Current Status of Stevia Mark D. Gold ------------------------ October 3, 1995 Stevia is widely used as a sweetener in Japan (~40% of the sweetener market), Brazil, South Korea, Paraguay, and a number of other countries. There has never been a report of an adverse reaction linked to the use of Stevia. In the early and mid 1980s, Stevia was growing in popularity. During the last part of the 1980s, the FDA began seizing Stevia from health food manufacturers without adequate explaination. In 1990, Food Processing magazine had an insert about stevia. Approximately 200 manufacturers including all of the major food manufacturers showed interest in using Stevia in the manufacturing of their products. In 1991, the FDA banned the importation of Stevia intended for use in foods. This ban was reportedly at the request of NutraSweet (owned by Monsanto) which produces a toxic artificial sweetener called aspartame. This action, a clear violation of the law which allows any product with a history of safe use before 1958 to be automatically approved, kept manufacturers from using stevia and kept NutraSweet from having to compete with a safe, "natural" sweetener. In 1992, the American Herbal Products Association (AHPA) petitioned the FDA to declare use of Stevia as GRAS (Generaly Recognized As Safe). The AHPA provide hundreds of documents showing that Stevia had been commonly and safely used before 1958, and thus met the requirements for GRAS status. In July, 1992 the FDA rejected the AHPA petition. When asked how much more information was needed, the FDA responded "Well, this may sound flippant, but we'll know it when we see it." (Translation: No matter what you provide we're not going to approve stevia to compete with artificial sweeteners.) After exchanges of letters and a meeting, the FDA demanded information that they do not have the authority to request and they demanded information based on proposed regulations that they did not pass. Still, in the spirit of cooperation, the Herbal Research Foundation provided additional information requested about the safety and use of stevia. In December 1993, the FDA again disallowed the filing of the AHPA petition for approval of Stevia. This meant that public comment on the petition by qualified experts could not take place and that stevia would not be approved. In September 1995, the FDA adjusted their "Import Alert" to allow for the importation of Stevia *only* if it is clearly marked that it is intended to be used as or in dietary supplements. This will tend to permit personal use, but keep food manufactuers from using Stevia in their products until they can be secure in their supply for all intended uses. Thus, the FDA is still in clear violation of the law (which, by the way, means nothing to the FDA when it comes to protecting their "clients," i.e., Monsanto/ NutraSweet), but at least it is a small step in the right direction. Below is a copy of the updated Import Alert. The FDA's statements about the inadequacy of Stevia's safety testing is irrelevant and ridiculous. See petitions to the FDA. ------------------------ Date: Sun, 1 Oct 1995 11:30:20 -0400 From: bbs@www.fda.gov (BBS Users ) Message-Id: <9510011530.AA11735@www.fda.gov.fda.gov> X-Within-Url: http://www.fda.gov///ora/fiars/ora_import_ia4506.html To: mgold@holisticmed.com Subject: ora_import_ia4506.html IA#45-06, REVISED 9/18/95, ----ATTACHMENT 9/18/95 SUBJECT: "AUTOMATIC DETENTION OF STEVIA LEAVES, EXTRACT OF STEVIA LEAVES, AND FOODS CONTAINING STEVIA" NOTE : This alert has been revised to clarify guidance for products containing stevia intended for use as a dietary supplement and create an attachment to identify products that have been found to contain stevia or stevioside. Additional 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).*** HARMONIZED CODE : 0712.[][].[][][][] 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. ***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 : September 18, 1995 ATTACHMENT TO IMPORT ALERT #45-06 REVISED 9/18/95 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