Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
6050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
April 7, 2014
Bryan E. Etchens, Owner
Iowa Orchard LLC
9875 Meredith Drive
Urbandale, IA 50322-7226
Dear Mr. Etchens:
The U.S. Food and Drug Administration (FDA) collected a sample of apple cider manufactured at your facility located at 9875 Meredith Drive, Urbandale, IA 50322, on November 4, 2013. FDA collected a second sample of apple cider manufactured at the same facility on December 18, 2013. Both tested positive for patulin. The mean level of patulin found for the first sample was 62.5 parts per billion (ppb). The mean level of patulin found in the second sample was 55.7 ppb.
Patulin is a mycotoxin that is produced by certain species of Penicillium, Aspergillus and Byssochylamys, molds that may grow on a variety of foods including apples. These levels of patulin cause the apple cider you produced to be 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)] in that the product bears or contains any poisonous or deleterious substance which may render it injurious to health. You can find the Act through links in FDA's home page at www.fda.gov.
Exposure over time to high levels of patulin may pose a health hazard. Therefore, FDA established an action level for patulin in apple juice of 50 micrograms per kilogram (50ppb) as determined on single strength apple juice or reconstituted single strength apple juice. An action level is a guideline that FDA uses in considering whether the level of a contaminant in a food may constitute a health hazard sufficient to warrant regulatory action by FDA against the product. See FDA's Compliance Policy Guide (CPG Section 510.150) concerning patulin for additional information: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManuallucm074427.htm
The violation cited in this letter is not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violation described above and prevent future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The Act authorizes the seizure of adulterated products and injunctions against the manufacturers and/or distributorsof those products [21 U.S.C. §§ 332 and 334].
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violation described above. Include in your response documentation to show that the correction has been achieved. lf you cannot complete the correction before you respond, state the reason for the delay and the time within which you will complete the corrections.
Your response should be sent to U.S. Food and Drug Administration, David L. Miser, Acting District Director at the address noted above. lf you have any questions with regard to this letter, Compliance Officer Matthew R. Sleeter can be reached at (913) 495-5151or email Matthew.Sleeter@fda.hhs.gov
David L. Miser
Acting Director, Kansas City District