Dreyer's Ice Cream Inc.

Department 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 Coatingâ„¢'' 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 Coatingâ„¢'' 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

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