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  5. STPCA Inc. dba Sun Ten Laboratories - 645336 - 04/07/2023
  1. Warning Letters

WARNING LETTER

STPCA Inc. dba Sun Ten Laboratories MARCS-CMS 645336 —

Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Mr. Michael Tsai
Recipient Title
COO
STPCA Inc. dba Sun Ten Laboratories

9250 Jeronimo Rd.
Irvine, CA 92618-1905
United States

Issuing Office:
Division of Human and Animal Food Operations West V

United States

WARNING LETTER

CMS # 645336

Dear Mr. Tsai:

The U.S. Food and Drug Administration (FDA) inspected your facility, located at 9250 Jeronimo Rd., Irvine, CA 92618, on September 19-21, 29 and October 5, 2022. In February 2023, we also reviewed your website at the Internet address https://sunten.com/. Based on inspectional findings and a review of your website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New Drugs/Misbranded Drugs

FDA reviewed your website at the Internet address https://sunten.com/ in February 2023, and has determined that you take orders there for the products Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Yi Min

  • “Relief of allergy related symptoms”

Jian Shen

  • “Improve… low blood sugars”

Yu Zhi

  • “Relief of hemorrhoids conditions and constipation”

Xiao Yan

  • “Reduce urinary tract infections symptoms”

Qu Yu

  • “Support trauma injury relief”

Yi Jun

  • “Relief of inflammation and fungal infection”

Platcladus Leaves Ce Bai Ye

  • “Aids in stopping bleeding”

Shu Jin 2

  • “Relief of pain and stiffness in the lower body”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Jian Shen, Xiao Yan, and Platcladus Leaves Ce Bai Ye are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Jian Shen, Xiao Yan, and Platcladus Leaves Ce Bai Ye fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

Adulterated Dietary Supplements

The facility inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Based on these violations, your Lycium Formula Huan Shao Dan, (b)(4) Zinc (b)(4), and (b)(4) products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Your significant violations of CGMP requirements are as follows:

1. Your firm failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.70(a). Specifically:

a. You failed to establish an identity specification for each component you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). For example, the identification specification for the Lycium Formula (Huan Shao Dan) dietary ingredient for your Lycium Formula Huan Shao Dan finished product lists a specification as “Positive” and a testing result of “Confirm.” The Material Test Report related to this dietary ingredient has a differing specification of “Positive (Match with (b)(4) Standard)” and a result stated as “conforms” for Lycium Formula (Huan Shao Dan), lot number (b)(4). “Positive” and “Positive (Match with (b)(4) Standard)” do not provide specific ranges or parameters regarding the testing method used to determine if a dietary ingredient has been appropriately identified. In addition, a testing report should show various bands relating to the components of the blend or the dominant constituents of each ingredient for this type of multi-ingredient product;

b. You failed to establish specifications that are necessary to ensure that the specifications for purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). For example, you did not have specifications for the ingredients Fructus Foeniculi and Radix Rehmanniae praeparata to ensure the purity, strength, and composition specifications will be met for the Lycium Formula Huan Shao Dan finished product; and

c. You failed to establish specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). For example, you did not establish specifications for identity, purity, strength, and composition for your Lycium Formula Huan Shao Dan finished product.

Once you have established specifications, you must determine whether the specifications that you establish under 21 CFR 111.70 are met, as required by 21 CFR 111.73 and 21 CFR 111.75(c). Specifically, before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Further, you must verify that your finished batch of the dietary supplement meets product specifications for the identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c). You must also make and keep records, including records for the specifications you establish, in accordance with 21 CFR 111.95.

In addition, under 21 CFR 111.75(a)(2), you must either conduct appropriate tests or examinations or rely on a certificate of analysis (COA) from the supplier of the component that you receive, provided that the COA meets specific requirements. To the extent you receive dietary ingredients from suppliers from which you receive a COA, you may only rely on a COA if the following conditions are met: (A) you first qualify the supplier by establishing the reliability of the supplier's COA through confirmation of the results of the supplier's tests or examinations; (B) the COA includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) you maintain documentation of how you qualified the supplier; (D) you periodically reconfirm the supplier's COA; and (E) your quality control personnel review and approve the documentation setting forth the basis for qualification (and re‐qualification) of any supplier.

We have reviewed your responses, dated October 20, 2022, and November 7, 2022. Your October 2022 response included a revised identification specification for the Lycium Formula (Huan Shao Dan) dietary ingredient. This revised specification continues to have “Confirm” as the testing result and does not provide any quantitative data to determine the ingredient’s identity has been confirmed.

The component specification sheets provided in your October 2022 response include an identity specification for (b)(4), and (b)(4) (components of your (b)(4) product) listing a retention value (Rf value) via (b)(4) analysis for each dietary ingredient. The Rf values identified in your Raw Material Specification sheets differ from the Rf values identified in the ingredient supplier’s Certificate of Analysis for each ingredient. Your component specification sheets document that the identity test is conducted via an in-house (b)(4) method. You did not provide documentation to support the identity specification documented via your in-house (b)(4) method. In addition, and as noted above, because the product is multi-ingredient product, we would expect the finished testing specifications to include multiple bands for each of the components that would give the respective Rf values.

Your October 2022 response also included a revised finished product specification for your Lycium Formula Huan Shao Dan finished product. The identity specification for this product also only contains the test result of “Confirmed” and no quantitative data.

Your responses did not include any information regarding purity, strength, composition specifications related to the ingredients referenced above or to the finished product. You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met.

Furthermore, the component specification sheets in your October 2022 response document (b)(4) analysis and Fournier Transform Infrared Spectroscopy (FT-IR) analysis will be conducted against an “in-house reference standard which is established by outsourcing testing Labs.” You do not have an adequate identity specification because you are not conducting identity testing against a qualified reference standard. You did not provide procedures for creating a qualified reference standard. You did not provide documentation that you are creating a reference standard by obtaining reference standard material of highest purity by reasonable effort and thoroughly characterizing the material to ensure identity, purity, quality, and strength. You did not provide qualification documentation for these standards showing they have been reviewed and approved by quality control personnel prior to use.

2. Your quality control personnel failed to reject a component or dietary supplement when a specification established in accordance with 21 CFR 111.70 was not met, nor did they approve a permitted treatment, an in-process adjustment, or reprocessing, as required by 111.113(b)(2). Your firm’s quality control personnel also failed to conduct a material review and make a disposition decision when the established specification was not met, as required by 21 CFR 111.113(a)(1). For example, your finished product testing result found (b)(4)/serving of zinc in your (b)(4) Zinc (b)(4) product, lot number (b)(4), which exceeded your established finished product specification for zinc at (b)(4) (per serving or capsule). Your quality control unit did not conduct a material review and make a disposition decision that the specification was not met.

In addition, your quality control unit released the product (b)(4) Zinc (b)(4), lot number (b)(4), on June 28, 2022, but third-party laboratory results for microbial testing and zinc potency were not released until July 5, 2022, and July 7, 2022, respectively.

We have reviewed your responses, dated October 20, 2022, and November 7, 2022. Your October 2022 response stated that you have trained personnel on conducting investigations when specifications are not met. Your response did not describe the type of training provided or include evidence of training records demonstrating the associated personnel will be able to release components and finished products appropriately.

Your November 2022 response included an OOS [out-of-specification] Investigation Report regarding the zinc levels in (b)(4) Zinc (b)(4), lot number (b)(4). As part of this investigation, it appears that a reserve sample of (b)(4) Zinc (b)(4), lot number (b)(4), was tested and found to have a level of (b)(4) per capsule, which would have been within the specification. However, the investigation testing was performed using a different methodology and by a different laboratory than the laboratory which conducted the original analysis, thus making it difficult to compare the results and to verify accuracy.

3. You failed to establish master manufacturing records (MMRs) that include all required components of 21 CFR 111.210. Specifically, the MMRs for your Lycium Formula Huan Shao Dan, (b)(4), and (b)(4) Zinc (b)(4) products failed to include:

  • A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].

The MMRs for your (b)(4) Zinc (b)(4) product failed to include:

  • A complete list of components to be used [21 CFR 111.210(b)];
  • An accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)];
  • The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)]; • A statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)];
  • A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
  • Written instructions [21 CFR 111.210(h)], including the following:

      o Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packed and labeled as specified in the master manufacturing record [21 CFR 111.210(h)(1)].
      o Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
      o Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h)(3)].
        i. Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component [21 CFR 111.210(h)(3)(i)]; and
        ii. For manual operations, such specific actions must include [21 CFR 111.210(h)(3)(ii)]:
          A. One person weighing or measuring a component and another person verifying the weight or measure [21 CFR 111.210(h)(3)(ii)(A)]; and
          B. One person adding the component and another person verifying the addition [21 CFR 111.210(h)(3)(ii)(B)].
    o Special notations and precautions to be followed;
    o Corrective action plans for use when a specification is not met

Misbranded Dietary Supplements

In addition, the Lycium Formula Huan Shao Dan, (b)(4), and (b)(4) Zinc (b)(4) products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:

1. The Lycium Formula Huan Shao Dan product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343 (f)] because the product label’s front panel and dietary ingredients listed in the proprietary blend contain information in two languages but do not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

2. The Lycium Formula Huan Shao Dan product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

3. The Lycium Formula Huan Shao Dan, (b)(4), and (b)(4) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product label fails to declare the common or usual name (standardized common name) or Latin binomial of each ingredient (in the absence of a standardized common name per Herbs of Commerce) used as required by 21 CFR 101.4(h).

4. The Lycium Formula Huan Shao Dan and (b)(4) Zinc (b)(4) products are misbranded within the meaning of section 403(q)(5)(F) the Act [21 U.S.C § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. For example:

a. Your Lycium Formula Huan Shao fails to place the heading, “Amount Per Serving,” above the listed quantitative amount per serving in accordance with 21 CFR 101.36(e)(1).

b. Your (b)(4) Zinc (b)(4) includes a footnote to the % Daily Value for zinc that specifies Recommended Daily Allowances for zinc that vary depending on different groups or persons. There is no provision in the regulation for a symbol that links to the same symbol appearing before information concerning Recommended Daily Allowances for different groups or persons. Furthermore, this Recommended Daily Allowance statement represents that this product is intended for different groups of persons. The product’s Supplement Facts label fails to list the serving size for each of the groups indicated on the label. If the product is represented for persons within more than one group, the quantitative amount and percent of Daily Value for each group shall be presented in separate columns in accordance with 21 CFR 101.36(b)(2)(iii)(E).

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild Irvine, CA 9261

Refer to Unique Identification Number CMS# 645336 when replying.

If you have any questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov or 510-337-6854.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5

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