05-9233. Iceberg Industries Corp.; Revocation of Temporary Permit for Market Testing

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of a temporary permit issued to Iceberg Industries Corp. to market test products designated as “Borealis Iceberg Water” because there is no evidence that the company is operational, and the need for the permit no longer exists.

FOR FURTHER INFORMATION CONTACT:

Loretta Carey, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal Register of September 7, 2000 (65 FR 54283), FDA issued a temporary permit to Iceberg Industries Corp., 16 Forest Rd., suite 300, St. John's, Newfoundland, Canada, A1C2B9, to market test products identified as “iceberg water,” a name that is not permitted under the U.S. standard of identity for bottled water in § 165.110 (21 CFR 165.110). The agency issued the permit to facilitate market testing of products whose labeling differs from the requirements of the standard of identity for bottled water issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341). The permit covered limited interstate market testing of products that deviated from the standard for bottled water in § 165.110 in that they were identified as “iceberg water” rather than as “bottled water” or one of the other names specified in § 165.110(a)(2). The test product met all the requirements of the standard with the exception of this deviation.

On September 28, 2001, Iceberg Industries Corp. requested that its temporary permit be extended to allow for additional time for the market testing of its products under the permit in order to gain additional information in support of its petition. In the Federal Register of June 27, 2002 (67 FR 43325), FDA announced that it was extending the temporary permit issued to Iceberg Industries Corp. to market test products designated as “Borealis Iceberg Water.” The extension allowed the permit holder to continue to collect data on consumer acceptance of products while the agency considered the petition to amend the standard of identity for bottled water, which was submitted by the permit holder. Under the extension, FDA invited interested persons to participate in the market test under the conditions that applied to Iceberg Industries Corp., except for the designated area of distribution. No one accepted the invitation to participate in the market test. In March 2004, FDA attempted to contact Iceberg Industries Corp. to discuss some issues regarding its petition at the telephone number listed in its petition. The telephone number was no longer in service. Attempts to reach the applicant by letter were unsuccessful. Therefore, under 21 CFR 130.17(g)(3), FDA is revoking the Iceberg Industries Corp.'s temporary permit because the need no longer exists.

Dated: May 3, 2005.

Barbara Schneeman,

Director, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition.