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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fairfield Gourmet Food Corp 9/1/10

 

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740

WARNING LETTER


VIA OVERNIGHT MAIL

Ari Margulies, CEO
David’s Cookies
12 Commerce Rd.
Fairfield NJ  07004  

Re: CFSAN-OC-10-22

Dear Mr. Margulies:

The Food and Drug Administration (FDA) has reviewed the label for your “David’s Chocolate Marble Truffle Cake” product.  Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Your “David’s Chocolate Marble Truffle Cake” product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 USC § 343(r)(1)(A)] because the label bears a nutrient content claim that is not made in accordance with the applicable requirements.  You can find the Act and FDA regulations through links in FDA’s home page at http://www.fda.gov.

Your product bears the nutrient content claim “0 grams TRANS FAT” on the principal display panel. The phrase “0 grams TRANS FAT” meets the definition of a nutrient content claim because it characterizes the level of trans fat, which is a nutrient of the type required to be declared in nutrition labeling.  21 USC § 343(r)(1)(A); 21 CFR 101.13(b).  The product is misbranded because its label does not contain, prominently and in immediate proximity to the nutrient content claim, the required disclosure statement: “See nutrition information for fat, saturated fat, and cholesterol content.”  21 USC § 343(r)(2)(B).  Such a disclosure statement is required for a food that bears a nutrient content claim and contains more than 13 g of total fat, 4 g of saturated fat, or 60 mg of cholesterol per labeled serving.  21 CFR 101.13(h)(1).  The Nutrition Facts panel for your product declares the nutrient values of 32 g total fat, 20 g saturated fat, and 135 mg cholesterol per serving.   

The above violation is not meant to be an all-inclusive list of deficiencies in your products or their labeling.  It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violation.  Failure to promptly correct the violations may result in regulatory action without further notice, such as seizure or injunction. 

You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations.  Include any documentation necessary to show that correction has been achieved.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

You should direct your written reply to Felicia B. Williams, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.   

Sincerely,

/s/

Jennifer A. Thomas
Acting Director

Office of Compliance
Center for Food Safety 
And Applied Nutrition

cc:  New York District