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Ebook Starvation Diet: FDA Lacks Adequate Resources for its Nutritional Health and Consumer Protection Missions

Submitted by puput on Wed, 09/16/2009 - 02:52

The Food and Drug Administration’s (FDA) Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) is responsible for numerous essential public health and consumer protection programs. These programs include:

  • ensuring that foods are honestly labeled;
  • guaranteeing the quality of infant formula;
  • regulating dietary supplements;
  • enforcing standards for medical foods used by hospital and nursing home patients, as well as foods for special dietary use purchased by diabetics, consumers with allergies, and others with sensitive medical conditions;
  • promoting the nutritional well-being of all Americans by conducting research on the nutritional status of the American population;
  • providing FDA with clinical expertise to help ensure that nutrients in fortified foods are consumed in safe amounts;
  • verifying that the ingredient lists and the Nutrition Facts labels on hundreds of thousands of packaged foods are accurate;
  • approving new health and nutrient content claims that appear on food labels;
  • determining the minimal amount of key ingredients in standardized foods ranging from mayonnaise to frozen cherry pie and;
  • assessing whether the percentage of particular ingredients needs to be disclosed to prevent consumer deception.

The purpose of this report is to ascertain how resource limitations are affecting ONPLDS’ ability to fulfill its responsibilities. Given the importance of those responsibilities, it is essential that ONPLDS receives adequate funding to accomplish its mission.

Part I of this report will specifically review each major aspect of ONPLDS’ responsibilities and discuss the degree to which resource limitations are affecting the Office’s ability to fulfill its mission. FDA, in response to a request from Congress, has recently completed a detailed assessment of the additional resources it needs to effectively accomplish its mission in the area of dietary supplements.2 Because this information has already been submitted to Congress, this report will focus on estimating the amount of additional resources that ONPLDS needs to fulfill other aspects of its mission.

Part II of this report will examine a number of emerging issues related to scientific and technological developments, changes in the law, marketing trends, and other factors that are likely to tax ONPLDS’ resources to an even greater extent in the future and further undermine its ability to fulfill its mission of protecting consumer health.

Part III of this report analyzes the Office’s workload in terms of pending rulemaking petitions and proceedings and discusses the impact of budgetary shortfalls on the Agency’s ability to take timely action on those matters. Part III also evaluates the impact of budgetary shortfalls on ONPLDS’ ability to enforce the law, and reviews the impact of this problem on consumers and the food industry.

Part IV of this report documents the decline of resources over the last decade. This report concludes that without a phased in budget increase of $30 million over the next three years, ONPLDS will be unable to administer adequately the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) for which it is responsible.

CONTENTS

EXECUTIVE SUMMARY
INTRODUCTION
PART I - FDA’S OFFICE OF NUTRITIONAL PRODUCTS, LABELING AND DIETARY SUPPLEMENTS: RESPONSIBILITIES AND CURRENT ACTIVITIES
A. OVERVIEW OF MISSION AND STAFFING
B. SPECIFIC RESPONSIBILITIES OF ONPLDS
1. Dietary Supplements
2. The Nutrition Labeling and Education Act

    a) Approval of Health Claims
    b) Approval of Nutrient Content Claims
    c) Mandatory Nutrition Labeling
    d) Voluntary Nutrition Labeling of Raw Fruits, Vegetables and Fish

3. Structure/Function Claims
4. Infant Formula
5. Other Foods for Use by Special Populations

    a) Foods for Special Dietary Use
    b) Medical Foods

6. Scientific Research
7. Ingredient Labeling

    a) Label Readability
    b) Misleading Ingredient Claims
    c) Declaration of the Percentage of Characterizing Ingredients

8. Food Quality

    a) Standards of Identity
    b) Temporary Marketing Permits
    c) Use of Descriptive Terms such as “Natural” and “Fresh”

PART II - EMERGING ISSUES WILL STRAIN ONPLDS’ RESOURCES EVEN MORE
A. FUNCTIONAL FOODS
B. REGULATING INTERNET CLAIMS
C. BIOTECHNOLOGY
D. USE-BY DATES TO ENSURE SAFETY
E. FOOD FORTIFICATION POLICY
F. IRRADIATION LABELING
G. REQUIRING CHOKING HAZARD WARNINGS
H. CODEX ALIMENTARIUS COMMISSION
PART III - INADEQUATE RESOURCES HAVE FORCED ONPLDS TO DELAY ACTION ON PETITIONS, PROPOSED RULES, AND ENFORCEMENT EFFORTS
A. PENDING PETITIONS

    1. Allergenic Ingredients
    2. Caffeine Labeling
    3. Added Sugars

B. PROPOSED RULES

    1. Trans Fatty Acids: Establishment of a Daily Value, Regulation of Nutrition and Health Claims, and Explanatory Material on the Nutrition Facts Label
    2. Medical Foods

C. ENFORCEMENT ACTIONS
PART IV - EXTENT OF DECLINING RESOURCES AND RECOMMENDATIONS FOR BUDGETARY INCREASES
A. CURRENT STAFFING
B. DECLINING STAFFING OVER THE PAST DECADE
C. INCREASING REGULATORY RESPONSIBILITIES, DECLINING RESOURCES
D. ONPLDS NEEDS AN INCREASE OF $30 MILLION PHASED IN OVER A THREE-YEAR PERIOD TO EFFECTIVELY CARRY OUT ITS MANDATE
APPENDIXES
I. TEN YEAR BUDGET SUMMARY FOR ONPLDS
II. EXAMPLES OF PENDING ONPLDS PETITIONS SUBMITTED FROM 1991-2002
III. EXAMPLES OF PENDING ONPLDS RULEMAKING ACTIVITIES
IV. ENFORCEMENT ACTIONS FY 1997 TO FY 2001 CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

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