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January 14, 2009

The Food and Drug Administration

Division of Dockets Management (HFA-305)

5630 Fishers Lane

Rm. 1061

Rockville, MD 20852

SUBJECT: Docket No. FDA---2006---N---0429: Food Labeling: Current Trends
in the Use of Allergen Advisory Labeling: It's Use, Effectiveness, and
Consumer Perception; Public Hearing; Request for Comments

The American Dietetic Association and its 68,000 members appreciate this
opportunity to provide comment and data to inform the FDA of dietitians'
perspectives of allergen advisory labeling.\
To respond to this request for comments, ADA conducted a survey of ADA
members to determine how they consider allergen advisory labeling when
providing nutrition education and counseling in clinical settings.  A
full report of the survey will be published in the Journal of the
American Dietetic Association.

**[ADA food labeling principles]{.underline}**

The American Dietetic Association has established seven principles that
inform its review of labeling proposals.[^1] These principles are
consumer-focused; and while federal labeling law is designed to protect
and inform the consumer, there are examples in which the intent is not
fully realized. Some consider allergen advisory labeling to be one
example since it is not fully clear who is being protected, the food
manufacturer or the consumer.

**[Summary of ADA research about dietitian opinion of allergen advisory
labeling]{.underline}**\
An electronic survey was sent to American Dietetic Association members
in September 2008 who belong to one or more of ADA's Dietetic Practice
Groups (n = 27,333).  A total of 5,051 were returned with 4,490 (16%
percent response rate) fully answered.  The results from the 4,490 fully
answered surveys were tabulated and used for describing dietitian
perceptions and use of allergen advisory labeling. The survey results
were further segmented based on self-identification as a clinical
practitioner who worked with patients, approximating 57% (n = 2415) of
the fully answered surveys. Ninety-eight percent were registered
dietitians. The non-clinical practitioners included students, retirees,
and dietitians in food service management, business/industry, community,
and research or education practice.

Of the clinical practitioners, approximately 82% advise patients with
food allergies and intolerances to look for allergen advisory
information on labels and most (94%) think that the information is
helpful. Seventy-four percent of the clinical practitioners indicated
that their patients are avoiding food products that they used to eat
before advisory allergen statements were included on the label.

Approximately 16% of respondents indicated that they were aware of
patients who had ignored the advisory labeling and suffered from a
subsequent adverse reaction. Fewer than 3% have ever advised a patient
to ignore the advisory labeling.

When asked about the kinds of language and statements that should be
used for advisory labeling, 71% indicated that "May contain..." was
helpful to allergy patients and 61% chose "May contain traces of..."
Nearly an equal number indicated that statements about whether the food
was manufactured "in a facility that also processes..." (61%) or "on the
same equipment as products containing..." (59%) were also helpful. Other
similar statements were considered helpful by fewer than 50% of the
clinical practitioners. These other statements tended to be longer and
use less common terminology.

The clinical practitioners indicated that they believed allergen
advisory labeling to be helpful both to consumers and to food
manufacturers. Nearly 82% of the practitioners indicated that advisory
labeling protects consumers and 76% indicated that it was helpful. And
yet, 71% responded that advisory labeling protects the manufacturers.

Only about one-third indicated that they considered advisory labeling to
be truthful (36%) and to adequately inform consumers (30%) and that it
limits food choices (31%). Fewer than 15% indicated that advisory
labeling had increased food choices for patients. The majority (74%) did
not feel there were better alternatives for advisory labeling. Roughly
one-quarter (27%) thought there were better alternatives, although a
minority believed that advisory labeling needed to be better regulated.

In summary, those ADA members who responded to the allergen advisory
labeling survey view allergen advisory labeling as protecting and being
helpful for consumers, but also acknowledge that it benefits food
product manufacturers. Only one-third indicated that advisory labeling
was truthful.

**[Specific comments]{.underline}**

Based on the survey results, ADA is able to specifically address some of
the questions posed in the Federal Register notice.

*Issue 2: FDA is also assessing whether advisory labeling is useful to
consumers and how consumers interpret advisory labeling statements.
Currently, industry uses many different advisory statements, such as...
We are concerned that allergic consumers may be risking their health by
ignoring labeling designed to inform them of the potential presence of
allergens in foods. To help us better understand what type of advisory
labeling is most effective in helping consumers avoid adverse allergic
reactions, we ask the following questions.*

[Question 8:]{.underline} What specific advisory statements adequately
inform consumers of the potential risk of cross-contact with allergenic
materials? What advisory statements most accurately communicate to
consumers and their caregivers the potential risk of the presence of the
allergen? Why?

> ADA's survey responses suggest that the simplest statements may be the
> best understood (e.g. "May contain...," "May contain traces of...,"
> "Manufactured in a facility that also...," etc.). Without validated
> methods, it is not possible to verify the presence or absence of an
> allergen when a food product is exposed to equipment that is shared
> either in the transport of raw materials or in manufacturing of a food
> product. Additional consumer research is needed to answer this
> question.

[Question 9:]{.underline} If you are a food-allergic consumer or
caregiver to such a consumer, do you ever ignore advisory statements? If
so, which types of statements, and why?

> ADA's research indicates that dietitians seldom advise consumers to
> ignore advisory labeling, and that to do so would potentially place a
> patient at risk. The survey also indicated that dietitians were aware
> of patients having experienced an adverse effect. A few practitioners,
> who know their patients well, may be able to tailor their counseling
> based on the patient's perceived or known threshold to a specific
> allergen.

[Question 10]{.underline}: In addition to the information and data
mentioned in this document, what additional information or data are
available that would assist us in understanding consumers' perceptions
of, use of, and need for specific advisory statements and labeling in
general?

> ADA collected responses to open-ended questions that were part of the
> survey and would be willing to share these raw data upon FDA request.
> The specific questions for which we collected written responses
> follow:

a.  Do you advise patients/clients with food allergies to look for this
    additional voluntary advisory information on labels?

> *82.1% said yes; 17.9% said no; 1,174 respondents explained their
> answers.*

b.  Do you think this information is helpful?

> *94.1% said yes; 5.9% said no; 1,014 respondents explained their
> answers.*

c.  Have you ever advised a patient/client to ignore advisory labeling?

> *2.3% said yes; 97.7% said no; 456 respondents explained their
> answers.*

d.  After responding to a list of advisory statements dietitians
    believed are helpful to allergy patients in determining which foods
    to avoid, 146 offered other statements not included as options.

e.  When asked whether advisory labeling needs to be better regulated,
    519 respondents explained their answers.

f.  Are there better alternatives to advisory allergen labeling?

> *26.7% said yes; 73.3% said no; 833 respondents explained their
> answers.*

*Issue 3: FDA is assessing how advisory statements should be worded. To
help us better understand how advisory statements should be worded to be
the most effective in communicating the likelihood that an allergen may
be present in a food, FDA asks:*

[Question 11:]{.underline} What elements are needed in an advisory
statement to adequately inform consumers of the potential for the
inadvertent presence of an allergen and would communicate to allergic
consumers a consistent and effective message regarding the risk of
consuming the product?

> Advisory statements should be truthful, not misleading, and be
> consistent with any nutrient or ingredient claim, including the
> ingredient listing, on the label. The results of ADA's survey suggest
> that practitioners prefer simple language and direct statements. The
> results also suggest that the presence or absence of an allergen is
> perceived as an absolute; either it is present or it is not. ADA would
> suggest, where technically feasible and verifiable, that the FDA
> consider consumer responses to claims such as "(allergen
> ingredient)-free" or "prepared in an (allergen)-free..." claims.

[Question 12:]{.underline} How would the use of consistent and effective
advisory labeling affect consumer understanding of the potential for an
allergen to be present in a food?

> ADA recommends consistent advisory labeling. The effectiveness of the
> labeling would need to be substantiated through consumer testing.

**[Summary]{.underline}**

The American Dietetic Association urges the FDA to develop a process
that would ensure that allergen advisory labeling is consistent and that
it is effective in helping consumers choose a wide array of foods
compatible with a healthful diet within the constraints of an allergen
avoidance dietary regimen.

Thank you for the opportunity to contribute to FDA's dialogue on
developing a long-term strategy to assist manufacturers in using
allergen advisory labeling that is truthful and not misleading, conveys
a clear and uniform message, and adequately informs food-allergic
consumers and their caregivers. Please contact me at 202-775-8277 or
<mhager@eatright.org> for additional information about ADA's survey
results, including individual comments from survey respondents.

Best regards,

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Mary H. Hager, PhD, RD, FADA

Director, Regulatory Affairs

[^1]: ADA believes that consumers should be able to understand the label
    information to make food purchase decisions that achieve their
    personal dietary and health goals.

    Label claims should be clear and understandable to consumers

    The label must be truthful and not misleading

    Content on the label should help consumers make informed decisions
    to be a healthy diet

    Label content should have consistent type and format so products can
    be read and consumers can make product comparisons

    All claims should include labeling of accurate quantitative
    information about the dietary substance (%DV in a single serving of
    the product, when known, or the daily dietary intake necessary to
    achieve the claimed effect)

    Consumer research is imperative before making changes to the label

    The label is only a source of information. Sustained support for
    educational programs and individual counseling by registered
    dietitians is essential

    > Geiger C, Hager MH. Truth in labeling: It's a matter of principle.
    > *J Amer Diet Assoc*. 2007, 107 (12), p 2055.