Pbm Products, LLC

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

Paul B. Manning

PBM Products, LLC

204 N. Main St.

Gordonsville, VA 22942

Re: CFSAN-OC-10-14

Dear Mr. Manning:

The Food and Drug Administration (FDA) has reviewed the labels of your Parent's Choice

Little Puffs Plus Calcium Blueberry Naturally Flavored product and your Parent's Choice

Little Puffs Made With Whole Grains Peach-Mango Naturally Flavored product. These

products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 USC

343(r)(1)(A)] because their labels contain 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 statements describing the percentage of a vitamin or mineral in relation to 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 FDA regulations. The above-listed

products are marketed specifically for infants and children under age 2. For example, the

information panel of your Parent's Choice Little Puffs Plus Calcium Blueberry Naturally

Flavored product states "for babies beginning to self feed" and "Your baby is ready for Little

Puffs when she: Sits upright without support; Opens her mouth when food approaches[.]"

Similarly, the principal display panel of your Parent's Choice Little Puffs Made With Whole

Grains Peach-Mango Naturally Flavored product states that the product is "for Babies

Beginning to Self-Feed."

The label of your Parent's Choice Little Puffs Plus Calcium Blueberry Naturally Flavored

bears the nutrient content claims "plus calcium, up to 10% more than the leading brand per

serving." The circumstances under which these claims are permitted are defined in 21 CFR

101.130) and 101.54(e). However, the regulations do not allow the use of these claims for

foods intended for infants and children under age 2.

The label of your Parent's Choice Little Puffs Made With Whole Grains Peach-Mango

Naturally Flavored product bears nutrient content claims such as:

• "A good source of calcium"

• "A good source of Vitamin D"

• "A good source of Iron"

The circumstances under which these claims are permitted are defined in 21 CFR 101.54(c).

However, the regulation does not allow the use of these claims for foods intended for infants

and children under age 2.

Your Parent's Choice Little Puffs Made With Whole Grains Peach-Mango Naturally Flavored

product is also misbranded within the meaning of Section 403(q) of the Act [21 USC 343(q)]

in that the nutrition facts information is not presented in an appropriate format as defil cd in

21 CFR 101.9. Specifically:

• The nutrition label on the Parent's Choice Little Puffs Whole Grains Peach -Mango

Naturally Flavored violates 21 CFR 101.90)(5) because it lists saturated fat.

cholesterol, and calories from fat.

• The dual column format used for the % Daily Value of vitamins and miner als,

"Infants 0-1" and "Children 1-4," violates the requirements in 21 CFR 101.9(e)

because when a dual column format is used, the dual columns must begin

following the subheading "Amount Per Serving."

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 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: FDA Baltimore District

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