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  5. Bageladies, LLC - 08/18/2015
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WARNING LETTER

Bageladies, LLC


Recipient:
Bageladies, LLC


United States

Issuing Office:
Baltimore District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, Maryland 21215 

 

FEI: 3004353686
 
WARNING LETTER
CMS#457835
 
 
August 18, 2015
 
 
Ms. Janet K. Doh, Managing Member
Bageladies, LLC
210 W 12th St.
Waynesboro, VA 22980-4771
 
Dear Ms. Doh:
 
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 210 W 12th St., Waynesboro, VA 22980-4771, on February 25 and March 9, 2015. Your firm is a manufacturer of frozen organic bagels for wholesale distribution. During the inspection, several product labels were collected for review. FDA has reviewed your product labels as well as your website labeling at www.bageladies.com, and based on our review, we have concluded that your products are in violation of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 United States Code (U.S.C. § 343)], and the food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR). You may find the Act and these regulations through links at FDA's home page at www.fda.gov.
 
1.    Your Bake'mmm Bagel products. Including, but not limited to, the "Grain+ Seed Xchange," "Cranberry Apple 'Licious," "Harvest Country," and "Tuscan Tomato" varieties are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labels bear nutrient content claims, but the products do not meet the requirements to bear these claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]. For example:
 
•    The nutrient content claim "60% Fewer Sugars" is used without including a reference food, as required by 21 CFR 101.13(j).
 
In addition, your website labeling and social media pages also list similar nutrient content claims:
 
On your homepage (www.bageladies.com):
•    ''[H) as 60% fewer sugar and zero wheat glucose."
 
One your "OUR STORY" page:
•    "60% fewer sugars ... "
 
On your "CONTACT US" page:
•    "Our healthy new NY bagels have 60% fewer sugars and zero glucose."
 
On your Facebook page:
(https://www.facebook.com/pages/Bakemmm-Bagels/48453664975)
 
Under the "About" tab:
•    "[R]esulting product has 60% fewer sugars and is free of glucose!"
 
February 7, 2015 post:
•    "60% Fewer Sugars, zero wheat starch glucose .. . "
 
March 8, 2014 post:
•    "60% fewer sugars & zero wheat starch glucose"
 
On your Twitter feed, posted on February 7, 2015: (https ://twitter.com/bageladies)
•    "60% Fewer Sugars, zero wheat starch glucose ... "
 
2.    Your "Everything Seeded," "Grain+ Seed Xchange," "Olive Rosemary," "Cranberry Apple 'Licious,'' "Harvest Country," and "Tuscan Tomato" varieties of Bake'mmm Bagels are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is incomplete and not in a correct format, as required by 21 CFR 101.9.
 
For example:
 
•    Your '"'Everything Seeded," "Grain+ Seed Xchange," and "Olive Rosemary'' varieties of Bake'mmm Bagel products declare a serving size that is not expressed in the proper common household measure, as required by 21 CFR 101.9(b)(5). Specifically, the serving size is declared as "1g(100g)" for these products, but the serving size should be declared as "_piece(s) (_g)"; "1 bagel (100g)" would also be acceptable.
 
•    Your "Cranberry Apple 'Licious" variety of Bake'mmm Bagel product fails to declare a statement and number of "Servings Per Container," in accordance with 21 CFR 101.9(d)(3)(ii).
 
•    Your "Cranberry Apple 'Licious," "Harvest Country," and "Tuscan Tomato" varieties of Bake'mmm Bagel products declare "Fructose," "Glucose," "Sucrose," "Maltose," and "Lactose," which are not required or voluntary nutrients that can be declared within the nutrition facts panels, in accordance with 21 CFR 101.9(c). Title 21 CFR 101.9(c)(6)(ii) requires that the sum of all free mono- and disaccharides to be declared as "Sugars;" it does not allow for the individual sugars to be declared within the Nutrition Facts Label.
 
•    Your "Grain+ Seed Xchange," and "Olive Rosemary" varieties of Bake'mmm Bagel products fail to declare vitamin A, as required by 21 CFR 101.9(c)(8)(ii).
 
•    Your "Everything Seeded," variety of Bake'mmm Bagels product declares Vitamin A as 1% and Vitamin C as 5%, however, the appropriate format of the Recommended Daily Intake (RDI) for vitamins and minerals is to the nearest 2-percent increment up to and including 10-percent level, in accordance with 21 CFR 101.9(c)(8)(iii).
 
•    Your "Everything Seeded," "Grain+ Seed Xchange," "Cranberry Apple 'Licious," and "Harvest Country" varieties of Bake'mmm Bagel products declare 195 Calories; however, caloric content per serving should be expressed in 10-calorie increment above 50 calories, in accordance with 21 CFR 101.9(c)(1).
 
3.    Your "Tuscan Tomato" variety of Bake'mmm Bagel product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4(b)(2). Specifically, your label lists the ingredient "Italian herb seasoning," which is a multi-component ingredient; however, the sub-components are not declared in the ingredient list of the "Tuscan Tomato" product label.
 
The requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your manufacturing, packaging and repacking operations are in compliance with the Act and the Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
 
You should take prompt action to correct these deviations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
 
If you have questions regarding any issues in this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer at (410) 779-5437.
 
 
Sincerely,
/S/
Evelyn Bonnin
District Director