Inspections, Compliance, Enforcement, and Criminal Investigations
Beech-Nut Nutrition Corporation 2/22/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|College Park, MD 20740|
FEB 22 2010
VIA OVERNIGHT MAIL
Mr. Christoph Rudolf
President and CEO
Beech-Nut Nutrition Corporation
13 British American Blvd
Latham, NY 12110
Dear Mr. Rudolf:
The Food and Drug Administration (FDA) has reviewed the labeling for your Whole Grain Oatmeal & Mixed Fruit Cereal and the following products in your DHA PLUS™ line: Apple Delight, Apples with Pomegranate Juice, Banana Supreme, Butternut Squash with Corn, Macaroni & Cheese, Multi Grain with Apples & Yogurt Cereal, Pasta Vegetable Medley, Rice Cereal, Sweet Potatoes, Sweet Potatoes & Wild Alaskan Salmon, Whole Grain Cereal with Raspberries, Whole Wheat Pasta Parmesan, Yogurt Blends with Juice - Mixed Berry, and Yogurt Blends with Juice - Tropical Fruit. We have concluded that these products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. You can find the Act and regulations on FDA's website at www.fda.gov.
Specifically, the above-listed products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 USC 343(r)(1)(A)] because their labeling includes unauthorized nutrient content claims. Except for claims regarding percentages of vitamins and minerals for which there is an 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. 21 CFR 101.13(b)(3). The above-listed products are intended for infants and children under age 2. For example, Beech-Nut generally represents itself as a "baby" and "toddler" food company and specifically represents its DHA PLUS line of products as intended for infant and baby nutrition. Further, your Whole Grain Oatmeal & Mixed Fruit Cereal is labeled for use "from about 6 months" on the product's principal display panel (PDP).
The labeling found on your company website (www.beechnut.com) contains nutrient content claims for each of the above-listed products in your DHA PLUS line such as:
• "No added refined sugar"
• "Fortified for enhanced functional benefits"
• "Plus vitamin and minerals."
The circumstances under which these claims are permitted are defined in 21 CFR 101.60(c) and 101.54(e), respectively. However, those regulations do not permit these claims for products intended for infants and children under age 2.
The label for your DHA PLUS Apple Delight also bears the claim, "Contains natural sugars only," which implies that there is no added sugar in the product. The circumstances under which a "no sugar added" claim is permitted are defined in 21 CFR 101.60(c). However, that regulation does not allow the claim for conventional food products intended for infants and children under age 2.
The label for your Whole Grain Oatmeal & Mixed Fruit Cereal also bears nutrient content claims such as:
• "Low sodium"
• "Plus fiber"
• "Plus vitamins & minerals"
• "Excellent source of iron, vitamin D, calcium, zinc, 7 B-vitamins."
The circumstances under which these claims are permitted are defined in 21 CFR 101.61 and 101.54(e) and (b), respectively. However, the regulations do not allow these claims for products intended for infants and children under age 2 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 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.
We note that the label for your Whole Grain Oatmeal & Mixed Fruit cereal includes the statement "Contains Wheat;" however, the ingredient statement does not include wheat. The presence of an allergen "Contains" statement may be confusing or misleading to consumers if the product does not contain an allergenic ingredient. FDA notes that advisory labeling should not be used as a substitute for adherence to current Good Manufacturing Practices and that all labeling must be truthful and not misleading.
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.
Roberta F. Wagner
Office of Compliance
Center for Food Safety
And Applied Nutrition
cc: FDA New York District