Bob's Red Mill Natural Foods, Inc. 7/31/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
July 31, 2012
RETURN RECEIPT REQUESTED
In reply, refer to Warning Letter SEA 12-28
Robert G. Moore, President and CEO
Bob’s Red Mill Natural Foods, Inc.
13521 SE Pheasant Court
Milwaukie, Oregon 97222
On December 13-14, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your firm located at 13521 SE Pheasant Court, Milwaukie, Oregon. Our inspection found significant violations of the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR Part 101). During this inspection, the FDA collected a sample of your Whole Grain Low-Carb Bread Mix. An analysis of the collected sample and a review of your product labeling demonstrate that your Whole Grain Low-Carb Bread Mix product is misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You may find the Act and the referenced CFR regulations through links on FDA’s internet home page at www.fda.gov.
FDA analyzed your Whole Grain Low-Carb Bread Mix product to determine whether the information in the Nutrition Facts panel accurately reflects the nutrient content of the product. Your label states that the product contains 11 grams of protein per serving size of 21 grams. However, FDA’s analysis, which was based on the Kjeldahl nitrogen method, found that your product contained 8.15 grams of protein per serving, which is 74.1 percent of the amount declared on the label. A check analysis found 7.67 grams of protein per serving, which is 69.7 percent of the amount 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 or misleading because the amount of protein content is less than 80 percent of the amount declared [21 CFR 101.9(g)(4)(ii)].
Your Whole Grain Low-Carb Bread Mix is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition facts information is not in an appropriate format in accordance with 21 CFR 101.9. For example:
- Your product declares the serving size as “1 Slice (21 g dry mix).” The Reference Amount Customarily Consumed (RACC) for bread is 50 grams; therefore, the serving size of a bread mix must be the amount of mix that is required to make the reference amount of 50 grams [21 CFR 101.12(c)(2)] and it must be declared in a household measure that is appropriate for a powdered mix.
- The sodium content is not rounded in accordance with 21 CFR 101.9(c)(4).
- The percent daily value for iron is not rounded in accordance with 21 CFR 101.9(c)(8)(iii).
Your Whole Grain Low-Carb Bread Mix is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], because it is fabricated from two or more ingredients, but the label fails to declare the common or usual name of each ingredient in the product in accordance with 21 CFR 101.4. Specifically, your product lists, “Evaporated Cane Juice” in the ingredient statement; however, evaporated cane juice is not the common or usual name of any type of sweetener. The proper way to declare this ingredient can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm181491.htm.
The above violations concern certain labeling requirements and are not meant to be an all-inclusive list of deficiencies on your labels. Other label violations can subject the food to legal action. It is your responsibility to assure that all of your products are labeled in compliance with all applicable statutes enforced by FDA.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
During our label review we also noted these additional observations:
- You declare the amount of “Net Carbs” on your product label; however, the label does not adequately describe how the number of “net carbs” is derived. It appears that the “net carbs” number was calculated by subtracting the number of grams of dietary fiber from the number of grams of total carbohydrate but there was no explanation on the label. The statement and explanation must be truthful and not misleading.
- In accordance with 21 CFR 101.9(c)(6), the amount of total carbohydrate is calculated by subtraction of the sum of crude protein, total fat, moisture and ash from the total weight of the food. Therefore, if the amount of protein is less than the amount declared on the label, as indicated above, the total carbohydrate amount may be greater than the amount declared on the label.
- The information panel includes intervening material between the nutrition label and the manufacturer name and address [21 CFR 101.2(e)].
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Jessica Kocian at 425-302-0444.
Charles M. Breen
cc: Dennis R. Vaughn, Vice President of Operations
13521 SE Pheasant Court
Milwaukie, Oregon 97222
Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301