Inspections, Compliance, Enforcement, and Criminal Investigations
DS Waters of America, LP 6/8/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|5100 Paint Branch Parkway
College Park, MD 20740
JUN - 8 2009
RETURN RECEIPT REQUESTED
Mr. Stewart E. Allen
Mr. Dillon Schickli
Chief Executive Officers
DS Waters of America, Inc.
5660 New Northside Drive, Suite 500
Atlanta, GA 30328
Dear Mr. Allen and Schickli:
The Food and Drug Administration (FDA) has reviewed the label for the 1 Gal (3.78L) package of your NURSERY@ Purified Water with added fluoride, and your website at www.nurserywater.com in April 2009. Based on our review, we have found that your product label has serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find the Act and these regulations through links on FDA's Internet website at www.fda.gov.
Your significant violations are as follows:
Your product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)], because it bears an unauthorized health claim in its labeling. We have determined that your website www.nurserywater.com. the address for which appears on your product's label, is labeling for your product under section 201(m) of the Act [21 U.S.C. 321(m)]. This website bears the following unauthorized health claim: "Drinking water with added fluoride in the proper amounts has been shown to be so effective that the ADA supports municipal water fluoridation and refers to this as the single most effective measure to prevent tooth decay." Health claims may not be made for food products, including bottled water, for which the label represents or purports that the food is for infants or toddlers less than two years of age, unless FDA has provided for such claim by regulation. 21 CFR 101.14(e)(5). 1
Your product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. The Nutrition Facts panel uses abbreviations for serving size and servings per container that are not in accordance with 21 CFR 101.9(j)(13)(ii)(B), which provides that the use of specific abbreviations to list nutrients is only for packages that have a total surface area available to bear labeling of 40 or less square inches. In addition, the correct heading on the Nutrition Facts panel for declaring the quantity of a nutrient is "% Daily Value" (not "Amount") in accordance with 21 CFR 101.9(d)(6).
This letter is not meant to be an all-inclusive review of your NURSERY® Purified Water product and its 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 described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include each step that has been or will be taken to completely correct the labeling violations and to prevent the recurrence of similar violations, the time within which the correction will be completed, and any documentation necessary to show that the correction has been achieved. If applicable, please include a copy of your revised label. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
In addition, we have the following comments:
• The serving size of your NURSERY® Purified Water product is based on 8 fluid ounces. While FDA has not established a reference amount customarily consumed (RACC) for water by infants and toddlers, we recommend that you use the infant and toddler RACC for juices, which is 4 fl oz (120 mL) [21 CFR 101.12(b), Table I (Juices, all varieties)].
• Although minerals are added for taste, the statement of identity does not include this information (e.g., "purified water with minerals added for taste") [60 FR 57076 at 57080 and 57082, November 13, 1995].
If you need additional information or have questions concerning any products distributed through your website, please contact FDA. You may respond in writing to Felicia Binion Williams, Compliance Officer, Division of Enforcement, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740.
Roberta F. Wagner
Office of Compliance
Center for Food Safety
and Applied Nutrition
1. FDA notes that the following claim regarding fluoridated water and reduced risk of dental caries or tooth decay may be made consistent with a health claim notification under section 403(r)(3)(C) of the Act [21 U.S.C. 343(r)(3)(C)]: "Drinking fluoridated water may reduce the risk of [dental caries or tooth decay]." [www.cfsan.fda.gov/~dms/flfluoro.html]. However, the prohibition under 21 CFR 101.14(e)(5) applies to these health claim notifications, and this notification explicitly excluded bottled water products that are specifically marketed for use by infants, and therefore your product is not eligible to bear this health claim. Furthermore, the language of the claim on your website differs significantly from the language in the claim in the notification.