IA#45-06, REVISED 2/2/96, ATTACHMENT REVISED 12/19/95 SUBJECT : "AUTOMATIC DETENTION OF STEVIA LEAVES, EXTRACT OF STEVIA LEAVES, AND FOOD CONTAINING STEVIA" NOTE : This alert has been revised to incorporate analytical methodology. Changes are bracketed by asterisks (***). TYPE OF ALERT : Automatic Detention (Note: This import alert contains guidance to FDA field personnel only. It does not establish any requirements or obligations on FDA or on regulated entities.) PRODUCT : Stevia> leaves, stevioside (extract of stevia leaves), foods containing stevia, unless explicitly labeled as a dietary supplement or for use as a dietary ingredient of a dietary supplement. PRODUCT CODE : 45T[][]99 All food product codes where the leaves or stevioside are present as an ingredient (except for dietary supplements). PROBLEM : Unsafe food additive PAC : 09006A COUNTRY : See attachment MANUFACTURER/ SHIPPER : See attachment MANUFACTURER/ SHIPPER I.D.# : N/A IMPORTERS I.D. # : N/A CHARGE : "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a food additive which is unsafe within the meaning of Section 409, namely stevia leaves or the extract thereof (stevioside) [Adulteration, Section 402(a)(2)(c)]." RECOMMENDING OFFICE : DAL-DO (HFR-SW140); CFSAN/Office of Special Nutritionals/Regulatory Branch, (HFS-456); CFSAN/Office of Field Programs/Import Programs Branch, (HFS-637) REASON FOR ALERT : <Stevia> leaves are a native product in Brazil and Paraguay. The extract, stevioside, has reportedly been approved for use in foods in Brazil and Japan. The product is used in these countries as a table-top sweetener in virtually all food commodities and as a flavor enhancer in such products as teas. Stevioside is reportedly 250-300 times sweeter than sugar and contributes no calories to the diet. With regard to its use in foods, stevia is not an approved food additive nor affirmed as GRAS in the United States. Available toxicological information on stevia is inadequate to demonstrate its safety as a food additive or to affirm its status as GRAS. However, with regard to its use in dietary supplements, dietary ingredients, including stevia, are not subject to food additive regulations. <Stevia> leaves and stevioside have been offered for entry both in bulk and in finished products. Examples of products detained because of stevia include teas, drinks, seafood, fruits, vegetables, and candies. FDA analysis performed by Dallas district found diet teas to consist of up to six percent of stevioside. GUIDANCE : Districts may detain without physical examination all products identified on the attachment to this alert. If review of the labeling or import paperwork reveals stevia leaves, stevioside, or products containing stevioside, districts may detain these items without physical examination, unless explicitly labeled as a dietary supplement, or for use solely as a dietary ingredient in the manufacture of a dietary supplement product. If stevia is to be used in a dietary supplement for a technical effect, such as use as a sweetener or flavoring agent, and is labeled as such, it is considered an unsafe food additive. However, in the absence of labeling specifying that stevia is being or will be used for a technical effect, use of stevia as a dietary ingredient in a dietary supplement is not subject to the food additive provisions of the FD&C Act. If districts determine through analysis that a product contains stevia leaves or stevioside, recommendations for automatic detention should be forwarded to DIOP, HFC-170, with the analytical package unless the product is explicitly labeled as a dietary supplement or for use solely as a dietary ingredient in the manufacture of a dietary supplement product. In FY'95, there have been several shipments of pickled radishes from Japan detained because of presence of stevioside. Also, in recent years stevia has been found in many seafood products from Japan. Districts should consider sampling these products for the presence of stevioside if its presence cannot be determined from the label. <Stevia> leaves/stevioside may be under study in the United States in research settings as a basis for establishing toxicological information for future food additive petitions. As stevia leaves/stevioside are not available in the United States, imported shipments of stevia leaves/stevioside may be considered for release when documentation exists to demonstrate that the pending destination and use of the product is for research purposes. ***The Division of Field Science recommends that district laboratories utilize the method published in the Journal of Chromatography, 474 (1989), p. 447-451, "Simultaneous Determination of Stevioside, Rebaudioside A and C and Dulcoside A on Foods by High-Performance Liquid Chromatography." A laboratory must assure that recommended methodologies are reliable and accurate by utilizing appropriate validation procedures. Reference to any commercial materials, equipment, or processes does not in any way constitute approval, endorsement, or recommendation by FDA.*** For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007. PRIORITIZATION GUIDANCE : II FOI : No purging required. KEYWORDS : <Stevia, stevioside, sweetener, flavor enhancer, unsafe food additive DATE LOADED INTO FIARS : February 2, 1996 ATTACHMENT TO IMPORT ALERT #45-06 REVISED 12/19/95 SPECIFIC FIRMS AND PRODUCTS IDENTIFIED FOR AUTOMATIC DETENTION JAPAN (JP, 490) FIRM: PRODUCT: AUTO DET: PRODUCT CODE: Kuroda Shokuhin Pickled Radish 9/18/95 25J[][]26 Co., Inc. Kobe City, Hyogo, Japan MID# JPKURSHO1511KOB Nozaki Tsukemono Co., Ltd Salted Radish 12/19/95 25J[]P26 95 Takaasu-Cho 25J[]P27 Miyazaki, Japan MID# JPNOZTSU95MIY FEI# 1000339196 Shinshin Shokuryo Kogyo Salted Radish 12/19/95 25J[]P26 Co., Ltd. 25J[]P27 3-38 Kanda Chiyoda-Ku, Tokyo, Japan MID# JPSHISHO338TOK FIE# 1000152843