First Juice 2/22/10

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

David Glasser, CEO

First Juice, Inc.

19 Tulip Lane

Randolph, NJ 07869

Re: CFSAN-OC-10-13

Dear Mr. Glasser:

The Food and Drug Administration (FDA) has reviewed the labeling for your Organic Fruit and Veggie Juice Beverage line of products, which includes four products: apple + carrot, banana + carrot, blueberry + purple carrot, and peach + purple carrot. Based on our review, we have concluded that these products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and regulations on FDA's website at www.fda.gov.

Your Organic Fruit and Veggie Juice Beverage products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the product labels and the labeling on your website (http://www.firstjuice.com/) bear unauthorized nutrient content claims. Title 21, Code of Federal Regulations, section 101.13(b)(3) (21 CFR 101. 13(b)(3)) states that except for claims regarding the percentage of a vitamin or mineral in relation to its established Reference Daily Intake, a nutrient content claim cannot be made for a food that is intended for use by infants and children less than two years of age unless the claim is specifically provided for in parts 101, 105, or 107 of the regulations. Your Organic Fruit and Veggie Juice Beverage products are intended for infants and children under age 2. For example, the labeling states that the products are "fruit and vegetable juice for infants and toddlers," "designed specifically for young, developing taste buds," and "nurturing healthy taste-preference development before they are old enough to tug at our shirts and say, juice." In addition, your website provides dual nutrition labeling information for children 6-12 months (infants) and children over 12 months.

The labeling of your Organic Fruit and Veggie Juice Beverage products includes claims such as "plus calcium" and states that the products contain "50% less sugar." The circumstances under which these nutrient content claims are permitted are defined in 21 CFR 101.54(e), and 101.60(c)(5). However, the regulations do not authorize the use of the claims for foods intended for infants and children under the age of 2.

Your blueberry + purple carrot and peach + purple carrot products are further misbranded under section 403(r)(2) of the Act because their labeling includes unauthorized health claims. FDA considers a claim about an ingredient in a food to be an implied claim about the food itself. The labeling on your website claims that purple carrots "reduce[ ] risk of cancer and stroke" and "guard against heart disease and some cancers." These health claims are not authorized by the Act or FDA regulations. In addition, FDA has not issued a letter of enforcement discretion regarding such claims.

This letter may not list all the violations regarding your products or their labeling. It is your responsibility to ensure that your firm and 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 York District

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