January 20, 2004

Division of Dockets Management (HFA-305)

Food and Drug Administration\
Room 1061\
5630 Fishers Lane\
Rockville, MD 20852

Re: Two Guidance on Qualified Health Claims

FDA Docket No. 2003N-0069

[68 Fed. Reg. 41387 (July 11, 2003)             ]{.underline}

On December 18, 2002, FDA announced a major new initiative, the Consumer
Health Information for Better Nutrition Initiative. This initiative is
part of the agency's continuing implementation of the Court of Appeals
decision in [Pearson]{.underline} v. [Shalala]{.underline} and the
District Court decisions that followed.[^1] A Task Force was established
by the Commissioner of Food and Drugs and charged with preparing a
report on the implementation of this initiative. The Task Force
established FDA Docket No. 2003N-0069 to receive views and comments from
interested persons.

Because the issues raised by the new initiative cut across the entire
food industry, several food trade associations formed a Coalition,
chaired by the Grocery Manufacturers of America, to provide consolidated
comments to FDA on this matter. Attached is a copy of the comments
submitted to that Docket on May 14, 2003.

For the same reasons that the Coalition submitted its comments in May
with respect to the new initiative, the same Coalition, with additional
trade associations that have joined in the interim, now submits these
comments with respect to the two final interim guidance documents that
are the subject of the FDA notice in 68 Fed. Reg. 41387 (July 11, 2003):
(1) the Interim Evidence-Based Ranking System for Scientific Data and
(2) the Interim Procedures for Health Claims in the Labeling of
Conventional Human Food and Human Dietary Supplements.

[Executive Summary]{.underline}

[Interim Evidence-Based Ranking System for Scientific Data]{.underline}

> The interim guidance should be clarified to emphasize that the focus
> of any rating

system must be on the evidence in support of the specific claim
involved, not just the nutrient-disease relationship. The precise
wording of the claim will determine what specific data are relevant for
rating. Because rating scientific evidence is necessarily a subjective,
not an objective, process, FDA must be very flexible in recognizing
creative claims that adequately reflect the continuum of scientific
evidence rather than the four arbitrary categories posited by FDA.

> The interim guidance should be revised to recognize that scientific
> information

other than human clinical data may well be important in supporting
health claims for food products. A credible dispute resolution mechanism
should be included to resolve any scientific issues that arise.

[Interim Procedures for Qualified Health Claims]{.underline}

> The Coalition strongly supports the pre-market notification procedure
> adopted in

the interim guidance. Both the filing of a pre-market notification and
the final FDA determination on the matter should be the subject of a
Federal Register notice. The qualifying language suggested in the
interim guidance cannot be applied rigidly by FDA, but could be regarded
as a "safe harbor" without the need for further testing or discussion.

[Interim Evidence-Based Ranking System for Scientific Data]{.underline}

This interim guidance would designate four categories of scientific data
(A through D) and establish a six-part evidence-based rating system that
would result in ranking the totality of the evidence in accordance with
the four categories of scientific data described above.

1.  The Coalition agrees with FDA that the weight of the scientific
    evidence in support of a claim about the relationship between a
    nutrient and disease will determine the relative strength with which
    the claim may be worded in order to assure that it is truthful and
    not misleading. The Coalition urges that the interim guidance be
    clarified to emphasize that the focus of any rating system must be
    on the weight of the evidence in support of the specific claim
    involved. Although this will inherently involve consideration of the
    disease relationship, Section 403(r)(1)(B) of the Federal Food,
    Drug, and Cosmetic Act makes it clear that the primary issue to be
    addressed is the relationship of the scientific evidence to the
    proposed claim in the label or the labeling of a food. Accordingly,
    the precise wording of the claim will determine what scientific data
    are relevant for rating.

2.  The Coalition also wishes to emphasize that the rating of the weight
    of any body of scientific evidence is necessarily a subjective, not
    an objective, process. The weight of scientific evidence exists in a
    continuum, not in a series of well-defined categories. Put simply,
    the weight of the scientific evidence in support of a claim cannot
    always be fit into a neat classification such as the four categories
    (A through D) posited by FDA. The boundaries between these four
    categories are not clear-cut. Reasonable scientists will undoubtedly
    reach different conclusions in rating the identical body of
    scientific evidence.

Accordingly, if FDA pursues this approach, the agency must be very
flexible and recognize that these four categories represent arbitrary
and rigid distinctions that will in many instances not be susceptible to
objective analysis. The weight of scientific evidence will often reside
at the boundaries between these four categories, requiring flexibility
in the application of the FDA rating system. Creativity in formulating
appropriate claims that adequately reflect the continuum of scientific
evidence \-- rather than the four arbitrary categories posited by FDA
\-- is therefore essential to the success of this approach.

3.  The Coalition notes that, as presently worded, the interim rating
    and ranking system would rely only upon human clinical data. The
    Coalition believes that other scientific evidence may well be
    important in supporting health claims for food products. Such
    evidence would include in vitro data, the results of animal
    experimentation, and scientific evidence on the mechanism of action
    involved in any nutrient/disease relationship. The Coalition
    therefore urges FDA to include in the final guidance reference to
    scientific information other than clinical data.

4.  Because the interim rating and ranking system set forth by FDA in
    the interim guidance is inherently and irretrievably subjective, it
    is important that FDA establish a credible dispute resolution
    mechanism to resolve scientific issues that will inevitably arise in
    the application of this interim guidance. The Coalition endorses, as
    a model, the dispute resolution approach in the draft guidance on a
    process for resolving disputes arising over scientific and technical
    issues related to pharmaceutical current good manufacturing
    practices (cGMP) announced by FDA on September 3, 2003. A tier one
    dispute resolution should be handled at the Center level, and a tier
    two dispute resolution should be handled through a neutral panel of
    scientific experts at the level of the Office of the Commissioner.

[Interim Procedures for Qualified Health Claims]{.underline}

As a general matter, the Coalition strongly supports the pre-market
notification procedure adopted by FDA for qualified health claims in
this interim guidance. The interim procedure closely follows the
approach recommended by the Coalition in its May 14, 2003 comments, a
copy of which is attached. For the reasons set forth in those attached
comments, the Coalition urges FDA to retain this approach, with the
modifications suggested below.

1.  The Coalition continues to believe that the filing of a qualified
    health claim premarket notification should be the subject of a
    Federal Register notice, providing time for public comment, and that
    the final FDA determination with respect to a premarket notification
    should be the subject of a brief notice that is also published in
    the Federal Register. Additional information would, of course, also
    be appropriate for posting on the FDA website. The Coalition
    strongly supports a transparent process and believes that Federal
    Register publication of the two seminal events \-- the filing of the
    premarket notification and the ultimate FDA decision on the matter
    \-- will assure the most widespread public notice.

```{=html}
<!-- -->
```
5.  The Coalition has pointed out above that the weight of scientific
    evidence in support of a particular claim will not always fit neatly
    into the four-category scheme posited by FDA. Accordingly, the
    qualifying language suggested in this interim guidance as
    appropriate for a particular category cannot be applied rigidly by
    FDA, for several important reasons. First, the First Amendment to
    the Untied States Constitution requires that FDA permit the use of
    any explanatory or qualifying terms that accurately convey the
    weight of the scientific evidence and are not misleading. Second,
    where the weight of the scientific evidence falls midway between any
    two of the FDA categories, it will be necessary to fashion
    appropriate qualifying language that reflects the weight of the
    scientific evidence rather than just using the standard phrases set
    forth by FDA in the interim guidance. In short, the focus must
    always be on the accuracy, truthfulness, and nonmisleading nature of
    whatever claim is presented in a premarket notification, and not
    upon the use of some standardized terminology offered by FDA.

At most, the standardized qualifying language suggested by FDA in the
interim guidance might serve as a "safe harbor" that could, in the
discretion of the person submitting the premarket notification, be
adopted without the need for further discussion. Where a premarket
notification submits different terminology, however, FDA must consider
it in the light of First Amendment principles and cannot deny it absent
empirical evidence that it is false or misleading. This is particularly
true where the premarket notification contains consumer survey evidence
demonstrating that the proposed claim meets the new FDA "reasonable
person" standard. In this respect, the work of the International Tree
Nut Council in supporting its proposed claim by submission of consumer
survey evidence can serve as a model.

[Conclusion]{.underline}

In summary, the Coalition commends FDA, and in particular the Task
Force, for the important work that it has done in these two interim
guidances that further implement the [Pearson]{.underline} and
[Whittaker]{.underline} court decisions. With the minor modifications
recommended in these comments, these guidances will provide a strong
foundation for the new Consumer Health Information for Better Nutrition
Initiative and will allow the food industry to make available more and
better information about the food supply to help American consumers
improve their health and prevent disease by making sound dietary
decisions.

> Grocery Manufacturers of America, Chair
>
> American Bakers Association
>
> American Frozen Food Institute

Association for Dressings and Sauces

> Calorie Control Council
>
> Institute of Shortening and Edible Oils

International Dairy Foods Association

International Food Additives Council

> International Tree Nut Council
>
> Juice Products Association
>
> National Association of Margarine Manufacturers

Snack Foods Association

Vinegar Institute

[^1]: [Pearson]{.underline} v. [Shalala]{.underline}, 164 F.3d 650 (D.C.
    Cir. 1999), rehearing denied, 172 F.3d 72 (D.C. Cir 1999) (en
    banc.), 130 F. Supp. 2d 105 (D.D.C. 2001), 141 F. Supp. 2d 105
    (D.D.C. 2001); [Whittaker]{.underline} v. [Thompson]{.underline},
    248 F. Supp. 2d 1 (D.D.C. 2002).