Inspections, Compliance, Enforcement, and Criminal Investigations
Baker's Breakfast Cookie, Inc. 10-Jul-08
Department of Health and Human Services
Public Health Service
July 10, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-26
Erin Baker-Geschwill, President
Baker's Breakfast Cookie, Inc.
4208 Meridian Street
Bellingham, Washington 98226
Dear Ms. Baker-Geschwill:
The Food and Drug Administration (FDA) conducted an inspection of your firm located at 4208 Meridian Street, Bellingham, Washington, on January 8-9, 2008. At the close of the inspection, we collected a sample of the Erin Baker's Homestyle Peanut Butter Granola (12 oz ),lot number " Best Before 092108," to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's food labeling requirements (21 CFR Part 101 - Food Labeling). You can find the Act and the food labeling regulations through links on FDA's web page at www.fda.gov.
FDA analyzed the sample of your Homestyle Peanut Butter Granola to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states that one serving (45g) contains 1g saturated fat. In the original analysis your granola was found to contain 1.32g saturated fat, or 32% in excess of the value for saturated fat declared on the label. In the check analysis your granola was found to contain 1.42g saturated fat, or 42% in excess of the value for saturated fat declared on the label. Therefore, your product is misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false,and misleading because the amount of saturated fat present is more than the amount declared [see 21 CFR 101.9(g)(5)].
This letter is not intended to be, an all-inclusive review of your firm's products and their labeling: It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations: You should take prompt action to correct the violation. Failure to promptly correct this violation may result in regulatory action without further notice. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
You should notify this office in writing, within 15 working days of receipt of this letter, of any corrective actions, including an explanation of each step being taken to prevent the recurrence of similar conditions. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within 15 working days, state when the corrections will be completed and the reason for your delay.
We offer the following additional label comment on your Homestyle Peanut Butter Granola:
• The ingredients listed in the ingredient statement on your product label as "natural peanut butter" and "pure vanilla extract" are subject to the requirements in the standards of identity for these foods (21 CFR 164.150 and 21 CFR 169.175, respectively), and must be declared in accordance with the names specified in the standards of identity, "peanut butter" and "vanilla extract." FDA's ingredient labeling regulations require the ingredients of a food to be declared by their common or usual names (see 21 CFR 101.4(a)). Because peanut butter and vanilla extract are subject to standard of identity regulations, their common or usual names are the names established in the applicable standard of identity (see 21 CFR 101.3(b), 102.5(d)). The terms "natural" and "pure" are not included in the standards of identity. Additionally, under 21 CFR 101.2(e), information required to be on the label of a food must appear without intervening material. The words "natural" and "pure" are considered intervening material because they are not part of the common or usual names of the ingredients, as established by their standards of identity. However, provided that terms are used in a manner that is truthful and not misleading, terms such as "natural" and "pure" may appear outside of the ingredient list.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any question regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen