Inspections, Compliance, Enforcement, and Criminal Investigations
Oberlander Baking Co. 29-Aug-07
Department of Health and Human Services
Public Health Service
Food and Drug Administration
AUG 29 2007
RETURN RECEIPT REQUESTED
Oberlander Baking Co.
161 22nd Street
Brooklyn, New York 11232
Dear Mr. Oberlander:
The Food and Drug Administration (FDA) has reviewed the label of your Oberlander Bakery Fresh Sugar Free Assortment (12 oz.) product. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (21 CFR). You can find the Act and regulations at www.fda.gov
Your product is misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] for failing to meet the requirements of the "No Cholesterol" claim declared on its side panel. Under 21 CFR 101.62(d)(1)(ii)(C), a food must contain 2g or less of saturated fatty acids per Reference Amount Customarily Consumed (RACC) in order to make a "No Cholesterol" claim. Your product's Nutrition Facts label identifies the product as cookies. Under 21 CFR 101.12, the RACC for cookies is 30 g. The Nutrition Facts label for this food declares 2.5g of saturated fat per 25g serving which equates to more than 2g of saturated fat per 30g RACC.
Your product is also misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] for failing to characterize the level of the nutrient "sugar" in accordance with the regulations. The product label declares "Sugar Free" on the Principal Display Panel, but fails to label the required disclaimer statement "Not a Low Calorie Food," "Not a Reduced Calorie Food," or "Not for Weight Control" as required by 21 CFR 101.60(c)(1)(iii)(B). The disclaimer statement is required because your product does not meet. the requirements to bear a "low calorie" claim [see 21 CFR 101.60(b)(2)(i)(B)] and your product does not bear a "reduced calorie" claim or other relative claim of special dietary usefulness.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as corrective labeling or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
In addition to the deviations stated above, we also have the following labeling comments:
This product is an assortment of cookies with three different fruit toppings. The ingredient statement includes "and/or" labeling for the three different fruit ingredients. The current ingredient regulations in 21 CFR 101.4 do not provide for "and/or" labeling of fruit ingredients in a cookie assortment.
The nutrition format does not include the footnote required by 21 CFR 101.9(d)(9) concerning percent daily values. Product labels must include the 21 CFR 101.9(d)(9) footnote unless the product qualifies for the simplified nutrition labeling format set out in 21 CFR 101.9(f) or qualifies for the labeling exemption in 101.9(j)(13)(ii)(C) for foods in small packages.
This letter is not intended to be an all-inclusive review of all of your firm's labels. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.
Please forward your response to the attention of Lynn Szybist, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-608, College Park, MD 20740-3835.
Joseph R. Baca
Office of Compliance
Center for Food Safety
and Applied Nutrition