The Food and Drug Administration (FDA) conducted an inspection of your facility located at 417 Eccles Avenue, San Francisco, California March 3 - 23, 2015. During the inspection, our investigators collected labels of your Ten Ren Chamomile Tea, Relaxing Tea, Chrysanthemum Tea, and Hibiscus Spice Tea. Based on the inspection and our review of your product labeling we found serious violations of the Federal Food, Drug and Cosmetic Act and applicable regulations. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
The FDA reviewed the regulatory status of the ingredient, "Stevia leaf, tea bag cut", used as an ingredient in your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea. We have determined your products are adulterated under Section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(2)(C)(i)] because they bear or contain an unsafe food additive. Specifically, your product contains Stevia leaf, which is an unapproved food additive under Section 409 of the Act [21 USC 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170).
Additionally, based on our review of your product labels and formulas, your Ten Ren Chamomile Tea, Relaxing Tea, Chrysanthemum Tea, and Hibiscus Spice Tea products are misbranded within the meaning of Section 403 of the Act [21 USC 343] as described further below.
Unapproved Food Additive
Any substance added to a conventional food, such as your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of Stevia leaf. We are not aware of any information to indicate that Stevia leaf is the subject of a prior sanction (see 21 CFR 181). As explained below, we are not aware of any basis to conclude that Stevia leaf is GRAS for use in conventional foods.
FDA's regulations in 21 CFR 170.30(a) - (c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts. The basis of such views may be either (1) scientific procedures, or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.
- Under 21 CFR 170.3(h), "[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance." Under 21 CFR 170.30(b ), "[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient." Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.
- Under 21 CFR 170.3(f), "[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers."
- Under 21 CFR 170.30(c)(1 ), "[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information." Importantly, however, the fact that a substance was added to food before 1958 does not, in itself, demonstrate such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
- Under 21 CFR 170.3(i), "[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use." The regulation provides that, in determining safety, the following factors are to be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).
While FDA has received inquiries and petitions for the use of whole-leaf Stevia or its crude extracts in food, data and information necessary to support the safe use have been lacking. In fact, literature reports have raised safety concerns about the use of such forms of Stevia, including concerns about control of blood sugar, and effects on the reproductive, cardiovascular and renal systems.
In light of these safety concerns, the use of Stevia leaf in your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea products does not satisfy the criteria for GRAS status outlined above. Furthermore, FDA is not aware of any other exemption from the food additive definition that would apply to Stevia leaf for use as an ingredient in a conventional food, such as your tea products. Therefore, the Stevia leaf in your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea products is a food additive under Section 201(s) of the Act [21 USC 321(s)] and is subject to the provisions of Section 409 of the Act [21 USC 348]. Under Section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Stevia leaf is not approved for use in any food, including teas. Therefore, your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea products are adulterated within the meaning of Section 402(a)(2)(C)(i) of the Act [21 USC 342(a)(2)(C)(i)].
Your Hibiscus Spice Tea, Chamomile Tea, Relaxing Tea, and Chrysanthemum Tea are misbranded under section 403(f) of the Act [21 USC 343(f)] because the product labels contain information in a foreign language but do not appear to represent all the required label information in both English and the foreign language [21 CFR 101.15(c)(2)]. The net quantity of contents statement and the brand name, for example, are declared in English and in a foreign language but none of the other mandatory label information appears in both languages.
This letter is not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should take prompt action to correct these and similar violations. Failure to promptly correct the violation may result in regulatory action without further notice, including seizure and/or injunction.
We also offer the following comments regarding your Hibiscus Spice Tea, Chamomile Tea, Relaxing Tea, and Chrysanthemum Tea:
- To meet the requirements of 21 CFR 101.5(d), your product labels must include the zip code for the place of business of the manufacturer, packer, or distributor. "The statement of the place of business shall include the street address, city, State, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory." While we note that your firm is shown in a current telephone directory, your labels fail to include the zip code for the facility.
- Further, the name and place of business and the ingredient statements are not on the same panel of all four product labels [21 CFR 101.2(d)(1)].
- Your Hibiscus Spice Tea product is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, in descending order of predominance by weight, as required under 21 CFR 101.4(a)(1). Your Hibiscus Spice Tea product was originally labeled with no ingredient statement which was pointed out to you during our inspection. Various other of your teas contained incomplete ingredient statements. Your proposed corrective action of placing a white stick-on label with the full ingredient declaration is an acceptable correction pending continuous correction so long as the label does not cover any mandatory label statements and is tightly adhered. This is acceptable until your next label printing.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.