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Health Claims for Dietary Supplements: Regulatory History and Summary
with a Focus on Qualified Health Claims
By Rakesh Amin
On December 18, 2002, the Food and Drug Administration (FDA) announced its
intention for future guidance on qualified health claims in the labeling of conventional
foods and dietary supplements.1 The proposed guidance documents are
continuing efforts by the FDA in its implementation of the court of appeals decision
in Pearson v. Shalala2 which involved labeling for health claims
in dietary supplements. The new guidance documents expand the decision in Pearson
to include health claims for dietary supplements as well as conventional foods.
As background, the Nutrition Labeling and Education Act (NLEA) was passed in
1990. Among many other innovations, NLEA required all packaged foods to bear nutrition
labeling.3 The NLEA preempted state regulations for foods, labeling
and health claims, and authorized the FDA to issue regulations relating to health
claims. Under the NLEA, a “health claim” is a statement that shows a relationship
between a nutrient or other substance in food and a disease or health-related
condition; an example of a heath claim describing the relationship between dietary
fat and cancer would read, “Development of cancer depends on many factors. A diet
low in total fat may reduce the risk of some cancers.”4
The NLEA amended the Federal Food, Drug and Cosmetic Act (FD&C Act or simply
the “Act”) by adding Section 403(r) that gave the FDA discretion to allow health
claim labeling on foods. 5 However, FDA would approve a health
claim only if the Agency determined that, based on “the totality of publicly available
scientific evidence” (including evidence from well-designed studies conducted
in a manner which is consistent with generally recognized scientific procedures
and principles), the claim was supported by significant scientific agreement
(SSA) among experts who were qualified and had sufficient experience to evaluate
such claims. 3, 6 The Dietary Supplement Health
and Education Act (DSHEA) was later passed in 1994 and together with the NLEA,
allowed the FDA to adopt the same general requirements for the labeling of health
claims in dietary supplements.
Pearson v. Shalala and Legislative
History
As part of the NLEA, Congress required the FDA to evaluate whether proposed
claims regarding specific substance/disease relationships met the criteria established
for health claims.3 Not all of the proposed claims were found to meet
the SSA standard and were therefore not authorized by the FDA. A subsequent lawsuit
arose based on 4 of those claims determined not to have met the SSA standard.
The court determined in Pearson v. Shalala that the First Amendment to
the U.S. Constitution does not permit the FDA to reject health claims that it
deemed “misleading” if using a disclaimer would eliminate any misconception.2
In response to the decision in Pearson, the FDA published a notice in the
Federal Register on October 6, 2000, outlining its intention for regulation of
dietary health claims that did not currently meet the very high and controversial
SSA standard.7 The proposed regulation would consider whether the supporting
scientific evidence for a health claim outweighed the evidence against it.
The FDA announced in a December 18, 2002 notice that it would apply the Pearson
decision to health claims in both conventional foods and dietary supplement
labeling. 1 In tandem with
this announcement, on December 20, 2002, the FDA revealed a new proposal designed
to facilitate information regarding the health benefits of conventional foods
and dietary supplements to consumers.8 The goal of this proposal was the dissemination of
accurate, current, and science-based information to consumers in order for them
to make healthier and more informed dietary choices regarding both conventional
foods and dietary supplements. In this proposal, the FDA stated that it intended
to initiate guidelines to ensure that the information complied with legal formalities
and that the information was truthful, non-misleading and based on sufficient
scientific evidence. 8
The proposal, entitled “Consumer Health Information for Better Nutrition,”
included two main objectives. The FDA focused its efforts on this proposal to
provide better, more comprehensive and up-to-date scientific information to consumers
about how their dietary choices affect their health and to encourage competition
among companies based on health and nutrition in addition to other product characteristics
such as taste and ease of preparation. To achieve the objectives of the proposal,
the FDA announced further steps it would take, including a proposed system for
review of health claims that do not meet the SSA standard. At present, claims
that do not meet the SSA standard are unqualified health claims governed by the
provisions of the NLEA. These claims are subject to notice-and-comment rulemaking
regulations. The FDA announced its intention to publish several guidance documents
concerning this proposed system. Additionally,
the FDA presented a report, reinforcing its commitment to enforcement of DSHEA
and organized The Task Force on Consumer Health for Better Nutrition to improve
consumer health information. The Task Force was charged to develop a regulatory
framework in order for the FDA to make timely and informed decisions on health
claims and to develop scientific guidance on how to apply an appropriate scientific
standard.
In July 2003, based on recommendations from the Task Force, the FDA issued
interim guidelines entitled, “Guidance: Interim Evidence-Based Ranking System
for Scientific Data”9 and “Guidance: Interim Procedures for Qualified
Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements.”10
Defining Health Claims, Nutrient Content Claims, and Structure/Function
Claims
At present, claims fall into three categories: health claims, nutrient content
claims, and structure/function claims.11 Health claims include
statements that describe a relationship between a food or dietary supplement ingredient
and its effect in reducing the risk of a disease or health-related condition.
Health claims must be approved by the FDA before they can be used on labeling
or in marketing materials. Nutrient content claims describe the level of a nutrient
in a dietary supplement by using terms such as “free” or “low” or a comparison
of the nutrient in a food to that of another food, using terms such as “more”
or “reduced.” Nutrient content claims are typically used for nutrients that have
an established Reference Daily Intake (RDI) as the nutrient must meet a specific
level as compared to its RDI. For example, a product may be labeled as “low sodium”
if it contains less than 140 mg of sodium per 100 g.12 Structure/function
claims as authorized by DSHEA are statements that describe the role of a nutrient
or dietary ingredient in affecting the structure or function in humans or that
characterize the mechanism by which a nutrient or dietary ingredient acts to maintain
such structure/function (i.e., promotes healthy heart function).13
Structure/function claims are not< pre-approved by the FDA; companies must
simply notify the Agency within 30 days after a product is marketed
with a particular claim, and the Agency can accept or reject the claim, or require
that the company submit more scientific data to support the claim, which if not
forthcoming to FDA’s satisfaction, can result in the claim being disallowed. Because
they are approved by FDA and are written in a manner that states reduction of
risk of a particular disease, the educational and marketing benefits of health
claims over structure/function claims should be obvious; they can be legally printed
on labeling and advertising describing the particular food or supplement ingredient’s
ability to reduce the risk of diseases, health-related conditions or symptoms.
Health claims and structure/function claims cannot make any references to the
treatment or prevention of a disease as the Food and Drug Administration would
then consider the product to be an unapproved or misbranded drug, defined as “articles
intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease in man or other animals” and “articles (other than food) intended to
affect the structure or any function of the body of man or other animals.”14
The primary distinction between a food and a drug is its intended use, i.e., the
use considered by the manufacturer and the claims made about the product by the
manufacturer. Structure/function claims are actually required to contain a disclaimer
that the product is not intended to diagnose, treat, cure, or prevent any disease.
Types of Health Claims
There are three ways in which a health claim may be used in food or dietary
supplement labeling. They include NLEA-authorized health claims, health claims
based on authoritative statements, and qualified health claims. 11
1. NLEA-Authorized Health Claims
NLEA-authorized health claims characterize the relationship between a food
or dietary supplement ingredient and the risk of a certain disease. The claims
must meet certain criteria, usually submitted to the FDA by a health claim petition,
and must be based on scientific data sufficient to meet the SSA criteria. There
are currently 12 approved health claims covering the relationship between the
following 15:
• Calcium
and osteoporosis
• Sodium
and hypertension (high blood pressure)
• Dietary
fat and cancer
• Dietary
saturated fat and cholesterol and risk of coronary heart disease
• Fiber-containing
grain products, fruits and vegetables, and cancer
• Fruits,
vegetables, and grain products that contain fiber, particularly soluble fiber,
and risk of coronary heart disease
• Fruits
and vegetables and cancer
• Folate
and neural tube birth defects
• Dietary
sugar alcohol and dental caries (cavities)
• Dietary
soluble fiber, such as that found in whole oats and psyllium seed husk, and coronary
heart disease
• Soy
protein and risk of coronary heart disease
• Plant
sterol/stanol esters and risk of coronary heart disease
2.
Authoritative Statement Health Claims
A second method for authorization of health claims was made under the Food
and Drug Administration Modernization Act of 1997 (FDAMA) in which a manufacturer
or distributor could make certain health claims if such claims are based on current,
published, authoritative statements from certain federal scientific bodies. 16
An “authoritative statement” under the FDAMA is a statement “about the relationship
between a nutrient and a disease or health-related condition” for a health claim
or a statement that “identifies the nutrient level to which the claim refers”
for a nutrient content claim. The statement must be published by a scientific
body and does not include statements of an employee of a scientific body acting
in the employee’s individual capacity as such. 16 The FDAMA
has specifically identified certain federal scientific bodies which constitute
appropriate resources for the authoritative statement, including the National
Academy of Sciences (NAS), subdivisions of the NAS, the National Institutes of
Health (NIH), and the Centers for Disease Control and Prevention (CDC). 16
These health claims only apply to food and do not include dietary supplements.
Health claims based on authoritative statements include 15:
• Whole
grain foods and risk of heart disease and certain cancers
• Potassium
and the risk of high blood pressure and stroke
3. Qualified Health Claims
Qualified health claims are allowed when there
is enough evidence to show a relationship
between a food or dietary supplement and a reduced risk of disease or health-related
condition. The evidence required for qualified health claims is not sufficient
to meet the SSA standard. On a qualified health claim, qualifying language must
be included as part of the claim to show that the evidence doesn’t meet the SSA
standard and that the evidence in itself is limited. There are currently eight
qualified health claims that have been approved by the FDA. They include the following
ingredients and resulting relationships17 :
• Selenium and cancer
• Antioxidant vitamins and cancer
• Nuts and heart disease
• Walnuts and heart disease
• Omega-3 fatty acids and coronary heart disease
• B vitamins and vascular disease
• Phosphatidylserine and cognitive dysfunction and dementia
• 0.8 mg Folic acid and neural tube birth defects
An example of a required claim statement would read as follows:
(1) Selenium may reduce the risk of certain cancers.
Some scientific evidence suggests that consumption of selenium may reduce the
risk of certain forms of cancer. However, FDA has determined that
this evidence is limited and not conclusive, or
(2) Selenium may produce anticarcinogenic
effects in the body. Some scientific evidence suggests that consumption
of selenium may produce anticarcinogenic effects in the body. However,
FDA had determined that this evidence is limited and not conclusive. 17
Qualified Health
Claims Petition Process
Based on the interim guidelines for qualified health claims, submittal of
such health claims are done through a health claims petition. The FDA began accepting
such petitions on September 1, 2003. The petitions should include evidence substantiating
the wording of the claim and why the wording of the claim is accurate and not
misleading.10
The petition should also include the claim’s potential effect on
the total intake of the substance (i.e., current intakes plus increases due to
the claim) and any positive or negative dietary changes that result from the intake
of the substance.
After submittal of the petition, the FDA allows 45 days to determine if
the petition is complete. If not, the FDA will notify the petitioner of any deficiencies
and allow corrective action. If a petition is deemed complete, the FDA will post
the petition on its website for 60 days for public comment. The next phase of
the petition process is to review the scientific evidence submitted in support
of the claim. The FDA plans to review the data itself or to use an appropriate
third party to conduct the review. The interim guidance documents describe a six-step
process for evaluating the substance/disease relationship of the qualified health
claim. The process provides for:
1. Identification between a substance and a disease or health-related condition;
2. Collecting individual studies relevant to the substance/disease relationship;
3. Classifying the individual studies according to study design type, with
those minimizing bias given a higher ranking;
4. Rating each individual study by a designated quality factor;
5. Ranking the strength of the scientific evidence submitted in support of
the substance/disease relationship; and
6. Reporting the rank.
The FDA, using its interim ranking system, has established three categories
to classify the supporting data. The standardized qualifying language for the
qualified health claims is shown in Table 1 11 :
Table 1:
Standardized Qualifying Language for Qualified Health claims
Scientific Ranking* |
FDA Category |
Appropriate Qualifying Language |
| Second Level |
B |
“although there is scientific evidence supporting the claim, the evidence
is not conclusive.” |
| Third Level |
C |
“Some scientific evidence suggests…however, FDA has determined that this evidence
is limited and not conclusive.” |
| Fourth Level |
D |
“Very limited and preliminary scientific research suggests…FDA concludes that
there is little scientific evidence supporting this claim.” |
* In essence there is no first level of a qualified health claim. Any
claim that meets the standard for a first level claim, i.e., a category “A” claim,
would not need any qualification, but would meet the SSA standard (the significant
scientific agreement standard previously used, and preferred, by the FDA).
On or before 270 days after receipt of the petition, the FDA intends to
notify the petitioner by letter of its determination on the qualified health claim
and the basis for its determination. The FDA will also notify the petitioner if
the agency intends to use its enforcement discretion and the provisions of 21
C.F.R. 101.1418
it intends to use in its enforcement discretion. The letter and third
party findings will be posted on the FDA website. If the petitioner or third party
does not agree with the FDA’s determination, the party can ask the FDA for reconsideration
if the party presents “significant new relevant evidence” or provides persuasive
arguments that the FDA’s determination of the original evidence was incorrect.10
As the final step in this initiative, the FDA issued an Advance Notice of
Proposed Rulemaking (ANPRM) on November 25, 2003. 19 The
task force identified three possible regulatory frameworks the FDA could use to
regulate qualified health claims (i.e., those not meeting significant scientific
agreement):
1. An interim ranking system as outlined in the above guidance;
2. Subject qualified claims to notice-and-comment rulemaking after applying
the accuracy of the nature of the evidence supporting the claims instead of relying
on the substance/disease relationship; and
3. Classify the qualified health claim outside the NLEA and regulate the claims
on a post-market basis, i.e., if the claim is later found to be false or misleading.
The FDA has indicated that the interim ranking system would be the preferred
method as it would be the most cost-effective and the least resource intensive
for the agency. The third option is not highly regarded as it is a reactive rather
than a proactive method and is similar to the approach the Federal Trade Commission
(FTC) uses for false and misleading advertising. The FDA commented that it would
not have the FTC’s subpoena power to obtain a company’s evidence supporting the
health claim and would instead have to build enforcement through extensive literature
search and expert consultation. Furthermore, the FDA would not effectively protect
the consumers from false and misleading claims that would already be in the marketplace
prior to any enforcement action. 20
In response to the FDA’s interim guideline and subsequent proposals relating
to qualified health claims, the FTC has submitted its own comments about the proposed
regulations. The FTC stated in its support of these proposals that the initiative
is likely to increase the dissemination of truthful and non-misleading information
to consumers while keeping strong protections against deception.21
The FTC added that the FDA should include two elements: that of designing an approach
such that maximum communication is effectuated, given the importance of the dissemination
of the information, and the approach taken should be flexible enough to allow
changes to the claims as the science changes.
The proposed regulations for qualified health claims are but one part of
the FDA’s “Consumer Health Information for Better Nutrition Initiative” which
is intended to promote more informative and healthier dietary choices by the American
consumer. The new qualified health claims system is an extension of the court
decision in Pearson and has the potential to allow manufacturers
and distributors better dissemination of product information relating to dietary
supplements and their nutritive value without having to meet the previously stricter
standard provided by the FDA.
References:
1 U.S. Food and Drug Administration. Qualified
Health Claims in the Labeling of Conventional Foods and Dietary Supplements (
December 18, 2002). Available at <http://www.cfsan.fda.gov/~dms/hclmgui2.html>.
2 Pearson v. Shalala , 164 F. 3d
650 (D.C. Cir. 1999).
3 Nutrition Labeling and Education Act of 1991. P.L. 101-535 (November
8, 1990).
4 21 C.F.R. 101.73(e)(1)
5 U.S. Food and Drug Administration. Labeling of Dietary Supplements. Available
at <http://www.cfsan.fda.gov/~dms/ds-labl.html>.
6 21 C.F.R. 101.14 (c) (2003).
7 U.S. Food and Drug Administration. Food Labeling; Health Claims and Label
Statements for Dietary Supplements; Update to Strategy for Implementation of Pearson
Court Decision, 65 Fed. Reg. 59855 (October 6, 2000).
8 U.S. Food and Drug Administration. FDA’s Consumer Health Information for
Better Nutrition Initiative (December 20, 2002). Available at <http://www.fda.gov/oc/nutritioninitiative/whitepaper.html>.
9 U.S. Food and Drug Administration. Interim Procedures for Qualified Health
Claims in the Labeling of Conventional Human Food and Human Dietary Supplements
(July 10, 2003). Available at <http://www.cfsan.fda.gov/~dms/hclmgui3.html
>.
10 U.S. Food and Drug Administration. Interim Evidence-Based Ranking System
for Scientific Data (July 10, 2003). Available at <http://cfsan.fda.gov/~dms/hclmgui4.html>.
11 U.S. Food and Drug Administration. Claims That Can be Made for Conventional
Foods and Dietary Supplements (September 2003). Available at <http://www.cfsan.fda.gov/~dms/hclaims.html>.
12 21 C.F.R. 101.61 (b)(4)(ii)(5)(i) (2003)
13 Pape, S., Kracov, D. and Rubin, P., Dietary Supplements and Functional
Foods: A Practical Guide to FDA Regulation, Thompson Publishing Group, Inc. (2001).
14 Federal Food, Drug, and Cosmetic Act §201(g)(1) (2003).
15 U.S. Food and Drug Administration. A Food Labeling Guide (September 1994,
Revised June 1999 and November 2000). Available at <http://www.cfsan.fda.gov/~dms/flg-6c.html>.
Federal Food, Drug, and Cosmetic Act §201(g)(1) (2003).
16 U.S. Food and Drug Administration. Notification of a Health Claim or
Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
(June 11, 1998). Available at
<http://www.cfsan.fda.gov/~dms/hclmguid.html>.
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