Gerber Products Company

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

Mr. Kurt Schmidt

Business Head

Nestle Nutrition

North American Headquarters

12 Vreeland Road

Florham Park, NJ 07932

Re: CFSAN-OC-10-09

Dear Mr. Schmidt:

The Food and Drug Administration (FDA) has reviewed the labels for the products in your Gerber Graduates Fruit Puffs line and the label of your Gerber 2nd Foods Carrots product, as well the labeling for these products on your website, www.gerber.com. 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.

The products in your Gerber Graduates Fruit Puffs line are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because their labeling includes unauthorized nutrient content claims. Except for claims regarding the percentage of a vitamin or mineral for which there is an established Reference Daily Intake (RDI), a nutrient content claim may not be made for a food intended specifically for use by infants and children less than 2 years of age unless the claims is specifically provided for in parts 101, 105, or 107 of FDA regulations. 21 CFR 101.13(b)(3). Your Graduates Fruit Puffs products are specifically intended for infants and children under age 2. For example, the labeling indicates that the products are designed for the "crawler" stage of a child's life. The labeling for these products includes nutrient content claims such as "good source of iron, zinc, and vitamin E for infants and toddlers." The circumstances under which "good source" claims are permitted are defined in 21 CFR 101.54. That regulation does not allow such claims for foods intended specifically for infants and children under 2.

Your 2nd Foods Carrots product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because its labeling includes unauthorized nutrient content claims. This product is also intended specifically for infants and children under the age of two. For example, its labeling states that the product is appropriate for a "sitter," and sitting is a developmental milestone that generally occurs by the age of one. The 2nd Foods Carrots product label bears the nutrient content claim "healthy" as part of the statement "As Healthy as Fresh," and nutrient content claims such as "Excellent Source ... of Vitamin A" and "No Added Sugar." These circumstances under which such claims are permitted are defined in 21 CFR 101.65(d), 21 CFR 101.54(b), and 21 CFR 101.60(c). However, these regulations do not allow the claim for products specifically intended for children under two years of age.

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 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 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 Kathleen M. Lewis, 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: FDA New Jersey District

FDA Detroit District

Mr. Mark E. Shipley

Plant Manager

Gerber Products Company

405 E. State Street

Fremont, MI 49412

-