FDA WARNING_LETTER - Bageladies, LLC - March 09, 2015

On August 18, 2015, the FDA issued a Warning Letter to Bageladies, LLC, following an inspection on February 25 and March 9, 2015, at their facility in Waynesboro, VA. The firm manufactures frozen organic bagels for wholesale distribution. The inspection and subsequent review of product labels and website labeling (www.bageladies.com) revealed violations of the Federal Food, Drug and Cosmetic Act (the Act), specifically section 403 [21 U.S.C. § 343], and food labeling regulations in 21 CFR Part 101.

Key violations include:

1. **Misbranded Nutrient Content Claims:** Bake'mmm Bagel products (e.g., "Grain+ Seed Xchange," "Cranberry Apple 'Licious," "Harvest Country," "Tuscan Tomato") are misbranded under section 403(r)(1)(A) of the Act. Claims like "60% Fewer Sugars" are used without a required reference food, as per 21 CFR 101.13(j). Similar claims were found on the firm's website, Facebook, and Twitter.

2. **Incomplete/Incorrect Nutrition Information:** Several varieties ("Everything Seeded," "Grain+ Seed Xchange," "Olive Rosemary," "Cranberry Apple 'Licious," "Harvest Country