FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial Resistance

By: Stephen M. Ostroff, M.D.

In my third and final post reflecting on FDA’s work to protect and promote public health in 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation.

Acting FDA Commissioner, Stephen Ostroff, M.D.Modernizing Food Safety

In a groundbreaking development, in 2015 FDA took several major steps to prevent foodborne illness by finalizing five rules that will implement the landmark FDA Food Safety Modernization Act (FSMA).

In September, we issued the first two final FSMA rules mandating modern, preventive practices in both human and animal food facilities. They will help establish a food safety system in which industry systematically implements measures we know are effective in preventing contamination.

In November, we took another step toward modernizing our food-safety system by issuing the final produce safety rule and two import safety rules. For the first time, these new rules establish enforceable science-based safety standards for the growing and harvesting of produce and make importers accountable for conducting risk-based verification to determine that imported food meets U.S. safety standards. In addition, through this rulemaking we established a program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food facilities.

Together, these rules are designed to reduce the burden of foodborne illness in the United States. They support the broad goal of the law to proactively prevent problems across the entire food system, and to strengthen food safety coordination with other nations that produce the foods that Americans consume.

Strengthening Nutrition, Protecting Health

2015 also saw important progress in the area of nutrition. We finalized our determination that partially hydrogenated oils, the primary dietary source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in human food, a decision that will make an enormously positive difference in the health of Americans. We also are continuing to work to develop sodium reduction targets, which have the potential for major public health gains and cost savings to the health care system.

And late in 2014, we finalized two new rules requiring caloric information on restaurant menus and menu boards and on vending machines. These rules are designed to provide consumers with more information so they can make informed choices for themselves and their families, without placing an undue burden on small businesses or individual food establishments. We are working with industry to support implementation.

We also proposed additional changes to the familiar “Nutrition Facts” label on packaged foods which, when finalized, will give Americans updated nutrition information, reflecting the most current nutrition science, to help them make healthy choices when purchasing packaged foods. This includes a revision that would establish a Daily Reference Value for added sugars and require the percent Daily Value on the label. There is strong evidence healthy dietary patterns of intake associated with a decreased risk of cardiovascular disease are characterized, in part, by lower intakes of sugar-sweetened foods and beverages.

Combating Antibiotic Resistance

Another area in which we saw great progress in 2015, thanks to collaborative efforts across our government and with our international partners, was in combating antibiotic resistance. If left unchecked, this growing problem threatens to turn back the clock on decades of progress in infectious disease control and medical discoveries, drive health care costs higher, and increase human disease and death.

Early in 2015, the White House released the National Action Plan for Combating Antibiotic-resistant Bacteria, a plan that that recognizes that humans and animals share the same environment – and the same microbes – and so we must address the use of antibiotics in both.

One of the central principles for slowing the development of resistance – in both humans and animals – is the judicious use of antibiotics. For decades medically-important antibiotics have been used not only to treat sick animals, but to promote growth in healthy ones. The FDA has already made significant progress developing policies to promote appropriate use of antibiotics in animal health. For instance, we issued the Veterinary Feed Directive (VFD) final rule, an important part of our overall strategy because it promotes judicious use of medically important antimicrobials in feed for food-producing animals by bringing the use of these drugs under veterinary supervision.

But a critical part of combating resistance is to know the changing patterns and use of antibiotics in farming and how these changes impact resistance patterns among foodborne pathogens associated with farm animals. We are strengthening our data collection under the National Antimicrobial Resistance Monitoring Program in several ways, and in September we held a Public Meeting with several other federal agencies on data collection on farms. This and other work will help us to develop a more comprehensive and science-based understanding of antimicrobial drug use and resistance in animal agriculture and help us to measure the impact of our regulatory actions.

While the problem of antimicrobial resistance is finally getting the attention it warrants, it will require an ongoing and sustained effort to overcome the decades of neglect that led to the current situation.

Regulating Tobacco Products

Our newest area of regulatory oversight is one of our busiest. It’s hard to believe it was more than 50 years ago that the Surgeon General issued the first Report on Smoking and Health. But it’s been just six years since Congress passed the Tobacco Control Act, which gave FDA the authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products and protect the public from their dangers.

We’ve already built a great deal on that foundation, creating our Center for Tobacco Products and establishing a framework for industry registration, product listing and submission of information on ingredients in tobacco products; implementing and enforcing a statutory ban on cigarettes with certain characterizing flavors; and restricting access and marketing of cigarettes and smokeless tobacco products to youth. We’ve also already begun to build a robust regulatory science program to conduct and fund science and research programs designed to help us better understand the risks associated with tobacco use.

After an extraordinary amount of study and research, and review of tens of thousands of public comments, FDA is preparing to publish the final rule to extend the agency’s authority over additional, unregulated tobacco products, such as e-cigarettes, cigars, hookah tobacco, and pipe tobacco. Like everything we do at FDA, this policy will be based on a thorough scientific evaluation of how individual products in each category may affect public health.

And in 2015, we unveiled a dynamic public education campaign designed to prevent and reduce tobacco use among at-risk African Americans, Hispanics, and Asian American/Pacific Islander youth age 12 to 17. This promising effort flows from our “Real Cost” campaign launched in 2014, which I’m pleased to note, won a gold “Effie Award” for effectiveness in advertising in the Disease Awareness and Education category.

It’s been a fruitful and productive year at the FDA. I am proud of all we have accomplished in 2015 and look forward to our continued progress.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

FDA’s New Research Videos on E-Cigarettes, Nicotine and Cigarillos

By: Cathy L. Backinger, Ph.D., M.P.H. and Cindy Miner, Ph.D.

How dramatic is the increase in e-cigarette use? Why are flavored little cigars and cigarillos increasingly popular among ethnic minorities? What would happen if we reduced the amount of nicotine in cigarettes so that they were no longer addictive?

These are just some of the questions that FDA-funded scientists are answering. Often research is focused on innovation and discovery to expand the body of scientific knowledge. Regulatory science is different—and exciting in its own way. How often do scientists get to see their research findings used to improve people’s lives? Tobacco regulatory scientists are doing just that.

We Need a Strong Science Base to Address Issues that Matter Now

In 2009 Congress passed the Family Smoking Prevention and Tobacco Control Act, creating the Center for Tobacco Products (CTP) at FDA and giving us the responsibility to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to protect public health.

Our challenge is to regulate effectively in a changing marketplace. The 2014 National Youth Tobacco Survey found that while cigarette smoking has continued to decline, a new trend emerged—more middle- and high-school students used e-cigarettes than traditional cigarettes and 2.2 million students reported using two or more types of tobacco products. In April 2014, FDA proposed a new rule to extend FDA’s authority to cover additional tobacco products, including e-cigarettes, little cigars, and cigarillos.

Data on these and other key topics—from harmful chemicals in tobacco to the effect of chewing tobacco on oral health to tobacco advertising—will help inform future regulatory actions and monitor the impact of those actions on public health.

Some of the Researchers Who Are Leading the Way

FDA is currently funding a broad range of important research, including the following via a partnership with the National Institutes of Health:


Andrew Hyland (Roswell Park Cancer Institute) is the lead investigator for the landmark Population Assessment of Tobacco and Health (PATH) Study, which will help us learn how and why people start using tobacco, switch from one tobacco product to another, quit using it, and start using it again after they’ve quit. The PATH Study collects information on new tobacco products like e-cigarettes and will give us many insights.

Watch Andrew Hyland’s “Tobacco Regulatory Science in Action” interview on FDA’s website.


Eric Donny (University of Pittsburgh) is studying how reduced levels of nicotine in cigarettes might affect the way people smoke. What are the benefits? Could there be adverse effects, such as people smoking more cigarettes to get the same amount of nicotine? Does it make a difference whether the levels are reduced gradually or at once?

Watch Eric Donny’s “Tobacco Regulatory Science in Action” interview on FDA’s website.


Kymberle Sterling (Georgia State University) is studying what people, especially ethnic minorities, think about little cigars and cigarillos. Little cigars and cigarillos are used by many people who are younger and in ethnic minority groups. Understanding what contributes to this behavior will help the nation begin to address some of the disparities that exist among vulnerable populations.

Watch Kymberle Sterling’s “Tobacco Regulatory Science in Action” interview on FDA’s website.


To learn more about the breadth of research we support, please look at all of our research videos* or look at the abstracts of research we’ve funded in our search tool. These projects are just a part of the work that FDA has undertaken to improve public health and inspire the next generation of researchers interested in tobacco regulatory science.

Cathy L. Backinger, Ph.D., M.P.H, is FDA’s Deputy Director for Research in CTP’s Office of Science

Cindy Miner, Ph.D., is FDA’s Director of the Division of Health, Regulatory and Scientific Communication in CTP’s Office of Health Communication and Education

*The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring, 2014).

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.

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