FDA CDC News

FDA Outlines Steps to Strengthen Tobacco Program

Published

2 years ago

February 24, 2023

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 evaluation External 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.

Application Review

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:

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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 quit External 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.

Source: FDA

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FDA CDC News

Alert: Kroger Issues Food Recalls Affecting Multiple States

Published

4 weeks ago

February 7, 2025

Hal Machina

Senior woman with tablet computer in the store.

As of early February 2025, Kroger has announced a series of food recalls affecting customers across at least 15 states, as well as several subsidiary stores nationwide. The recalls, initiated due to safety concerns, include a variety of products that consumers should be aware of.

Twelve Hummus Tubs from King Harvest

Kroger subsidiary stores Fred Meyer and QFC, located in Alaska, Idaho, Oregon, and Washington, have recalled the following King Harvest hummus tubs, each weighing 10 oz:

King Harvest Lemon Hummus
King Harvest Classic Hummus
King Harvest Roasted Garlic Hummus
King Harvest Toasted Onion Hummus
King Harvest Chipotle Hummus
King Harvest Spinach Hummus
King Harvest Black Olive Hummus
King Harvest Sesame Hummus
King Harvest Jalapeño Hummus
King Harvest Balsamic Hummus
King Harvest Sun Dried Tomato Hummus
King Harvest Roasted Pepper Hummus

These products were recalled on February 5, 2025, due to a defect in their plastic tubs that may lead to the presence of plastic foreign objects within the containers. Kroger has advised customers, “Customers who purchased any of the item(s) below should not eat the product.” It remains unclear whether this recall is connected to a previous incident from September 2024 involving similar concerns.

DJs Boudain Products in Texas and Louisiana

Kroger stores in Texas and Louisiana have also issued a recall for the following DJs Boudain products:

DJs Boudain Hot Jalapeño Boudain, 12 oz
DJs Boudain Boudain Sausage, 24 oz
DJs Boudain Boudain Sausage, 16 oz

These items were recalled on February 1, 2025, due to potential contamination with pieces of a pen. This recall is part of a broader action directed by the U.S. Department of Agriculture (USDA), which called for around 17,720 pounds of boudain sausage link products to be removed from stores across Louisiana, Mississippi, and Texas.

Gerber Products for Teething Children

In addition, two Gerber products intended for teething children were recalled from Kroger stores across multiple states, including Ohio, Virginia, Michigan, Indiana, Illinois, Missouri, Kentucky, Tennessee, Alabama, North Carolina, West Virginia, Texas, and Louisiana. The affected products are:

Gerber Soothe N Chew Teething Sticks Banana, 3.2 oz
Gerber Soothe N Chew Teething Sticks Strawberry Apple, 3.2 oz

These products were removed from shelves due to potential choking hazards. Kroger has assured customers that those who purchased these items can return them for a full refund. This recall is part of a nationwide action announced by the Food and Drug Administration (FDA). Gerber has expressed regret over the situation, stating, “The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm…We sincerely apologize for any concern or inconvenience this action represents to parents, caregivers, and retail customers.”

Conclusion

Customers who have purchased any of the recalled products are urged to refrain from consuming them and to return the items for a refund. It is always advisable to stay informed about food recalls to ensure the safety of you and your family. For more updates on recalls and food safety, keep an eye on announcements from Kroger and the relevant health authorities. Stay safe!

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

Read the article in Newsweek: https://www.newsweek.com/kroger-food-recalls-issued-15-states-full-list-products-impacted-2027160

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Author

Hal Machina

Hal Machina is a passionate writer, blogger, and self-proclaimed journalist who explores the intersection of science, tech, and futurism. Join him on a journey into innovative ideas and groundbreaking discoveries! View all posts journalist

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A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

On January 15, 2025, the FDA proposed regulating nicotine levels in cigarettes to minimize addiction, aiming to prevent millions from smoking. This significant public health initiative promotes fewer smoking-related diseases and economic benefits.

Published

1 month ago

January 27, 2025

Charles Elliot

close up photo of cigarette ashes. nicotine — Photo by Basil MK on Pexels.com

On January 15, 2025, the U.S. Food and Drug Administration (FDA) made headlines with a groundbreaking proposal that could revolutionize the landscape of tobacco products. The agency announced a plan to limit the nicotine content in cigarettes and certain combusted tobacco products to levels that will make them minimally or nonaddictive. This significant step is geared towards preventing future generations from falling victim to the perils of tobacco addiction and smoking-related diseases.

A Bold Move Towards a Healthier Future: FDA’s Proposed Nicotine Regulation

A Step Long in the Making

The journey to this proposal began in 2018 when the FDA first expressed intentions to regulate nicotine levels in tobacco products. Now, as we stand on the brink of potentially transformative change, it’s clear that the FDA’s vision is not only ambitious but also rooted in a wealth of scientific evidence. The proposed nicotine cap, set at a mere 0.7 milligrams per gram of tobacco, is poised to dismantle the addictive potential of cigarettes, thus reducing the likelihood of new smokers picking up the habit.

Saving Lives and Reducing Costs

The impact of this regulation could be enormous. According to the FDA’s research, by the year 2100, this new nicotine standard has the potential to prevent around 48 million young people from starting to smoke. Additionally, it could encourage over 12.9 million current smokers to quit within the first year of the regulation’s enactment—numbers that elevate to an astonishing 19.5 million after five years. Ultimately, the FDA estimates that over the coming decades, we could see 1.8 million lives saved, climbing even higher to 4.3 million by the end of the century.

The financial implications are just as compelling. With an estimated annual benefit of over $1.1 trillion—not to mention the reduction in healthcare costs, lost productivity, and the avoidance of tobacco-related diseases—the proposal is not only a public health victory but also an economic one.

A Public Health Perspective

Cigarettes remain the deadliest consumer product in history, accounting for nearly half a million preventable deaths each year in the U.S. alone. The FDA Commissioner Robert M. Califf, M.D., expressed a clear commitment to making significant progress in combating this public health crisis. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” he stated.

The focus on addiction prevention and smoking cessation aligns with a broader goal: to create a healthier society where smoking-related diseases are no longer a pervasive threat. The proposed rule does not impose a ban on tobacco products but instead aims to create a safer environment by altering the products themselves. This is a crucial distinction as it allows for a path that encourages adult smokers to transition to less harmful alternatives without criminalizing their existing choices.

Why Public Engagement Matters

With the proposal open for public comment from January 16 to September 15, 2025, the FDA is keen on gathering input from diverse stakeholders, ensuring that a myriad of perspectives is considered. This effort to foster public dialogue is essential as it demonstrates a collaborative approach to policymaking, inviting the voices of health advocates, smokers wishing to quit, and the general public into the conversation.

The FDA is also reaching out to its Tobacco Products Scientific Advisory Committee to explore further implications of this proposal, underlining the importance of scientific scrutiny in shaping effective tobacco regulations.

Looking Ahead

As we await the final decision on this transformative proposal, the message is clear: reducing nicotine levels in combusted tobacco products could redefine smoking norms in America. The FDA’s intent to prioritize public health and encourage cessation underscores a commitment to safeguarding future generations.

While no tobacco product is completely safe and the best choice for individual health is to avoid all forms of tobacco, the proposed regulations represent a critical stride towards mitigating the risks associated with smoking. With collective efforts and robust community engagement, a healthier future is not only possible, but within reach.

Join the Conversation

Are you interested in contributing to this historic movement? The FDA encourages public input, and your voice matters! Take part in this important conversation in shaping the future of tobacco regulation. Together, we can help create a society where smoking-related deaths are significantly reduced, and a healthier lifestyle becomes the norm.

Stay engaged, stay informed, and let’s pave the way for a smoke-free future!

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FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

Published

1 month ago

January 25, 2025

Rod Washington

In a significant health alert, the U.S. Food and Drug Administration (FDA) has upgraded the recall of Costco’s Kirkland Signature Smoked Salmon to a Class I designation, indicating a serious health risk. This recall follows the discovery of Listeria monocytogenes during routine laboratory testing.

Originally announced in late October, the recall involved 111 cases of smoked salmon packaged in twin 12-ounce units, with a UPC number of 0 96619 25697 6 and a lot number of 8512801270. The affected products have a best-by date of November 13, 2024, and were distributed between October 9 and October 13, 2024, specifically to Costco locations in Florida.

Listeria monocytogenes is known to cause listeriosis, a severe infection that can result in serious health complications or even death, especially among vulnerable populations such as pregnant individuals, the elderly, and those with weakened immune systems. Although no illnesses have been reported in connection with this product, consumers are advised to check their freezers for these recalled items.

FDA Issues Class I Recall for Costco’s Kirkland Signature Smoked Salmon

Costco is urging customers who purchased this product to return it for a full refund.

For your safety, the FDA reminds consumers that Listeria can be found in a variety of foods, particularly raw or smoked seafood, unpasteurized dairy products, and deli meats. If you suspect you may have consumed contaminated food, please consult with a healthcare professional.

Stay safe and informed by regularly checking for updates on food recalls from reliable sources.

Related links:

The FDA Issued a Class I Recall on Costco’s Kirkland Signature Smoked Salmon https://www.foodandwine.com/costco-kirkland-signature-smoked-salmon-class-i-recall-listeria-monocytogenes-8780336

https://www.fda.gov/food/foodborne-pathogens/listeria-listeriosis

https://stmdailynews.com/