Inspections, Compliance, Enforcement, and Criminal Investigations
Guangzhou Yong Want Foods Ltd, 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
Want Want Foods
5, Xin Yuan Road
Yong He Economic Zone of GETDD
Guangzhou, China 511356
The Food and Drug Administration (FDA) has reviewed the labeling for your Baby Mum-Mum Original Selected Superior Rice Rusks product. Based on our review, we have determined that your product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations on FDA's website at www.fda.gov. Your Baby Mum-Mum Original Selected Superior Rice Rusks product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 USC 343(r)(1)(A)] because its labeling bears 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 for which there is an established Reference Daily Intake, a nutrient content claim may not be made regarding a food intended specifically 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 product is specifically intended for children under the age of two, as evidenced by the use of the term "Baby" in the product name, and statements that the product is a "traditional 'first snack' for babies," can be used"... as soon as he or she is ready for solid food," and "Dissolves easily... [.]") These statements appear on the product label and in the labeling on your website (www.mummums.com).
The labeling of Baby Mum-Mum Original Selected Superior Rice Rusks claims that the product is "Low in Fat" and contains "No Added Fats or Oils." The circumstances under which fat-related nutrient content claims are permitted are described in 21 CFR 101.62. That regulation does not authorize such claims for foods intended for infants and children under the age of 2.
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's operations and 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.
If you do not respond or if we find your response inadequate, we may take further action to refuse admission of your products under Section 801(a) of the Act [21 USC 381(a)], including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the labeling regulation is Import Alert #99-20. This alert can be found on FDA's web site at: http://alpha.ora.fda.gov/www_fiars/files/ia9920.lst
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.
Roberta F. Wagner
Office of Compliance
Center for Food Safety
And Applied Nutrition