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:

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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Daily News Staff

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Food and Beverage

Cinnamon, spice and ‘everything nice’ – why lead-tainted cinnamon products have turned up on shelves, and what questions consumers should ask

A Consumer Reports investigation revealed alarming lead levels in ground cinnamon, prompting concerns over safety, especially for children and pregnant women.

Published

1 month ago

December 22, 2024

The Conversation

It’s important to buy cinnamon from reputable dealers. Anjelika Gretskaia/Moment via Getty Images

Katarzyna Kordas, University at Buffalo

Spices bring up feelings of comfort, cultural belonging and holidays. They can make our homes smell amazing and our food taste delicious. They can satisfy our cravings, expand our culinary horizons and help us eat things that we might normally dislike. Spices have health-enhancing properties and, in medicine, have been used to heal people since the ancient times.

Recently, however, spices have been getting a bad rep.

In September 2024, Consumer Reports, a nonprofit organization created to inform consumers about products sold in the U.S., investigated more than three dozen ground cinnamon products and found that 1 in 3 contained lead levels above 1 part per million, enough to trigger a recall in New York, one U.S. state that has published guidelines for heavy metals in spices.

The Food and Drug Administration issued three alerts throughout 2024, warning consumers about lead in certain brands of cinnamon products. Such notices rightfully put consumers on alert and have people wondering if the spice products they buy are safe – or not. https://www.youtube.com/embed/QxAwznMht8M?wmode=transparent&start=0 A Consumer Reports investigation of more than three dozen ground cinnamon products found that 1 in 3 contain lead levels above 1 part per million.

As an environmental epidemiologist with training in nutritional sciences, I have investigated the relationship between nutritional status, diets and heavy metal exposures in children.

There are several things consumers should be thinking about when it comes to lead – and other heavy metals – in cinnamon.

Why is lead found in cinnamon?

Most people are familiar with cinnamon in two forms – sticks and ground spice. Both come from the dried inner bark of the cinnamon tree, which is harvested after a few years of cultivation. For the U.S. market, cinnamon is largely imported from Indonesia, Vietnam, Sri Lanka, India and China.

One way that lead could accumulate in cinnamon tree bark is when trees are cultivated in contaminated soil. Lead can also be introduced in cinnamon products during processing, such as grinding.

When ground cinnamon is prepared, some producers may add lead compounds intentionally to enhance the weight or color of the product and, thus, fetch a higher sale price. This is known as “food adulteration,” and products with known or suspected adulteration are refused entry into the U.S.

However, in the fall of 2023, approximately 600 cases of elevated blood lead levels in the U.S., defined as levels equal to or above 3.5 micrograms per deciliter – mostly among children – were linked to the consumption of certain brands of cinnamon apple sauce. The levels of lead in cinnamon used to manufacture those products ranged from 2,270 to 5,110 parts per million, indicating food adulteration. The manufacturing plant was investigated by the FDA.

Horizontal photo of cinnamon trees, with trunks in foreground. — Cinnamon trees in Zanzibar, Tanzania. Zanzibar is known the world over as the ‘spice islands.’ Dong Jianghui/Xinhua via Getty Images

More broadly, spices purchased from vendors in the U.S. have lower lead levels than those sold abroad.

There is some evidence that cinnamon sticks have lower lead levels than ground spice. Lead levels in ground cinnamon sold in the U.S. and analyzed by Consumer Reports ranged from 0.02 to 3.52 parts per million. These levels were at least 1,500 times lower than in the adulterated cinnamon.

There are no federal guidelines for lead or other heavy metals in spices. New York state has proposed even stricter guidelines than its current level of 1 part per million, which would allow the New York Department of Agriculture and Markets to remove products from commerce if lead levels exceed 0.21 parts per million.

What does it mean that ‘the dose makes the poison’?

The current FDA guideline on daily intake of lead from diets overall is to limit lead intake to 2.2 micrograms per day for children. For women of reproductive age, this value is 8.8 micrograms.

The lead dose we are exposed to from foods depends on the level of lead in the food and how much of that food we eat. Higher doses mean more potential harm. The frequency with which we consume foods – meaning daily versus occasionally – also matters.

For spices like cinnamon, the amount and frequency of consumption depends on cultural traditions and personal preference. For many, cinnamon is a seasonal spice; others use it year-round in savory dishes or sauces.

Cinnamon is beloved in baked goods. Take a cinnamon roll recipe calling for 1.5 tablespoons (slightly less than 12 grams) of the spice. If a recipe yields 12 rolls, each will have around 1 gram of cinnamon. In the Consumer Reports investigation, some cinnamon products were classified as “okay to use” or “best to use.”

The highest value of lead in cinnamon products in the “okay to use” category was 0.87 parts per million, and in the “best to use” category, it was 0.15 parts per million. A child would have to consume 2.5 or more rolls made with the “okay to use” cinnamon to exceed the FDA guideline on limiting lead intake from foods to 2.2 micrograms per day, assuming that no other food contained lead. To exceed this guideline with “best to use” cinnamon, a child would have to eat 15 or more rolls.

Stick cinnamon and cinnamon powder on rustic wooden table. — Research suggests that ground cinnamon contains higher lead levels than cinnamon sticks. Helen Camacaro/Moment via Getty Images

Can cinnamon contribute to elevated blood lead levels?

Because of lead’s effects on development in early life, the greatest concern is for exposure in young children and pregnant women. Lead is absorbed in the small intestine, where it can latch onto cellular receptors that evolved to carry iron and other metals.

The impact of a contaminated spice on a person’s blood lead level depends on the dose of exposure and the proportion of lead available for intestinal absorption. For several spices, the proportion of available lead was 49%, which means that about half of the lead that is ingested will be absorbed.

Lead absorption is higher after a fast of three hours or more, and skipping breakfast may contribute to higher blood lead levels in children.

People who have nutritional deficiencies, such as iron deficiency, also tend to absorb more lead and have higher blood lead levels. This is because our bodies compensate for the deficiency by producing more receptors to capture iron from foods. Lead takes advantage of the additional receptors to enter the body. Young children and pregnant women are at higher risk for developing iron deficiency, so there is good reason for vigilance about lead in the foods they consume.

Studies show that among children with lead poisoning in the U.S., contaminated spices were one of several sources of lead exposure. Studies that estimate blood lead levels from statistical models suggest that consuming 5 micrograms of lead or more from spices daily could substantially contribute to elevated blood lead levels.

For occasional or seasonal consumption, or lower levels of contamination, more research is needed to understand how lead in spices would affect lead levels in the blood.

For people who have other sources of lead in their homes, jobs or hobbies, additional lead from foods or spices may matter more because it adds to the cumulative dose from multiple exposure sources.

How to test for elevated blood lead levels

The Centers for Disease Control and Prevention recommends that children at risk for lead exposure get a blood lead test at 1 and 2 years of age. Older children can also get tested. Finger-prick screening tests are often available in pediatric offices, but results may need to be confirmed in venous blood if the screening result was elevated.

Adults in the U.S. are not routinely tested for lead exposure, but concerned couples who plan on having children should talk to their health care providers.

What to consider when using or buying cinnamon or other spices

If the product is on an FDA Alert or the Consumer Reports “don’t use” list, discard it.

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FDA CDC News

Seafood Recall: Important Information on Hannaford Seafood Salads

Published

2 months ago

November 30, 2024

Rod Washington

seafood based dish served on white plate — Photo by Valeria Boltneva on Pexels.com

In early November, the U.S. Food and Drug Administration (FDA) announced a Class II recall concerning Hannaford Seafood Salads, affecting over 1,600 units across five states: Maine, New Hampshire, Vermont, Massachusetts, and New York. The recall, initiated on October 31, was due to a mislabeling incident that poses a significant risk to consumers with soy allergies.

Understanding the Class II Risk Level

The FDA has classified this recall as a Class II risk, indicating that exposure to the affected products may cause “temporary or medically reversible adverse health consequences.” However, the risk of experiencing serious health consequences remains “remote.” Despite this classification, consumers with an allergy or severe sensitivity to soy must take this recall seriously, as they could face life-threatening allergic reactions if they consume the mislabeled salads.

What Happened?

The problem arose when the printer responsible for the salad labels provided Elevation Foods, the manufacturer of the salads, with labels that did not accurately reflect the current product formulation. Instead of the correct labels, the printer mistakenly issued labels meant for an upcoming formulation change. As a result, the affected salads may contain undeclared hydrolyzed soy protein, a known allergen that must be clearly stated on product labels to protect consumer safety.

Product Details

The implicated Hannaford Seafood Salads were distributed between October 25 and 29, and they feature use-by dates of November 13 and 14. Consumers can find these dates printed on the lid of the containers. Following the recall announcement, all affected products were promptly removed from store shelves.

Health Risks Associated with Soy Allergies

For individuals with soy allergies, the immune system mistakenly identifies soy proteins as harmful invaders, leading to a range of symptoms that can vary in severity. Common reactions include stomach issues, coughing, itching, wheezing, vomiting, hives, and difficulty breathing. In severe cases, these reactions can escalate to life-threatening conditions, such as anaphylaxis.

To mitigate risks, those with soy allergies are advised to carry an epinephrine injection (Epi-Pen) to counteract severe allergic reactions swiftly.

What Should Consumers Do?

Customers who purchased Hannaford Seafood Salads before the recall are urged not to consume the products. Instead, they can return them to the store where they made the purchase for a full refund. Elevation Foods has not reported any known cases of illness related to these salads, but consumer safety remains a top priority.

Conclusion

This seafood salad recall serves as a crucial reminder about the importance of accurate labeling, especially when it comes to potential allergens. Consumers should remain vigilant and informed about the products they purchase, particularly if they have food allergies. Stay safe and always check your labels!

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pets

Urgent Dog Treat Recall: Carolina Prime Pet Issues Warning Due to Salmonella Risk

Published

2 months ago

November 27, 2024

Lynette Young

Dog Treat Recall

In a recent announcement that has concerned dog owners across the Southeastern, Midwestern, and Mid-Atlantic regions of the United States, the FDA has reported a recall of “Hollywood Feed Carolina Made Chicken Chips” dog treats manufactured by Carolina Prime Pet, Inc. of Lenoir, North Carolina. This recall, affecting approximately 400 bags of these popular dog treats, is attributed to the potential risk of Salmonella contamination.

Why Is This Recall Important?

While there have been no reported illnesses linked to the consumption of these chicken chips, the safety of pets—and by extension, their human companions—is paramount. Salmonella, a bacteria that can cause severe gastrointestinal distress in animals and humans alike, can be particularly dangerous for pets, leading to symptoms such as vomiting, diarrhea, and lethargy. For individuals, Salmonella can also result in serious health complications, especially in young children, elderly adults, or those with weakened immune systems.

@stmblog
🚨🍖 Important: Carolina Prime Pet is recalling dog treats due to Salmonella risk! Check your pantry and stay safe! 🐾 #DogSafety #Recall ♬ original sound – STMDailyNews

Details of the Recall

The recall specifically pertains to 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” that carry the lot number 20051324L2 and an expiration date of 11/13/25. Consumers can easily identify the affected product by checking the back of the packaging, which features a distinctive purple-and-black design. The recall extends to retail locations across 19 states, including:

Alabama
Arkansas
Florida
Georgia
Illinois
Indiana
Kansas
Kentucky
Louisiana
Michigan
Mississippi
Missouri
North Carolina
Ohio
Oklahoma
Pennsylvania
South Carolina
Tennessee
Texas

For those who purchased the treats online, they were also available on the company’s website at www.hollywoodfeed.com.

What Should Consumers Do?

Carolina Prime Pet, Inc. has advised consumers to check their homes for the affected product. If your dog treats match the recalled lot number and expiration date, it is crucial not to feed them to your pet. Instead, return the products to the place of purchase for a full refund. For those who have questions or need more information, the company encourages contacting their customer service.

Final Thoughts

As pet owners, it is our responsibility to stay informed about the products we give our furry friends. The safety of our pets is essential, and recalls like these serve as a reminder to always check product packaging and stay updated on food safety announcements. If you have any concerns about your pet’s health or have noticed any unusual symptoms after consuming potentially contaminated food, it is advisable to consult with a veterinarian immediately.

Stay alert, stay informed, and together we can ensure the safety and well-being of our beloved pets.