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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hain Celestial Group Response Letter

VIA ELECTRONIC MAIL & EXPRESS MAIL

 

September 18, 2007

 

Ms. Lynn Szybist, Compliance Officer
Food and Drug Administration, Center for Food Safety and Applied Nutrition,
Office of Compliance, Division of Enforcement
5100 Paint Branch Parkway (HFS-608)
College Park, MD 20740

Re: Celestial Seasonings, Zingers to Go™ Herbal Tea Supplements

Dear Ms. Szybist:

This is to confirm that the issues addressed in the Warning Letter to The Hain Celestial Group, Inc. dated August 17th, 2007 have all been resolved. After working closely with the FDA and making the changes to our labels: "Herbal Supplement" is more prominently stated, "iced tea mix" has been removed, and all other revisions to the label as directed have been made. For your records, attached is the revised artwork for the new label which was approved by the FDA. Please contact us if you have any questions or concerns.

Please note that Hain Celestial takes regulatory compliance very seriously. We employ full time regulatory scientists, attorneys and professors to ensure regulatory compliance of our products. As always, we are prepared to fully cooperate with the FDA to resolve any issues or concerns.

Based on the foregoing, and our previous discussions resolving the matter, we would appreciate the posting of this response on the FDA's website showing the matter has been properly resolved.

Respectfully submitted,

/S/

Troy Aykan,
The Hain Celestial Group, Inc.
Corporate Regulatory Affairs