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Stephen Ostroff

FDA Compliance

FDA 2015: A Look Back (and Ahead), Part 3

Our progress addressing food safety, tobacco use, and antimicrobial resistance

Published: Monday, January 18, 2016 - 14:45

In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation. In part one I shared the FDA’s 2015 accomplishments in medical product innovation, and I reviewed the FDA’s effect on medical product safety and oversight in part two.

Modernizing food safety

In a groundbreaking development during 2015, the FDA took several major steps to prevent food-borne illness by finalizing five rules that will implement the landmark 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. These practices will help establish a food safety system in which industry systematically implements measures we know are effective in preventing contamination.

We took another step toward modernizing our food-safety system in November by issuing the final produce-safety rule and two import-safety rules. These new rules establish, for the first time, enforceable science-based safety standards for the growing and harvesting of produce. They also 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 food-borne 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 U.S. citizens consume.

Strengthening nutrition, protecting health

We made important progress regarding nutrition by finalizing the determination that partially hydrogenated oils, the primary dietary source of trans fat in processed foods, are not generally recognized as safe (GRAS) for use in human food. This decision will make an enormous difference in people’s health.

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 healthcare system.

In late 2014, we finalized two new rules requiring caloric information on restaurant menus and menu boards, as well as 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. When finalized, the labels will provide updated nutritional information reflecting the most current nutrition science to help people make healthier choices when purchasing packaged foods. This includes a revision that would establish a Daily Reference Value for added sugars and require the Daily Value percentage on the label. There is strong evidence that 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 throughout the U.S. federal 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 healthcare 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 which recognizes that humans and animals share the same environment—and the same microbes—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 in developing policies to promote the appropriate use of antibiotics to maintain animal health. For instance, we issued the Veterinary Feed Directive (VFD) final rule, an important part of our overall strategy because it promotes the 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 affect resistance patterns among food-borne pathogens associated with farm animals. We are strengthening our data collection under the National Antimicrobial Resistance Monitoring Program in several ways, one being a public meeting held in September 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 effect of our regulatory actions.

The problem of antimicrobial resistance is finally getting the attention it warrants, however, 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. It’s been just six years, however, since Congress passed the Tobacco Control Act, which gave the FDA authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products to protect the public from their dangers.

On that foundation we created the Center for Tobacco Products and established a framework for industry registration, product listing, and submission of information on ingredients in tobacco products; for 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.

Also during 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 aged 12 to 17. This promising effort flows from our “Real Cost” campaign launched in 2014, which 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’m proud of all that we’ve accomplished in 2015 and look forward to our continued progress.


About The Author

Stephen Ostroff’s picture

Stephen Ostroff

Stephen Ostroff, M.D., is the Food and Drug Administration’s acting commissioner of food and drugs. Before being named acting commissioner, Ostroff served as the FDA’s chief scientist since January 2014. In this capacity, he was responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. Ostroff graduated from the University of Pennsylvania School of Medicine.