Tabatchnick Fine Foods, Inc. 2/10/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Telephone (973) 331-4900

February 10, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Barry Tabatchnick
President & Chief Executive Officer
Tabatchnick Fine Foods, Inc.
1230 Hamilton Street
Somerset, New Jersey 08873     

11-NWJ-09 

Dear Mr. Tabatchnick:

On June 17, 2010 an investigator from the New Jersey District Office of the United States Food and Drug Administration (FDA) collected a sample of your Frozen Barley and Mushroom Soup product. Based on our analysis of the product and review of the product label, 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 Part 101). You can find the Act and the food labeling regulations through links on FDA’s web page at www.fda.gov.   

Your Frozen Barley and Mushroom Soup product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because the amount of sodium present is greater than 20 percent in excess of the value declared on the label (21 CFR 101.9(g)(5)). The product label states that one serving (1 pouch/213 g) contains 40 mg of sodium. However, FDA analysis found the sodium content in your soup product was 205.4 mg per serving (original analysis) and 227.7 mg of sodium per serving (check analysis). The original analysis was 414% and the check analysis was 469% in excess of the sodium amount declared on your product’s label.  

Your product is further misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the label bears a nutrient content claim, but does not meet the requirements to make the claim. 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 food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product 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.  

Your Frozen Barley and Mushroom Soup product declares “LOW SODIUM” on the label. The phrase “LOW SODIUM” meets the definition of a nutrient content claim because it characterizes the product’s level of sodium which is a nutrient of the type required to be in nutrition labeling (21 CFR 101.13(b)). Under 21 CFR 101.61(b)(4), a “low sodium” claim may be used on the label or in the labeling of foods if it contains 140 mg or less sodium per Reference Amount Customarily Consumed (RACC) greater than 30 g. The RACC for all varieties of “soups” is 245 g (21 CFR § 101.12(b)). Your product was found to contain at least 205.4 mg of sodium per 213 g serving. Therefore, the amount of sodium per RACC contained in your product is greater than 140 mg, and does not meet the requirements to bear a “low sodium” claim.

This letter is not intended to be an all-inclusive review of your firm’s products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. 

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. Such action may include, but is not limited to, seizure or injunction. 

We also offer the following additional comment about the label for your Frozen Barley and Mushroom Soup product. Your Frozen Barley and Mushroom Soup product bears the claim language “No Salt ♦ No Sugar Added.” Please note that references to the salt content of a food product in labeling must meet the requirements under 21 CFR 101.61(c). Additionally, a food label bearing a “No Added Sugar” claim must meet all of the requirements under 21 CFR 101.60(c)(2).  

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to assure similar violations do not occur. You should include in your response documentation such as revised labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen working days, state the reason for the delay and the time frame within which any remaining violations will be completed.

Your reply should be sent to the following address: U.S. Food & Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attn: Andrew Ciaccia, Compliance Officer.

   
Sincerely,

/s/

Diana Amador-Toro
District Director, New Jersey District

 

 

 

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