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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dreyer's Ice Cream 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

Mike Mitchell, CEO and President
Dreyer's Grand Ice Cream, Inc.
5929 College Avenue
Oakland, California 94618-1391

Re: CFSAN-OC-10-19

Dear Mr. Mitchell:

The Food and Drug Administration (FDA) has reviewed the label for your "Nestle
Drumstick® Classic Vanilla Fudge" and "Dreyer's Dibs Bite Sized Ice Cream Snacks Vanilla
Ice Cream with Nestle Crunch Coating™'' ice cream products. Based on our review, we have
concluded that these ice cream products are 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). These ice cream products are misbranded within the
meaning of section 403(r)(1)(A) of the Act [21 USC § 343(r)(1)(A)] because the products'
labels bear a nutrient content claim but do 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 "Nestle Drumstick® Classic Vanilla Fudge" and "Dreyer's Dibs Bite Sized Ice Cream
Snacks Vanilla Ice Cream with Nestle Crunch Coating™'' products are misbranded because
your products' labels bear a nutrient content claim but fail to bear the disclosure statement
required by 21 CFR 101.13(h). Your products bear the phrase "0 g Trans Fat" on the
principal display panel of the product label. The phrase "0 g Trans Fat" meets the definition
of a nutrient content claim because it characterizes the products' 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 Nestle Drumstick® product declares the nutrient values of 19 g total fat
and 10 g saturated fat per serving, and the Nutrition Facts panel of your Dreyer's Dibs Bite
Sized Ice Cream Snacks product declares the nutrient values of 28 g total fat and 20 g
saturated fat per serving. A food that bears a nutrient content claim that contains more than
13 g of total fat or 4 g of saturated fat 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 and saturated fat content" as required in 21
CFR 101.13(h)(1); however, the labels of your products fail 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 directed 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 207403835.
If you have any questions, you may contact Ms. Robinson at 301-436-1890.


Sincerely,
/S/
Roberta Wagner
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition


cc: San Francisco District Office