Inspections, Compliance, Enforcement, and Criminal Investigations
Tree Top, Inc. 2/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
February 8, 2012
VIA OVERNIGHT DELIVERY
In reply refer to Warning Letter SEA 12-14
Thomas Stokes, President and CEO
Tree Top, Inc.
P.O. Box 248
220 East 2nd Avenue
Selah, Washington 98942
Dear Mr. Stokes:
On July 18 through 21, 2011, representatives of the Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 205 South Railroad Avenue, Selah, Washington. During the inspection FDA collected samples of pear juice concentrate from your firm's retain sample cooler. Analysis of three samples (704954, 704952, and 671270) of pear juice concentrate revealed inorganic arsenic at levels of 24 nanograms per gram (ng/g) or parts per billion (ppb), 34 ng/g (ppb), and 50 ng/g (ppb) in single strength or ready-to-be consumed pear juice when utilizing the minimum Brix level listed in 21 CFR 101.30(h)(1) to calculate the percentage of juice from concentrate for a single strength juice. As evidenced by the sample results, your pear juice concentrate, represented by samples 704954, 704952, and 671270, is adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(1). You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
Inorganic arsenic is a toxic substance and prolonged exposure to high levels of inorganic arsenic is associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans 1. Based on the Agency's April 2008 hazard assessment 2 chronic consumption of pear juice products containing over 23 ppb inorganic arsenic represents a potential health risk. Samples 704954, 704952, and 671270 all contained levels of inorganic arsenic above 23 ppb. Based on the levels of arsenic in these samples, and other data and information on the adverse health effects of arsenic at such levels, pear juice concentrate represented by these samples is adulterated within the meaning of section 402(a)(1) of the Act, 21 U.S.C. 342(a)(1), because it bears or contains an added poisonous or deleterious substance which may render the food injurious to health.
On October 19, 2011 , the FDA contacted your firm by telephone to apprise you of the results of the analysis and inquire as to what steps would be taken with regard to the pear juice concentrate product in distribution. In a letter dated October 24, 2011, Bonna J. Cannon, Director for Quality and Food Safety, responded that based on your firm 's assessment Tree Top, Inc. would not take any action as your firm believed that all the material in question had already been used, the product did not pose a health risk, and that your firm 's own analysis was below guidance levels. The letter did not contain enough detail for us to evaluate your firm's assessment of the situation. For example, Ms. Cannon's letter indicated that although some products had a shelf life of up to 36 months, because the products may no longer be in the "hands of the parties that purchased" them, Tree Top's assessment deemed that no action be taken. Ms. Cannon further explained a calculation Tree Top, Inc. utilized to determine the health risk from consumption of the juice in fruit packs, based on the use of pear juice containing 50 ppb inorganic arsenic, and with no supporting data included to support the assessment.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your facility and all of your products are in compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations listed above and take prompt actions to correct the violations and to bring your products into compliance. Failure to promptly correct these violations and implement lasting corrective action may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
Please notify this office in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation and useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your reply should be sent to the following address: Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at ( 425) 483-4940.
Charles M. Breen
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
1 WHO/FAO Joint Expert Committee on Food Additives (JECFA), 2010, Evaluation of Certain Contaminants in Food, 72nd Report of the World Health Organization/Food and Agriculture Organization of the United Nations Joint Expert Committee on Food Additives, accessed online at http://whqlibdoc.who.int/trs/WHO_TRS_959_eng.pdf.