Import Alert 45-06

"Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts"

***Revision to this import alert dated 7/22/2015 updates specific language in order to reflect more recent GRAS notifications. The revision updates the reason for alert, guidance, and keywords sections. Changes are bracketed by asterisks.***

The term stevia, as used in commerce, refers to Stevia rebaudiana (Bertoni) Bertoni, a plant native to various parts of South America.

With regard to use in conventional foods, stevia leaf is not an approved food additive and has not been affirmed as GRAS in the United States due to inadequate toxicological information. Whole leaf stevia has not been the subject of a GRAS notice.

With regard to use in dietary supplements, dietary ingredients (including stevia) are not subject to food additive regulations.

Stevia leaves are known to contain several high intensity sweetener compounds, which are collectively called steviol glycosides. 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; these differ from stevia leaves in that they are purified extracts obtained from the leaves. Steviol glycosides are approximately 200-300 times sweeter than sucrose.

Stevia-derived products have reportedly been 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-derived products have been offered for entry both in bulk and in finished products such as teas, drinks, seafood, fruits, vegetables and candies.

CFSAN/Office of Food Additive Safety (OFAS) has responded to GRAS notices concerning highly purified steviol glycosides obtained from stevia leaves, wherein FDA did not question the basis for the petitioners' GRAS determinations. Consequently, products that are/or contain 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, for which FDA does not have questions following the review of a GRAS notification,*** as determined by the method cited below or any other equivalent method) are not subject to detention under this Import Alert. 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.

Districts may detain without physical examination all products identified on the Attachment to this Import Alert.

In addition, if review of the labeling and/or entry documentation reveals stevia leaves or stevia-derived products, Districts 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, such as a certificate of analysis, should be provided to demonstrate the composition 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), Districts may contact CFSAN/OC/Labeling Compliance Team;

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 as described above (see Reason for Alert) and provided there are no other compliance issues.

If Districts determine through sample collection and analysis that a food product contains stevia leaves and/or crude stevia extracts that do not meet the specification for highly purified steviol glycosides as described above (see Reason for Alert), a recommendation for detention without physical examination should be forwarded to the ***Division of Import Operations (DIO)***, HFC-170, with the analytical package; UNLESS the product is labeled as a dietary supplement or for use solely as a dietary ingredient in the manufacture of a dietary supplement product.

The ***ORA, Office of Regulatory Science(ORS)*** recommends that laboratories utilize the method published in the ***Journal of Food Additives and Contaminants: Part A, Vol. 29, issue 12(2012) p. 1861-1871, "Simultaneous determination of steviol and steviol glycosides by liquid chromatography-mass spectrometry."***

All standards cited in the publication can be obtained commercially. Please note that ***the method analyzes for nine (9) of the steviol glycosides, as well for steviol.*** The testing laboratory should determine that the ***total***steviol glycosides constitute > 95% of the product on a dried weight basis.

Reference to any commercial materials, equipment, or processes does not in any way constitute approval, endorsement, or recommendation by FDA.

***In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis using FDA recommended methods.

If a firm wishes to request removal from detention without physical examination (DWPE), information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future shipments will be in compliance.

Additional information regarding being removed from Import Alert can be found at:

http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179271.htm

In its request, the firm should forward information supporting its position to FDA at the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive
ELEM - 3109
Rockville, MD 20857

Or via e-mail: Importalerts2@fda.hhs.gov

For questions or issues concerning import operations, contact FDA's Division of Import Operations at (301) 796-0356.***

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact ***ORA, Office of Regulatory Science *** at (301)***796-6600***.

For questions or issues concerning technical/scientific interpretation of documents provided at the time of entry, contact***CFSAN, Office of Compliance, Division of Enforcement at (240) 402-1750 or via email at: CFSANEnforcement@fda.hhs.gov ***

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% or more steviol glycosides (see Reason for Alert below). (For purposes of this Alert, extracts that do not contain 95% or more steviol glycosides are referred to as "crude extracts.")

All food product codes where stevia leaves or crude extracts obtained from stevia leaves are present as an ingredient (except for dietary supplements).

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a food additive that is unsafe within the meaning of Section 409, namely stevia leaves or crude extracts obtained from stevia leaves. [Adulteration, Section 402(a)(2)(C)]"

OASIS Charge Code: UNSAFE ADD

PROBLEM: Unsafe food additive