Inspections, Compliance, Enforcement, and Criminal Investigations
Blue Heron Bakery, Inc. 16-Aug-07
Department of Health and Human Services
Public Health Service
August 16, 2007
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 07-18
Evan J. Price, President
Blue Heron Bakery, Inc.
4935 Mud Bay Road
Olympia, Washington 98502
We inspected your facility, located at 4935 Mud Bay Road, Olympia, Washington, on April 4, 20, and 24, 2007. During this inspection, the investigator collected labels from several of your products. After reviewing the labels for your "Spelt Chocolate Chip" cookie, "Alternate Date Pecan Oatmeal"cookie, "Spelt Peanut Butter Chocolate Chip" cookie, "Angie's Soul Cookie," "Spelt Bread," "Sourdough Spelt Bread,"and Mathew's Rye/Spelt River Bread" products, the information on your firm's website at www.blueheronbakery.com, and other evidence collected during our investigation, FDA concludes that these products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). Regulations implementing requirements of the Act are found in Title 21, Code of Federal Regulations (21 CFR). You may find the Act and the FDA regulations through links in FDA's home page at http://www.fda.gov.
The labeling violations we noted are as follows:
1. Your "Spelt Chocolate Chip" cookie, "Alternate Date Pecan Oatmeal" cookie, "Spelt Peanut Butter Chocolate Chip" cookie, "Angie's Soul Cookie," "Spelt Bread," "Sourdough Spelt Bread,"and "Mathew's Rye/Spelt River Bread" products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the labels fail to declare the presence of the major food allergen wheat, as required by section 403(w)(1).
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as major food allergens 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, 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) (section403(w)(1)(B) of the Act [21 U.S.C. 343(w)(1)(B)]).
Each of these products is manufactured With spelt, which is Triticum spelta L. The term "wheat" in section 201(qq) means any species in the genus Tritium. Thus, for the purposes of section 201(qq), wheat includes grains such as spelt.
2. Your spelt products are misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false or misleading. Your website bears the statement, "Spelt (Triticum spelta) is a tasty alternative to wheat." As stated above, such a claim is false and misleading because spelt is a variety of wheat.
This letter is not meant to bean all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products, product labeling, and your establishment complies with all requirements of the Fair Packaging and Labeling Act, the Food, Drug, and Cosmetic Act, and FDA regulations. Failure to promptly correct the violations described above result in regulatory action without further notice. Such actions may include seizure and injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and, state when you will correct any remaining violations.
In addition to the labeling violations above; we have the following additional comments:
Information on the labels of some of your products do not meet the minimum type size requirements. For example:
The net weight declaration on the labels of your "Spelt Chocolate Chip" cookie; "Alternate Date Pecan Oatmeal" cookie, "Spelt Peanut Butter Chocolate Chip" cookie, and "Angie's Soul Cookie" products fail to comply with the requirements for type size [21 CFR 101.105(i)(2)]. The principal display panel (PDP) on these products has an area of more than 5 but not more than 25 square inches: 21 CFR 101.105(i)(2) requires that the print size on a PDP of these dimensions must be not less than one-eighth inch in height, as determined by the height of the lowercase letter "o" [21 CFR-101.105(h)(2)]. The print size of the net weight declaration on your labels for these products measures less than one-eighth inch in height.
The ingredient declaration on your "Spelt Chocolate Chip" cookie, "Spelt Peanut Butter Chocolate Chip" cookie, and "Angie's Soul Cookie" fail to comply with the requirement in 21 CFR 101.2(c). The list of declared ingredients must appear prominently and conspicuously, and in no case may the letters or numbers be less than one-sixteenth inch in height. The print size of the listed ingredients on the labels for these products measures less than one-sixteenth inch in height.
In addition, during the inspection you informed our investigator that the products that you ship in response to orders received through your website are shipped unlabeled. Please be advised that these products are required to be fully labeled to comply with the Act and the applicable labeling requirements under 21 CFR part 101.
The inspection further determined that you are not labeling any of your food products with nutritional information and that you have not filed for a Small Business Nutrition Labeling Exemption with respect to any of your products. Please be advised that, if you have fewer than 10 full time equivalent employees, you do not have to file for this exemption with respect to any food product with annual sales of less than 10,000 units; otherwise, you are required to provide nutrition-information labeling on the product, to comply with 21 CFR 101.9, or file for the exemption, if applicable.
The labels for your °Spelt Chocolate Chip" cookie, "Alternate Date Pecan Oatmeal" cookie, and "Spelt Peanut Butter Chocolate Chip" cookie products fail to bear the common or usual name of the food, as required in 21 CFR 101.3.
The labels of your "Spelt Chocolate Chip" cookie, "Spelt Peanut Butter Chocolate Chip" cookie, and "Angie's Soul Cookie" listed the sub-ingredients of the ingredient Chocolate chips after an asterisk below the ingredient declaration: Such sub-ingredients should be listed within the ingredient declaration, either parenthetically following the ingredient, or by incorporating the sub-ingredients into the statement of ingredients in descending order of predominance in the finished food, referring to each component by its common or usual name without listing the ingredient itself, as required in 21 CFR 101.4.
Please send your reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
cc: WSDA with disclosure statement