Note: The revision of this Import Alert (IA) dated 03/14/2025 updates the reason for alert, guidance section including agency contacts, and PAC. Changes to the import alert are bracketed by asterisks (***). The term stevia, as used in commerce, refers to the leaves of Stevia rebaudiana (Bertoni) Bertoni, a plant native to various parts of South America. With regard to use in conventional foods, stevia leaf, or its crude extract, is not an approved food additive and is not considered GRAS due to inadequate toxicological information. With regard to use in dietary supplements, dietary ingredients (including stevia) are not subject to food additive regulations. Stevia leaf-derived products are approved for use as sweeteners in foods in Japan, Brazil, Australia, New Zealand, and other countries. Said products are used in a variety of foods, including teas, and are commonly used as table-top sweeteners. Historically, stevia leaves and stevia leaf-derived products have been offered for entry both in bulk and in finished products such as teas, drinks, seafood, fruits, vegetables and candies. Stevia leaves are known to contain high intensity sweetener compounds, which are collectively called steviol glycosides, and are approximately 200-300 times sweeter than sucrose. Steviol glycosides differ from stevia leaves in that they are purified extracts obtained from the leaves. Stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides, and other steviol glycosides for which FDA does not have questions following the review of a GRAS notification, individually or in combination, are the principal steviol glycosides used as sweeteners. ***HFP/Office of Office of Premarket Additive Safety (OPMAS)*** responded to GRAS notices concerning highly purified steviol glycosides(>=95% steviol glycosides on a dried weight basis with stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides or other steviol glycosides as principal components), and determined these products are not subject to detention under this Import Alert (see #3 in Guidance Section for documentation required under this provision). Other steviol glycosides that may be present in these products as minor components of the >=95% total steviol glycosides content specified above include other rebaudiosides, dulcoside A, rubusoside, and steviolbioside. It should be noted that steviol glycoside(s) may also be produced by fermentation technology without a need to use stevia leaves in the manufacturing process. In such cases, the import alert does not apply.
Stevia leaves and foods containing stevia leaves, UNLESS explicitly labeled as a dietary supplement or for use as a dietary ingredient of a dietary supplement; And Extracts obtained from stevia leaves and foods containing said extracts, UNLESS the stevia ingredient contains >= 95% steviol glycosides. (For purposes of this Alert, extracts that do not contain >= 95% steviol glycosides are referred to as "crude extracts.")
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409. [Adulteration, Section 402(a)(2)(C)(i)] OASIS charge code: UNSAFE ADD
Divisions may detain, without physical examination, shipments of identified products from firms on the Red List of this Import Alert. ***Recommendations for DWPE, addition to Red List require documentation of Human Foods Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO).*** In addition, if review of the labeling and/or entry documentation of products not on the Red List reveals stevia leaves or stevia-derived products, Divisions may detain these items under the charge in this import alert, UNLESS: (1) the product is labeled as a dietary supplement. If stevia leaves or crude extracts obtained from stevia leaves are used in a dietary supplement for a technical effect, e.g., as a sweetener or flavoring agent AND are labeled as such, they are considered unsafe food additives; consequently, said products would be subject to detention. However, in the absence of labeling specifying their use for a technical effect, the use of these substances as a dietary ingredient in a dietary supplement is not subject to the food additive provisions of the Federal Food, Drug & Cosmetic Act; Or (2) the product is intended for use solely as a dietary ingredient in the manufacture of a dietary supplement product. If stevia leaves or crude extracts obtained from stevia leaves are used in a dietary supplement for a technical effect, e.g., as a sweetener or flavoring agent AND are labeled as such, they are considered unsafe food additives; consequently, said products would be subject to detention. However, in the absence of labeling specifying their use for a technical effect, the use of these substances as a dietary ingredient in a dietary supplement is not subject to the food additive provisions of the Federal Food, Drug & Cosmetic Act; Or (3) the product is or contains highly purified steviol glycosides that meet the specification for >=95% steviol glycosides as described above (see Reason for Alert). In this case documentation, including a certificate of analysis and manufacturing process information, should be provided to demonstrate the acceptability of the article in question. For questions or issues concerning the composition of the product offered for import (including analytical documentation or principal vs. minor components), ***Divisions may contact HFP/OFCSDSI Office of Pre-Market and Additive Safety (OPMAS), Division of Food Ingredients (DFI).*** Or (4) documentation exists to demonstrate the product is intended for research. Stevia leaves and stevia-derived substances may be undergoing further study in the United States in research settings as a basis for establishing toxicological information for future safety assessments. Shipments of stevia leaves and stevia-derived substances offered for import are indicated for release when, documentation exists to demonstrate that the ultimate destination and end use of the product is for research purposes and provided there are no other compliance issues; Or (5) further processing into highly purified steviol glycosides will meet the specification for >= 95% steviol glycosides as described above (see Reason for Alert). Stevia leaves and crude extracts obtained from stevia leaves are also indicated for release when, documentation exists to demonstrate that the ultimate destination and end use of these substances is for the production of highly purified steviol glycosides that will meet the specification for >= 95% steviol glycosides and provided there are no other compliance issues. Reference to any commercial materials, equipment, or processes does not in any way constitute approval, endorsement, or recommendation by FDA. ***The above exemptions do not apply to products identified on the Red List of this Import Alert. *** Release of Articles Subject to Detention Without Physical Examination Under This Import Alert: In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain stevia leaf or its crude extract. Such evidence could include private laboratory analysis of a representative sample(s) collected from the affected article. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the FDA Notice of Action (detention notice). If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)," ***If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov *** ***Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov. Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 03/14/2025 updates the reason for alert, guidance section including agency contacts, and PAC. Changes to the import alert are bracketed by asterisks (***). The term stevia, as used in commerce, refers to the leaves of Stevia rebaudiana (Bertoni) Bertoni, a plant native to various parts of South America. With regard to use in conventional foods, stevia leaf, or its crude extract, is not an approved food additive and is not considered GRAS due to inadequate toxicological information. With regard to use in dietary supplements, dietary ingredients (including stevia) are not subject to food additive regulations. Stevia leaf-derived products are approved for use as sweeteners in foods in Japan, Brazil, Australia, New Zealand, and other countries. Said products are used in a variety of foods, including teas, and are commonly used as table-top sweeteners. Historically, stevia leaves and stevia leaf-derived products have been offered for entry both in bulk and in finished products such as teas, drinks, seafood, fruits, vegetables and candies. Stevia leaves are known to contain high intensity sweetener compounds, which are collectively called steviol glycosides, and are approximately 200-300 times sweeter than sucrose. Steviol glycosides differ from stevia leaves in that they are purified extracts obtained from the leaves. Stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides, and other steviol glycosides for which FDA does not have questions following the review of a GRAS notification, individually or in combination, are the principal steviol glycosides used as sweeteners. ***HFP/Office of Office of Premarket Additive Safety (OPMAS)*** responded to GRAS notices concerning highly purified steviol glycosides(>=95% steviol glycosides on a dried weight basis with stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides or other steviol glycosides as principal components), and determined these products are not subject to detention under this Import Alert (see #3 in Guidance Section for documentation required under this provision). Other steviol glycosides that may be present in these products as minor components of the >=95% total steviol glycosides content specified above include other rebaudiosides, dulcoside A, rubusoside, and steviolbioside. It should be noted that steviol glycoside(s) may also be produced by fermentation technology without a need to use stevia leaves in the manufacturing process. In such cases, the import alert does not apply.
Country-specific information is available in the full alert detail on the FDA website.
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