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Lester M. Crawford, D.V.M., Ph.D. - 28 th Annual National Food Policy Conference

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
28 th Annual National Food Policy Conference

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Commissioner of Food and Drugs


September 19, 2005

Good morning and thank you Cal (Cal Dooley, President and CEO, Food Products Assoc) for your kind introduction. It’s always a real pleasure for me to participate in this conference as I have done many times before, and a special honor to be your opening speaker. I want to commend the Consumer Federation of America (CFA) and FPA for a long history of sponsoring this important annual event to facilitate the dialogue between the federal agencies involved in food policy and their stakeholders.

This morning I’d like to give you just a brief update on some overarching Agency activities and then discuss a few more specific activities relative to the work of our Center for Food Safety and Applied Nutrition (CFSAN). Later in your program you’ll be hearing from Dr. Robert Brackett, Director of CFSAN, on the many food safety challenges FDA faces.

FDA, along with other Health and Human Services Agencies and the Office of the Secretary, is heavily involved in the disaster relief activities in the Gulf Coast states struck by Hurricane Katrina. FDA has deployed almost 300 Commissioned Corps Officers to the affected areas. These individuals are all health experts, including doctors, registered nurses, pharmacists, veterinarians and others, all of whom are playing significant roles in the relief efforts.

Our FDA website is providing information about the safety of medications and medical devices potentially damaged by flooding or high temperatures and our Center for Biologics is an active participant in monitoring the blood supply and other biological products such as vaccines and immune globulins. We’ve also made sure that antivenins will be available for treating bites from poisonous snakes in the flood waters.

The challenges of distribution of the drug supply are an increasing concern and our Center for Drug Evaluation and Research (CDER) is working to facilitate donation of inhalation drug products for treatment and prevention of asthma for patients in the hurricane affected areas as well as identifying private entities willing to donate and assist in delivering critical medical assets. We’ve issued recommendations on insulin storage and switching of product for patients who need insulin but have lost access to their normal healthcare providers in the hurricane aftermath.

Our Center for Veterinary Medicine (CVM) is coordinating with USDA and other Agencies on animal disposal and rendering issues, and in conjunction with CFSAN is examining aquaculture issues that may arise as a result of contaminated pond waters.

FDA is actively distributing important food safety messages to the Gulf region, providing consumers with information on how to deal with food that may have been temperature abused due to power outages, how to treat drinking water to destroy bacterial pathogens. We are using our SAFEFOOD line to respond to questions from consumers and industry on hurricane-related issues as they pertain to food safety.

Clearly, FDA personnel will be involved with the aftermath of Katrina for a long time. We’ll be working closely with both pharmaceutical and food processing industries in the affected regions as they work on restarting their businesses, especially since facility and equipment contamination as well as the purity of the water supply needed for processing will be major issues. CFSAN has published a notice to growers, food manufacturers, food warehouse managers and food transporters about crops and processed foods that will have to be destroyed due to contamination by flood waters.

Due to the destruction and flooding we’ve had to move our New Orleans district office and personnel to Nashville for the foreseeable future. But they are heavily involved in working with LA, MS, and AL state officials to oversee destruction of food products contaminated by flood waters.

Of course, this huge effort on the part of all FDA employees is in addition to our normal activities and responsibilities of protecting and promoting public health.

Some of you may be aware that 2006 marks the 100 th anniversary of the passage of the Pure Food and Drug Act, the founding law that transformed FDA into a scientific regulatory agency, thus making it the oldest consumer protection agency in the nation. This Centennial year is a major milestone in FDA’s history and will be a year in which FDA and the entire country can take pride in and reflect on the richness of that history as well as the many challenges that lie ahead. We’re excited about how the Centennial offers a unique opportunity to work with our stakeholders, to broaden public awareness of FDA’s responsibilities, and to increase the Agency’s ability to carry out its mission.

Today, many Americans are understandably interested in FDA’s programs, and the steps the Agency is taking to ensure that the promise of new science translates into longer and healthier lives. Consumers also want the opportunity to participate, in a meaningful way, in our work, whether we are discussing a complex scientific issue, proposing a regulation to address a particular problem or implementing a new law.

In recognition of the public’s interest in contributing to the work of the FDA I have scheduled a series of public meetings entitled “Vision 2006 – A Conversation with the American Public”. We are holding these meetings to update the public on current agency programs, engage the public in discussion, and obtain consumer input on specific issues. We may use this public input to strengthen our understanding of the public's expectations and concerns and to evaluate and modify, if necessary, our programs and activities. These meetings will be held in an open format in which the public can interact with the top leadership of FDA in a discussion of a broad range of issues.

Now, let me update you on various activities specifically within our Center for Food Safety and Applied Nutrition and our Center for Veterinary Medicine (CVM) that I believe may be of interest to you. As you know, CFSAN works very closely with the CVM on issues related to foods of animal origin. Two of those areas that may be of great interest to you are BSE and cloned animals.

With respect to BSE, CVM is in the final stages of preparing amendments to the BSE feed rule, and on Sept 6, we announced the amendment of the interim final rule on use of cattle materials in human food and cosmetics. FDA amended the rule to allow use of the small intestine in human food and cosmetics, provided that the distal ileum has been removed. The amendments also clarify that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited for use in human food and cosmetics .

FDA issued the interim final rule to minimize human exposure to materials that studies have demonstrated are highly likely to contain the BSE agent in cattle with the disease. The amended interim final rule provides the same level of protection against the agent that causes BSE as the original provisions.

With respect to use of cloned animals for human food, FDA has stated upfront that the risk assessment methodology and all the information used in performing the risk assessment would be publicly available. We published a draft executive summary of the risk assessment of animal cloning in 2003. Let me just say two things about this. Until the risk assessment is complete and publicly available, the voluntary moratorium on release of these products into the food supply remains in effect; and secondly, while our risk assessment only addresses the safety of food from animal clones and the risks to the cloned animals, we are well aware that there are many social and ethically issues related to the cloning of animals.

To broaden access to the risk assessment, once it as been finalized CVM will publish an article summarizing the findings in a peer-reviewed scientific journal.

FDA plays a major role in providing the tools to enable consumers to select more nutritious and healthy diets. One of the most important tools that we have is the food label. The Nutrition Labeling and Education Act of 1990 (the NLEA) and the final regulations to implement the NLEA (January 6, 1993), provided for a number of fundamental changes in how food is labeled, including requiring that nutrition labeling be placed on most foods, requiring that terms that characterize the level of nutrients in a food be used in accordance with definitions established by FDA, and providing for the use of claims about the relationship between nutrients and diseases or health-related conditions. FDA considered the available science at that time and recognized the benefits of fiber, and whole grains as a source of fiber. FDA authorized two health claims, which, as you may know, must be based on significant scientific agreement.

The 1997 FDA Modernization Act (FDAMA) specifically provided for the use of health claims based on authoritative statements from a scientific body of the U.S. Government or the National Academy of Sciences. We issued Guidance to Industry in 1998 that outlined submission procedures for health claims based on authoritative statements, and defined what would be considered an authoritative statement.

In 1999, we approved the first health claim for whole grain foods under FDAMA. And in 2003 as a part of our Consumer Health Information for Better Nutrition Initiative we issued draft Guidance to Industry on a review process for the use of qualified health claims. The central focus of the initiative to allow qualified health claims had the twin goals of making available better, easily understood, up-to-date scientific information about how dietary choices can affect health, as well as encouraging companies to compete based on health and nutrition consequences, in addition to such non-health-related features of products like taste and ease of preparation. A better-informed public - aided by science-based health information -- would be able to choose foods that are more nutritious, potentially addressing such urgent public health problems as the rise in obesity and overweight. Moreover, as public understanding of sound nutrition grows, food and dietary supplement producers will have to compete increasingly on the basis of nutritional value rather than portion size or taste alone.

So, where are we today with respect to the food label?

I’m sure that many of you in this room are aware that FDA has published two Announcements of Proposed Rulemaking (ANPRMs) with respect to potential changes in the food label relative to serving size and calories. CFSAN is also in the process of evaluating Petitions concerning the definition of net carbohydrates and use of the terms “reduced” or “low” with respect to carbohydrate content.

CFSAN has, as one of its priorities for the coming year, the development of a strategy to initiate rulemaking on label claims for whole grains. As a part of this priority we expect to define the term “whole grain” and establish the framework for appropriately using claims about whole grains considering the recommendations of the Dietary Guidelines.

Before I leave the topic of labeling I want to comment on the rapidly approaching deadline of January 1, 2006 for implementation of the mandatory listing of trans fat on the food label. The trans fat nutrition labeling rule responds, in part, to a citizen petition from the Center for Science in the Public Interest (CSPI), and is based on recently published human studies and health expert advice on trans fat.

The Institute of Medicine, National Academies of Science published a report a couple of years ago that found that trans fatty acids increase low density lipoprotein cholesterol, thereby increasing the risk of coronary heart disease, and recommended that "trans fat consumption be as low as possible while consuming a nutritionally adequate diet," to help reduce the incidence of coronary heart disease.

This regulation will provide information on food labels about the amount of trans fat in foods so that consumers can select foods with lower levels of trans fat. FDA is not banning food manufacturers from using trans fat in packaged foods. Rather, we are requiring food manufacturers, processors, and distributors to label the amount of trans fat in a serving of food on the Nutrition Facts panel. As a result, Americans will have information they need to reduce their intake of trans fat as part of a heart-healthy diet.

Based on informal reports from industry, the requirement to declare trans fat on product labeling is already changing consumer demand and prompting product reformulation. Representatives from industry have indicated to FDA that the transition from use of oils containing trans fats to healthier oils that are both suitable for various processing techniques and continue to meet consumer taste preferences will take time as supplies of healthier oils catch up with demand. High consumer demand for healthier oils, and the accompanying industry response, is a testament to the success of the agency's trans fat labeling rule and industry's move to using healthier oils.

I look forward to further interactions with you as FDA continues to do its part towards helping consumers lead healthier and longer lives through better nutrition and food safety.

Thank you.