FDA going after Muscle Milk (misbranded/mislabeled)

[Guest guest]

Cytosport Inc 6/29/11

Department of Health and Human Services

Public Health Service

Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda. CA 94502-7070

Telephone: 510/337-6700

WARNING LETTER

Via UPS

Delivery Signature Requested

June 29, 2011

Mr. Pickett

Chief Executive Officer and President

CytoSport, Inc.

4795 Industrial Way

Benicia, CA 94510

Re: FEI 3004427822

Dear Mr. Pickett:

The Food and Drug Administration (FDA) has reviewed the labels for your

" Chocolate Muscle Milk Protein Nutrition Shake " (14 fl. oz.), " Vanilla Crème

Muscle Milk Light Nutritional Shake " (4-8.25 oz. servings), and " Chocolate

Peanut Caramel Muscle Milk " (5.57 oz.) products. Based on our review, we have

concluded that these 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 Part 101). These products are misbranded

within the meaning of section 403 of the Act [21 U.S.C. § 343]. You can find

copies of the Act and these regulations through links on FDA's home page

athttp://www.fda.gov

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055451 & v=3 & \

key=5c88 & skey=fae1306759 & url=http%3A%2F%2Fwww.fda.gov%2F> .

1. Your " Chocolate Muscle Milk Protein Nutrition Shake " and " Vanilla Crème

Muscle Milk Light Nutritional Shake " products are misbranded within the meaning

of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are

false or misleading. For example:

* These product labels prominently feature the word " MILK, " however these

products contain no milk. The actual statements of identity, " Protein Nutrition

Shake " and " Nutritional Shake " are in significantly smaller and less prominent

type than the words " MUSCLE MILK " on these product labels.

* These product labels include the statement " Contains No Milk " on the principal

display panel; however, according to the ingredient statements, these products

contain the following milk-derived ingredients: calcium and sodium caseinate,

milk protein isolate, and whey. The allergen statement printed on both of these

products states ''This product contains ingredients derived from milk . . . . "

The " Contains No Milk " statement could give consumers the impression that these

products are free of milk-derived ingredients.

2. Your " Chocolate Muscle Milk Protein Nutrition Shake " and " Vanilla Crème

Muscle Milk Light Nutritional Shake " products are misbranded within the meaning

of section 403(g)(1) of the Act [21 U.S.C. § 343(g)(1)] because they purport to

be a food for which a definition and standard of identity has been prescribed by

regulation but they fail to conform to such definition and standard.

Specifically, these products purport to be milk by prominently featuring the

word " MILK " on the labels. Milk is a food for which a definition and standard of

identity has been prescribed by regulation. The standard of identity for milk

(21 CFR 131.110) describes milk as " the lacteal secretion, practically free from

colostrum, obtained by the complete milking of one or more healthy cows " and it

lists the vitamins and other ingredients that may be added. According to the

ingredient list on your product labels, your products contain no milk and

contain numerous ingredients not permitted by the standard; therefore, your

products do not conform to the standard of identity for milk.

3. Your " Chocolate Muscle Milk Protein Nutrition Shake " and " Chocolate Peanut

Caramel Muscle Milk " products are misbranded within the meaning of section

403®(1)(A) of the Act [21 U.S.C. § 343®(1)(A)] because the product labels

and labeling bear nutrient content claims that are not authorized by regulation

or fail to comply with the regulations that authorize nutrient content claims,

nor are they authorized under section 403®(3)©.1; Under section 403®(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 misbrands a product unless the

characterization of the level made in the claim uses terms which are defined in

FDA regulations. For example:

* To bear the nutrient content claim " healthy, " under 21 CFR 101.65(d)(2),

foods: (1) must be " low fat " as defined in 21 CFR 101.62((2) (total fat

content of 3 g or less per Reference Amount Customarily Consumed (RACC)); (2)

must be " low saturated fat " as defined in 21 CFR 101.62©(2) (saturated fat

content of 1 g or less per RACC and no more than 15 percent of calories from

saturated fat); (3) must not exceed the disclosure level for cholesterol set

forth in 21 CFR 101.13(h) (60 mg cholesterol per RACC); (4) must contain at

least 10 % of the Daily Value per RACC of one or more of the following

nutrients: vitamin A, vitamin C, calcium, iron, protein, or fiber; and (5) must

contain no more than 480 mg sodium per RACC and per labeled serving.

o The label of your " Chocolate Muscle Milk Protein Nutrition Shake " bears the

claim " Healthy, Sustained Energy " in connection with the statements " Protein

Nutrition Shake " and " 25 g Protein. " In addition, your

webpagehttp://www.cytosport.com/products/muscle-milk/muscle-milk-ready-to-drink

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055453 & v=3 & \

key=2700 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-ready-to-drink> under the heading entitled " 14-oz. Muscle

Milk® Ready-To-Drink (RTD) " includes the claim " healthy sustained energy. " Based

on the Nutrition Facts panel, this product contains 9 g of fat per 414 mL

serving. According to 21 CFR 101.12(, Table 2, the RACC for beverages is 240

mL. Thus, your product contains 5 grams of fat per the RACC of 240 mL. Your

product's fat content exceeds the 3 g of fat per RACC of food maximum in the

" low fat " definition (21 CFR 101.62((2)). Accordingly, this product does not

meet the requirements for the use of the nutrient content claim " healthy " on

food labeling (21 CFR 101.65(d)(2)).

o The label of your " Chocolate Peanut Caramel Muscle Milk " product bears the

claim " 25g Protein for Healthy, Sustained Energy " in connection with the claim

" 0g Trans Fat. " In addition, your webpage

http://www.cytosport.com/products/muscle-milk/muscle-milk-bars

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055455 & v=3 & \

key=4b59 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-bars> under the heading entitled " Muscle Milk® Bars " includes

the claim " healthy, sustained energy, " in connection with the claims " loaded

with 25 grams of high-quality muscle-source protein, " and " no trans fats. " Based

on the Nutrition Facts panel, this product contains 11 g of fat and 8 g of

saturated fat per 73 g serving. According to 21 CFR 101.12(, Table 2, the

RACC for all other candies is 40 g. Thus, your product contains 6 grams of fat

and 4.5 grams of saturated fat per 40 gram RACC. Your product's fat and

saturated fat content exceeds the 3 g of fat per RACC of food maximum in the

" low fat " definition (21 CFR 101.62((2)) and the 1 g of saturated fat per RACC

of food maximum in the " low saturated fat " definition (21 CFR 101.62©(2)).

Accordingly, this product does not meet the requirements for the use of the

nutrient content claim " healthy " on food labeling (21 CFR 101.65(d)(2)).

* Your " Chocolate Peanut Caramel Muscle Milk " product label bears the nutrient

content claim " 0g Trans Fat. " This statement is a nutrient content claim

provided for in 21 CFR 101.13(i). 21 CFR 101.13(h) requires that if a food

contains a nutrient content claim and more than 13.0 g of fat, 4.0 g of

saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium per RACC

or per labeled serving, then that food must also bear a statement disclosing

that the nutrient exceeding the specified level is present in the food as

follows: " See nutrition information for ____ content " with the blank filled in

with the identity of the nutrient exceeding the specified level, e.g., " See

nutrition information for saturated fat content. " However, your product contains

a nutrient content claim and more than 4 g of saturated fat per labeled serving

and per RACC, but fails to bear the required disclosure statement.

* Only the claims specified in 21 CFR 101.62 may be made for fat or fatty acids,

and there are no nutrient content claims for carbohydrates authorized in the

regulations. However, your " Chocolate Muscle Milk Protein Nutrition Shake, "

" Vanilla Crème Muscle Milk Light Nutritional Shake, " and " Chocolate Peanut

Caramel Muscle Milk " product labels bear the following unauthorized nutrient

content claims:

o Your webpage http://www.cytosport.com/products/muscle-milk/muscle-milk-bars

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055455 & v=3 & \

key=4b59 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-bars> on the tab entitled " Benefits and Uses " under the

heading entitled " Benefits of Using Muscle Milk® Bars " includes the unauthorized

nutrient content claim " trans-fat free. "

o Your " Chocolate Muscle Milk Protein Nutrition Shake " product label and your

webpagehttp://www.cytosport.com/products/muscle-milk/muscle-milk-ready-to-drink

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055453 & v=3 & \

key=2700 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-ready-to-drink> under the heading entitled " 14-oz. Muscle

Milk® Ready-To-Drink (RTD) " bear the unauthorized nutrient content claims

" healthy fats " and " good carbohydrates. "

o Your webpage

http://www.cytosport.com/products/muscle-milk/muscle-milk-light-ready-to-drink

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055457 & v=3 & \

key=a382 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-light-ready-to-drink> under the heading entitled " 14-oz.

Muscle Milk® Light Ready-To-Drink " for your " Vanilla Crème Muscle Milk Light

Nutritional Shake " product includes the unauthorized, undefined nutrient content

claim " good fats. "

4. Your " Chocolate Muscle Milk Protein Nutrition Shake, " " Vanilla Crème Muscle

Milk Light Nutritional Shake " and " Chocolate Peanut Caramel Muscle Milk "

products are misbranded within the meaning of Section 403(q)(2)(A) of the Act

[21 U.S.C. § 343(q)(2)(A)] because your nutrition labels for these products do

not include the amounts of polyunsaturated and monounsaturated fats present in

the product, as required by 21 CFR 101.9©(2)(iii) and (iv) when claims about

fatty acids or cholesterol are made. Because your products bear the following

claims about fatty acids, they must declare the amounts of polyunsaturated and

monounsaturated fats present in these products:

* Your " Chocolate Peanut Caramel Muscle Milk " product label bears the claim " 0g

Trans Fat. " Your webpage at

http://www.cytosport.com/products/muscle-milk/muscle-milk-bars

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055455 & v=3 & \

key=4b59 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-bars> under the heading entitled " Muscle Milk® Bars " bears

the claim " no trans-fats. " Your webpage at the same web address on the tab

" Benefits and Uses " under the heading entitled " Benefits of Using Muscle Milk®

Bars " bears the claim " trans-fat free. "

* Your webpage for your " Chocolate Muscle Milk Protein Nutrition Shake "

producthttp://www.cytosport.com/products/muscle-milk/muscle-milk-ready-to-drink

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055453 & v=3 & \

key=2700 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-ready-to-drink> on the tab entitled " Benefits and Uses "

under the heading entitled " Features " bears the claim " Medium-Chain

Triglycerides (MCTs) are more likely metabolized for muscle energy and heat than

stored as fat. Monounsaturated fats provide Essential Fatty Acids. "

* Your webpage for your " Vanilla Crème Muscle Milk Light Nutritional Shake "

producthttp://www.cytosport.com/products/muscle-milk/muscle-milk-light-ready-to-\

drink

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055457 & v=3 & \

key=a382 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-light-ready-to-drink> on the tab entitled " Benefits and

Uses " under the heading entitled " Features " bears the claim " Trans-fat free

Medium-Chain Triglycerides (MCT's) are more likely metabolized for muscle energy

than stored as fat. Polyunsaturated and monounsaturated fatty acids canola oil

and sunflower oil contain important essential fatty acids. "

5. Your " Chocolate Muscle Milk Protein Nutrition Shake, " " Vanilla Crème Muscle

Milk Light Nutritional Shake, " and " Chocolate Peanut Caramel Muscle Milk "

products are misbranded within the meaning of Section 403(i) of the Act [21

U.S.C. § 343(i)]. For example:

* Your " Chocolate Peanut Caramel Muscle Milk " product label does not bear a

statement of identity, in accordance with 21 CFR 101.3, which requires that the

principal display panel of a food in package form shall bear as one of its

principal features a statement of identity of the commodity and that such

statement of identity shall be in terms of the name now or hereafter specified

in or required by any applicable Federal law or regulation; or in the absence

thereof, the common or usual name of the food; or in the absence thereof, an

appropriately descriptive term, or when the nature of the food is obvious, a

fanciful name commonly used by the public for such food.

* The ingredients statements of your " Chocolate Muscle Milk Protein Nutrition

Shake " and " Vanilla Crème Muscle Milk Light Nutritional Shake " products do not

meet the requirements in 21 CFR 101(a)(1), which states that ingredients must be

listed by common or usual name in descending order of predominance by weight,

and do not meet the requirements in 21 CFR 101.4(, which requires that the

name of an ingredient shall be a specific name and not a collective (generic)

name. However, these product labels list " vitamin mineral blend " in the

ingredients statement and list the individual ingredients of your " vitamin

mineral blend " in a separate statement below the ingredients 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.

In addition, we note that your webpage for " Vanilla Crème Muscle Milk Light

Nutritional

Shake " http://www.cytosport.com/products/muscle-milk/muscle-milk-light-ready-to-d\

rink

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3790098105 & u=24055457 & v=3 & \

key=a382 & skey=fae1306759 & url=http%3A%2F%2Fwww.cytosport.com%2Fproducts%2Fmuscle-\

milk%2Fmuscle-milk-light-ready-to-drink> under the heading entitled " 14-oz.

Muscle Milk® Light Ready-To-Drink " does not meet the requirements to make

relative claims. The webpage bears the claims " Light " and " lower in calories, "

but does not provide the identity of the reference food as required by 21 CFR

101.13(j)(1), or the percent (or fraction) that the calories were reduced in

immediate proximity to the most prominent claim and does not provide

quantitative information comparing the levels of calories in the product per

labeled serving size with that of the reference food it replaces declared

adjacent to the most prominent claim or to the nutrition label, as required by

21 CFR 101.13(j)(2) and 21 CFR 101.56((3).

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 the violations cited above and to prevent similar violations in the

future. Your response should include 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.

Please send your reply to the attention:

Darlene Almogela

Director, Compliance Branch

U.S. Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502

If you have any questions regarding any issue in this letter, please contact

Carl Lee, Compliance Officer at , or by fax at .

Sincerely,

/s/

Barbara Cassens

District Director

1

Seehttp://www.fda.gov/Food/LabelingNutrition/LabelClaims/FDAModernizationActFDAM\

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m

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com

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