The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluationExternal Link Disclaimer I commissioned last year from an independent panel of evaluators working through the Reagan-Udall Foundation. The evaluation was an important opportunity to take a critical look at the Tobacco Program’s regulatory processes and operations.
We have made tremendous progress preventing death and disability caused by tobacco use, but I am a strong believer that we can always benefit from examining how we can work most effectively and proactively to protect public health, support our staff, and be as responsive as possible to external stakeholders. When I started my career in intensive cardiac care, hospitals were full of relatively young people with sudden death, heart attacks, strokes and cancer attributable to tobacco use. The effectiveness of the public health and medical communities to reduce the toll of tobacco products was enhanced when the FDA was granted the authority to regulate tobacco.
As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle. Our ability to keep pace with these changes will depend on immediate, short-term and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products.
CTP Director Brian King, Ph.D., M.P.H., has provided more detail about our approach to respond to the evaluation recommendations and our new plans, which will include the release of a 5-year strategic plan and comprehensive policy agenda by the end of the year. CTP has committed to providing regular updates on the progress of these activities, including some noted here.
In the past several years in particular, CTP has made important progress in the review of applications for e-cigarette products – authorizing several tobacco-flavored e-cigarette products and devices and rejecting marketing applications for millions of products that did not meet the requirements in the law.
Given the ever-evolving tobacco marketplace, it is imperative that we optimize the framework for application reviews to ensure any products marketed meet the law’s public health and regulatory standards. This work will include, among other things:
- further streamlining of reviews when appropriate;
- increasing the use of the Tobacco Products Scientific Advisory Committee to discuss broader scientific matters central to premarket evaluation and individual product applications;
- posting current and future scientific policy memos and reviewer guides when appropriate; and
- working internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency. These critical efforts will be bolstered by a new director in CTP’s Office of Science, who will begin in late March.
To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco. Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products. The FDA also continues to explore ways, including engaging with the U.S. Department of Health and Human Services and the Office of Personnel Management, to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match CTP’s needs.
Compliance and Enforcement
As the agency continues to make progress on its review of new and pending applications for novel products like e-cigarettes, the FDA will take additional action to remove illegal products from the market—particularly ones that have led to e-cigarettes being the most commonly used tobacco product among youth.
Between January 2021 and February 17, 2023, the FDA has issued more than 550 warning letters to companies for continuing to sell e-cigarette products that lacked the required FDA marketing authorization. These companies had millions of products listed with the FDA. After receiving warning letters, a majority of these companies have complied and removed their products from the market. However, in cases where companies did not do so, the FDA can pursue further enforcement action. For example, the FDA recently worked with the Department of Justice (DOJ) to file the first complaints for permanent injunctions against six e-cigarette manufacturers. Additionally, for the first time, the FDA this week filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling new e-liquids without marketing authorization. The agency will continue to work as expeditiously as possible to remove illegal products from the market while identifying new ways to strengthen compliance and enforcement.
As recommended by the external evaluation, effective immediately, the FDA will begin planning to convene a summit with senior officials from the HHS and DOJ related to enforcement. The agency will also continue to work with other government agencies, such as U.S. Customs and Border Protection, the U.S. Postal Service, the Federal Trade Commission, Bureau of Alcohol, Tobacco, Firearms and Explosives, as well as with our compliance and enforcement partners at the state/local/territorial/tribal levels. This work will maximize compliance and enforcement activities where there are shared interests. Additionally, the FDA will explore alternative approaches to achieve compliance outside of judicial enforcement actions.
The agency acknowledges that some unlawful e-cigarette products continue to be sold in the U.S. Many companies have challenged the agency’s marketing denial orders in courts around the country. In some cases, this has constrained our ability to remove these products from the market while the legal cases are pending. It is also important for the public to understand that the agency does not have the authority to independently bring legal cases seeking injunction or seizure against those who violate the law. Instead, the agency must rely on DOJ, who must evaluate the legal risks of pursuing particular enforcement actions and decide whether to dedicate its finite resources to litigate cases on our behalf. The FDA will continue to use all the tools at our disposal to hold companies accountable; however, the agency cannot be everywhere at all times. The agency needs additional resources to ensure that companies comply and that we have the ability to take action against those who break the law and tie up the system in court proceedings.
Transparency and Communication
As part of the center’s work, the agency plans to enhance and increase its public communications to provide greater transparency about the agency’s approach to compliance and enforcement. By this spring, we plan to begin posting content to a new comprehensive webpage for all enforcement activities, which will include a searchable public database of all tobacco products that have an FDA marketing order to discourage the sale of illegal products. Additionally, the center plans to conduct additional public meetings and workshops, as well as provide more information regarding the application review process.
The center will also explore new ways for soliciting and considering public input on its public education campaigns, including input on formative research into messaging for adult smokers that nicotine – while highly addictive – is delivered through products that represent a continuum of risk.
The State of Tobacco Regulation in the U.S.
When Congress tasked the FDA with regulating tobacco products more than 13 years ago, the vision was to make tobacco-related disease and death part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.
We’ve made notable progress, but important opportunities and challenges lie ahead as we seek to regulate an evolving marketplace. Current cigarette smoking among U.S. adults declined from 20.6% of the population in 2009 to 11.5% in 2021. Despite this progress, nearly 500,000 Americans still die every year from cigarette smoking and continued youth vaping is producing another generation plagued with addiction to products with unknown long-term health consequences.
We’ve announced plans to prevent initiation and help people quitExternal Link Disclaimer the deadliest form of tobacco use – combustible tobacco products. The agency is working to finalize product standards that would ban menthol in cigarettes and characterizing flavors (including menthol) in cigars. We’ve also announced plans for future potential regulatory actions, including developing a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. These actions are key to achieving the Cancer Moonshot goal of cutting the cancer death rate in half over the next 25 years, a key pillar of President Biden’s Unity Agenda.
Additionally, we continue to make significant strides in our science-based review of more novel tobacco products, such as e-cigarettes. The FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The agency has also issued marketing denial orders for more than one million flavored e-cigarette products that lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health concerns posed by the well-documented, alarming levels of youth use of such products. While certain e-cigarettes may help adult smokers transition completely away from, or significantly reduce their use of more harmful combusted cigarettes, the law’s public health standard balances that potential with the known and substantial risk with regard to youth appeal, uptake, and use of these highly addictive products.
Unfortunately, the tobacco industry has fought the agency on many of the science-based actions we’ve taken – putting profits over public health. For example, despite being the only country with sweeping regulatory authority over the industry, unlike many other nations, legal challenges have twice prevented us thus far from implementing Congressionally mandated warnings on cigarette packs depicting the serious health risks of cigarette smoking. And, as noted earlier, many decisions about product applications have also been challenged in court, which has, among other things, required significant resources to defend.
The FDA will continue to undertake our critical work to improve public health. It’s imperative that we are able to meaningfully implement transformational regulations and make decisions based on the public health standard in the law, with the American public – not the interests of the tobacco industry – at the forefront. We’ve made progress, but there’s a lot more work to come.
Understanding RSV: Symptoms, Treatment, and Prevention
RSV: a viral respiratory infection affecting children and adults. Learn about symptoms, treatment, and prevention for a healthier future.
RSV, short for Respiratory Syncytial Virus, is a common viral infection that primarily affects the respiratory system, particularly young children. While RSV infections are usually mild, they can pose a greater risk to infants, older adults, and individuals with weakened immune systems. If you or a loved one are facing RSV, it can be overwhelming to know what to do next. That’s why it’s important to know the symptoms, treatment options, and preventative measures available to you. By being informed and taking action, you can give yourself and those around you hope and guidance during this difficult time. So let’s explore what you can do to fight RSV and emerge victorious.
Symptoms and Diagnosis:
RSV presents symptoms resembling a cold, including cough, runny nose, fever, and occasionally, difficulty breathing. Infants may exhibit irritability, decreased appetite, and lethargy. Diagnosing RSV usually involves a medical professional evaluating symptoms, conducting a physical examination, and, if necessary, performing laboratory tests to confirm the presence of the virus.
Treatment and Management:
In most cases, RSV infections can be managed at home with supportive care. This includes ensuring proper hydration, maintaining a comfortable environment, and using over-the-counter medications to alleviate symptoms under a doctor’s guidance. However, for high-risk individuals or severe cases, hospitalization may be required for closer monitoring and specialized treatment, such as oxygen therapy or intravenous fluids.
Prevention is Key:
Preventing the spread of RSV is crucial, especially for vulnerable populations. Practicing good hygiene, such as frequent handwashing, covering coughs and sneezes, and avoiding close contact with infected individuals, can significantly reduce the risk of transmission. Additionally, promoting a clean and sanitized environment, particularly in daycare centers and schools, can help curb the spread of the virus.
While RSV can be concerning, it’s important to remember that most cases resolve on their own with time and supportive care. In fact, the majority of children infected with RSV recover fully without complications. By following preventive measures, seeking medical attention when needed, and staying informed about the latest developments in RSV research and treatment, we can approach this viral infection with hope and confidence.
Respiratory Syncytial Virus (RSV) is a common viral infection that primarily affects young children, causing cold-like symptoms and occasionally resulting in more severe respiratory distress. However, with proper care and attention, RSV can be managed effectively. By understanding the symptoms, seeking medical help when necessary, and adopting preventive measures, we can protect ourselves and our loved ones from the impact of RSV and look forward to brighter days ahead.
You can find more information about RSV, including its treatment and prevention, by visiting the CDC website. https://www.cdc.gov/rsv/index.html
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.
“The FDA continues to address unmet medical need and advance the development of safe and effective therapies for the millions of Americans whose lives are affected by rare tumors,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Desmoid tumors are rare tumors that can lead to severe pain and disability. Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.”
The effectiveness of Ogsiveo was evaluated in an international, multicenter, randomized, double-blind, placebo-controlled trial in 142 adult patients with progressing desmoid tumors not amenable to surgery. Patients were randomized to receive 150 milligrams (mg) of Ogsiveo or placebo orally, twice daily, until disease progression or unacceptable toxicity. The main efficacy outcome measure was progression-free survival (the length of time after the start of treatment for which a person is alive and their cancer does not grow or spread). Objective response rate (a measure of tumor shrinkage) was an additional efficacy outcome measure.
The pivotal clinical trial demonstrated that Ogsiveo provided clinically meaningful and statistically significant improvement in progression-free survival compared to placebo. Additionally, the objective response rate was also statistically different between the two arms with a response rate of 41% in the Ogsiveo arm and 8% in the placebo arm. The progression-free survival results were also supported by an assessment of patient-reported pain favoring the Ogsiveo arm.
The most common side effects seen in at least 15% of the patients in the trial were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea.
Ogsiveo was granted Priority Review under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition compared to available therapies. Ogsiveo also received FDA Fast Track and Breakthrough Therapy designations for the indication noted above, as well as Orphan-Drug designation for treatment of desmoid tumor (aggressive fibromatosis). Orphan-drug designation provides incentives to assist and encourage drug development for rare diseases.
The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.
Salmonella Outbreak: Cantaloupe Recall Investigation
Salmonella outbreak: Cantaloupes recalled. Ongoing investigation. Stay informed for updates on the recall.
In recent weeks, an outbreak of Salmonella linked to cantaloupes has raised concerns across the United States and parts of Canada. The outbreak, which began in early November 2023, has resulted in numerous cases of illness reported from various states. Health authorities, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), are diligently investigating this outbreak to identify the source of contamination and prevent further illnesses. This blog post aims to provide an overview of the outbreak investigation, affected products and stores, symptoms of Salmonella infection, and recommendations for consumers and businesses.
On November 22, 2023, Crown Jewels Produce, Sofia Produce, and CF Dallas initiated a recall of fresh cantaloupes and related products due to potential Salmonella contamination. As of November 24, CDC reported a total of 99 cases from 32 states, with the latest onset date being November 10, 2023. The investigation is still ongoing, as authorities are working to determine if additional products are linked to the illnesses. The FDA will provide updates on this situation as more information becomes available.
Affected Products and Stores:
The following brands of whole fresh cantaloupes have been recalled:
- Cantaloupes labeled “Malichita” or “Rudy,” with the numbers “4050” and “Product of Mexico/produit du Mexique.”
- These cantaloupes were sold in retail stores located in Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Indiana, Kentucky, Michigan, Ohio, Oklahoma, Wisconsin, Texas, Florida, and Canada. It is important to note that this list may not include all states, as the cantaloupes could have reached consumers through further retail distribution.
Recalled cut cantaloupe and products made from the recalled whole cantaloupes include:
- ALDI’s cantaloupe, cut cantaloupe, and pineapple spears in clamshell packaging with Best-by dates between October 27 and October 31.
- Vinyard’s cantaloupe chunks and cubes, fruit mixes, melon medleys, and fruit cups containing cantaloupe. Most of these products have a “Vinyard” label, and some have a red label with “Fresh” sold between October 30 and November 10 in Oklahoma stores.
- Freshness Guaranteed seasonal blend, melon trio, melon mix, fruit blend, fruit bowl, seasonal fruit tray, fruit mix, and cantaloupe chunks. RaceTrac fruit medley sold in clear square or round plastic containers at select retail stores in Indiana, Michigan, Ohio, Kentucky, North Carolina, Tennessee, Virginia, Illinois, Texas, and Louisiana.
Symptoms of Salmonella Infection:
Salmonella infection typically manifests within 12 to 72 hours after consuming contaminated food and typically lasts for four to seven days. Common symptoms include diarrhea, fever, and abdominal cramps. It is important to note that severe infections are more likely to occur in children younger than five, the elderly, and individuals with weakened immune systems.
Status and Recommendations:
The investigation into the cantaloupe-related Salmonella outbreak is still ongoing. Authorities will continue to provide updates as new information becomes available. In the meantime, the following recommendations are crucial:
- Consumers, restaurants, retailers, and wholesalers should refrain from consuming, selling, or serving recalled cantaloupes or products containing cantaloupe.
- Those who have frozen cantaloupes for later use should check their freezers and discard any recalled fresh or cut cantaloupes.
- If you are unsure whether your cantaloupe is part of the recall, it is best to err on the side of caution and dispose of it.
- Retailers and wholesalers who received recalled whole melons should identify the boxes labeled “Malachita/Z Farms” or “Malichita” or “Rudy” from Crown Jewels Produce and Sofia Produce (TruFresh) and remove them from their inventory.
- It is crucial to follow FDA’s safe handling and cleaning advice, ensuring that any surfaces and containers that may have come in contact with the recalled products are thoroughly cleaned and sanitized to prevent cross-contamination.
- If you suspect you may be experiencing symptoms of a Salmonella infection after consuming recalled cantaloupes, it is essential to seek medical attention promptly.
The outbreak investigation of Salmonella linked to cantaloupes is a matter of concern, and authorities are actively working to protect public health. By staying informed, following the recommendations, and taking necessary precautions, we can collectively mitigate the risks associated with this outbreak. Stay tuned for updates and adhere to the guidance provided by health authorities to ensure the safety of yourself and your loved ones.
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