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

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

FDA Voice Interviews Lawrence R. Deyton, M.S.P.H., M.D.

FDA Voice: What is your current position at FDA and, briefly, what is the mission of the Center for Tobacco Products?

Dr. Deyton: I joined FDA in the fall of 2009 as Director of FDA’s Center for Tobacco Products. CTP has a clear-cut mission: to help make tobacco-related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every person and every family.  That means putting programs and regulations in place that will help people, especially children, to not start using tobacco products, help current users to quit, and educate Americans about the risks of tobacco use. 

Lawrence R. Deyton, M.S.P.H., M.D. FDA Voice: Can you tell us in basic terms about the Family Smoking Prevention and Tobacco Control Act?

Dr. Deyton: Sure. When the Tobacco Control Act was enacted in 2009, FDA was given a series of important new responsibilities and authorities to protect the public from the dangers of tobacco use. And we’re implementing and enforcing the law’s provisions as they take effect.

For example, we’re helping to reduce access and the attractiveness of tobacco to kids by restricting advertising, marketing and retail practices related to cigarettes and smokeless tobacco products. We’ll be educating Americans about the contents of tobacco products and smoke and, as we do, we’ll be helping families understand the health effects of tobacco use.

The law is also requiring tobacco manufacturers to register with us and submit information about their products and product ingredients, including additives. As incredible as it sounds, consumers of cigarettes, a mass-consumed product, currently don’t know the chemicals they’re inhaling that cause or have the potential to cause harm to them.  And, FDA now has the authority to set standards that can make tobacco products less addictive and harmful.

I should add that FDA has clear authority to enforce all these provisions. Take the case of retailers. Most retailers are happy to take on their new responsibilities under the Tobacco Control Act to make sure kids don’t buy cigarettes or smokeless tobacco products. But some are not.  And FDA has not been shy about using our authority to enforce penalties against them.

FDA Voice: Can you tell us how CTP is unique and how it differs from other Centers at FDA?

At CTP we’re regulating a product which, if you look at what is available today, is fundamentally unsafe. So, we employ a different regulatory standard than other centers: a public health/population health standard that focuses on reducing the health threat tobacco use poses to all of us, not just the individual consumer. That’s a different strategy than other FDA Centers use, but CTP is regulating a very different product.

FDA Voice:  If you could tell the American public one thing that they might not know about what CTP does to directly benefit them, what would it be?

Dr. Deyton: I think Americans ought to know that, even though we’re a new part of FDA, CTP is really grounded in values that have guided FDA since its inception: the belief that government has a responsibility to take action when people’s lives are needlessly put in danger.

You know, I’ve yet to meet anyone anywhere in this country who wants kids to start to use tobacco. Current smokers tell us, “Help keep this stuff out of kids’ hands.” They want them to grow up healthy. And I should add that those smokers also tell us how badly they’d like to quit. That’s why this law doesn’t only help to prevent initiation; it also promotes cessation and includes provisions for reducing the addictiveness and toxicity of future tobacco products. If we achieve these goals, we will accomplish our mission of making the harm caused by tobacco use part of America’s past, not America’s future.

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