Proposed Rule Would Expand FDA’s Tobacco Control Authority

By: Margaret A. Hamburg, M.D.

Today we usher in a new chapter in FDA’s role in tobacco control, which began nearly five years ago when the Family Smoking Prevention and Tobacco Control Act enabled us to regulate certain tobacco products, including cigarettes and smokeless tobacco. Now, FDA has proposed a rule that would extend our authority to additional products meeting the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority, as well as future tobacco products.

Margaret Hamburg, M.D.The tobacco product marketplace is evolving at a dizzying pace with many unanswered questions about the health effects of novel products. Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction. The proposed rule—which would “deem” other tobacco products to be subject to FDA authority—is poised to help make that happen.

FDA is committed to protecting public health. Expanding our authority over tobacco products gives FDA additional tools to help reduce the number of illnesses and premature deaths associated with the use of tobacco products. Under FDA’s proposal, these powerful regulatory tools would include age restrictions, rigorous review of new tobacco products and claims, and health warnings.

“Deeming” – and the new health warning requirements included in the proposed rule – would also help to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products. Equally important, “deeming” would allow FDA to issue future regulations regarding these products, including regulations to reduce their harmfulness, if we determine that would be appropriate to protect public health.

As we work to finalize the proposed rule, we welcome comments and will consider all that are submitted, as well as any data, research and other information submitted to the docket for this proposed rule.

For more information:

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

Crossing the Country to Connect with the Cancer Research Community

By: Mitch Zeller, J.D.

One of my goals as the director of FDA’s Center for Tobacco Products (CTP) is to get feedback from everyone interested in our groundbreaking work of regulating tobacco products. We’ve heard that some people outside the Beltway – meaning those beyond the nation’s capital – would appreciate the chance to interact with us. When we can, we make those opportunities happen. We especially want to hear more comments from the public on the scientific issues associated with our regulatory process.

Mitch Zeller

Mitch Zeller speaking to reporters at a media availability during the American Association of Cancer Research annual meeting in San Diego, Calif.

One of those opportunities occurred this week when about 10 FDA staff members and I participated in the annual meeting of the American Association for Cancer Research (AACR) in San Diego. The meeting provides a unique opportunity for members of the worldwide cancer research community to learn about cutting-edge advances, obtain feedback on their own research, and make connections that will foster future collaborations.

CTP kicked off its participation with an educational session to introduce cancer researchers to what tobacco regulatory science is – and what it is not. Science grounds all of our efforts to reduce the disease and death toll of tobacco use. This includes both funding and conducting research that helps determine the regulatory steps we must take to protect public health.

Next, CTP hosted a listening session so that our senior scientific staff could hear presentations on topics relevant to science-based regulation of tobacco products. This public session was held in conjunction with the AACR meeting for the convenience of the many researchers who attend and for members of the public living on the West Coast, but participants did not have to be registered for the AACR meeting to attend or present. We were particularly interested in hearing from the public in connection with FDA’s goals for regulating tobacco:

  • Prevent youth tobacco initiation.
  • Encourage adults who use tobacco to quit.
  • Reduce product harms and addictiveness.
  • Develop a science base and continue meaningful product regulation to reduce the toll of tobacco-related disease, disability and death.

Finally, I participated in a symposium panel and press conference marking AACR’s release of a special commemorative publication of the 2014 Surgeon General’s Report: The Health Consequences of Smoking: 50 Years of Progress. As I said in an interview for the special issue, it is amazing that, with everything we’ve learned about the dangers of tobacco use, our progress has slowed in terms of reducing smoking rates nationally. Nearly one in five adults still smokes, and too many kids become regular smokers. At the press conference, our panel of leaders in the field of tobacco research took questions from cancer and research media about current tobacco control efforts. We discussed smoking patterns and the evolution of tobacco control over the last 50 years, as well as highlighted this newest data from the Surgeon General’s Report on tobacco’s negative health effects. I emphasized the critical role that the regulation of tobacco products can play in these efforts.

Tobacco-related cancer researchers are key partners of FDA as we work toward our goal of ending the epidemic of tobacco use. Hearing from this audience – as well as others – was incredibly valuable to us because we use these insights and feedback as part of the regulatory process. We welcome the opportunity to further engage with the research community as we work to reduce the destructive health consequences of tobacco use.

Mitchell Zeller, J.D., is the Director of FDA’s Center for Tobacco Products  

For more information please visit these Web links:

Informing Tobacco Regulation through Research

2014 Surgeon General’s Report: The Health Consequences of Smoking: 50 Years of Progress

Q&A: Mitchell Zeller on the FDA and Tobacco, AACR Journals

FDA’s First-Ever NSE Orders for Marketed Tobacco Products

By: Ann Simoneau, J.D.

Ensuring compliance with the law is critical to FDA’s mission to protect public health. As part of that mission, FDA is committed to making sure that all tobacco products that are sold and distributed to the public meet the requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

Ann SimoneauIn support of this commitment, we recently announced that four tobacco products now on the market – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone – do not meet the criteria in the law to remain on the market. These products entered the market during a grace period set up in the Tobacco Control Act. However, after a thorough review of the submitted applications, FDA determined that Jash International, the manufacturer of the four new products, did not provide sufficient evidence to demonstrate that they are “substantially equivalent” to eligible products that were previously marketed (otherwise known as predicate products). Specifically, the company did not identify eligible predicate tobacco products and was unresponsive to multiple requests for information that was necessary for FDA to determine whether the new products raised different questions of public health. This marks the first time that we have used our authority under the Tobacco Control Act to stop the continued sale and distribution of currently marketed tobacco products because they were not found “substantially equivalent” – and it is not an action we take lightly.

New tobacco products that FDA determines to be “Not Substantially Equivalent” (NSE) to predicate products can no longer be legally imported, sold, or distributed in interstate commerce, and failure to comply may result in FDA initiating enforcement action—such as seizures or injunctions – without further notice.

We have released a draft guidance document that explains the enforcement policy the agency intends to follow with respect to tobacco products that entered the market during the grace period and later receive NSE orders. The draft guidance is available for public comment and details our current thinking on this topic, including:

  • Products determined to be NSE cannot be sold or distributed in interstate commerce and may be subject to seizure at any time;
  • Companies that continue to sell and distribute these products in the United States may be subject to enforcement actions by FDA;
  • FDA does not intend to take enforcement action at the retail level for 30 days after an NSE order is issued, understanding that retailers may have existing inventories of NSE products in specific retail locations as of today; and
  • Retailers are encouraged to contact their supplier or manufacturer to discuss possible options for the NSE products in their current inventory.

We have also developed a new webpage, entitled Misbranded and Adulterated NSE Tobacco Products, to inform the public and companies in the distribution chain about products that have been on the market but are now considered misbranded and adulterated due to the failure of the manufacturer to satisfy the requirements for an SE marketing order. The webpage will be updated whenever any currently marketed products receive an NSE order.

Today’s announcement is an important step for the FDA as we continue to review new product applications, make science-based decisions, and take enforcement actions to ensure the protection of the nation’s public health.

Ann Simoneau is the Director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products

FDA Public Education Campaign Aims to Prevent and Reduce Youth Tobacco Use

By: Margaret A. Hamburg, M.D.

Today, FDA launches something truly unique: its first public education campaign to prevent and reduce youth tobacco use. Never before has the Agency embarked on an education campaign of this nature and magnitude. It’s the ultimate synergy of public health and regulation. The first of five distinct youth-focused efforts we have in the works, “The Real Cost” campaign seeks to reduce the number of youth smokers in our country over the next few years. 

Margaret Hamburg, M.D.Those of us in the public health and medical communities know all too well the startling statistics surrounding teen tobacco use, especially smoking, and want to do all we can to prevent young people from becoming addicted. Unfortunately, there are more than 10 million youths ages 12 to 17 who are open to smoking or already experimenting with cigarettes. 

As a physician and especially as a parent, I also know getting the message right to reach teens is critical. We have to be smart about how we talk to children about  a behavior like experimenting with tobacco products. So instead of sounding like yet another authority figure citing statistics or telling teens not to do something because it is bad for them, we dedicated significant time and research into creating something that will catch their attention. Our multimedia campaign is designed around visually compelling and personally relevant messages that will appeal to, and resonate with, teens at-risk for smoking. 

Through television, radio, social media and outlets associated with their interests, including music, fashion, sports, gaming, and comedy, our campaign  seeks to surround at-risk teens with messages that reach them where they are in their daily lives. 

“The Real Cost” aims to make them acutely aware of the potential risk from every cigarette by highlighting consequences they are concerned about.  

One set of creative materials challenges the beliefs of independence-seeking youths who  think they will not get addicted or feel they can quit at any time by portraying addiction to cigarettes as a loss of control. 

Another approach dramatizes the health consequences of smoking by graphically depicting results like tooth loss and skin damage to demonstrate that every cigarette comes with a “cost” that is more than just financial. 

Some ads highlight the fact that menthol cigarettes cause the same health consequences as regular cigarettes, as youths are more likely to report smoking menthol cigarettes than regular cigarettes. 

The development of the “The Real Cost” campaign is grounded in research and supported by best marketing practices as well as multiple rounds of testing with our target audience. Our ads will run nationwide across multiple platforms beginning February 11.  And that’s only the beginning: subsequent youth tobacco prevention campaigns will target other audiences, including multicultural, rural, and lesbian, gay, bisexual, and transgender youths. 

So today, FDA is taking our mission of protecting kids from tobacco to the next level  – by reaching out to them with images and words that speak to them. We look forward to seeing the impact of this important public health effort and to making tobacco use a part of America’s past, not its future.

Margaret A. Hamburg, M.D., is Commissioner of Food and Drugs

We Moved Forward on Many Fronts This Year

By: Margaret A. Hamburg, M.D.

At the FDA, the agency that I’ve had the privilege to lead for the past five years, I am gratified to report that we have a lot to be proud of this year. In fact, this past year’s accomplishments on behalf of public health have been as substantial as any in FDA’s recent history.

Margaret Hamburg, M.D.We moved significantly forward, for example, in creating a system that will reduce foodborne illness, approving novel medical products in cutting-edge areas of science, and continuing to develop our new tobacco control program. We worked successfully with Congress and with regulated industry to reach agreement on a number of difficult issues, while continuing to use the law to the full extent possible to protect consumers and advance public health.

While there were many significant actions and events to recognize, below are some of the highlights of 2013.

In the foods area, there were many new actions this year that will have a long-standing impact on improving our food supply for consumers. Throughout the year we have been proposing new rules to reach the goals set forth by the FDA Food Safety Modernization Act (FSMA). These science-based standards will help ensure the safety of all foods produced for our market, whether they come from the U.S. or from other countries.

We also took important steps towards reducing artery-clogging trans fat in processed foods, and understanding the health impact of arsenic in rice. With a final rule that defines when baked goods, pastas and other foods can be considered free of gluten, people with celiac disease can have confidence in foods labeled “gluten free.” And we are studying whether adding caffeine to foods may have an effect on the health of young people and others.

There have likewise been many accomplishments in advancing the safety and effectiveness of medical products. We worked closely with Congress on the recently enacted Drug Quality and Security Act, which contains important provisions relating to the oversight of human drug compounding. The law also has provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Using tools provided by last year’s landmark Food and Drug Administration Safety and Innovation Act (FDASIA), we are continuing to improve the speed and efficiency of medical product reviews, including those involving low-cost, high quality generic drugs and innovative new medical devices. The average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval applications that we approve has increased since then, after steadily decreasing each year since 2004.

We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic (such as a vaccine) if preliminary clinical evidence indicates that it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. This offers real opportunities to get promising drugs more quickly to patients who need them. In fact, using this new approach, FDA recently approved two advanced treatments for rare types of cancer and one for hepatitis C. We have also strengthened efforts to ensure product quality, increased protection of the drug supply chain, and reduced drug shortages.

We confronted the growing misuse of powerful opioid pain relievers by advising manufacturers on how to make these drugs harder to abuse with formulations that are more difficult to crush for inhalation or dissolve for injection. And we recommended that hydrocodone combination products be subject to stricter controls to help prevent abuse. 

We took an important step towards fighting the development of antibiotic-resistant bacteria by implementing a voluntary plan to phase out the use of antibiotics to enhance the growth of food-producing animals, and to move any remaining therapeutic uses of these drugs under the oversight of a licensed veterinarian. So-called “production” use is considered a contributing factor in the development of bacteria that are resistant to the antibiotics used in human medical treatment.

In many areas of our work we are supporting the emerging field of personalized medicine. Advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients.

Many cancer drugs today are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. In May, FDA approved two drugs and companion diagnostic testing for the treatment of certain melanoma patients with particular genetic mutations.

Advances in science and technology are also seen in the creation of new medical devices. For example, 3-D printing - the making of a three-dimensional solid object from a digital model – was once considered the wave of the future. But in February, FDA cleared for marketing a device created by 3-D printing – a plate used in a surgical repair of the skull that is built specifically for the individual patient.

While we have worked hard to get therapies to patients, we are at the same time using the tools available to us to remove unsafe and dangerous products from the market. In November, we used new enforcement tools provided by the food-safety law to act quickly in the face of a potential danger to public health presented by certain OxyElite Pro products. These supplements had been linked to dozens of cases of acute liver failure and hepatitis. After FDA took action, the manufacturer agreed to recall and destroy the supplements.

Finally, we made significant progress in implementing the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. We have signed contracts with numerous state and local authorities to enforce the ban on the sale of tobacco to children and teens; conducted close to 240,000 inspections; and written more than 12,100 warning letters to retailers. And, in the first quarter of 2014 we will launch a public education campaign aimed at reducing the number of young people who use tobacco products.

All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration

20 Years Later: Returning to FDA to Regulate Tobacco

By: Mitch Zeller, J.D.

Since its emergence in colonial times, tobacco has been one of America’s most lucrative industries – and one of its least regulated. But four years after the Family Smoking Prevention and Tobacco Control Act became law and gave FDA the authority to start regulating tobacco, we can say that FDA isn’t only making policy, we’re making history.

Mitch Zeller, J.D., Director of FDA's Center for Tobacco Products

Mitch Zeller

This summer, FDA’s first decisions on substantial equivalence marked the very first time any tobacco maker was told they could either sell, or not sell, a tobacco product because of its potential public health implications. It was a historic moment for all of us at CTP and the entire FDA family, but it had particular resonance for me, personally.

Twenty years ago, I joined the staff of then-FDA Commissioner Dr. David Kessler, and was soon given the assignment to examine the practices of the tobacco industry – an industry not regulated by FDA. That transforming experience led to my serving as associate commissioner and director of FDA’s first Office of Tobacco Programs. I oversaw FDA’s investigation of the tobacco industry from 1994 to 1996, and helped craft FDA’s 1996 inaugural tobacco regulation. In 2000, the Supreme Court overturned the agency’s assertion of jurisdiction over tobacco.

As we all know, in 2009 Congress provided FDA with explicit authority to regulate tobacco through the Family Smoking Prevention and Tobacco Control Act. By then I had left FDA to work within the public health community on behalf of tobacco control, but standing in the White House Rose Garden when President Obama signed the new law, I immediately knew that FDA would be on the leading edge of protecting Americans from the dangers of tobacco use. That’s why I didn’t hesitate for a moment when Commissioner Hamburg asked me earlier this year to take the helm as the director for the Center of Tobacco Products.

Much of what’s made my experience at CTP so gratifying is that I’ve had the opportunity to build on the strong foundation left to me by CTP’s first director, Dr. Lawrence Deyton. From that foundation, we will continue to move forward, using all the tools available to us in the Tobacco Control Act to transform tobacco for a healthier tomorrow. This is particularly important – especially since each year, more than 300,000 kids under 18 become regular smokers. But we can, and must, change that.

It’s true that tobacco use remains the leading cause of preventable death and disease in the U.S., resulting in more than 443,000 deaths every single year. But FDA’s ability to enact science-based regulation has true potential to reduce the huge death and disease toll from tobacco use.

I am thrilled to be back at FDA, working with such talented and dedicated colleagues who have joined forces to help reduce tobacco-related disease and death for all Americans.

Mitchell Zeller, J.D., is FDA’s Director, Center for Tobacco Products  

FDA Announces First Decisions on New Tobacco Products

By Mitch Zeller, J.D.

Mitch Zeller, J.D., Director of FDA's Center for Tobacco Products

In March, I became director of the FDA’s Center for Tobacco Products (CTP) after spending more than three decades working on FDA-related issues, including a seven-year stint at FDA from 1993-2000.  From 1997-2000 I was director of the agency’s first Office of Tobacco Programs. Since I’ve rejoined FDA, CTP has made great progress on multiple fronts. I look forward to discussing my strategic goals and priorities in a future blog post, but today I want to share some information about one immediate priority—decisions regarding tobacco product reviews.

Today, for the first time since FDA received the authority to regulate certain tobacco products, the agency has authorized the marketing of two new tobacco products through the substantial equivalence (SE) pathway, while denying the marketing of four other new products.

These actions are unprecedented and mark the start of other forthcoming decisions related to the marketing of new tobacco products. Substantial equivalence is one pathway manufacturers can use to market a new tobacco product. To do so, a manufacturer must establish that their product has the same characteristics as a valid previously marketed tobacco product, what we call a predicate product, or, if the new product has different characteristics, that it does not raise different questions of public health.

SE submissions require rigorous review. FDA has a responsibility to protect public health, and to do so, we work to ensure that any new tobacco product brought to market through the SE pathway will not present more harm to public health than a valid predicate product identified by the manufacturer.

Today’s SE orders allow the marketing of two new Lorillard Tobacco Company tobacco products: Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. The agency has found these two products to be substantially equivalent to predicate products, based on the company’s submissions and other readily available science and information that demonstrate that each product will not present more harm to the public health than the predicate.

It is important to emphasize that an SE decision does not mean that the agency considers a product to be safe, nor is it FDA-approved. The SE decision only means that a new product does not raise different questions of public health as compared to the predicate product.

FDA is also issuing the first not substantially equivalent, or NSE, orders denying marketing of four new tobacco products after finding that the products have different characteristics from their predicate products and that the applicant did not adequately show that the new products did not raise different questions of public health.

FDA has been working diligently to review all pending SE submissions. We know it’s taken time, but expect the process will move more quickly in the future as everyone involved gains more experience. FDA has offered feedback to the industry on the requirements for substantial equivalence and will continue to offer such feedback. We have also created a new webpage that tracks SE decisions to date and provides general information on FDA’s pathways to market new tobacco products. Our goal is to work through the remaining SE submissions in a consistent, transparent and predictable manner.

Mitch Zeller, J.D., is the Director of FDA’s Center for Tobacco Products.

Celebrating American Heart Month—Making Heart Healthy Choices in 2013

By: Janelle Derbis, PharmD

Each year, nearly half of all Americans make New Year’s resolutions. They often include losing weight, starting an exercise program, quitting smoking, and making healthier food choices—all of which contribute to a heart-healthy lifestyle. February is American Heart Month, and the timing couldn’t be better to make these lifestyle changes, especially since heart disease is the leading cause of death in the U.S.

FDA joins in the commemoration of American Heart Month by highlighting agency initiatives to help Americans reduce their risk of heart disease.

Achieve a healthy weight. Obesity contributes to a number of health conditions, including high blood pressure and high cholesterol. To help obese and overweight Americans who have been unsuccessful in getting their weight under control with diet and exercise alone, FDA approved two long-term weight management medications in 2012—Belviq and Qsymia. These are the first medications the agency has approved for the treatment of chronic weight management in 13 years.

Quit smoking. Smoking and tobacco use contribute to many health hazards, including heart disease. Nearly half of adult Americans are at risk for heart disease and stroke, and over 20% are at risk due to cigarette smoking. To address the huge public health problem of tobacco use, FDA is building a national tobacco product regulation program to reduce the impact of tobacco use on the nation’s health. Using powerful new regulatory tools provided by the law, FDA’s work supports the objective of the Department of Health and Human Services to end the epidemic of tobacco-related death and disease in America. In November 2012, HHS announced the availability of a new comprehensive tobacco website, BeTobaccoFree.gov, a providing one-stop access to the best and most up-to-date tobacco-related information from across its agencies. This consolidated resource includes general information on tobacco, federal and state laws and policies, health statistics, and evidence-based methods on how to quit.

Eat right. Consumers can eat for a healthy heart and choose foods that are lower in salt, cholesterol, and trans-fat by reading the Nutrition Facts label on food and beverage packages.  In January 2013, the agency announced it is planning to update the Nutrition Facts label based on the latest science-based nutrition recommendations. The updates are still being formulated, and public input will be sought when they are proposed.

Lower cholesterol levels.  Making lifestyle modifications can help reduce cholesterol levels. However, hereditary issues can make some people more likely to have high cholesterol levels regardless of diet and exercise. The good news is there are treatment options for people who are unable to lower their cholesterol levels. There are several FDA-approved cholesterol lowering medications on the U.S. market.

In December 2012, FDA approved Juxtapid for a rare cholesterol disorder called homozygous familial hypercholesterolemia (HoFH), an inherited condition that makes the body unable to remove the “bad” cholesterol (LDL cholesterol) from the blood, which  can lead to heart attacks and death before age 30. The approval of Juxtapid is an example of how FDA provides the scientific and regulatory advice needed to bring new treatment options to market.

Control high blood pressure.  Adopting a healthy lifestyle can help prevent high blood pressure. If lifestyle modifications are not enough to lower your blood pressure so that it is within the normal limit (less than 120 over 80), medications are often prescribed. There are many FDA-approved medications to treat high blood pressure so talk with your health care provider to determine which is best for you.

In April 2012, FDA approved the first generic versions of Avapro (Irbesartan) and Avalide (Irbesartan and Hydrochlorothiazide) for the treatment of high blood pressure.  Generic drugs such as these provide safe and effective alternatives to brand-name drugs. 

Exercise. And lastly, physical activity is an essential component of a healthy lifestyle and when done in combination with healthy eating can help prevent heart disease. In 2013, make a commitment to exercising on a routine basis and keep your heart strong!

To receive up-to-date information on heart-related drug and device approvals, safety announcements, and notices of upcoming meetings, subscribe to FDA’s CardioBeat or visit FDA’s cardiovascular webpage.

Janelle Derbis, PharmD, co-manages the Cardiovascular and Endocrine Liaison Program (CELP), at FDA’s Office of Special Health Issues.

National Conference on Tobacco or Health: Convening for a Healthier Future

By: Lawrence R. Deyton, M.S.P.H., M.D.

As director of FDA’s Center for Tobacco Products (CTP), I am delighted that representatives from many areas within CTP will be participating in the National Conference on Tobacco or Health (NCTOH). NCTOH is one of the oldest and largest meetings on tobacco education and action, bringing together more than 2,500 national, state, territorial and local tobacco control scientists, program managers, communicators and other professionals in the field every three years. The mission of the conference is to improve the reach and effectiveness of tobacco control programs and activities throughout the United States.

This is the first time that CTP has participated in this meeting. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) which gave the FDA the authority to regulate tobacco products, was actually passed by Congress during the last NCTOH meeting in 2009. When the vote was announced, it drew large cheers from the participants.

Some of the staff from the FDA’s Center for Tobacco Products attending NCTOH stand in the FDA exhibit. (from left to right): Tarsha McCrae, David Ashley, Les Weinstein, Laura Shay, Sarah Landry, Andrea Frydl, Greta Tessman, and Gail Cherry-Peppers.

FDA’s participation in this year’s conference comes at a critically important point in our history. Since CTP was established we have achieved success in moving science-based regulation forward with historic advances in public health.

Key accomplishments include:

  • enforcing the ban on candy-like characterizing flavors in cigarettes;
  • restricting youth access to cigarettes and smokeless tobacco;
  • enforcing requirements for larger smokeless tobacco health warnings;
  • enforcing prohibition of misleading advertising claims;
  • restricting cigarette and smokeless tobacco marketing to youth;
  • awarding nearly $43 million in contracts to 37 states and the District of Columbia for conducting inspections of retail establishments. So far they have conducted more than 86,000 inspections to determine whether the establishments are complying with regulatory requirements which, among other things, forbid selling cigarettes and smokeless tobacco products to minors;
  • issuing more than 3,500 warning letters and 290 fines to retailers for violating the law.

Sharing what we’ve learned and accomplished will be an important part of CTP’s participation in the NCTOH conference. I will be giving remarks during the opening and closing plenaries as well as presenting during a panel session. Many other CTP staff members will be moderating or presenting during the conference on critical tobacco-related issues including:

  • key elements of FDA’s regulatory authorities;
  • consumer perceptions of dissolvable tobacco products;
  • the development of data systems to support tobacco regulation;
  • national tobacco education campaigns; and
  • strategic partnerships for retail tobacco enforcement.

If you are participating in the meeting, we encourage you to engage with us by attending our sessions and visiting our booth. CTP experts will be looking forward to taking your questions, sharing information and hearing about the activities in your community that are helping to reduce tobacco use and keeping young people from starting to smoke. 

Lawrence R. Deyton, M.S.P.H., M.D., is the Director of FDA’s Center for Tobacco Products

Information Technology, Tools, Tobacco Products and Public Health

By:  Cindy Miner, Ph.D.

Providing stakeholders with easy to find information that they need to know on FDA’s web site is paramount.

Cindy Miner, Ph.D.Today, I am pleased to announce a new tobacco product section on FDA’s website that organizes important information on tobacco product regulation. This new section brings together information on the three pathways available to legally market new tobacco products under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA).

We created this section, called Tobacco Product Review and Evaluation, to centralize information on the pathways for review and evaluation of new tobacco products, before they are marketed. This information does not replace the TCA or any other legal document – it simply guides the user through the key elements of each of the three pathways to market.

Using a creative new interactive tool, users can determine which of the three pathways is most appropriate when seeking to market a new tobacco product. To legally market a new tobacco product in the United States, manufacturers must seek and receive permission from FDA by either:

Although FDA may issue a marketing order for a tobacco product to be marketed, that order does not indicate the tobacco product is either safe or “approved.” The marketing order means the manufacturer has complied with the requirements under the law to bring its product to market. With the passage of the TCA, manufacturers of tobacco products are now required to submit scientific information and seek permission from FDA prior to marketing a new tobacco product, including when making changes to existing products. Learn more about how FDA is protecting public health through tobacco regulation.

This section will also serve as a building block for more information as we develop it. We have already added additional content on modified risk tobacco products and guidance on how to request a meeting with FDA’s Center for Tobacco Products Office Science.

Three years after the Tobacco Control Act was signed into law, we have taken great strides in implementing its provisions. Making sure stakeholders can get the information they need quickly and in a user-friendly manner is a critical aspect of our overall mission.

Cindy Miner is the Associate Director for Scientific Communication, Office of Science, at FDA’s Center for Tobacco Products