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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gorton's, Inc.

   

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


Judson Reis, President & CEO
Gorton's, Inc.
128 Rogers Street
Gloucester, Massachusetts 01930


Re: CFSAN-OC-10-03


Dear Mr. Reis:

The Food and Drug Administration (FDA) has reviewed the label for your "Gorton's Beer
Batter Crispy Battered Fish Fillets" 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 "Gorton's Beer Batter Crispy Battered Fish Fillets" product is misbranded within the
meaning of section 403(r)(1)(A) of the Act [21 USC ยง 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 product is misbranded because your product's label bears a nutrient content claim but
fails to bear the disclosure statement required by 21 CFR 101.13(h). Your product bears the
phrase "0 grams TRANS FAT SAME GREAT TASTE!" on the principal display panel of the
product label. The phrase "0 grams TRANS FAT" 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 declares
the nutrient values of 19 g total fat, 4.5 g saturated fat, and 680 mg sodium per serving (2
fillets (103g)). A food that bears a nutrient content claim that contains more than 13 g of total
fat, 4 g of saturated fat, or 480 mg of sodium per labeled serving must bear a disclosure
statement on the label (immediately adjacent to the claim) referring the consumer to nutrition
information for those nutrients, e.g., "See nutrition information for fat, saturated fat, and
sodium content" as required by 21 CFR 101.13(h)(1); however, the label of your product falses
to bear the required disclosure statement.

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
violations. Failure to promptly correct these violations may result in regulatory actions
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/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety
And Applied Nutrition


cc: New England District