Department of Health and Human Services
|Public Health Service
Food and Drug Administration
College Park, MD 20740|
DEC 22 2008
Chief Executive Officer
Newman's Own Organics
7010 Soquel Drive Suite 200
Aptos, California 95003-3671
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.html1. 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.
Office of Compliance
Center for Food Safety and Applied Nutrition
This page was posted on July 19, 2010.