FDA WARNING_LETTER - Tree Top, Inc. - July 21, 2011

On July 18-21, 2011, an FDA inspection of Tree Top, Inc.'s manufacturing facility in Selah, Washington, revealed significant violations. Samples of pear juice concentrate (704954, 704952, 671270) contained inorganic arsenic at 24, 34, and 50 ng/g (ppb) respectively, when calculated to single-strength juice. These levels exceed the FDA's potential health risk threshold of 23 ppb for chronic consumption, rendering the product adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)), as it contains a poisonous substance that may render the food injurious to health.

On October 19, 2011, FDA informed Tree Top of the findings. Tree Top's October 24, 2011, response from Bonna J. Cannon, Director for Quality and Food Safety, stated no action would be taken, citing belief that the product was used, posed no health risk, and their own analysis was below guidance levels. FDA found this response lacked sufficient detail, specifically regarding products with a 36-month shelf life and unsupported health risk calculations. Tree Top must investigate and correct these violations promptly. Failure to do so may result in