Inspections, Compliance, Enforcement, and Criminal Investigations
Aloha Juice Company 25-Jul-03
Public Health Service
22201 23rd Drive SE
Bothell, WA 98021-4421
July 25, 2003
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 03-23
James M. Henry, Owner
Aloha Juice Company
935 SE Belmont
Portland, Oregon 97214
Dear Mr. Henry:
On April 3,2003, the Food and Drug Administration (FDA) conducted an inspection of your plant located at 935 SE Belmont, Portland, Oregon. During the inspection, our investigator collected labels for three of your juice products and found them to be in violation of Section 403 (a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21 of the Code of Federal Regulations 21 CFR Part 1O1- Food Labeling. You can find this Act and the Food Labeling regulations through links in FDAs homepage at www.fda.gov.
The deviation found is as follows:
The products are misbranded within the meaning of section 403(a)( 1) of the Federal Food, Drug, and Cosmetic Act (the act) in that the term Fresh, which appears on the labels of 100% Natural Lemonade, 100% Natural Orange Juice, and 100% Natural Grapefruit Juice is false because the products have been pasteurized by Sun Orchard. Furthermore, title 21, Code of Federal Regulations (21 CFR), section 101.95 does not permit the term Fresh to be used on juice products that have been pasteurized.
The above violation concerns labeling requirements but is not meant to be an all-inclusive list of deficiencies on your label or in your plant. Other violations can subject the food to legal action. It is your responsibility to assure that all of your products are in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations
noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
We also note the following regarding your labeling:
- The term pasteurized must be included on the principal display panel as part of the name of orange juice products that have been pasteurized, as required by 21 CFR 101.3(a), (d) and 146.140(d)(1).
- Your product labeled as 100% Natural Lemonade includes the ingredients natural cane or fruit sugars on its ingredient statement. All ingredients must be listed in the ingredient statement by their common or usual name, as required by 21 CFR 101.4. The regulations do not protide for the use of and/or labeling for sugars in juice products.
- The label of a beverage (e.g., Lemonade) which is required to bear a percent juice declaration and is less than 100% juice may not contain any other percentage declaration that describes the juice content of the beverage, such as 100% natural, as provided in 21 CFR 101.30(1).
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any question regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4813.
Charles M. Breen