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Contents
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Labeling of Dietary Supplements
Please Check Dates for Latest Information
General Labeling Issues
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Health Claims
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Structure Function Claims
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Claims Based on Authoritative Statements
See also: Label Claims (includes conventional foods &
dietary supplements)
General Labeling
Issues
Dietary Supplement Claims
FDA receives many consumer inquiries about the validity of claims
for dietary supplements, including product labels, advertisements,
media and printed materials.
There are three categories of claims that can be used on foods and dietary
supplement labels: health claims, structure/function claims, and nutrient content
claims. The responsibility for ensuring the validity of these claims rests with
the manufacturer, FDA, or, in the case of advertising, with the Federal Trade
Commission.
Health Claims
Health claims describe a relationship between a food substance and a disease
or health-related condition. There are three ways by which FDA exercises its oversight
in determining which health claims may be used on a label or in labeling for a
food or dietary supplement: 1) under the 1990 Nutrition Labeling and Education
Act (NLEA), FDA can authorize a health claim for a food or dietary supplement
based on FDA's careful review of the scientific literature; 2) under the 1997
Food and Drug Administration Modernization Act (FDAMA), upon successful submission
of a "notification," a health claim may be made for a food based on
an authoritative statement of a scientific body of the U.S. government or the
National Academy of Sciences; and 3) under a 1999 court decision in the case of
Pearson v. Shalala, certain qualified health claims may be used for a dietary
supplement. The differences between these three methods of oversight for health
claims are summarized below. For those health claims that have been approved for
use on food and dietary supplement labels, see:
http://www.cfsan.fda.gov/~dms/flg-6c.html.
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NLEA Authorized Health Claims. Under the provisions of the Nutrition
Labeling and Education Act (NLEA) of 1990, the Dietary Supplement Act of 1992,
and the Dietary Supplement Health and Education Act of 1994 (DSHEA), health claims
pertaining to substance-disease relationships, for example, "diets high in
calcium may reduce the risk of osteoporosis," may be made on the labels of
foods and dietary supplements, provided the claims meet certain criteria. FDA
authorizes these types of health claims based on an extensive review of the scientific
literature generally as a result of the submission of a health claim petition
using the significant scientific agreement standard to determine that the nutrient/disease
relationship is well established. For guidance on the significant scientific agreement
standard, see: http://www.cfsan.fda.gov/~dms/ssaguide.html.
Health Claims Based on Authoritative Statements. In 1997, the Food
and Drug Administration Modernization Act (FDAMA) provided a second way for a
health claim to be used on foods. It allows certain health claims to be made as
a result of a successful submission of a notification based on an "authoritative
statement" from a scientific body of the U.S. Government or the National
Academy of Sciences. There is a separate guidance document that explains how a
firm can make these types of health claims. It can be found at:
http://www.cfsan.fda.gov/~dms/hclmguid.html.
Congress did not include dietary supplements in the provisions for health claims
based on authoritative statements. Consequently, this method of oversight for
health claims cannot be used for dietary supplements at this time.
Examples of health claims based on authoritative statements may also found
at: http://www.cfsan.fda.gov/~dms/flg-6c.html.
- Public Meetings
- Proposed and Final Regulations and Related Information
- Guidance Documents
Qualified Health Claims. This kind of health claim
was provided for by FDA as a result of the U.S. Court of Appeals for the D.C. Circuit
1999 decision in the case of Pearson v. Shalala [64 F.3d 650 (D.C. Cir. 1999)].
This court decision, which focused on dietary supplements, specified that when the
link between the substance's ability to reduce the risk of the disease does not meet the
standard of "significant scientific agreement," FDA can allow appropriately qualified
health claims that would be misleading without such qualification. These qualified
claims are based on the weight of the scientific evidence, i.e., there is more evidence for
than against the relationship, but need not reach the standard of significant scientific
agreement. A detailed discussion of this matter can be found in the agency's Federal
Register notice of December 1, 1999, 64 FR 67289,
(http://www.cfsan.fda.gov/~lrd/fr991201.html).
In the October 6, 2000
Federal Register notice, FDA published its updated strategy for implementation
of the court decision that describes when the agency will exercise enforcement
discretion to allow qualified dietary supplement claims for nutrient/disease
relationships that fail the significant scientific agreement validity standard.
It can be found on the Web at:
http://www.cfsan.fda.gov/~lrd/fr001006.html.
On December 18, 2002, FDA Commissioner McClellan announced that these
provision would be expanded to include conventional foods as well as dietary
supplements and that a special Task Force would be tasked to guide the
implementation process. (See FDA Press Release at:
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00859.html
and FDA Guidance for Industry at:
http://www.cfsan.fda.gov/~dms/hclmgui2.html.)
- Proposed and Final Regulations and Related Information
- Phosphatidylserine and Cognitive Dysfunction and Dementia
(Qualified Health Claim: Final Decision Letter) May 13, 2003
- Selenium and Certain Cancers (Qualified Health Claim: Final
Decision Letter) April 28, 2003
- Letter Regarding Dietary Supplement Health Claim for
Antioxidant Vitamins and Risk of Certain Cancers April 1, 2003
- Letter Regarding Dietary Supplement Health Claim for
Phosphatidylserine and Cognitive Dysfunction and Dementia February 24, 2003
- Letter Regarding Dietary Supplement Health Claim for Selenium and
Certain Cancers February 21, 2003
- Letter Responding to a Request to Reconsider
the Qualified Claim for a Dietary Supplement Health Claim for Omega-3
Fatty Acids and Coronary Heart Disease February 8, 2002
- Settlement Reached for Health Claim Relating B Vitamins
and Vascular Disease May 15, 2001
- Letter Regarding Dietary Supplement Health Claim for
Antioxidant Vitamins and Certain Cancers May 4, 2001
- Letter Regarding Completion of Review of a Health
Claim that was the Subject of the Pearson Court Decision April 20, 2001
- Letter Regarding a Health Claim for Folic Acid And
Neural Tube Defects April 3, 2001
- Letter Regarding Continuing Review of a Health Claim
that Was the Subject of the Pearson Court Decision March 30, 2001
- Letter Regarding Review of a Health Claim that Was
the Subject of the Pearson Court Decision February 23, 2001
- Letter Clarifying Conditions for a Dietary Supplement
Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease February
16, 2001
- Letter Responding to Request Regarding Dietary Supplement
Health Claim for Folic Acid, Vitamin B6 and Vitamin B12 and Vascular Disease
February 9, 2001
- Letter Regarding Dietary Supplement Health Claim for
Vitamin E and Heart Disease February 9, 2001
- Letter Regarding a Dietary Supplement Health Claim
That Was the Subject of the Pearson Court Decision December 22, 2000
- Letter Regarding Dietary Supplement Health Claim for
Folic Acid, Vitamin B6 , and Vitamin B12
and Vascular Disease November 28, 2000
- Letter Regarding Dietary Supplement Health Claim for
Omega-3 Fatty Acids and Coronary Heart Disease (Docket No. 91N-0103) October
31, 2000
- Letter Regarding Two Health Claims that Were the Subject
of the Pearson Court Decision October 24, 2000
- FDA Announces Decision on Two Health Claims
for Dietary Supplements FDA Talk Paper, October 11, 2000
- Letter Regarding Dietary Supplement Health Claim for
Folic Acid with Respect to Neural Tube Defects October 10, 2000
- Letter Regarding Dietary Supplement Health Claim for
Fiber with Respect to Colorectal Cancer October 10, 2000
- Letter Regarding Health Claims that Were the Subject
of the Pearson Court Decision October 10, 2000
- Notice: Food Labeling; Health Claims and Label
Statements for Dietary Supplements; Update to Strategy for Implementation of Pearson
Court Decision Federal Register, October 6, 2000
- Revocation: Food Labeling: Health Claims and
Labeling Statements; Dietary Fiber and Cancer; Antioxidant Vitamins and Cancer;
Omega-3 Fatty Acids and Coronary Heart Disease; Folate and Neural Tube Defects
Federal Register, October 3, 2000
- Public Meetings
Structure Function Claims
DSHEA created another category of statements, generally referred to as "structure/function"
claims, that may be made for dietary supplements. These statements may claim a
benefit related to a nutrient deficiency disease (like vitamin C and scurvy),
as long as the statement also tells how widespread such a disease is in the United
States. Structure/function claims may also describe the role of a nutrient or
dietary ingredient intended to affect a structure or function in humans, for example,
"calcium builds strong bones." In addition, they may characterize the
means by which a nutrient or dietary ingredient acts to maintain such structure
or function, for example, "fiber maintains bowel regularity," or "antioxidants
maintain cell integrity," or they may describe general well-being from consumption
of a nutrient or dietary ingredient. The manufacturer is responsible for ensuring
the accuracy and truthfulness of these claims; they are not approved by FDA. For
this reason, the law says that if a dietary supplement label includes such a claim,
it must state in a "disclaimer" that FDA has not evaluated the claim.
The disclaimer must also state that the dietary supplement product is not intended
to "diagnose, treat, cure or prevent any disease," because only a drug
can legally make such a claim.
For more information see the January 6, 2000 Federal Register (65 FR 1000)
that describes the types of claims that can and can not be made for dietary supplements.
It can be found on the Web at:
http://www.cfsan.fda.gov/~lrd/fr000106.html.
Manufacturers of dietary supplements that make structure/function claims on
labels or in labeling must submit a notification to FDA no later than 30 days
after marketing the dietary supplement that includes the text of the structure/function
claim.
- FDA Contacts for Structure/Function Claims of Dietary Supplements
"Dear Colleague" Letter, February 29, 2000
- Public Meetings
- Proposed and Final Regulations and Related Information
- Letter Regarding Petition for Reconsideration and Stay of Action,
Structure Function Claims, Docket No. 98N-0044
(available in PDF)
September 25, 2000
- Petition for Reconsideration and Stay of Action,
Structure Function Claims, Docket No. 98N-0044
(available in
PDF)
February 7, 2000
- Availability of Citizen Petitions for Comment:
Statements Made for Dietary Supplements Concerning the Effect of
the Product on the Structure or Function of the Body
Federal Register, October 23, 2000
- Partial Stay of Compliance: Regulations
on Statements Made for Dietary Supplements Concerning
the Effect of the Product on the Structure or Function of the Body
Federal Register, September 29, 2000
- Final Rule: Statements
Concerning Effect on Structure or Function
Federal Register, January 6, 2000
- Final Rule: Notification
Procedures Federal Register, September 23, 1997
- Additional Background Information
- Guidance Documents
Nutrient Content Claims
Under NLEA, foods and dietary supplements can use claims called "nutrient
content claims." These claims describe the level of a nutrient or dietary
substance in the product, using terms such as "good source," "high,"
or "free." Nutrient content claims may only be made if FDA has a regulation
specifying the criteria that a food must meet in order to use the claim. With
few exceptions, nutrient content claims can only be made for nutrients or dietary
substances that have an established daily value. The requirements that govern
the use of nutrient content claims help ensure that descriptive terms, such as
"high" or "low," are used consistently for all types of food
products and are thus meaningful to consumers. Examples of nutrient content claims
can be found on the Web at: http://www.cfsan.fda.gov/~dms/flg-6a.html
and http://www.cfsan.fda.gov/~dms/flg-6b.html.
Like it did for health claims, the Food and Drug Administration Modernization
Act (FDAMA) of 1997 provided a second way for a nutrient content claim to be used
on foods. FDAMA allows certain nutrient content claims to be made based on an
"authoritative statement" as discussed above for health claims. However,
these claims may be made for both conventional foods and dietary supplements.
There is a separate guidance document, posted on FDA's Web site
(http://www.cfsan.fda.gov/~dms/hclmguid.html),
that explains how a firm can make these types of nutrient content claims.
Percentage claims for dietary supplements represent yet another category of
nutrient content claims. These claims are used to describe a percentage level
of a dietary ingredient for which there is no established Daily Value. Examples
include simple percentage statements such as "40% omega-3 fatty acids, 10
mg per capsule," and comparative percentage claims, e.g., "twice the
omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)."
(See 21 CFR 101.13(q)(3)(ii), which can be found on the Web at
http://www.cfsan.fda.gov/~lrd/cf101-13.html.)
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