Inspections, Compliance, Enforcement, and Criminal Investigations
Langers Juice Co. 17-Apr-07
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
April 17, 2007
David W. Langer, Vice President
Langer Juice Company, Inc.
16195 Stephens St.
City of Industry, California 91745-1718
Dear Mr. Langer:
This letter is in reference to the inspection of your facility located at 16195 Stephens St., City of Industry, California, between December 19, 2006, and January 19, 2007, by the U.S. Food and Drug Administration (FDA). During the inspection, labels of some of your juice blend products were collected. Our review of your labeling and other evidence collected by the investigator shows violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (CFR). You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
Our review of some of your labels found your Pomegranate 100, Cranberry Berry 100, and Cranberry Raspberry 100 products to be misbranded as follows:
Your Cranberry Berry 100 product is misbranded under section 403 (r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the product fails to meet requirements for making the nutrient content claim on its label. Your Cranberry Berry 100 product label claims that the product is "an excellent source of calcium." The claim "excellent source of may be used on the label and in the labeling of a food provided that the food contains 20 percent or more of the Reference Daily Intake (RDI) per reference amount customarily consumed (RACC) [21 CFR 101.54(b)]. According to the product's Nutrition Facts panel, the serving size for this product is equal to the RACC, i.e., 8 fl. oz., but the amount of calcium declared is only 10% of the RDI.
Your Pomegranate 100 and Cranberry Berry 100 products are misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)] because they bear unauthorized health claims. In particular, your products make the following claims:
Pomegranate 100: "Antioxidants have been shown to help prevent heart disease and cancer..."
The claim is an unauthorized health claim because it fails to meet the requirements of 21 CFR 101.76-78. FDA has authorized a health claim associating diets low in fat and high in fiber-containing grain products, fruits, and vegetables with reduced risk of cancer [21 CFR 101.76], and a health claim associating diets low in saturated fat and cholesterol and high in fruits, vegetables and grain products that contain fiber and risk of heart disease [21 CFR 101.77]; this product does not qualify for either claim because, among other things, the nutrition label states that it is not a significant source of fiber. Your Pomegranate 100 product also does not qualify for the health claim under 21 CFR 101.78 regarding fruits and vegetables and cancer because it does not contain all of the elements required in 21 CFR 101.78(c)(2)(i) regarding the nature of the claim.
Cranberry Berry 100: "[C]ontains lutein, which... may reduce the risks of cataracts and macular degeneration."
No health claims about lutein and reduced risk of cataracts or reduced risk of macular degeneration have been authorized either by regulation (see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. 343(r)(3)(A)-(B)]) or under authority of the health claim notification provision of the Act (see section 343(r)(3)(C) of the Act [21 U.S.C. 343(r)(3)(C)]).
Furthermore, your Cranberry Raspberry 100 product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. 343(u)] in that it is represented as containing ginseng, but the purported ginseng ingredient is not from a plant classified within the genus Panax. The ingredient statement for your product lists Siberian Ginseng (Eleutherococcus senticosus). Section 10806(b)(1) of the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171) provides that the term "ginseng" may only be considered to be a common or usual name (or part there of) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Therefore, Eleutherococcus senticosus may not be declared under a name that includes the term "ginseng."
You should take prompt action to correct these violations. Failure to correct the violations promptly may result in enforcement action without notice, including seizure and or injunction.
This letter is not intended to be an all inclusive review of your products and their labeling. You are responsible for ensuring that all of your product labels, labeling, and business operations are in compliance with the Act and applicable regulations.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these deviations and to prevent similar violations. You should include in your response documentation for our evaluation of your corrective actions. If you cannot complete all corrections within 15 working days, we expect you to explain the reasons for your delay and state when you will correct any remaining deviations.
In addition to the violations described above, we have several comments concerning the labeling of your products. For instance, we note that 21 CFR 102.33(d) applies to blends of single-strength juices where one or more, but not all, of the juices are named on the label other than in the ingredient statement, and where the named juice is not the predominant juice. If any of your juices meet these criteria; then the common or usual name for the product must (1) indicate that the named juice is present as a flavor or flavoring (e.g., "Cranberry Raspberry 100"; cranberry and raspberry flavored juice drink); or (2) include the amount of the named juice, declared in a 5 percent range (e.g., "Cranberry Raspberry 100"; cranberry and raspberry juice beverage, 10-to 15-percent cranberry juice and 3-to 8-percent raspberry juice) [21 CFR 102.33(d)(1) and (2)].
Also, we note that your Pomegranate 100, Cranberry Berry 100, and Cranberry Raspberry 100 products all declare that they are not a significant source of saturated fat, trans fat, and cholesterol at the bottom of the Nutrition Facts panel. These nutrients should be removed from the "not a significant source of statement since your products already declare the amounts and, where appropriate, the % Daily Value for saturated fat, trans fat, and cholesterol below Total Fat in the table of nutrient values. Under FDA's nutrition labeling regulations, the nutrients are to be declared either in the table of nutrient values or in the "not a significant source of statement, but not both [21 CFR 101.9(c)(2)(i)-(ii), (c)(3)].
Furthermore, the Pomegranate 100 product declares vitamins A and E at 5% of the Daily Value in the Nutrition Facts panel; however, 21 CFR 101.9(c)(8)(iii) specifies that the percent Daily Value for vitamins shall be expressed to the nearest 2-percent increment up to and including the 10-percent level.
Please send your reply to the U.S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, CA 92612-2445, Attention: Ms. Pamela B. Schweikert, Director, Compliance Branch. If you have any questions regarding any issue in this letter, please contact Mr. Robert McNab, Compliance Officer at (949) 608-4409.
Alonza E. Cruse
Los Angeles District
cc: Mr. Nathan Langer
President, Langer Juice Co.
Department of Health Services
Attn: Chief, Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95899-7413