Dietary Supplement Labeling Compliance Review, Third Edition

229 Pages·2004·3.058 MB·English

by  James L. Summers(auth.)

DIETMY SUPPLEMENT LABELING
COMPLIANCE REVIEW
Third Edition
James L. Summers
With contributions by
Elizabeth J. (Betty) Campbell
Blackwell
Publishing
James L. Summers is a senior consultant at AAC Consulting Group, Inc. (Rockville, MD), a firm providing con-
sulting services in food, dietary supplement, cosmetics and other areas that fall under the jurisdiction of the FDA. He
is a former FDA food and diem supplement labeling expert with 32 years tenure at FDA. He has held positions as
Aquatic Sampling Specialist, SupeMsory Microbiologist, Public Health Sanitarian, Gened Biologist, FDA Inspector,
Regional SheMsh Specialist, and Consumer SafetyO5cer (Division of Regulatory Guidance). His last position with the
FDA was as Supenisory Consumer Safety Officer, Branch Chief in the Office of Food Labeling, where he handled the most
controversial and precedent-setting problems involving regulatoly compliance issues dealing with food and diems up
plement labeling. He participated in the development of policies and regulatory strategies regarding the enforcement
of NLEA and other food and dietary supplement labeling regulations.
Elizabeth J. (Betty) Campbell joined AAC Consulting Group, Inc. (Rockviie, MD) as a Senior Food Labeling
Consultant after a 35-year career with the FDA where she served as Director of Programs and Enforcement Policy in the
O5ce of Food Labeling in the Center for Food safety and Applied Nutrition and as Acting Director of the Office of Food
Labeling. Ms. Campbell played a key role in writing the Nutrition Iabeling and Education Act (NLEA) regulations in the
early 1%ba, nd then had major responsibility for implementing those regulations.
02000 James L. Summers
Q2004 Blackwell Publishing
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8P rinted on acid-free paper in the United Slates of America
First edition, 199, AAC Consulting Group, Inc.
Second edition, 2000, AAC Consulting Group, Inc.
Third edition, 2004, Blackwell Publishing
Library of Congress Cataloging-in-Publication Data
Summers, James L. Uames Lee), 1936
Dietary supplement labeling compliance review / James L. Summers.-3rd ed.
p. cm.
Includes bibliographical references and index.
ISBN 0-8138-0426-4 (manual : alk. paper) - ISBN 0-813 8-0407-8
(manual and cd-rom : alk. paper) - ISBN 0-8138-0437-X (cd-rom)
1. Food x labeling. I. Title.
TX551.SS297 2004
363.19'2--dc22
2004006867
The last digit is the print number: 9 8 7 6 5 4 3 2 1
Preface
The Dietary Supplement Labeling Compliance Review is a comprehensive compliance dietary
supplement labeling guide designed to aid in understanding the requirements of the Food and Drug
Administration (FDA) as they relate to dietary supplements. This invaluable tool can assist regulatory
officials, industry personnel, and others responsible for assuring that the labels and labeling of dietary
supplement products in interstate commerce are in compliance with the requirements of the Federal
Food, Drug, and Cosmetic Act, as amended, and its related regulations.
The publication, authored by James L. Summers, former FDA food and dietary supplements labeling
expert in the Office of Food Labeling, is a practical, hands-on, user-friendly tool that contains, and is
based on, information published in the Federal Food, Drug, and Cosmetic Act, as amended; regulations
issued under the act; and FDA's policies and interpretations.
Disclaimer
The information contained in this publication is accurate to the best of the author's knowledge. However,
laws, regulations, policies, and official interpretations are subject to change. Since conditions under
which the information presented in this publication is used are beyond the control of the author and
publisher, we assume no responsibility for the usage of this information. Therefore, no expressed or
implied warranty or guarantee should be construed from the content of this publication or its periodic
revisions.
Acknowledgement
The publication is dedicated to my devoted wife, Annie B., and my three daughters, Vilecia C., Kiea Y.,
and Narvia M. Summers.
Special thanks are given to Nannie Rainey for her technical and editorial writing skills, Edward A. Steele
and Elizabeth J. Campbell for their helpful suggestions relative to the organization of this manual.
Contents
I. Introduction ....................................................................................................................................... 1
II . Overview of Dietary Supplements Labeling ..................................................................................... 5
Ill . Definitions ........................................................................................................................................ 9
IV . Need for Specific Regulations Governing Dietary Supplements .................................................... 13
A . Safety of Dietary Supplements ............................................................................................... 15
B. New Dietary Ingredients. .......................................................................................................... 16
1. New Dietary Ingredients .................................................................................................... 16
2 . Premarket Notification for a New Dietary Ingredient ......................................................... 17
V . Outline for Compliance Review of Dietary Supplement Labels ..................................................... 19
A . Establish Jurisdiction ............................................................................................................... 19
1. Dietary Supplement is Subject to the Requirements of the Federal Food,
Drug, and Cosmetic Act, as Amended (FD&CA) .............................................................. 19
2 . On Requests for Information on a Label Review and Certificate of Free Sale .................1 9
B. Determine the Completeness and Accuracy of the Required Label Information. .................... 19
C. Determine the Degree of Compliance with Applicable Regulations ........................................ 20
D. Advise Responsible Firm of Label(s) Needing Corrections ..................................................... 20
1. Untitled Letter .................................................................................................................... 20
2 . Product Recall ................................................................................................................... 20
3 . Warning Letter ................................................................................................................... 20
4 . Seizure .............................................................................................................................. 20
5. Citation .............................................................................................................................. 20
6 . Prosecution. ....................................................................................................................... 20
7 . Injunction ........................................................................................................................... 21
8. Release with Comment Notices (Import) .......................................................................... 21
9 . Detention (Import) ............................................................................................................. 21
vii
Contents
. ..............................................................................................................
VI Compliance Label Review 23
. ....................................................................................................................
A Identity Statement 23
1. Summary of the Requirements for Dietary Supplements. ................................................. 23
. ...............................................................................................
2 Questions and Responses 24
. .......................................................................
3 Illustrations of the Principal Display Panel 26
4 . Identity Labeling Regulations ........................................................................................... 27
5. Flavor Labeling Regulations ............................................................................................. 29
B. Designation of Ingredients ....................................................................................................... 33
1. Summary of the Requirements for Dietary Supplements. ................................................. 33
2 . Questions and Responses ................................................................................................ 35
3 . Illustrations of the Information Panel ................................................................................ 38
4 . Food: Exemptions from Labeling. ..................................................................................... 39
C. Name and Place of Business. .................................................................................................. 43
1. Summary of the Requirements for Dietary Supplements. ................................................. 43
2 . Questions and Responses ................................................................................................ 43
D. Net Quantity of Contents Statement ........................................................................................ 45
1. Summary of the Requirements for Dietary Supplements. ................................................. 45
2 . Questions and Responses ................................................................................................ 46
E. Nutrition Labeling for Dietary Supplements ............................................................................. 50
1. Summary of the Nutrition Labeling Requirements ............................................................ 50
2 . Questions and Responses ................................................................................................ 54
3. Illustrations of Supplement Facts Boxes ........................................................................... 62
......................................................................................................
(i) Multiple Vitamins 62
(ii) Multiple Vitamins for Children and Adults ................................................................ 62
(iii) Multiple Vitamins in Packets .................................................................................... 63
(iv) Dietary Supplement Containing Dietary Ingredients with and
without RDls and DRVs ........................................................................................... 64
(v) A Proprietary Blend of Dietary Ingredients .............................................................. 64
(vi) Dietary Supplement of an Herb ............................................................................... 65
(vii) Dietary Supplement of Amino Acids ........................................................................ 65
(viii) Format Split and Continued to the Right ................................................................. 66
4 . Daily Values for Nutrition Labeling ................................................................................... 67
5 . Illustration of Format Using Dots ...................................................................................... 68
6 . Reference Amounts Customarily Consumed Per Eating Occasion
for Dietary Supplements. ................................................................................................... 69
7 . Rounding Rule Table for Serving Sizes ............................................................................ 70
viii
Contents
8 . Nutrition Labeling Exemptions/Special Labeling Provisions ............................................. 71
(i) Exemptions under 21 CFR 101.9(j) ............................................................................ 71
(ii) Exemptions under 21 CFR 101.36(h) ......................................................................... 74
(iii) Special Labeling Provisions under 21 CFR 101.36(i) ................................................. 74
9 . Type Size Requirements for Nutrition Labeling. ................................................................ 76
9.1 Illustration of Supplement Facts Box with Arrows Showing Type Size ............................. 77
10. Rounding Rule Table for Declaring Nutrients ................................................................... 78
1 1 . Guidelines for Determining Metric Equivalence of Household Measures ......................... 80
F. Nutrient Content Claims. .......................................................................................................... 83
1. Summary Statements ........................................................................................................ 83
2 . Questions and Responses ................................................................................................ 84
3 . Definitions of Nutrient Content Claims .............................................................................. 90
4 . Conditions for Use of “Healthy” ......................................................................................... 99
G . Health Claims. ........................................................................................................................ 100
1 . Summary Statements ...................................................................................................... 100
2 . Questions and Responses - NLEA Authorized .............................................................. 102
(i) NLEA Authorized Health Claims Chart ...................................................................... 104
3 . General Criteria All Claims Must Meet ............................................................................ 110
4 . Authoritative Statements Provided for under the Food and Drug Administration
Modernization Act of 1997 (FDAMA) .............................................................................. 111
(i) Notifications of Health Claims Based on “Authoritative Statements”. ....................... 112
(ii) Claims Authorized on Authoritative Statements by Federal Scientific Bodies. .........1 13
(iii) Interim Final Rules Prohibiting Health Claims Based on “Authoritative
Statements” .............................................................................................................. 114
5. Interim Procedure for Qualified Health Claims ................................................................ 124
(i) Interim Procedures for Qualified Health Claims in the Labeling of Conventional
Human Food and Dietary Supplements .................................................................... 124
(ii) Interim Evidence-based Ranking System for Scientific Data ................................... 130
(iii) Examples of Decision Letters ................................................................................... 139
(A) Letter Regarding a Health Claim for Antioxidant Vitamins and Risk of
Certain Cancers .................................................................................................. 139
(B) Letter Regarding a Health Claim for Selenium and Certain Cancers ................1 40
(C) Letter Regarding Phosphatidylserine and Cognitive Dysfunction. ..................... 149
(iv) Summary of Permitted Qualified Health Claims ....................................................... 158
H. Statement Made Concerning the Effect of a Product on the Structure or Function of
the Body ................................................................................................................................. 166
1 . Summary Statements ...................................................................................................... 166
2 . Questions and Responses .............................................................................................. 168
ix
Contents
3 . Notification Procedures for Certain Types of Statements on Dietary Supplements ....... 170
4 . Certain Types of Statements on Dietary Supplements ................................................... 171
5. Other Evidence that the Intended Use of a Product is for the Diagnosis. Cure.
..........................................................
mitigation. Treatment. or Prevention of a Disease 172
6 . Examples of Disease Claims and Structure/Function Claims for Dietary Supplements 173
VII . Exemptions from FDA Requirements. .......................................................................................... 179
A . Procedure for Requesting Variations and Exemptions from Required Label
Statements ............................................................................................................................. 179
B. Exemptions from Required Label Statements ....................................................................... 177
C. Exemptions when it is Technologically Impracticable to Nutrition Label ............................... 180
D. Temporary Exemptions for Purposes of Conducting Authorized Food Labeling
Experiments ........................................................................................................................... 180
VIII . Compliance Provisions ................................................................................................................. 183
A . Failure to Reveal Material Facts ............................................................................................ 183
B. Misleading Containers ........................................................................................................... 183
C . Food with a Label Declaration of Nutrients ............................................................................ 184
D. Food Subject to Nutrition Labeling. ........................................................................................ 185
E. Food; Prominence of Required Statements .......................................................................... 185
F. Misbranding of Food .............................................................................................................. 185
IX . Dietary Supplement Labeling Issues ............................................................................................ 187
A . FDA Letter on Labeling Food Products Presented or Available on the Internet. ..................1 88
B. Safety Concerns Associated with Dietary Supplement Products .......................................... 189
1 . Adverse Events with Ephedra and Other Botanical Dietary Supplements. ..................... 189
2 . Safety Concerns Associated with Dietary Supplement Containing Ephedra ..................1 90
3 . Iron-Containing Supplements and Drugs: Small Entity Compliance Guide ...................1 90
4 . Letter to Reiterate Certain Public Health Aid Safety Concerns to Firms Manufacturing
.......................
or Importing Dietary Supplements that Contain Specific Bovine Tissues 191
5 . FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products
from the Market ............................................................................................................... 193
C. FDNFTC Labeling Responsibility .......................................................................................... 195
D. Dietary SupplemenVDrug Combination Products. ................................................................. 196
1 . Letter about the Regulatory Status of the Pill ...................................... 196
2 . Letter of Concern about Marketing the Product and All Other
.............................................
Products that Combine a Dietary Supplement and a Drug 197
3 . Letter about the Regulatory Status of Products that Combine an Over-the-Counter
Drug with a Dietary Supplement. ..................................................................................... 198
X . Listing of Charts, Graphics, Guidelines, Illustrations, and Regulations ....................................... 201
X
Contents
XI . The Off ice of Dietary Supplements .............................................................................................. 203
XI1. Conforming Amendments ............................................................................................................ 205
XI11 . Notices and Proposed. Interim Final. and Final Rules Related to Dietary Supplements ............2. 07
XIV . Index to the September 23. 1997. Federal Register Preambles and the Final DSHEA
Regulations. .................................................................................................................................. 217
XV . Index to the June 22. 1998. Federal Register Preambles to the Interim Health Claims
Final Rules. ................................................................................................................................... 221
Index ............................................................................................................................................ 227
Bibliography .................................................................................................................................. 231
xi
Chapter
It-
In trod uc tion
Dietary Supplements
Health professionals have long recognized that vitamin and mineral dietary supplements particularly in
moderate potencies are often useful. This is true, for instance, for women who are pregnant or breast-
feeding, people with very low calorie intakes, and patients with disorders that alter nutrient requirements.
Moreover, some consumers who tend to eat on the run report that using a multi-nutrient supplement daily
gives them a level of comfort that they are getting adequate nutrition.
More recently, attention has focused on the possible role of certain nutrients and other food components
in reducing the risk of chronic diseases. U.S. Dietary Guidelines even advise changing dietary patterns to
promote health and reduce disease risk.
Growing scientific support for diet-disease relationships and increased consumer interest in improving
health through diet were among the primary motivating factors for the decisions of the Nutrition Labeling
and Education Act of 1990 (NLEA). Among other things, the NLEA allows health claims to be declared om
the labels of foods, including dietary supplements. The new interest in dietary supplements, however,
raises questions about how the Food and Drug Administration should regulate these products.
Important Issues
The Federal Food, Drug, and Cosmetic Act (FD&CA), which authorizes FDA to regulate foods, is
designed to ensure that foods are safe and that their labels are truthful and not misleading. As directed by
Congress, FDA implemented the NLEA by proposing to extend nutrition labeling to dietary supplements
and to require that disease-related claims are scientifically valid. (See June 18, 1993; 58 FR 33715) The
agency believed that consumers have a right to truthful labeling of supplements so that their free choices
are well informed.
Yet, FDA critics sought to restrict the agency’s regulation of health information, including health claims on
supplement labels, and to reduce safety requirements for these products. Such restrictions could affect
the safety, well-being, and pocketbooks of consumers. Indeed, use of products that have misleading
claims or that haven’t undergone a safety review may waste health-care dollars and jeopardize the health
and lives of people who pass up proven remedies.
Fortunately, safety and labeling are not issues for the majority of supplements of vitamins and minerals.
Scientists know a great deal about most of these nutrients, and most are offered at potencies reasonably
close to the U.S. Recommended Daily Allowances.
1
Chapter I
Some people may not realize the potential risks posed by certain types of supplements. Others want
supplements for perceived health benefits and believe FDA is restricting product availability. Still others
may not understand how drugs, by law, differ from foods, including dietary supplements, or how U.S. laws
affect the regulation of these products.
A few promoters flout the laws for their own gains, despite risks, sometimes serious risks, to consumers’
health. Some promoters claim FDA is going to take supplements off the market, although the agency has
said in numerous public statements that it has no such plans for safe, properly labeled dietary supplement
products.
FDA subsequently terminated the June 18, 1993, proposed rulemaking in accordance with the provisions
of the Dietary Supplement Act of 1992. That act, among other things, established a moratorium until
December 15, 1993, on the implementation of the nutrition labeling provisions of the NLEA for dietary
supplements.
What is a Dietary Supplement?
Traditionally, FDA has considered a dietary supplement to be a product in capsule, tablet or liquid form
that provides an essential nutrient, such as a vitamin, an essential mineral, or a protein. The NLEA,
however, expanded the category to include “herbs, or similar nutritional substances.”
In addition to vitamins and minerals, substances being marketed in dietary supplements include herbs
and other botanicals, such as ginseng and yohimbe; amino acids; oil of evening primrose; fibers, such as
psyllium and guar gum; compounds that are not generally recognized as foods or nutrients, such as
bioflavonoids, enzymes, germanium, nucleic acids, para-amino-benzoic acid, and rutin; and mixtures of
these ingredients.
In the past, FDA has devoted less than one percent of its workforce annually to regulate these varied
supplement products. When these products are marketed for food use, FDA regulates them through its
Center for Food Safety and Applied Nutrition. When they are marketed for drug use, FDA regulates them
through its Center for Drug Evaluation and Research. The FD&CA defines “drugs” as products intended
to diagnose, cure, mitigate, treat, or prevent disease or as non-food products intended to affect the
structure or a function of the body.
A Half-Century of Regulation
Under the FD&CA of 1938, dietary supplements were regulated as ‘Yoods for special dietary uses.” Such
a food was misbranded unless its label contained information about its vitamin, mineral, or other dietary
properties necessary to fully inform purchasers as to its value for such uses.
FDA’s concerns are about other products marketed under the dietary supplement banner, such as amino
acids, herbs, and glandular extracts. Many of these types of products contain substances about which
little is known or contain substances which haven’t been evaluated for safety. Some people share these
concerns and say the agency doesn’t do enough to get fraudulent and potentially unsafe products off the
market.
Dietary Supplement Health and Education Act of 1994 (DSHEA)
Congress passed the DSHEA to clarify how dietary supplements should be labeled and marketed. The
DSHEA also broadened the definition of dietary supplements and changed the standard of safety for
ingredients in these products. (See Chapter 2 of this manual.) Subsequently, to carry out the mandates of
the DSHEA, on September 27, 1994, FDA published five final rules addressing various aspects of the
labeling of dietary supplements. These rules became final on March 23, 1999.
2