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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Schwan's Consumer Brands

   

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

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

FEB 22 2010


WARNING LETTER


VIA OVERNIGHT MAIL

Mark Dalrymple, President
Schwan's Consumer Brands North America, Inc.
8500 Normandale Lake Boulevard, Suite 2000
Bloomington, MN 55437-3813

Re: CFSAN-OC-10-18

Dear Mr. Dalrymple:

The Food and Drug Administration (FDA) has reviewed the label for your "Mrs. Smith's
Classic Coconut Custard Pie" 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). This
product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. §
343(r)(1)(A)] because the product label bears a nutrient content claim but does not meet the
requirements to make the claim. You can find copies of the Act and these regulations through
links in FDA's home page at http://www.fda.gov.

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 promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a
claim. Characterizing the level of a nutrient in 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 "Mrs. Smith's Classic Coconut Custard Pie" product is misbranded because your
product bears a nutrient content claim but fails to bear the disclosure statement required by 21
CFR 101.13(h). Your product bears the phrase "0g TRANS FAT PER SERVING" on the
principal display panel of the product label. The phrase "0g TRANS FAT PER SERVING"
meets the definition of a nutrient content claim because it characterizes the product's level of
trans fat, which is a nutrient of the type required to be in nutrition labeling (21 CFR
101.13(b)). The Nutrition Facts panel of your product declares the nutrient values of 17 g
total fat, 9 g saturated fat, and 65 mg cholesterol per serving. A food that bears a nutrient
content claim that contains more than 13 g of total fat, 4 g of saturated fat, or 60 mg of
cholesterol per labeled serving must bear a disclosure statement (immediately adjacent to the
claim) referring the consumer to nutrition information for those nutrients, e.g., "See nutrition
information for fat, saturated fat, and cholesterol content" as required by 21 CFR
101.13(h)(1); however, the label of your product fails to bear the required disclosure
statement.

This letter is not intended to be an all-inclusive review of your products and their labeling. It
is your responsibility to ensure that all of your products comply with the Act and its
implementing regulations. You should take prompt action to correct these violations. Failure
to do so may result in regulatory action without further notice. Such action may include, but
is not limited to, seizure or injunction.

Please respond in writing within 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
prevent similar violations. 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 before you respond, we expect that you will explain the
reason for the delay and state when you will correct any remaining violations.

Your written response should be sent to Latasha Robinson, 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. If
you have any questions please contact Ms. Robinson at 301-436-1890.


Sincerely,
/S/

Roberta Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition

cc: Minneapolis District Office