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| 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. |
Good afternoon and thank you Dave (David Schmidt, IFIC) for your kind introduction. I’m very pleased to be here, and I want to thank both the CFA and NFPA for their work in planning this important annual event. This event is now in its 27 th year and I have been honored to be an invited speaker at about half of those 27 conferences
I would especially like to acknowledge the excellent work done by several individuals whom I have known for many years, Ms. Carol Tucker Foreman and Stephen Brobeck of the Consumer Federation of America’s Food Policy Institute, and John Cady, President and CEO of the National Food Processors Assoc.
I want to tell you briefly of some important changes that have taken place at FDA’s CFSAN in the past 6 months. Some of you may already be aware, but for those who aren’t, I’m very pleased to acknowledge Dr. Robert Brackett, the new Center Director. In the short time that he has been CFSAN director, Dr. Bracket has taken some tremendous steps in renewing CFSAN’s focus on nutrition, spearheaded by the appointment of Dr. Barbara Schneeman of UC-Davis as the new director of the Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS).
Later this afternoon and tomorrow you will be engaging in facilitated debates with other representatives of CFSAN, Dr. Alan Rulis, (obesity and food industry panel); Ms Leslye Fraser (BT and food security panel); and Dr. Kathleen Elwood (labeling and health claims panel)
I would like to take this opportunity to announce that FDA is supportive of two pieces of food-safety related legislation adopted by the Senate on March 8, 2004 and which are currently under consideration in the House.
The Food Allergen Labeling and Consumer Protection Act of 2004, also known as the Food Allergy Bill is a piece of legislation that will help millions of Americans who suffer from food allergies by providing them with additional information on the food label to assist in identifying food allergens that may be a concern. This legislation would require that food labels identify in plain language if a product contains any of eight major food allergens: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. These eight allergens cause about 90 % of food allergic reactions.
The Minor Use and Minor Species Animal Health Act of 2004, (MUMS Bill) , is also supported by FDA as it is intended to increase availability of new therapies for animals including zoo animals and exotic pets and food animals. There is a severe shortage of approved animal drugs for use in minor species (all animal species except dogs, cats, horses, cattle, swine, chickens, and turkeys). This situation in many cases leaves the veterinarian and animal owner with the choice of leaving a sick animal untreated or treating with an unapproved drug. In the case of minor-species food animals (aquaculture species, farmed deer and elk, ostrich, emus, etc.) this could lead to public health and food safety risks.
Let me give you a brief overview of some key agency initiatives relative to food safety, and important food and nutrition policy recommendations from FDA’s Obesity Working Group. These initiatives are a major part of the implementation of FDA’s strategic plan relative to the goals of efficient risk management and improved consumer/patient safety and information.
Food GMPs
FDA has two very important initiatives in food safety as part of our strategic goal of more efficient risk management that I would like to share with you. Both of these initiatives, modernization of the current food GMPs and development of GMPs for dietary supplement manufacturers, are aimed at reducing risk of adverse health effects to consumers.
The food GMPs were originally promulgated in the late 1970’s and were last revised in 1986 in response to the identification of several newly emerging food-borne pathogens such as Salmonella enteriditis, and hemorrhagicE. coli. Food GMPs are an important part of the nation’s control over food safety problems. Processing failures from a lack of the application of modern GMP controls are a major cause of food product recalls.
Since the last revision of food GMPs, we have continued to greatly expand our understanding of food-borne illness and have recognized the importance of several new bacterial, viral, and protozoan foodborne pathogens, such as Listeria monocytogenes, Norovirus, and Cryptosporidium. In many cases, these pathogens can be adequately controlled only by the implementation of appropriate GMPs by food-processing establishments.
Food allergens and certain other food ingredients are now recognized as a hazard for sensitive individuals. Cross-contamination of food products with a food allergen may also be prevented through the implementation of appropriate GMPs in food processing.
Rapid advances in food processing technology have also occurred since the GMPs were last revised. Modernization of the GMPs will be essential in creating opportunities for incorporation of newer technologies and better manufacturing techniques and process controls.
We believe this effort, like our work on current good manufacturing practices for medical products, will improve the safety of conventional foods and dietary supplements.
FDA (CFSAN) began the effort to examine the underlying health basis and enforceability of its preventive controls, including GMPs by establishing a Food GMP Modernization Working Group in July of 2002. This Working Group initiated research in two areas: the impact of current GMPs on food safety, and the impact of revised GMPs on food safety and the likely economic impact of such revisions.
To date, the GMP Modernization working Group has completed: A literature review related to GMPs; and a solicitation of expert opinions, which will contribute to a qualitative evaluation of food risks and the ability of different preventive measures to address those risks.
I am pleased to announce that as a part of this continuing process to modernize the food GMPs, FDA will hold three public meetings this summer to obtain stakeholder input on ways in which the food GMPs should be updated. These meetings will be held in different regions of the country, with one in College Park, MD, one in Chicago, IL and one in the western part of the country, most probably Las Vegas. These meetings will include outreach to small businesses.
The meetings will be announced shortly in the Federal Register and will include a list of specific questions about food GMP modernization that FDA would like participants to address. FDA will then evaluate the data and information received from these public meetings to determine appropriate revisions to food GMP regulations. FDA will publish a white paper with a summary of its findings in September of this year (2004), and will then proceed as needed through (notice-and-comment) rulemaking.
In concert with this review and modernization of food GMPs, FDA is also pushing hard on finalizing the first GMP guidelines for dietary supplement manufacturers.
Last spring, we proposed comprehensive new regulations that will set manufacturing and labeling standards for the first time for all dietary supplements marketed in the United States. When these regulations are finalized later this year, the public will not be faced with “buyer beware” any longer when it comes to whether or not a dietary supplement was manufactured in ways that prevent impurities or contaminants from getting into the product, and when it comes to knowing that what it says on the label is really what’s in the product.
The agency will continue to coordinate future revisions of the food GMPS with dietary supplement GMPS.
Obesity Working Group
I’d like to bring to your attention to another important FDA initiative, one which tracks exactly with the theme of this conference, and that is FDA’s initiative to help reverse the obesity epidemic in this country.
In March of this year, FDA released the final report of its Obesity Working Group (OWG). As chair of this working group I can attest to the fact that this report is the culmination of many months of hard work, research, discussion and collaboration on the problem of obesity in the U.S. and how FDA can contribute to the solution of this problem in the context of its mission and regulatory authority.
This report is comprehensive, and offers a number of compelling recommendations on ways to combat obesity. The report also maps closely to our Strategic Plan, in particular our goal of providing consumers with better information to help them lead healthier lives through better nutrition.
The cornerstone of the Obesity Working Group report is the idea that America must get back to basics and that “Calories Count.” In other words, there is no substitute for the simple formula that ‘calories in must equal calories out’ in order to control weight. The report builds on these nutrition fundamentals through a comprehensive, science-based and consumer-friendly set of initiatives.
Food Labels
The first critical set of recommendations involves enhancing the food label. The report recommends that FDA evaluate how the Nutrition Facts panel (NFP) can be revised to highlight the critical role calories play in consumers’ diets. The goal in modifying the food label is to arm consumers with more of the information they need to make sound food choices:
Calories – A notice of proposed rule making on possible revisions to the food label relative to calories. We want to increase the font size for caloric content to make it more visible and easier to read on the label. We also propose to have the % of the daily value for calories appear right next to the calorie content rather than in tiny print at the bottom of the NFP. That way a consumer can easily tell what proportion of their day’s allotment of calories they are consuming with a single food item
Serving Sizes – We are encouraging food manufacturers to consider revision of certain labels as single-servings if the food item can be reasonably consumed as one serving. For example, a 20 oz bottled soft drink would have the calorie content listed on the basis of the full 20 oz being a single serving rather than having the calorie content listed on the basis of an 8 oz serving and saying the bottle contains 2.5 servings. Flexibility in the current regulations would allow this change to be implemented immediately and we urge manufacturers to take advantage of that.
Comparative Labeling Statements – FDA is also encouraging the use of comparative labeling statements to make it easier for consumers to compare different types of foods and make healthy substitutions.
‘Calories Count’ Campaign
The second major recommendation of this report involves initiating an education campaign focused on the “Calories Count” message. Because the obesity epidemic is particularly alarming in children, we are focusing our education efforts towards children and young adults.
As a part of this education campaign, the Department recently developed a series of public service announcements in collaboration with the Ad Council that will begin airing in the near future, they are currently being pilot tested. In addition, the Department recently announced the signing of a Memorandum of Understanding (MOU) with the Girl Scouts of America, and is developing additional collaborative agreements with various private and public sector groups including NASULGC (Nat’l Assoc of State Universities and Land Grant Colleges) through their National 4-H program, and the Department of Education.
Restaurant Nutrition Information
The third set of recommendations from FDA’s Obesity Working Group is focused on encouraging restaurants to provide nutrition information. American consumers now spend approximately 46 percent of their total food budget on food consumed outside of the home, and these foods account for a significant portion of total calories consumed.
FDA is urging the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign for customers. FDA also encourages consumers to routinely request nutrition information when eating out. In addition, the final report calls for the development of options for providing voluntary, standardized, simple, and understandable nutritional information, including calorie information, at the point-of-sale in a restaurant setting. FDA hopes to involve restaurants in a pilot program to study these options in a well-controlled setting.
I’m pleased to say that we have already gotten responses from a number of ‘fast-food’ restaurant chains.
Increased Enforcement Activity
The fourth set of recommendations involves various enforcement activities to ensure the accuracy of the information in the NFP and ensure that consumers can monitor their intake of calories and nutrients.
FDA has issued a general letter to food manufacturers, encouraging them to review nutrition information and ensure that the serving size declared is appropriate for the commodity in question. The report also calls for stricter enforcement activities against those manufacturers that declare inaccurate serving sizes, and we intend to follow this guideline to make sure Americans have the best, safest information about the foods they are consuming.
Increased Research Collaboration
The final set of recommendations involves increased collaboration on obesity research – on everything from the relationship between overweight/obesity and food consumption patterns to incentives for product reformulation. It calls for joint research with USDA’s Agricultural Research Service on a USDA-sponsored obesity prevention conference to be held in October 2004. We also plan to convene a nationwide dialogue with interested stakeholders over the course of the year.
Finally I would like to mention that FDA is also hard at work in two other related areas to help Americans make sound nutritional and dietary choices.
Qualified Health Claims
In tandem with these recommendations from the OWG, FDA is also acting on the recommendations of its Health Claims Task Force, that builds on a number of other ongoing initiatives focused on improving food safety and nutrition…
Most notably, FDA has been hard at work defining a process and long-term regulatory alternatives to help consumers get more information about the health consequences of their food choices by providing interim guidance to industry on qualified health claims in labeling conventional foods and dietary supplements.
This past year also witnessed a major change in the nutrition label on foods to include a separate listing of trans fatty acids. This was the first significant change on the Nutrition Facts panel since it was established in 1993.
Dietary Supplements
The agency has also undertaken a broad effort to crack down on misleading and or unsafe dietary supplements; and proposed new regulations to set manufacturing and labeling standards for dietary supplements.
FDA has focused its enforcement efforts over the past year to ensure consumers are not being harmed as a result of claims that overstate the effectiveness of dietary supplement products.
Dietary supplements containing ephedrine alkaloids have been taken of the market. These products were extensively promoted for aiding weight control and boosting sports performance and energy. The totality of the available data showed little evidence of ephedra's effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These effects are linked to significant adverse health outcomes, including heart attack and stroke.
And just a few weeks ago, we announced various efforts to crack down on products containing androstenedione, or “andro.” – This set of products poses substantial safety risks to all Americans, particularly our nation’s youth and athletes.
One of the key messages of this effort is that there are no safe quick fixes when it comes to losing weight and improving athletic performance, and it is only through proper diets, nutrition and exercise that we can improve our performance and more importantly improve our health.
CONCLUSION
Taken together, these initiatives provide a comprehensive action plan for FDA that, when implemented, will go a long way towards helping us confront the Nation’s obesity epidemic and helping consumers lead longer, healthier lives through better nutrition.
I thank you for your attention, and the opportunity to share with you some of FDA’s many activities relative to food safety and nutrition in furthering its mission of protecting and promoting the public health.