TESTIMONY OF PATRICIA B. SWAN, PH.D. AMERICAN INSTITUTE OF NUTRITION AMERICAN SOCIETY FOR CLINICAL NUTRITION BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS OF THE COMMITTEE ON GOVERNMENT OPERATIONS U.S. HOUSE OF REPRESENTATIVES DECEMBER 10, 1987 1 I AM GRATEFUL FOR THE OPPORTUNITY TO TESTIFY AT THESE HEARINGS ON THE PROPOSED CHANGES IN THE REGULATIONS GOVERNING USE OF HEALTH CLAIMS ON FOOD LABELS. I AM CHAIR OF THE JOINT PUBLIC AFFAIRS COMMITTEE OF THE AMERICAN INSTITUTE OF NUTRITION AND THE AMERICAN SOCIETY FOR CLINICAL NUTRITION. I AM ALSO PROFESSOR OF FOOD SCIENCE AND NUTRITION AND ASSOCIATE DEAN OF THE GRADUATE SCHOOL AT THE UNIVERSITY OF MINNESOTA. MY TESTIMONY TODAY REPRESENTS THE VIEWS OF THE AMERICAN INSTITUTE OF NUTRITION AND THE AMERICAN SOCIETY FOR CLINICAL NUTRITION AND IS BASED ON A STATEMENT THAT WAS DRAFTED BY OUR JOINT PUBLIC AFFAIRS COMMITTEE AND SUBSEQUENTLY ENDORSED BY THE GOVERNING COUNCIL OF EACH SOCIETY. THESE TWO SOCIETIES ARE THE MAJOR PROFESSIONAL ORGANIZATIONS FOR NUTRITION SCIENTISTS IN CLINICAL, EDUCATIONAL AND RESEARCH INSTITUTIONS IN THE UNITED STATES. OUR MEMBERSHIP ALSO INCLUDES RESEARCHERS FROM OVER FORTY FOREIGN COUNTRIES. THE AMERICAN INSTITUTE OF NUTRITION IS A CONSTITUENT SOCIETY OF THE FEDERATION OF AMERICAN SOCIETIES FOR EXPERIMENTAL BIOLOGY. THE FEDERATION INCLUDES SIX OTHER BIOMEDICAL PROFESSIONAL SOCIETIES REPRESENTING 29,000 SCIENTISTS IN THE DISCIPLINES OF PHYSIOLOGY, BIOCHEMISTRY, MOLECULAR BIOLOGY, PHARMACOLOGY, PATHOLOGY, IMMUNOLOGY AND CELL BIOLOGY. THE FEDERATION BOARD RECOGNIZED THAT PUBLIC HEALTH DECISIONS BENEFIT FROM THE APPLICATION OF BROADLY BASED SCIENTIFIC EXPERTISE. ACCORDINGLY THEY REVIEWED THE PROPOSED CHANGES IN THE REGULATIONS GOVERNING USE OF HEALTH CLAIMS ON FOOD LABELS AND THEY ENDORSED AIN/ASCN POSITION REGARDING THE USE OF HEALTH CLAIMS ON FOOD LABELS. DURING THE PAST THREE YEARS OUR PUBLIC AFFAIRS COMMITTEE ACTIVELY CONSIDERED THE ISSUES RAISED BY THE PRESENCE OF DISEASE-SPECIFIC HEALTH CLAIMS ON FOOD LABELS, AND IN ADVERTISING. WE DEBATED THESE ISSUES AND CONSIDERED VARYING POINTS OF VIEW ABOUT THEM. WHEN THE PROPOSED CHANGES IN THE REGULATIONS WERE PUBLISHED THIS SUMMER, AND WE DECIDED TO TAKE THE OPPORTUNITY TO COMMENT ON 2 THEM, WE DISCOVERED THAT OUR MEMBERS WERE MUCH MORE UNANIMOUS IN THEIR VIEWS ON THIS CONTROVERSIAL SUBJECT THAN THEY HAVE BEEN ON ANY OTHER SUCH SUBJECT IN THE PAST SEVERAL YEARS. THE VIEWS WHICH I WILL EXPRESS TO YOU REFLECT A STRONG CONSENSUS AMONG OUR MEMBERS. WHY HAVE WE BEEN CONCERNED ABOUT PUBLIC POLICY RELATED TO HEALTH CLAIMS FOR FOOD? EVEN THOUGH OUR MEMBERSHIP IS MOST HEAVILY INVOLVED IN DOING RESEARCH TO INCREASE OUR KNOWLEDGE ABOUT HUMAN NUTRITION, WE HAVE A RESPONSIBILITY TO ASSURE THAT OUR KNOWLEDGE IS INTERPRETED ACCURATELY TO OUR STUDENTS, OUR PATIENTS, OUR FAMILIES AND FRIENDS, AND TO THE AMERICAN PEOPLE. WE DON'T WANT TO BE FALSELY MODEST ABOUT THE IMPORTANCE OF NUTRITION AND THE BENEFITS TO BE GAINED FROM APPLYING THAT KNOWLEDGE, BUT NEITHER DO WE WANT TO CLAIM THAT OUR KNOWLEDGE IS MORE COMPLETE THAN IS TRUE. WE ARE CONCERNED THAT THE PROPOSED CHANGES WILL FAVOR MISINFORMATION, OR MISLEADING INFORMATION, RATHER THAN FAVOR ACCURATE INFORMATION WHICH CAN BE USED TO MAKE WISE FOOD CHOICES. WHY ARE DISEASE-SPECIFIC HEALTH CLAIMS ON FOOD LABELS SO MISLEADING? IS INSUFFICIENT SPACE ON FOOD LABELS TO PROVIDE INFORMATION WHICH IS BOTH THERE RELEVANT TO THE INDIVIDUAL CONSUMER AND WHICH REPRESENTS FAIRLY ANY CONSENSUS OF NUTRITIONAL THOUGHT ON A SPECIFIC FOOD. MOREOVER, IT IS AN ESTABLISHED PRINCIPLE OF NUTRITION THAT INDIVIDUAL FOODS DO NOT HAVE "MERIT" BUT THAT MERIT LIES OVER THE TOTALITY OF FOOD INTAKE. A CLAIM FOR A SPECIFIC FOOD SHOULD NOT BE MADE WITHOUT CONSIDERATION AS TO WHAT ELSE IS BEING EATEN AND HOW THE SPECIFIC FOOD MIGHT IMPROVE, OR HARM, THAT TOTAL DIET. WE BELIEVE THAT THE DIETARY GUIDELINES FOR AMERICANS PROPOSED BY DHHS AND USDA ARE SUITABLE GUIDELINES FOR THE GENERAL POPULATION. POSSIBLY, A MEANS TO PROMOTE THE DIETARY GUIDELINES IN FOOD LABELING COULD BE DEVISED AND USED WITHOUT MISLEADING CONSUMERS. UNFORTUNATELY, THE HEALTH CLAIMS THAT WE HAVE SEEN RECENTLY ON FOOD LABELS AND IN ADVERTISING GROSSLY EXCEED THESE GUIDELINES AND DO NOT POINT OUT 3 THE INTERACTIONS OF FOOD WITH AN INDIVIDUAL'S GENETIC BACKGROUND, HEALTH OR DISEASE STATE, AND LIFESTYLE OR WITH A HOST OF BIOCHEMICAL, IMMUNOLOGICAL AND PHARMACOLOGICAL FACTORS: IT IS OBVIOUS THAT FOOD LABELS SIMPLY ARE NOT LARGE ENOUGH FOR ALL THAT INFORMATION. CAREFULLY-CONSIDERED FOOD FORTIFICATION HAS BEEN BENEFICIAL TO THE AMERICAN PUBLIC. REGRETTABLY, THE DESIRE TO CAPITALIZE ON DISEASE-SPECIFIC CLAIMS HAS ALREADY LED TO INDISCRIMINATE FORTIFICATION OF COMMON ITEMS IN THE FOOD SUPPLY. THE ESCALATION OF HEALTH-RELATED CLAIMS STIMULATED BY COMPETITION AMONG FOOD MANUFACTURERS CAN RAISE THE LEVEL OF FORTIFICATION TO AN UNDESIRABLE EXTENT. IT MAY LEAD TO EXCESSIVE OR UNBALANCED FORTIFICATION OF THE ENTIRE FOOD SUPPLY. AS THE FDA'S OWN POLICY STATES (21CFR 104.20): "RANDOM FORTIFICATION OF FOODS COULD RESULT IN OVER- OR UNDER-FORTIFICATION IN CONSUMER DIETS AND CREATE NUTRIENT IMBALANCES IN THE FOOD SUPPLY. IT COULD ALSO RESULT IN DECEPTIVE OR MISLEADING CLAIMS FOR CERTAIN FOODS." SIMILARLY, WE OPPOSE THE USE OF HEALTH CLAIMS ON DIETARY SUPPLEMENTS. WE BELIEVE THAT UNTIL WE HAVE MUCH BETTER UNDERSTANDING OF HUMAN NUTRITION, AND OF BOTH THE POSITIVE AND NEGATIVE EFFECTS OF NUTRIENT SUPPLEMENTS, THE USE OF HEALTH INFORMATION ON THE LABELS FOR THESE PRODUCTS IS COMPLETELY UNJUSTIFIED. WE BELIEVE THAT THE CONSUMER HOLDS THE CREDIBILITY OF THE FOOD LABEL IN HIGH ESTEEM. THE CONSUMER WILL BELIEVE THAT THE FDA HAS APPROVED LABEL CONTENTS AND HAS SUBSTANTIATED ANY STATED CLAIMS. THE ADDITION OF DISEASE-SPECIFIC CLAIMS, PURCHASE. UNDER THESE CONDITIONS IT IS NOT REASONABLE TO EXPECT THE CONSUMER TO BUT, MORE IMPORTANTLY, FROM THE POINT OF VIEW OF PUBLIC UNDERSTANDING OF THE ROLE OF THESE TWO DIFFERENT TYPES OF PRODUCTS. FINALLY, WE WISH TO EMPHASIZE OUR CONCERN THAT "AGREEMENT" BETWEEN ANY GOVERNMENT AGENCY, SUCH AS THE NATIONAL CANCER INSTITUTE, AND A FOOD MANUFACTURER IN THE FORMULATION OF DISEASE-RELATED CLAIMS IS STRUCTURALLY UNSOUND. SIMILARLY, A PROCESS OF HAVING COMMITTEES FORMALLY REVIEW CLAIMS FOR HEALTH AND DISEASE-SPECIFIC EFFECTS OF FOODS TENDS TO GIVE EXCESSIVE AUTHORITY AND PERMANENCE TO SUCH ACTIONS. WE PROFOUNDLY REGRET FDA'S FAILURE TO TAKE ACTION AGAINST THE USE OF THERAPEUTIC OR MISLEADING HEALTH-RELATED INFORMATION ON FOOD LABELING WHEN DISEASE-SPECIFIC HEALTH CLAIMS WERE FIRST INTRODUCED THREE YEARS AGO. FOR ALL THESE REASONS WE HAVE URGED COMMISSIONER YOUNG, OF THE FOOD AND DRUG ADMINISTRATION, TO SUSPEND THE PROPOSED RULE-MAKING AND TO RETURN TO THE PREVIOUS REGULATORY POSTURE WHEREIN (1) DISEASE-SPECIFIC CLAIMS WERE CATEGORICALLY PROHIBITED AND (2) THE FOOD LABEL WAS UTILIZED TO DESCRIBE THE NUTRITIONAL CHARACTERISTICS OF THE FOOD ITSELF AS EXEMPLIFIED BY NUTRITION LABELING, INGREDIENT LABELING, AND DESCRIPTORS OF MODIFICATIONS, DISEASE-SPECIFIC CLAIMS REPRESENT, IN OUR OPINION, A MISUSE OF THE INFORMATION AND SHOULD NOT BE ALLOWED ON FOOD LABELS AND LABELING. THE PROPOSED CHANGES FAIL TO PROVIDE THE PROTECTION OF THE PUBLIC HEALTH ASSURED BY PREVIOUS POLICY, AND OPEN THE DOORS TO UNCONTROLLED ABUSE. MR. CHAIRMAN, THANK YOU FOR HEARING OUR VIEWS ON THE PROPOSED CHANGES IN REGULATIONS GOVERNING THE USE OF HEALTH CLAIMS ON FOOD LABELS. WE APPRECIATE THE INTEREST AND CONCERN YOU HAVE SHOWN FOR THE PUBLIC'S HEALTH IN HOLDING THESE HEARINGS. THANK YOU. |