Fitoterapia 82 (2011) 5–10

Contents lists available at ScienceDirect

Fitoterapia
j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / f i t o t e

Review

History and overview of DSHEA

Annette Dickinson ⁎
Dickinson Consulting, LLC, 3432 Denmark Avenue, #350, St. Paul, Minnesota 55123, USA

a r t i c l e i n f o a b s t r a c t

Article history: The Dietary Supplement Health and Education Act (DSHEA), enacted in 1994, had two primary
Received 26 July 2010 goals: to ensure continued consumer access to a wide variety of dietary supplements, and to
Accepted in revised form 30 August 2010 provide consumers with more information about the intended use of dietary supplements. It
Available online 17 September 2010
accomplished these goals, and more, without changing the fundamental regulatory status of
dietary supplements as a category of foods. This article explores the history and reasoning
Keywords: behind the major provisions of the Act and reflects on the impact of each during 15 years of
Dietary supplements experience under DSHEA.
DSHEA
© 2010 Elsevier B.V. All rights reserved.
Label claims
Health claims
Nutrition labeling
Good Manufacturing Practices

Contents

1. Purpose of DSHEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2. Classification of dietary supplements as foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3. Access to a wide variety of products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4. Safety of new dietary ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5. Increasing consumer information about intended uses of dietary supplements. . . . . . . . . . . . . . . . . . . . . . . . . 7
6. Nutrition labeling appropriate for the dietary supplement category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7. Quality and Good Manufacturing Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
8. Commission on Dietary Supplement Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
9. Office of Dietary Supplements at NIH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
10. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1. Purpose of DSHEA information about the intended use of dietary supplements.

DSHEA did not change the longstanding classification of
The Dietary Supplement Health and Education Act dietary supplements as a category of foods [1].
(DSHEA), enacted in 1994, had two primary goals: (a) to
ensure the continued consumer access to a wide variety of 2. Classification of dietary supplements as foods
dietary supplements and (b) to provide consumers with more
Dietary supplements in the United States have always
⁎ Tel.: + 1 651 340 2866. been regulated as a category of foods. When the basic Food,
E-mail address: [email protected]. Drug and Cosmetic Act (FD&C Act) was enacted in 1938,

0367-326X/$ – see front matter © 2010 Elsevier B.V. All rights reserved.
doi:10.1016/j.fitote.2010.09.001
6 A. Dickinson / Fitoterapia 82 (2011) 5–10

vitamin and mineral supplements and other dietary supple- FDA withdrew the regulatory proposals on foods for special
ments were already available in the marketplace and had dietary use and on vitamin and mineral supplements in their
been available since at least the 1920s. Congress specifically entirety — the basic labeling provisions that had been upheld by
debated the regulatory placement of these products and the courts as well as the more controversial aspects regarding a
determined that they would be generally in the food category. standard of identity.
However, as is true for all foods, the products could be When Commissioner David Kessler arrived at FDA in 1990,
considered drugs if their labeling suggested that they were he identified dietary supplements as an area of unfinished
intended for drug purposes. For example, if an orange or a business and convened an internal agency committee to
vitamin C supplement is described as a component of a make recommendations on what should be done. The
healthy diet and a source of an essential nutrient, that is committee's findings were the basis of an Advance Notice of
consistent with its use as a food. If the same product is labeled Proposed Rulemaking published in June 1993, suggesting that
for use in preventing or curing the common cold, such labeling vitamin and mineral levels of dietary supplements should be
would indicate a drug use. This arises from the fact that drugs limited, that amino acids were illegal food additives not
are defined on the basis of their intended use, as Section 201 permitted in such products, and that botanical ingredients
(g) of the FD&C Act defines drugs in part as “articles intended were likely to be either unsafe or therapeutic in nature and,
for use in the diagnosis, cure, mitigation, treatment, or therefore, potentially not appropriate for marketing as
prevention of disease in man or other animals” [2]. dietary supplements [6]. This seemed to be an unfortunate
In the 1938 FD&C Act, Congress created a category of “foods throwback to the era of the Standard of Identity and created
for special dietary use”, which included products such as great consternation within the industry and among the ranks
vitamin supplements or fortified foods or infant formula. Such of believers in dietary supplements.
foods were required to bear labeling that would inform DSHEA was drafted in the offices of Senator Orrin Hatch (R-
consumers about the product's special dietary properties. In UT) and Senator Tom Harkin (D-IA) to ensure the continued
1941, the Food and Drug Administration (FDA) promulgated availability of a wide variety of dietary supplements by
regulations defining special dietary uses to include many establishing a definition of dietary supplements within the
specific functions, one of which is “supplying a vitamin, FD&C Act, specifying the categories of ingredients that were to
mineral, or other ingredient for use by man to supplement his be permitted — vitamins and minerals, amino acids, herbs or
diet by increasing the total dietary intake,” and this definition botanicals, and other components of food, plus any combina-
was incorporated in Section 411 of the FD&C Act in 1976 [3,4]. tions of these ingredients. When used as ingredients of dietary
In 1994, in enacting DSHEA, Congress again confirmed that this supplements, these ingredients were not to be considered as
category of products would generally be considered foods, “food additives” but instead would be covered under a
unless labeling suggested drug uses. Thus, Congress specifically separate set of requirements. Ingredients that had historically
considered the issue of the appropriate regulation of dietary been used in dietary supplements were “grandfathered” and
supplements on three separate occasions – in 1938, in 1976, could continue to be used without further FDA notification.
and again in 1994 – and on each occasion concluded that the This was the approach that had been taken with food additives
products were a subset of foods. and GRAS substances when the food additive amendments
were first enacted in 1958. At that time, old food ingredients
3. Access to a wide variety of products were “grandfathered” as GRAS (Generally Recognized as Safe),
and new ingredients were to be subject to food additive
DSHEA ensured access to a wide variety of products by approval unless they were demonstrated to be GRAS.
defining dietary supplements, specifying permissible classes Similarly, in DSHEA, old dietary supplement ingredients
of ingredients, exempting such ingredients from food were grandfathered, and manufacturers would have to notify
additive status, affirming statutory food safety requirements FDA before introducing new dietary ingredients.
for dietary ingredients and adding a new one, grandfathering
old ingredients, and establishing a notification requirement 4. Safety of new dietary ingredients
for new ingredients [1].
These actions were considered to be necessary, because FDA According to DSHEA, new dietary supplement ingredients
appeared to be launching another effort to systematically limit (“dietary ingredients”) can be marketed only after the
the formulation of dietary supplements. Beginning in 1962 and manufacturer notifies FDA and submits information regard-
continuing through 1979, FDA had attempted to establish a ing the identity of the ingredient and the basis for concluding
Standard of Identity for vitamin and mineral supplements. that it “will reasonably be expected to be safe.”
During that process, FDA held an extensive 2-year administra- The basic safety standard for food ingredients is established
tive hearing on the issue, and a regulation was finalized in 1973 in Section 402 of the FD&C Act, which declares a food to be
[5]. Under that regulation, products would have been limited to unsafe (adulterated) if it contains a substance “which may
about 150% of the reference value for vitamins and minerals (a render it injurious to health.” Since dietary supplements are a
limit of 90 mg in the case of vitamin C, for example), and the category of foods, they are subject to this provision. In addition,
number of permissible combinations of vitamins and minerals DSHEA specifies that a dietary supplement is considered unsafe
would also have been severely limited. The courts overturned (adulterated) if it “presents a significant or unreasonable risk of
this rule in part in 1974 and again in 1978, and in 1976 Congress illness or injury” under the conditions of use suggested in
passed legislation prohibiting FDA from establishing a Standard labeling or under ordinary conditions of use.
of Identity for vitamin and mineral supplements based on the In 15 years of experience with DSHEA, many new dietary
official view of “rationality” of the formulations [4]. In 1979, ingredients have been introduced, and many manufacturers
 A. Dickinson / Fitoterapia 82 (2011) 5–10 7

have made New Dietary Ingredient (NDI) submissions to FDA. described the relationship between a food substance and a
(Note that the term NDI should not be confused with the IND disease, and FDA was required to evaluate the scientific
or Investigational New Drug application, discussed in the article evidence and make a finding that “significant scientific
by S. Chen in this issue.) The agency reviews and responds to agreement” existed, before approving the claim. The drug
these notifications and has rejected a large fraction, most definition was even amended to make it clear that a food
often for failure to adequately identify the ingredient or for would not be considered a drug solely because its labeling
failure to provide substantive safety information [7]. There is included an FDA-approved health claim.
a perception in the industry and on the part of regulators that NLEA listed ten priority claims that FDA was instructed to
some new ingredients are being used without notification, review first, after which petitions for health claims could be
and this is an issue that needs to be addressed through submitted to the agency by industry or other interested
enforcement of the requirements put in place by DSHEA. parties. In 1993, FDA approved numerous health claims, only
The notification system for NDIs is in some ways similar to one of which could be used for dietary supplements [12].
the notification system for food ingredients that are Generally Three claims were approved for foods that were low in
Recognized as Safe (GRAS). FDA no longer officially reviews certain risk nutrients, specifically sodium, saturated fat, and
and approves GRAS petitions, but instead permits companies cholesterol. Three claims were approved for foods that were
to conduct their own GRAS determinations for food ingre- naturally good sources of dietary fiber, soluble fiber, or
dients, with or without notifying the agency of their actions antioxidant nutrients (vitamin C and beta-carotene); accord-
[8]. If the agency is notified, the ingredient appears on a list on ingly, neither dietary supplements nor fortified foods were
the FDA website, but if the company chooses not to submit a eligible for these claims. One health claim was approved for
notification, the ingredient does not appear on the list. foods (including dietary supplements) that were high in
Therefore, there is no authoritative list of all GRAS ingredients calcium, since FDA recognized that diets high in calcium could
of food. In the case of new dietary supplement ingredients, help reduce the risk of osteoporosis.
there is no public FDA tracking system or list, and there is no Since it appeared in 1993 that NLEA health claims would
FDA guidance document describing the information that not be an avenue for conveying consumer information about
should be included in an NDI submission. the benefits of dietary supplements, another avenue was
FDA has used the safety authority provided by DSHEA to sought. In section 201(g) of the FD&C Act, drugs are defined in
ban some dietary ingredients, including ephedra, on the part as “articles (other than food) intended to affect the
grounds that they are not reasonably expected to be safe, and structure of any function of man or other animals” [2]. This
the agency's determination has been upheld by the courts. part of the drug definition recognizes that foods also affect the
structure and function of the body, but FDA had historically
5. Increasing consumer information about intended uses permitted very few food claims regarding effects on structure
of dietary supplements and function, except for statements describing the recognized
functional effects of vitamins and minerals: calcium builds
DSHEA ensured that consumers would be provided with strong bones or vitamin A is essential for healthy vision, for
more information about the intended use of dietary supple- example. DSHEA specifically authorized Statements of Nutri-
ments by permitting a new category of label claims called tional Support (including structure/function claims) for
Statements of Nutritional Support, allowing claims describing dietary supplements and also amended the drug definition
the effects of a nutrient or ingredient on the structure or to make it clear that conventional foods or dietary supple-
function of the body [1]. The legislation also allows other ments would not be considered drugs solely because of such
types of Statements of Nutritional Support which are not statements [1]. This amendment of the drug definition would
widely utilized, including statements describing the mecha- never have been politically possible, if NLEA had not already
nism by which a product affects the structure or function of enacted a similar amendment relating to health claims.
the body, statements about general well-being, and state- DSHEA specified several conditions that must be met in
ments about nutrient deficiency diseases. order for structure/function claims to be used. The product may
Congressional support for a new category of label claims not claim to prevent or treat disease; the company using the
for dietary supplements arose after FDA's initial approval of claim must have substantiation for the statement; the company
certain health claims authorized under the Nutrition Labeling must notify FDA within 30 days that the claim is being made,
and Education Act of 1990 (NLEA). During the 1980s, there and the label must bear a “disclaimer.” The disclaimer is: “This
was an increasing scientific recognition of the relationship statement has not been evaluated by FDA. This product is not
between dietary habits and the risk of serious chronic intended to prevent, cure, or treat any disease.” This statement
diseases such as heart disease and cancer [9,10]. Public policy has two purposes. The first sentence is meant to distinguish
thinkers began to believe it would be a good idea to harness structure/function claims from approved health claims, which
the resources and capabilities of industry to help spread the are evaluated by FDA. The second sentence is meant to
message to consumers that certain dietary improvements distinguish structure/function claims from drug claims, which
could lead to health promotion and disease prevention. do offer the product for disease prevention or treatment.
Historically, FDA had prohibited claims in food labeling that After the passage of DSHEA in 1994, structure/function
suggested any effect relating to disease prevention, but in statements quickly appeared on myriads of dietary supple-
1990 Congress passed the Nutrition Labeling and Education ment labels, and a steady stream of 30-day letters of
Act (NLEA), which for the first time authorized FDA to permit notification began immediately to flow to the agency — and
certain well-supported “health claims” in food labeling [11]. A that flow has not stopped, since each new claim requires a
health claim was defined as a statement that specifically new notification. FDA published a rule defining the
8 A. Dickinson / Fitoterapia 82 (2011) 5–10

permissible scope of structure/function claims in January provision eliminated the requirement for a nutrition label
2000, and that rule is partly responsible for the high degree of characterized largely by “zeroes.” Most importantly for
agreement that exists between companies and the agency botanical products, DSHEA specifically permitted the inclu-
regarding the nature of such claims [13]. Tens of thousands of sion in nutrition labeling of all other ingredients or compo-
letters of notification have been filed. FDA does not approve nents in the product, whether or not those components could
these claims, but does send the company a “courtesy letter” if be listed in nutrition labeling for conventional foods.
a claim is not acceptable, and copies of the courtesy letters are FDA published the revised final rule on nutrition labeling
available on the FDA website [14]. It appears that about 10% of for dietary supplements in 1997 [17]. This rule provides for
the letters of notification trigger a courtesy letter, indicating complete and meaningful information to be provided to
that approximately 90% are on target. Structure/function consumers on the identity and quantity of all ingredients or
claims are a useful means of telling consumers about the components, except that proprietary blends may be quanti-
benefits of dietary supplements, but to date there has been fied as such, without stating the quantity of each component.
little enforcement of the requirement that the company have FDA is currently in the process of considering some major
substantiation for the statements. changes in nutrition labeling, and it is possible that the
dietary supplement format may point the way to future
6. Nutrition labeling appropriate for the dietary improvements in nutrition labeling for conventional foods. In
supplement category particular, many functional foods now contain health-related
ingredients that are not among the nutrients or components
As foods for special dietary use, nutritional supplements permitted to be listed in nutrition labeling. Some companies
have long been subject to a form of nutrition labeling. have taken the initiative of modifying the nutrition labeling
Beginning in 1941, FDA required nutritional supplements or format for conventional foods to include an “extension”
foods with added vitamins and minerals to have labeling that below the vitamin/mineral list, where they list other
showed the name of the nutrient added, the quantity added, components such as botanicals, omega-3 fatty acids, and
and the percent Minimum Daily Requirement (MDR) repre- amino acids. It is possible that new FDA proposals may permit
sented by that quantity. In 1973, FDA revised nutrition the inclusion of these and other functional components
labeling to adopt a different reference value and expand the within the nutrition labeling format, since this inclusive
format. The Nutrition Labeling and Education Act of 1990 approach has worked well for the broad range of functional
required another revision in nutrition labeling, putting more ingredients and components in dietary supplements.
emphasis on macronutrients and less emphasis on micro-
nutrients. FDA regulations implementing these requirements 7. Quality and Good Manufacturing Practices
for conventional foods were finalized in January 1993, and
final regulations on nutrition labeling for dietary supplements The legislators who drafted DSHEA and the industry that
were finalized in January 1994 — but the regulations for supported DSHEA recognized the existence of problems with
dietary supplements were seriously flawed [15,16]. Most product quality and with Good Manufacturing Practices.
notably, the regulations prohibited the listing within the Accordingly, DSHEA specifically stated that dietary supple-
dietary supplement nutrition label of substances other than ments would be considered misbranded if they failed to
those permitted or required in nutrition labeling for conven- provide 100% of the claimed ingredients, or if they failed to
tional foods. Thus, herbs and botanicals and their components have the quality they were represented to have. In addition,
could not have been listed or quantified in nutrition labeling DSHEA authorized FDA to develop Good Manufacturing
for dietary supplements. Practice (GMP) regulations for dietary supplements, “modeled
Under the 1994 FDA regulations, nutrition labeling for after current Good Manufacturing Practice regulations for
botanicals would have been like the current nutrition labeling foods” [1].
for teas (which are classified as conventional foods and The Council for Responsible Nutrition (CRN), a trade
therefore covered by conventional nutrition labeling). A typical association representing the dietary supplement industry,
nutrition label for teas looks very much like the nutrition label offered assistance to FDA in drafting GMP regulations, and the
for water or diet soda. It consists of a series of zeroes, indicating agency expressed a willingness to receive such assistance.
that the product contains no calories, fat, sodium, carbohydrate, CRN convened a working group of industry experts in quality
or protein. It contains no information at all on the actual assurance and GMPs, and it invited other trade associations
components of the tea. Tea ingredients are listed elsewhere on also to participate. A comprehensive draft was prepared and
the label, and controversial components such as caffeine may submitted to FDA by a coalition of trade associations in 1995
also be listed and quantified elsewhere on the label, but they are and was published by FDA for public comment as an Advance
excluded from the nutrition label. The industry was vocal in Notice of Proposed Rulemaking in 1997. A highly controver-
asserting that this was not an appropriate model for nutrition sial proposed rule was published in 2003 and extensively
labeling of botanical dietary supplements. modified before publication of a final rule in 2007 [18]. Large
DSHEA required FDA to promulgate nutrition labeling companies were required to be in compliance with the new
regulations more appropriate for dietary supplements, and GMP regulations by mid-2008, smaller companies by mid-
specified what some of the revised provisions should be [1]. 2009, and the smallest companies by mid-2010. FDA is now
The law provided that nutrition labeling for dietary supple- using the new GMPs as the basis for inspections of dietary
ments should first list those components included in supplement manufacturers, and there have been many
conventional food labeling, except that no component had training courses offered to help companies ensure compli-
to be listed if it was not present in a significant amount. This ance. The new dietary supplement GMP regulation is an
 A. Dickinson / Fitoterapia 82 (2011) 5–10 9

important step forward in ensuring the quality and reliability published a comprehensive Strategic Plan for 2010–2014,
of dietary supplements. outlining its many ambitious projects [20]. Within NIH, ODS
works in close collaboration with the National Center for
8. Commission on Dietary Supplement Labels Complementary and Alternative Medicine (NCCAM), origi-
nally established as the Office of Alternative Medicine (OAM)
DSHEA established a Commission on Dietary Supplement by Congressional mandate in 1991 and elevated to the status
Labels, to make recommendations to FDA regarding “the of a Center in 1998. The Office of Dietary Supplements,
regulation of label claims and statements for dietary supple- working together with the 27 Institutes and Centers at NIH,
ments.” The seven members of the Commission were exercises a substantial influence on research support for
appointed in 1995 by President Bill Clinton, and its members dietary supplements and on the perception of such products
included both the author of this article and Dr. Norman by legislators, regulators, and the scientific community. It is
Farnsworth of the University of Illinois at Chicago, in whose and will remain an important legacy created by DSHEA.
honor the symposium documented in this issue was
convened. The Chairman of the Commission was Dr. Malden
10. Conclusion
Nesheim of Cornell, and other members included Dr. Shiriki
Kumanyika (then at the University of Illinois at Chicago, now
The Dietary Supplement Health and Education Act of 1994
at the University of Pennsylvania); Margaret Gilhooley of
succeeded in its primary goals of ensuring the continued
Seton Hall University, School of Law; Robert McCaleb of the
availability of a wide variety of dietary supplements and of
Herb Research Foundation; and Anthony Podesta of Podesta
providing consumers with more information about the
Associates. Dr. Kenneth Fisher was appointed as Executive
intended uses of such products, by establishing a legal
Director, and the Commission had administrative support
definition of the category and by creating a new class of
from the Department of Health and Human Services.
label claims regarding effects on the structure and function of
The Commission held nine meetings, including three
the body. In addition, DSHEA required modifications in
public hearings, and deliberated for two years before
nutrition labeling for dietary supplements to convey full
publishing its final recommendations in November 1997
consumer information about the identity and quantity of the
[19]. The language of DSHEA appeared to anticipate that the
ingredients and their active components. It also maintained
Commission would call for different requirements for health
FDA's ability to exercise oversight over safety and authorized
claims for dietary supplements, as compared to conventional
the agency to strengthen requirements for Good Manufac-
foods, but in fact the Commission endorsed the FDA
turing Practices. DSHEA created the Commission on Dietary
conclusion that the same standards should apply to both
Supplement Labels, which had a brief existence and produced
categories of claims. The Commission also addressed the need
a meaningful report, and also created the NIH Office of Dietary
for adequate substantiation of Statements of Nutritional
Supplements, which has exerted and will continue to exert a
Support (structure/function claims), and these recommenda-
major influence on research and on perceptions of dietary
tions were referenced by FDA in establishing regulations for
supplements by key policy makers and consumers alike.
such claims. The Commission report also includes extensive
DSHEA changed the face of the dietary supplement category
discussion and guidance on dietary supplement safety, the
and reinforced the role of dietary supplements in the
appropriate regulation of botanical products intended for
consumer's search for wellness.
dietary supplement uses, as well as the need to recognize
appropriate drug uses of some botanicals, the need for more
research on dietary supplements, and the role of the Office of References
Dietary Supplements at the National Institutes of Health
(NIH). [1] Dietary Supplement Health and Education Act of 1994. Public Law 103–
417, 108 Stat. 4325-4335; October 25 1994.
[2] Federal Food, Drug and Cosmetic Act. www.fda.gov/RegulatoryInformation/
9. Office of Dietary Supplements at NIH Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm (updated
as of 3/5/2010).
DSHEA required the establishment of an Office of Dietary [3] Food and Drug Administration. Definition of “special dietary uses” and
label regulations for food represented for special dietary uses. Fed Regist
Supplements (ODS) within NIH. The purpose of the Office was November 22 1941;6:5921.
to “explore more fully the potential role of dietary supple- [4] Public Law 94-278, Title V, sections 501–502, 90 Stat. 410–413; April 22,
ments as a significant part of the efforts of the United States to 1976. [The vitamin bill, adding a new Section 411 to the FD&C Act.]
[5] Food and Drug Administration. Definition and standards of identity for
improve health care” and to “promote scientific study of the food for special dietary use: dietary supplements of vitamins and
benefits of dietary supplements in maintaining health and minerals. Fed Regist August 2 1973;38:20730–40.
preventing chronic disease and other health-related condi- [6] Food and Drug Administration. Advance notice of proposed rulemaking
regarding dietary supplements. Fed Regist June 18 1993;58:33690.
tions.” After 15 years of evolution, ODS, directed by Dr. Paul [7] McGuffin M, Young AL. Premarket notifications of new dietary
Coates, has a substantial staff and budget (over $27 million in ingredients — a ten-year review. Food Drug Law J 2004;59:229–44.
2009), participates in funding numerous research initiatives [8] Food and Drug Administration. About the GRAS notification program.
www.fda.gov/.../GenerallyRecognizedasSafeGRAS/GRASNotification
through collaboration with many NIH institutes and centers,
Program/default.htm (as of March 2009).
has established six Botanical Research Centers at leading [9] Surgeon General US. Report on nutrition and health. Washington, D.C.:
universities (including the University of Illinois at Chicago), U.S. Department of Health and Human Services; 1988.
and sponsors numerous scientific workshops and conferences [10] National Research Council. Diet and health: implications for reducing
chronic disease risk. Washington, D.C: National Academy Press; 1989.
on topics relating to dietary supplements (see also article by [11] Nutrition Labeling and Education Act of 1990. Public Law 101–535
P. Coates and C. Meyers in this same issue). ODS has recently (enacted November 8, 1990).
10 A. Dickinson / Fitoterapia 82 (2011) 5–10

[12] Food and Drug Administration. Health Claims That Meet Significant or other similar nutritional substances, final rule. Fed Regist January 4
Scientific Agreement. www.fda.gov/.../LabelClaims/HealthClaimsMeeting 1994;59:354–432.
SignificantScientificAgreementSSA/default.htm (updated as of 8/12/2010). [17] Food and Drug Administration. Food labeling regulation, amendments;
[13] Food and Drug Administration. Regulations on statements made for final rules. Fed Regist September 23 1997;62:49825–58.
dietary supplements concerning the effect of the product on the [18] Food and Drug Administration. Current good manufacturing practice in
structure of function of the body; final rule. Fed Regist January 6 manufacturing, packaging, labeling, or holding operations for dietary
2000;65:999–1050. supplements: final rule. Fed Regist June 25 2007;72:34752–958.
[14] Food and Drug Administration. Dietary supplements, Courtesy letters. [19] Commission on Dietary Supplement Labels. Report to the President,
www.fda.gov/ohrms/dockets/dockets/97s0163/33.htm (as of Novem- Congress, and the Secretary of the Department of Health and Human
ber 7, 2007). Services. Washington, D.C; November 1997.
[15] Food and Drug Administration. Food labeling: mandatory status of [20] Office of Dietary Supplements. Strategic plan, 2010–2014: strengthen-
nutrition labeling, format for nutrition label, final rule. Fed Regist ing knowledge and understanding of dietary supplements; January
January 6 1993;58:2079–205. 2010.
[16] Food and Drug Administration. Food labeling: general requirements for
nutrition labeling for dietary supplements of vitamins, minerals, herbs,