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U.S. Department of Health and Human Services

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Enforcement Actions

Nestle USA, 12/4/09

   

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

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

DEC 04 2009

 

 

Brad Alford, Chairman and CEO
Nestle U.S.A.
800 North Brand Boulevard
Glendale, CA 91203

WARNING LETTER

 

Re: CFSAN-OC-10-05

Dear Mr. Alford:

The Food and Drug Administration (FDA) has reviewed the labeling for several Nestle Juicy Juice products: Juicy Juice Brain Development Fruit Juice Beverage (Apple), Juicy Juice All-Natural 100% Juice Orange Tangerine, and Juicy Juice All-Natural 100% Juice Grape. Based on our review, we have concluded that these products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 343] because their labeling deviates from the requirements of the Act and FDA regulations at Title 21 of the Code of Federal Regulations.

Your Juicy Juice Brain Development Fruit Juice Beverage product is misbranded within the meaning of section 403(r) of the Act [21 USC 343(r)] because its labeling includes unauthorized nutrient content claims. Except for statements that describe the percentage of a vitamin or mineral in relation to a Reference Daily Intake (RDI), a nutrient content claim cannot be made for a food intended for use by infants and children less than 2 years of age unless the claim is specifically provided for in parts 101, 105, or 107 of FDA regulations. 21 CFR 101.13(b)(3). This product is marketed specifically for children under two years of age, as indicated by the claim "Helps support brain development***In children under two years old," which appears on the product label. The label also bears the nutrient content claim "no sugar added." The circumstances under which a "no sugar added" claim is permitted are defined in 21 CFR 101.60(c). That regulation does not allow the claim for conventional food products intended for use in children under age 2. 21 CFR 101.60(c)(4). Therefore, the claim "no sugar added" misbrands your product.

On October 30, 2009. we also reviewed your website, http://www.juicyjuice.com. the address of which is listed on the Juicy Juice Brain Development Fruit Juice Beverage label. The labeling found on your website makes an additional unauthorized nutrient content claim, which
further misbrands the product. The website claims that Juicy Juice Brain Development Fruit Juice Beverage is "naturally lower in sugar." As noted above, except for statements that describe the percentage of a vitamin or mineral in relation to an RDI, no nutrient content claims can be made for a food intended specifically for use by infants and children less than 2 years of age unless specifically permitted by FDA regulations. 21 CFR 101.13(b)(3). The circumstances under which a "lower in sugar" claim is permitted are defined in 21 CFR 101.60(c)(5). That regulation does not allow the use of the claim for food products intended for use in children under age 2.

Additionally, we have reviewed the labeling of your Nestle Juicy Juice All Natural 100% Juice Orange Tangerine and Nestle Juicy Juice All Natural 100% Juice Grape products. These products are misbranded under section 403(a)(1) of the Act [21 USC 343(a)(1)] because their labels are misleading. The label of the Orange Tangerine product is designed to imply that the product is 100% orange/tangerine juice, and the label of the Grape product is designed to imply that product is 100% grape juice. The principal display panels identify the products as "Orange Tangerine" and "Grape," respectively, in large, bold lettering outlined in black; however, neither orange/tangerine juice nor grape juice is the predominant juice in the products.The statements "All Natural-100% Juice" in close proximity to the words "Orange Tangerine"or "Grape" and vignettes of oranges or grapes also may lead consumers to believe that the products are 100% orange/tangerine juice or 100% grape juice when, in fact, they are not. The separate statement at the base of the respective principal display panels, "Flavored juice blend from concentrate with other natural flavors & added ingredients," appears in a smaller font and white print on a colored background. The manner in which the latter statement is presented makes it less conspicuous and prominent than the other label statements and vignettes and therefore less likely to be read or understood by consumers at the time of purchase.

The above violations are 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 and/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 Quyen Tien, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Brooch Parkway, Office of Compliance (HFS608), 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: FDA Los Angeles District Office