO of the American Cancer Society and American Cancer Society Cancer Action Network (ACS CAN), follows:

“The FDA’s decision to abandon its announced plan to clear the marketplace of all flavored e-cigarettes, including menthol, is unconscionable. Instead of moving forward with an effective proposal that could have a meaningful effect in curbing the youth e-cigarette epidemic, we once again have a hollowed-out policy that will allow the tobacco industry to continue to attract kids to a lifetime of nicotine addiction.

“It is well-documented that the tobacco industry uses flavored products to target youth with more than 80% of teens who report using tobacco products having started with a flavored product. This guidance is yet another giveaway to the industry, which will continue to have unfettered access to market its addictive products at the expense of public health.

“Vape shops and other retail stores are a source for e-cigarettes for youth. In fact, just last summer, the FDA issued more than 1,300 violations to retailers who sold e-cigarettes to minors. According to data from the 2018 National Youth Tobacco Survey, 14.8 percent of U.S. middle and high school e-cigarette users under 18 years of age reported obtaining e-cigarettes in the past 30 days from a vape shop or other store that sells e-cigarettes – more than the 8.4 percent who reported obtaining them from a gas station or convenience store. The federal government should not assume that retailers who only sell age-restricted products, like tobacco (or alcohol), are restricting who enters their store or effectively enforcing age of sale laws as evidenced by FDA’s warning letters. The FDA must hold retailers accountable by aggressively enforcing age restrictions to prevent youth access to these addictive products.

“In the limited locations where most flavors will be prohibited, we will now have a situation that provides a path for more youth users to continue to use or migrate toward menthol flavored e-cigarettes. Menthol is a derivative of mint, and there is little difference between these flavors. With nearly 64% of youth e-cigarette users reporting use of mint or menthol flavored products, the decision to allow menthol to remain on the market without any semblance of agency review or oversight dramatically undermines the potential public health impact of this proposal. With mint and menthol already being some of the most popular flavor choices among youth users, there’s reason to believe the popularity of menthol will only continue to rise. 

“The American Cancer Society Cancer Action Network urges the Department of Health and Human Services, in coordination with the FDA, to reconsider its finalized guidance and instead enact a comprehensive policy that will protect our children from the profit-driven tobacco industry by removing all flavored e-cigarettes from the market in order to improve the health of the nation. ACS CAN also calls on Congress to resist influence from the tobacco industry and prohibit all flavors in all tobacco products. ACS CAN will continue to advocate at the federal, state and local level, with a presence in all 50 states, to advance and implement effective tobacco control policies that make up for the shortcomings of this guidance.”

  • ACS CAN welcomes four new Board members

    Beginning January 1, 2020, the American Cancer Society Cancer Action Network (ACS CAN) Board of Directors will welcome four new directors:

    • Philip R. O'Brien – Mr. O'Brien is an attorney and shareholder with Reinhart Boerner Van Deuren, S.C., in Milwaukee, Wisconsin. He serves on the American Cancer Society Wisconsin State Leadership Board and previously served on the Midwest Division Board of Directors. He first became involved with the Society through Reinhart Boerner Van Deuren's Making Strides Against Breast Cancer campaign and has served as chair of the event since 2010. Mr. O'Brien currently serves as the ACT! Lead for the 4th Congressional District of Wisconsin. 
    • Marcus Plescia, MD, MPH – Dr. Plescia is the Chief Medical Officer of the Association of State and Territorial Health Officials and provides medical leadership and expertise across the agency and oversees the portfolio of chronic disease prevention and control programs. He has served in public health leadership roles at the local, state, and federal level in North Carolina and at the Centers for Disease Control and Prevention. Dr. Plescia serves on the American Cancer Society's Mission Outcomes Committee and served on the former South Atlantic Division Board of Directors. 
    • Alice L. Pomponio – Ms. Pomponio serves as a strategic and operational advisor of Red Sky Partners LLC, and is the founder and managing director of Accendo Bio, an independent social innovation consulting practice aimed at accelerating innovative solutions to patient access, affordability, and adherence through enterprise formation, impact investment, and nonprofit strategic planning. She serves on the Eastern New England Area Board and led record-breaking fundraising efforts as the chair of the New England Research Breakfast since 2018. 
    • Jose R. Ramos, Jr. – Mr. Ramos is the Senior Director for Global Customer Acquisition in the Consumer Business Unit at Symantec, one of the world's leading cybersecurity companies. He has held numerous leadership roles in public and private companies, and his experience includes other management roles in technology, energy, and management consulting. He served as chair of the former California Division Board and has served in a variety of other roles, including as a legislative ambassador for ACS CAN, chair of Relay For Life, and as a State Lead Ambassador.

    The following ACS CAN Board members were elected to serve as officers for 2020:

    • Sandra Cassese, MSN, RN, CNS – Chair

    • Maureen Mann, MS, MBA, FACHE – Vice Chair

    • Bernard Jackvony, JD – Secretary

    • John J. Manna Jr., Esq. – Treasurer

    Finally, we want to recognize and thank John W. Hamilton, DDS, Robert E. Youle, and Daniel P. Heist, whose terms on the Board end December 31, 2019..

  • Congress, President approve 2020 spending bill that includes a $2.6B boost for medical research

    Trump signs $1.4 trillion spending bill, raises age to buy tobacco to 21

    The week of Dec. 15, the House and then the Senate passed a funding bill that includes a $2.6 billion increase for medical research at the National Institutes of Health (NIH). The measure, signed by the President on Dec. 20, also provides $296 million increase for the National Cancer Institute (NCI), and a $10 million increase for cancer control programs at the Centers for Disease Control and Prevention (CDC), including for skin, prostate, and ovarian cancer programs. There is an additional $20 million for the Office on Smoking and Health (OSH). 

    The bill also includes a measure to raise the federal age of sale for tobacco to 21, extends Medicaid funding for Puerto Rico and U.S. territories, ensures funding for Federally Qualified Health Centers, which provide doctor-recommended cancer screenings to uninsured and underinsured people; and works to lower drug prices through greater generic and biosimilar prescription drug competition through the Creating and Restoring Equal Access to Equivalent Samples – CREATES Act. 

    What follows is a statement issued before the votes by Lisa Lacasse (pictured here), president of ACS CAN:


    “We’re excited to see the $2.6 billion funding increase for medical research at NIH in this bill, including the $296 million increase for the NCI. NCI has seen a 50 percent increase in research grant applications since 2013—far above any other Institute or Center—and funding has not kept pace with demand. The inclusion of new funding to address this issue recognizes NCI’s unique position and will directly lead to the development of new treatments and diagnostics for cancer patients.

    The measure also continues funding for the implementation of the Childhood Cancer Survivorship Treatment, Access, and Research Act (STAR) and allocates money for a new childhood cancer data initiative. Congress should be commended for its ongoing commitment to continued development of innovative new cancer detection tools and treatments for patients and spurring scientific discovery across the country. 


    “The additional $10 million for cancer prevention and detection programs at the CDC will help ensure more low-income, uninsured people have access to timely cancer screenings, while the inclusion of cancer registries in the $50 million data modernization initiative at the CDC will improve the infrastructure necessary to compile and track essential cancer data. The additional $20 million for OSH will provide a much needed boost to efforts aimed at preventing kids from starting tobacco use and helping adults to quit. 

    “While we are pleased this legislation would raise the federal age of sale of all tobacco products to 21, this policy alone is not enough. Amid the ongoing youth tobacco epidemic with more than 5 million youth using tobacco products, lawmakers must move comprehensive legislation forward that removes all flavored tobacco products from the marketplace, including mint and menthol, and prohibits the online sale of all tobacco products in order to have a substantial impact on preventing youth use.


    “Increasing Medicaid funding caps for Puerto Rico and the U.S. territories for two years is critical to helping cancer patients and survivors maintain access to life-saving treatments and follow-up care. 

    “Similarly, extending funding for federal qualified health centers ensures uninsured and underinsured Americans across the country can access the doctor-recommended cancer screenings they need when they need them. 

    “Patients throughout the country could also benefit from lower out-of-pocket prescription drug costs through the inclusion of the CREATES Act. CREATES has the potential to incentivize even more generic and biosimilar drug competition, giving patients less expensive access to lifesaving therapies.

    “Keeping the medical expense tax deduction more broadly available will also provide necessary tax relief to more patients who have especially high out-of-pocket health care costs. 

    “On behalf of all those affected by cancer, we urge the full House and Senate to pass this bill before the December 20 deadline and send it to the president for his signature. Critical NIH research, cancer prevention, and access to life-saving health coverage cannot wait.”

  • Federal court strikes down ACA's individual mandate

    The current health care law will remain in place in the meantime

    Seventeen of the nation’s leading patient advocacy groups are remaining steadfast in their commitment to protecting patients throughout the next phase of legal proceedings involving the health care law known as the Affordable Care Act (ACA).

    On Dec. 18, on a 2-1 decision, a panel of the U.S. Court of Appeals for the Fifth Circuit in New Orleans struck down the individual mandate without a tax penalty as unconstitutional. It sent the case back to the District Court to determine if the mandate can be “severed” from the rest of the law and to consider whether a ruling should be limited to just the plaintiff states or apply to all states.

    The Attorney General of California, who has been leading the defense of the ACA, indicated that California will be filing a petition to request that the Supreme Court of the United States hear an appeal.

    The law, including protections for people with pre-existing conditions and minimum insurance coverage standards, will remain in place in the meantime.

    The patient groups filed a joint amicus brief yesterday in support of upholding the law. Following is the group’s statement:

    “The Fifth Circuit ruling will cause more uncertainty for millions of Americans who live with serious, acute, and chronic health conditions and who rely on the Affordable Care Act to access comprehensive health coverage.

    “The critical patient protections remain in place for now, including for people who just purchased healthcare for 2020, but the long-term viability of these essential protections continues to be at risk. Those protections include prohibiting insurance companies from denying coverage or charging more for coverage to people with pre-existing conditions, requiring health plans to offer essential benefits needed to prevent and treat a serious condition, and eliminating arbitrary dollar limits on coverage. 

    “Millions of Americans have benefited from these fundamental protections. Today’s ruling continues to threaten the future of these basic protections and leaves those who rely on the law’s benefits in a state of flux.

    “On behalf of the millions of patients our organizations represent, we will continue to advocate for the quality care patients need and the lives that depend on this law throughout the legal process.”

  • House to address Medicare cost-sharing loophole for CRC screening

    Eliminating this deterrent to screening is a high priority for ACS CAN

    Bipartisan legislation that would ensure surprise out-of-pocket expenses are not a barrier to lifesaving colorectal cancer screenings for seniors on Medicare is expected to be taken up by the U.S. House of Representatives this week.

    The Removing Barriers to Colorectal Cancer Screening Act will be considered as part of HR 3, the Elijah E. Cummings Lower Drug Costs Now Act. The Removing Barriers to Colorectal Cancer Screening Act would eliminate cost-sharing for seniors on Medicare who are hit with a surprise bill during a routine screening colonoscopy when a polyp is discovered and removed during the same procedure. Under current law, Medicare covers the full costs of a preventive screening colonoscopy. However, if a polyp is found and removed during that preventive procedure, patients wake up to a pricey cost-sharing bill often totaling several hundred dollars. Evidence shows that any cost-sharing can deter people from getting a preventive, and potentially life-saving, screening.

    Following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN):

    “We know colorectal cancer can be prevented with regularly-scheduled screenings. Yet too many seniors on Medicare choose to forego this simple procedure because of cost. We applaud House lawmakers for taking the opportunity to help reduce the burden and suffering of colorectal cancer on senior citizens by advancing legislation to remove financial barriers to screenings.

    “Closing this loophole for seniors on Medicare has been a longtime priority for ACS CAN and legislation our volunteers in congressional districts across the country have tirelessly advocated for. The bill has unwavering bipartisan support with 335 sponsors in the House of Representatives and 60 sponsors in the U.S. Senate. We thank Reps. Donald Payne, Rodney Davis, Donald McEachin, and David McKinley for their work to move this important policy forward.

    “The Removing Barriers to Colorectal Cancer Screening Act would ensure everyone on Medicare has access to life-saving cancer screenings by eliminating unexpected out-of-pocket expenses. More than 145,000 Americans will be diagnosed with colorectal cancer this year and over 51,000 of them will die from the disease. ACS CAN is committed to increasing colorectal cancer screening rates, and removing financial barriers to screening would help increase screening rates and save more lives from this preventable disease.”

  • ACS CAN: Comprehensive action needed to stop tobacco industry from targeting youth with flavors, advertisements

    ​Government survey shows youth tobacco use at highest rate in 19 years due to e-cigarette epidemic

    Nearly 70% of middle and high school students who currently use tobacco report the use of flavored products, according to data released by the Centers for Disease Control and Prevention (CDC) today. Additionally, 9 out of every 10 students surveyed report exposure to tobacco industry advertisements and promotions.

    As part of its Morbidity and Mortality Weekly Report, the CDC released the results of the 2019 National Youth Tobacco Survey and included an in-depth analysis of the data. It found approximately one-quarter of youth are current tobacco product users. In its analysis, the CDC concludes that sustained and comprehensive implementation of evidence-based prevention and cessation strategies, paired with the regulation of all tobacco products by the Food and Drug Administration (FDA) can reduce all forms of tobacco product use among youth.

    Following is a statement from Lisa Lacasse, president of ACS CAN (pictured here):

    “With nearly 70% of youth tobacco users noting their use of flavored products, and nearly 23 million middle and high school students being exposed to tobacco advertisements, it’s clear the tobacco industry is still actively working to addict a new generation of Americans to its deadly products and decisive action is needed.

    “The disturbing figures released today once again highlight the tobacco industry’s tactics that have led to the current youth epidemic of addictive tobacco products. Policymakers at all levels of government need to act immediately. The FDA, Congress, and state and local lawmakers have the authority to clear the marketplace of all flavored tobacco products, including menthol cigarettes, which clearly appeal to youth.

    “In addition to acting on flavors, the CDC’s analysis notes that evidence-based tobacco control strategies, coupled with strong surveillance of all tobacco products are critical to preventing and reducing tobacco product use among youth. The FDA must exert the full extent of its regulatory authority over all tobacco products while also cracking down on the advertising practices of the profit-driven tobacco industry. The agency should also prioritize additional interventions such as the reduction of nicotine levels in all tobacco products. The time for comprehensive action is long overdue.”

  • Survey: cancer patients and survivors alter or delay care due to insurance barriers

    Issues include prescription drug coverage and surprise medical bills

    Some recent and current cancer patients are making changes to their cancer treatment due to the coverage and cost of prescription drugs and surprise medical bills, according to new survey results from ACS CAN.

    The latest survey from Survivor Views, a national cohort of cancer patients and survivors who complete surveys on a range of public policy issues important to the cancer community, found nearly one-third of patients and survivors have experienced some insurance barrier to accessing prescription drugs necessary for their cancer care, more than half of lower-income respondents have had to act to reduce their prescription costs, and roughly one-quarter of all patients have encountered surprise medical bills—the large bills that result from a patient unknowingly receiving care or a service from an out-of-network provider.

    The survey results come as Congress considers a series of end-of-the-year bills aimed at reducing patient out-of-pocket costs. 

    Prescription Drugs

    Patients surveyed report a variety of insurance barriers to accessing prescription drugs. The most common barriers were having to wait more than 24 hours for insurance approval (19%), being denied coverage for the doctor-prescribed drug (14%) or being required to try a less expensive prescription drug first (10%). Of those who experienced an insurance barrier, 79% reported experiencing at least one negative consequence including, having to spend time on the phone with their insurance provider (44%), paying for the prescription drug out-of-pocket (27%) and going without the prescription drug sometimes for a week or more (38%).

    More than half (54%) of lower income patients have tried to reduce their out-of-pocket costs, including asking for a generic or biosimilar (29%), using a manufacturer’s coupon or assistance program (18%) or asking for a lower-cost drug to be prescribed (17%). While these methods may help reduce overall health care costs, other common methods may have serious negative impacts on patients’ health. For instance, low-income patients were more likely to delay treatment (17%), endure a side effect without treatment (17%), take an over-the-counter medication instead of a prescription drug (16%) or cut pills in half or skip doses of their prescription drugs (9%) than their higher-income counterparts.

    Surprise Billing

    Additionally, nearly a quarter of all survey respondents said they had experienced a surprise medical bill. The Federal Reserve reports four in ten Americans cannot afford an unexpected bill of $400 or more, yet the majority of the surprise bills respondents received were for over $500 and 21% totaled $3,000 or more. 

    Receiving these large, unexpected bills negatively affected patients’ behavior. Nearly 70% said they experienced anxiety about receiving another surprise bill and worried about how such bills might hinder their ability to pay for their care, 60% said they were less likely to follow-up with a doctor-recommended specialist who may be out-of-network, and 42% said they were less likely to call an ambulance when experiencing a serious cancer-related health issue. Nearly one-third also reported that they would be less likely to get a certain treatment because of cost concerns and would be less likely to go to the emergency room for a serious cancer-related health problem.

    “Cancer patients and survivors need ready access to the right prescription drugs and care to treat their disease and side-effects at affordable prices. These results demonstrate the growing obstacles—both administrative and financial—that stand in the way of patients’ ability to get necessary care,” said Lisa Lacasse, president of ACS CAN. “On behalf of all cancer patients, we urge lawmakers to work together and swiftly pass meaningful bipartisan legislation to lower costs and increase access to prescription drugs and eliminate surprise billing. Patients cannot wait.”

    A detailed summary of the key findings can be found here.

  • Gary Reedy attends meeting at White House to discuss e-cigarettes and youth

    Public health partners urged the President to keep promise and remove all flavored e-cigarettes from market

    On Nov 22, Gary Reedy, CEO of ACS and ACS CAN, attended a meeting with President Trump and administration officials at the White Hous to discuss a regulatory next step to address the ongoing youth e-cigarette use epidemic. Leaders from several of our partner groups including the American Medical Association, the American Lung Association, American Academy of Pediatrics, Campaign for Tobacco-Free Kids, and the American Academy of Family Physicians also attended.

    CEOs from industry groups including the American Vaping Association, JUUL, Altria, and the National Association of Convenience Stores were also invited. The President has been on record noting he is working to arrive at regulatory guidance that will address the youth use epidemic without adversely impacting the business community.

    Gary communicated to the President that the public health perspective is clear: we will not compromise on the health of our next generation. Furthermore, the solution to solving the e-cigarette youth epidemic will not come from the industry responsible for it. Together with our public health partners, Gary urged the President to keep the commitment made in the Oval Office in September to release comprehensive compliance policy that pulls all flavored e-cigarettes off the market and direct the Food and Drug Administration (FDA) to execute its full authority over all tobacco products. The tobacco industry has used fruit, mint and menthol, and candy flavors to lure a new generation and addicted them to their products with nicotine.

    The invitation to attend this meeting was a direct result of ACS CAN's engagement – both staff and volunteer - on this issue in Washington, D.C. and across the country, and most recently the advertising that ACS CAN ran during the past few weeks and months.

    Gary said: "The meeting this afternoon was an important opportunity for the American Cancer Society and American Cancer Society Cancer Action Network to be on record reinforcing our call for comprehensive regulation of these products and immediately prohibiting all flavored e-cigarettes, including mint and menthol. President Trump expressly acknowledged that the perspective of our organizations is important and noted, 'We want to take care of our kids.'"

    Some of Gary's comments were picked up by the Associated Press

    "No formal proposal or guidance was issued coming out of this meeting, but we plan to continue to engage the administration, the President, and the public to ensure our voice is heard," Gary said.

    Together with our public health partners, we issued a joint statement following the meeting. 

  • ACS CAN to Administration: keep your promise to end all flavored e-cigarettes

    New ad urges President Trump to put kids' health over Big Tobacco company profits

    The American Cancer Society Cancer Action Network (ACS CAN) together with the American Academy of Pediatrics, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative launched an ad campaign this week urging President Trump to protect kids’ lives over tobacco industry profits and follow through on a commitment to pull all flavored e-cigarettes from the market.

    In September, the President, First Lady, and Administration officials committed from the Oval Office to issue comprehensive guidance to clear the market of all flavored e-cigarettes, including mint and menthol, and enforce the guidance on all e-cigarette retailers. Newly released data shows that the youth e-cigarette epidemic continues to get worse. More than 5 million kids now use e-cigarettes, with flavored products being a primary driver for use.

    A statement from the public health groups follows:

    “The ad campaign is in response to recent comments from the President and White House officials that appear to walk back a commitment that the Food and Drug Administration (FDA) would release and enforce comprehensive guidance to clear the marketplace of all e-cigarette flavors and proactively address the growing youth e-cigarette use crisis.

    “Any attempts to weaken this guidance will further fuel the public health epidemic that has resulted from FDA’s delayed regulation of these addictive products and can only be seen as bending to the agenda of the profit-driven e-cigarette industry. Flavor carveouts or exemptions for certain retailers are simply unacceptable and will continue to allow e-cigarette manufacturers to hook a new generation of users by masking nicotine addiction behind flavored products.

    “The Administration, through strong and comprehensive FDA guidance, must protect our children and halt the sale of all flavored e-cigarettes. Our kids’ health isn’t for sale and the President should not cave to industry interests.”

    Watch the new ad.

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