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Department
of Health and Human Services |
Public Health Service
Food and Drug Administration
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College Park, MD 20740
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WARNING LETTER
DEC 22 2008
Peter Meehan
Chief Executive Officer
Newman's Own Organics
7010 Soquel Drive Suite 200
Aptos, California 95003-3671
Re: CFSAN-OC-09-02
Dear Mr. Meehan:
The U.S. Food and Drug Administration (FDA) recently reviewed the
label for the seven ounce package of our product "NEWMAN'S OWN ORGANICS
THE SECOND GENERATION™ SPELT PRETZELS" (Spelt Pretzels product). Based
on our review of the product label, we have concluded that the Spelt
Pretzels product is misbranded within the meaning of section 403(w) of
the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)]
because the label fails to declare the presence of wheat, a major food
allergen, as required by section 403(w)(1).
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines "major food
allergens" as milk, egg, fish, Crustacean, shellfish, tree nuts, wheat,
peanuts, and soybeans, as well as any food ingredient that contains
protein derived from one of these foods, with the exception of highly
refined oils. A food is misbranded if it is not a raw agricultural
commodity and it is, or it contains an ingredient that bears or
contains, a major food allergen, unless either:
1. The word "Contains," followed by the name of the
food source from which the major food allergen is derived, is printed
immediately after or adjacent to the list of ingredients, [section
403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)]; or
2.
The common or usual name of the major food allergen in the list of
ingredients is followed in parentheses by the name of the food source
from which the major food allergen is derived (e.g., "spelt (wheat)"),
except that the name of the food source is not required when either the
common or usual name of the ingredient uses the name of the food source
or the name of the food source appears elsewhere in the ingredient
list, unless the name of the food source that appears elsewhere in the
ingredient list appears as part of the name of an ingredient that is
not a major food allergen [section 403(w)(1)(B) of the Act, 21 U.S.C. §
343(w)(I)(B)].
Your product label states that the product contains spelt, which is
Triticum spelta L. The term "wheat" in section 201(qq) means any species in the genus
Triticum.
Thus, for the purposes of section 201 (qq), wheat includes grains such
as spelt. See Guidance for Industry, Questions and Answers Regarding
Food Allergens, Section 11, #27, http://www.cfsan.fda.gov/~dms/alrguid4.html.
Accordingly, because your Spelt Pretzels product contains spelt, which
is considered wheat for the purposes of section 201(qq) of the Act, and
because your product label does not declare the presence of wheat in
the product, your Spelt Pretzels product is misbranded within the
meaning of section 403(w) of the Act.
In a letter dated December 26, 2006 (copy attached), FDA advised you
about the need to include information about the presence of a major
food allergen, wheat, on the label of your Spelt Pretzels product.
Based on our review of your current label for this product, your firm
did not bring this label into compliance with section 403(w) of the
Act.
This letter is not meant to be an all-inclusive list of deficiencies
relative to your Spelt Pretzels product label. It is your
responsibility to ensure that all of your products are in compliance
with the laws and regulations enforced by FDA. You should take prompt
action to correct the violations described above and prevent their
recurrence. Failure to promptly correct these violations may result in
regulatory action without further notice, such as seizure and/or
injunction.
We also offer the following label comments:
We note that the back of the Spelt Pretzels product package includes
the statement, "While Spelt is a member of the same grain family as
oats and wheat, it's an entirely different species." Although this
statement is true, FDA has stated that "wheat" means all species of the
genus
Triticum, of which spelt (
Triticum spelta L.)
is a part. Consequently, we are concerned that this statement may give
the impression that the Spelt Pretzels product does not contain the
allergen found in wheat and is safe and suitable for consumption by
consumers who are allergic to wheat.
In addition, the regulations found at 21 CFR § 101.105(h) require
that the net quantity of contents in a product be declared on the
principal display panel of the product in easily legible boldface print
in distinct contrast to other matter on the package. We note that the
black print used to declare the net quantity of contents on the label
of your Spelt Pretzels product does not provide sufficient contrast
with the dark brown background.
Please respond in writing within fifteen (15) working days from your
receipt of this letter. Your response should include each step that has
been or will be taken to completely correct the labeling violations and
to prevent the recurrence of similar violations, the time within which
the correction will be completed, and any documentation necessary to
show that the correction has been achieved. If applicable, please
include a copy of your revised label. If corrective actions cannot be
completed within fifteen (15) working days, state the reason for the
delay and the time within which the corrections will be completed.
If you need additional information or have questions concerning any
products distributed through your website, please contact FDA. You may
respond in writing to Felicia B. Williams, Compliance Officer, Division
of Enforcement, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740.
Sincerely yours,
/S/
Roberta Wagner
Director
Office of Compliance
Center for Food Safety and
Applied Nutrition