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![](media/image2.jpeg){width="5.572916666666667in"
height="0.3020833333333333in"}January 17, 2006

Division of Dockets Management (HFA-305)

Food and Drug Administration

Room 1061

5630 Fishers Lane

Rockville, Maryland 20852

Re: Assessment of Consumer Perceptions of Health and Disease Claims

FDA Docket No. 2005N-0413

[70 Fed. Reg. 60749 (October 19,
2005)                                              ]{.underline}

The Grocery Manufacturers Association[^1] (GMA) appreciates this
opportunity to supplement its oral comments at the November 17, 2005 FDA
public meeting on this matter with these additional written comments.
GMA member companies are deeply interested in the use of unqualified and
qualified health claims for food products.

> **Consumer Research Must be Continued In Order to Determine How to
> Present Both Unqualified and Qualified Health Claims in Food Labeling
> In a Way That Enhances Consumer Understanding**

The goal of any product claim contained in food labeling \-- whether an
unqualified or qualified health claim or a claim of any other nature \--
is to maximize the potential for consumer understanding and ultimately
benefit consumer health. No claim, however simple and direct, will be
understood equally by all consumers.

The [Pearson]{.underline} and [Whittaker]{.underline} cases hold that
the food industry has a constitutional right to present truthful and
accurate information relating to health claims that are supported by at
least credible scientific evidence unless there is [no]{.underline} way
that the information can be conveyed without it being misleading.
Consequently, both FDA and the food industry must share the goal of
finding which types of claims have the potential for maximizing consumer
understanding. As the [Whittaker]{.underline} court noted, this is a
particularly important goal because health claims communicate "an
important message that the American public is entitled to hear and
evaluate."

The consumer research that has thus far been conducted on disclaimers
for qualified health claims has been very narrow in scope. It has
consisted of assessing the interim evidence-based ranking system on
which FDA issued guidance in 68 Fed. Reg. 41387 (July 11, 2003). While
the results of this research are useful in determining that "report
card" grades have unintended adverse affects and that sentences using
closely-related adjectives do not allow a number of consumers to
correctly distinguish among the four categories tested, the research did
not explore other ways of conveying this information to consumers. It is
a good beginning, but much more work needs to be done.

The research to date does not demonstrate that **no** form of statement
can be devised to provide a higher level of consumer understanding.
Rather, the research shows that the specific approach suggested by FDA
in its July 2003 Guidance does not work well. There are a wide variety
of alternative approaches that should be considered. For example, it is
apparent from the consumer research that four levels of scientific
support are too many for most consumers to accurately distinguish.
However, more importantly, we learned from the consumer research that
qualified health claims do not exist in a vacuum, separated from
unqualified health claims. We must look at them as a continuum. A
consumer should be able to easily understand the difference in
scientific support between an unqualified health claim and a qualified
health claim. Today, the interim system lacks this cohesiveness.
Additional research should test the possibility of having three tiers of
health claims; one tier for unqualified health claims and two tiers for
qualified health claims. Although the best wording to use to distinguish
among such tiers must be the subject of future consumer research, GMA
offers the following examples to illustrate the concept of a three tier
system:

-   For an unqualified health claim (significant scientific agreement
    claim): Conclusive scientific evidence shows that calcium reduces
    the risk of osteoporosis.

-   For the first tier for qualified health claims (weight of scientific
    evidence claim): Strong scientific evidence shows that nuts may
    reduce the risk of heart disease.

-   For the second tier for qualified health claims (preliminary
    scientific evidence claim): Limited and preliminary scientific
    evidence shows that green tea may help reduce the risk of prostate
    and breast cancer.

> **Alternative Ways of Conveying Health Claims Must be
> [Explored                                                                 ]{.underline}**

It is apparent from the research conducted to date that three problems
need to be addressed.

First, the terminology presently required by FDA for an unqualified
health claim \-- a claim that meets the statutory standard of
significant scientific agreement \-- is in fact so qualified that
consumers cannot distinguish it from a qualified claim. At present, an
unqualified claim is actually qualified in two different ways \-- by
stating that the nutrient "may" (instead of "will") be useful in
"reducing the risk" of (instead of "eliminating") a particular disease.
This highly qualified claim is therefore very difficult to distinguish
from the qualified claims that do not meet the significant scientific
agreement standard. Moreover, the FDA-authorized wording for most
unqualified health claims is too wordy and unwieldy to function as a
motivator. Accordingly, this terminology must be strengthened both in
order to allow consumers to understand that an unqualified health claim
is the highest category of claim, for which FDA considers the scientific
evidence is conclusive, and in order to make these claims more
attractive and motivating.

Second, the three tiers of qualified health claims suggested by FDA in
its July 2003 Guidance are so closely overlapping, and use terminology
that is so similar, that consumers could not easily differentiate among
the three different levels of scientific support behind them. Reducing
these three categories of qualified claims to two could address this
issue. The higher of these two categories should be designated as
supported by "strong scientific evidence," and the lower category should
be designated as supported by "limited scientific evidence." Anything
below that would be regarded as not supported by credible science \--
the standard established by the courts.

Third, the use of these three terms \-- conclusive, strong and limited
scientific evidence \-- must be presented in a context that will allow
the consumer to understand that they relate to the scientific evidence
available to support the claim, not to quality of the product itself.
This can potentially be addressed through a number of approaches. One
approach would be simply to put "scientific evidence" as the first
element of the claim \-- e.g., "Strong scientific evidence shows that
nuts may reduce the risk of heart disease." A second way would be to use
a labeling format that explicitly shows that these terms relate only to
the scientific evidence for the claim and then also show all three
levels of scientific evidence, with the appropriate level for the claim
being checked. This would allow the consumer to see the level of
scientific support in context, i.e., to understand that the level of
scientific support is in the highest, middle, or lowest category but
without introducing "letter grades" that can be misinterpreted as a
negative statement about the product itself. The health claim format
could, for example, be shown as follows:

  ------------- ---------------------------------------------------------
  Scientific    Conclusive scientific evidence shows that calcium reduces
  evidence:     the risk of osteoporosis.

  Conclusive    

  Strong        

  Limited       
  ------------- ---------------------------------------------------------

  ------------- ---------------------------------------------------------
  Scientific    Strong scientific evidence shows that nuts may reduce the
  evidence:     risk of heart disease.

  Conclusive    

  Strong        

  Limited       
  ------------- ---------------------------------------------------------

  ------------- ---------------------------------------------------------
  Scientific    Limited scientific evidence shows that green tea may help
  evidence:     reduce the risk of prostate and breast cancer.

  Conclusive    

  Strong        

  Limited       
  ------------- ---------------------------------------------------------

GMA emphasizes that these are only examples of possible approaches to
achieve the objective of maximizing consumer understanding. Other
creative approaches could also be used.

For any future approach, additional consumer research will be essential
both to determine whether consumer understanding of the level of
scientific evidence is in fact improved and to determine whether the
potential for tangential consumer misunderstanding (for example,
misunderstanding that the level of scientific evidence relates to the
quality of the product as a whole) is minimized. As FDA conducts future
consumer research to determine the most effective language for qualified
health claims, GMA recommends that it also include unqualified health
claims in that research. The agency should recognize that changes in the
rules for unqualified health claims may be a necessary part of the
decisions that will need to be made regarding changes to the interim
rules for qualified health claims. The whole concept of health
claims---qualified or not---is to provide consumers with accessible
information they can -- and will -- use to improve their diets.

As previously noted, there must be a continuum across unqualified and
qualified health claims. Industry questions the effectiveness of the
language currently required for unqualified health claims as it is so
burdensome. Simplification of these claims would improve the chances
that a consumer would more clearly understand the relationship between
the claim and the product itself as a potential benefit, and thus be
motivated to make dietary changes.

Both qualified and unqualified health claims on food labels can make a
significant contribution to the public health. It is important to
remember that labels can reach all consumers -- even those who do not
have access to other nutrition information and who carry the greatest
burden of chronic disease risk in this country. At the recent American
Dietetic Association annual meeting, FDA pointed out that the food label
is the third jewel in the crown of nutrition policy, joining the Dietary
Guidelines and MyPyramid. GMA believes the food label as a whole, and
unqualified and qualified health claims in particular, are critical
tools that can be used to communicate the government's nutrition
messages detailed in the authoritative Dietary Guidelines.

> **The Process for FDA Evaluation of Qualified Health Claims [Needs
> Adjustment                                      ]{.underline}**

GMA believes that the current process for FDA evaluation of health
claims and qualified health claims (coupled with the lack of adequate
agency resources, to support the current process) has resulted in a
system that is too burdensome and cumbersome for FDA to handle the
substantial number of petitions that have been submitted in a timely
manner. GMA has two recommendations to improve the process.

First, while GMA understands the general appropriateness of the petition
format described in 21 C.F.R. 101.70 for the submission of applications
for either qualified or unqualified health claims, we believe that
greater clarity and standardization of the format could make it easier
for FDA to handle these petitions, as well as for petitioners to submit
them. To that end, we request the agency's commitment to an ongoing
dialogue with industry intended to develop best practices related to the
formatting of these petitions that could help organize and streamline
the agency's review.

Second, GMA would like to encourage the use of independent expert panel
reports as an adjunct to such a petition, as recommended by the
Institute of Food Technologists (IFT) in its recent expert report on
[Functional Foods: Opportunities and Challenges]{.underline}. IFT in
this expert report proposed a procedure, which is patterned after the
generally recognized as safe (GRAS) notification process. Under the IFT
recommendation, FDA would also have a specified time to review the
petition. If the agency did not act within that time, the petitioner
would be free to use the claim. GMA believes such an approach should not
be necessary if industry and FDA can work together to improve these
petitions and the expert analysis included in them in such a way as to
relieve some of the agency's review burden.

At its option, the petitioner could accompany its petition with an
independent expert report provided by a qualified scientist summarizing
the scientific basis for the claim following the outline in the IFT
Expert Report. The expert report might be prepared by an individual, a
panel or advisory group, a consulting organization, or other suitable
person. The qualifications of the individuals preparing the expert
report would be required to be included in the petition.

It would undoubtedly be helpful to FDA for a petition to include an
expert report that would summarize and evaluate all of the available
scientific evidence in support of the claim. Accordingly, FDA should
encourage and incentivize this approach by making every effort to
complete its review well within the 270-day period originally suggested
by the agency in the Interim Guidance for qualified health claims. One
possible approach to provide such an incentive to industry would be for
the agency to respond to a petition that contains an expert panel report
within 180 days rather than 270 days. As with GRAS notifications, FDA
would promptly make the petition, including the panel report and the
identity of the experts, publicly available. As with the current Interim
Guidance for qualified health claims, the agency would solicit the
submission of comparably expert and objective public commentary with
respect to the petition. If, upon review, the agency can conclude that
there is no apparent substantive basis to question the expert conclusion
provided in the petition, the agency, in the exercise of enforcement
discretion, would state that it has no further questions. Otherwise, the
agency would issue a letter explaining its decision not to accept the
claim. All agency letters in this regard would be publicly available.

This type of approach would accomplish important objectives. First, it
would assure that there is an adequate review of the scientific basis
for a claim by FDA before the claim is made in the marketplace. Second,
it would provide an incentive for helpful independent expert evaluations
of the relevant scientific information. Third, it would expedite the
process of review and evaluation. Fourth, it would eliminate the need
for FDA preparation of a lengthy analysis of all of the supporting
scientific information, for which FDA does not have adequate resources.
Thus, it would protect the rights of all interested persons. FDA would
maintain its leadership in reviewing all qualified claims, the industry
would be assured of an efficient review process, and consumers would
benefit from obtaining truthful and accurate information about the
relationship between diet and disease on a timely basis.

GMA looks forward to continuing to work with the agency on health
claims.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Alison J. Kretser

Senior Director, Scientific and Nutrition

Policy

[^1]: The Grocery Manufacturers Association (GMA) represents the world's
    leading branded food, beverage and consumer products companies.
    Since 1908, GMA has been an advocate for its members on public
    policy issues and has championed initiatives to increase industry
    wide productivity and growth. GMA member companies employ more than
    2.5 million workers in all 50 states and account for more than \$680
    billion in sales. The association is led by a board of member
    company chief executives. For more information, visit the GMA Web
    site at [www.gmabrands.com](http://www.gmabrands.com/).