Nashoba Brook Bakery, LLC FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The Whole Wheat Bread (retail) label bears the claim “A hearty whole grain loaf.” However, the product is made of predominantly wheat flour. We note that FDA has a Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements available at:https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm059088.htm. Questions 7, 9, and 11 from the draft guidance address “whole wheat” products and label claims. Depending on the context in which a "whole grain" statement appears on the label, it could be construed as meaning that the product is "100 percent whole grain." Consumers should be able to look at the ingredient statement to determine whether the predominant or first ingredient listed is a whole grain. We note that wheat flour should not be labeled as a

Potential Health Risks

Consumers should be aware of potential risks associated with products from Nashoba Brook Bakery, LLC.

Regulatory Context

Your Nashoba Granola label lists ingredient "Love". Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name [21 CFR 101.4(a)(1). "Love" is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.

Your firm has chosen to use the new nutrition facts label format on the retail label for your  Whole Wheat Bread product, however, it is not in an appropriate format in accordance with 21 CFR 101.9. Specifically,Vitamin D and Potassium are not declared in accordance with 21 CFR 101.9(c)(8)(ii) as revised in the Final Rule dated May 27, 2016.

We note that on the Whole Wheat Bread (retail) label the “Manufactured in a facility . . . .” statement is intervening material in accordance with 21 CFR 101.2(e).