Source: https://www.casewatch.net/fdawarning/prod/2013/prestige.shtml
Timestamp: 2019-04-26 02:17:17+00:00

Document:
Prestige Chinese Teas Company, Inc.
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, located at 882 Mahler Road, Burlingame, CA 94010, from April 2, 2013 through April 9, 2013. We found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products identified below to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
FDA reviewed your websites at the Internet address www.pcteas.com and www.teastohealth.com in November 2013 and has determined that you take orders there for the products Ginseng Lin-Chi TuoCha tea, Premier LIN-CHI Plus capsules, E-TEA Herbal Drink, E-TEA Capsules, and Herbal Eczema Capsules, which the websites promote for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites establish that the products are drugs 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.
Further, during the inspection of your facility, our investigators collected labels associated with many of your products. Our review of your product labels revealed that your Dieters’ Herbal Drink X-Strength, Dieters’ Herbal Drink Regular Strength, Dieters’ Herbal Drink capsules, E-Tea Herbal Drink tea bags, E-Tea Herbal Drink capsules and Premiere LIN-CHI Plus Capsule products are misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov.
“A. G. Payne … carried out an observational pilot study in a southern California medical clinic (1989) in which hypercholesterolemic patients were put on Yunnan Tuocha tea (3 cups per day) by the clinic's director … Payne documented a 19.33% average reduction in total (serum) cholesterol at the end of the thirty day test period.
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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Further, your products, Ginseng Lin-Chi Tuo Cha tea, Premier Lin-Chi Plus Capsules, E-Tea Herbal Drink, and E-Tea Capsules, are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under 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 which do not meet the CGMP regulations for dietary supplements. Additionally, even if your Ginseng Lin-Chi Tuo Cha tea, Premier Lin-Chi Plus Capsules, E-Tea Herbal Drink, E-Tea Capsules, and Herbal Eczema Capsules did not contain disease claims in their labeling that cause the products to be unapproved new drugs under section 505(a) of the Act [21 U.S.C. § 355(a)], they would still be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act because they have been prepared, packed, or held under conditions which do not meet CGMP regulations for dietary supplements.
Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label [21 CFR 111.70(g)].
Specifically, during our inspection, you told our investigator that you have not established and do not have written documentation of component, in-process, or finished product specifications for any of the dietary supplements you manufacture, including Dieters’ Herbal Drink tea bags regular strength, Dieters’ Herbal Drink tea bags extra strength, Dieters’ Herbal Drink capsules, Ginseng Lin-Chi Tuo Cha tea bags, Premier Lin Chi Plus capsules, E-Tea Herbal Drink tea bags, and E-TEA capsules. Once you have established specifications for your dietary supplements, you must also determine whether your specifications have been met, as required by 21 CFR 111.75.
2. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, you informed our investigator that you do not perform any tests or examinations to verify the identity of the dietary ingredients used to manufacture any of your finished dietary supplements. You also informed our investigator that you can determine the identity of your product based on your supplier’s certificate of analysis (COA). However, a COA from a supplier of the components that you receive may be used to confirm the identity of only components that are not dietary ingredients, as defined in section 201(ff) of the Act. In addition, before relying on a COA from the supplier of the components that you receive to confirm the identity of components and to determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, you must 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, as required by 21 CFR 111.75(a)(2)(ii)(A) and otherwise comply with the requirements of 21 CFR 111.75(a)(2)(ii). Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition FDA under 21 CFR 111.75(a)(1)(ii) and FDA exempts you from such testing.
3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement you manufacture, and for each batch size, to ensure uniformity in the finished batch, as required by 21 CFR 111.205(a). Specifically, written master manufacturing records have not been established for any of the dietary supplements manufactured by your firm, including Dieters’ Herbal Drink regular strength, Dieters’ Herbal Drink extra strength, Dieters’ Herbal Drink capsules, Ginseng Lin-Chi Tuo Cha tea bags, Premier Lin Chi Plus capsules, E-TEA Herbal Drink tea bags, and E-TEA capsules. Evaluating the production of each batch by the quantity of each finished product batch is not an appropriate substitute for written master manufacturing records. MMRs, once established, must include all of the requirements in 21 CFR 111.210.
4. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). During our inspection our investigator observed the manufacturing and packaging of Dieters’ Herbal Drink extra strength tea bags . You were unable to provide any records showing the production of the dietary supplement, and confirmed that you do not prepare a batch production record every time you manufacture a batch of a dietary supplement. Each batch production record that you prepare must include all of the requirements in 21 CFR 111.260.
5. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). During our inspection, you informed our investigator that you do not have any written procedures established or documented.
Your Dieters’ herbal Drink capsules finished product labels declare the ingredients Malva, Persimmon, Fennel and Aurantium fruit. However, based on our observations and the statements you provided during the inspection, the product does not contain the ingredients Malva or Persimmon.
7. Your E-Tea Capsules products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fails to identify the product using the term ‘dietary supplement,’ or other appropriately descriptive term, in accordance with 21 CFR 101.3(g).
8. Your Dieters’ Herbal Drink capsule and Premiere LIN-CHI Plus Capsule products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the labels fail to bear nutrition information in the form of a “Supplement Facts” panel in accordance with 21 CFR 101.36.
9. Your Dieters’ Herbal Drink capsule, Dieters’ Herbal Drink Regular Strength tea bags, Dieters’ Herbal Drink X-Strength tea bags, E-Tea Herbal Drink tea bags, E-Tea Herbal Drink capsules, and Premier LIN-CHI Plus Capsules are misbranded within the meaning of sections 403(q)(5)(F) and 403(s)(2)(A)(i) of the Act [21 U.S.C. § 343(q)(5)(F) and 21 U.S.C. § 343(s)(2)(A)(i)] in that the labels fail declare the total quantitative amount by weight per serving for each dietary ingredient or proprietary blend of dietary ingredients contained in the dietary supplement products.
Your Premiere Lin-Chi Plus Capsule, E-Tea Capsules, and Dieters’ Herbal Drink capsules fail are formulated as capsules, but the labels fail to declare capsule ingredients in accordance with 21 CFR 101.4(a) and 21 CFR 101.4(g).
11. Your blackberry, spearmint, lemon, orange, and cinnamon flavored E-Tea Herbal Drink teabags are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] in that the labels’ ingredient declaration does not list the presence of an artificial flavoring ingredient as required by 21 CFR 101.22(h) and 21 CFR 101.4(g).
The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all the products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction. Please be advised a description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
We note that during the inspection, our investigators collected promotional materials for your Ginseng Lin-Chi Tuo Cha tea, Premier Lin-Chi Plus Capsules, E-Tea Herbal Drink, and E-Tea Capsules that promote such products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act. To the extent that such materials accompany your products, the claims would establish that your Ginseng Lin-Chi Tuo Cha tea, Premier Lin-Chi Plus Capsules, E-Tea Herbal Drink, and E-Tea Capsules are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Your written response should be sent to Lawton W. Lum, Director of Compliance at the address noted above and reference unique identifier 396340. If you have any questions concerning this letter, please contact Compliance Officer Sergio Chavez at (510) 337-6886.
This page was posted on April 24, 2014.

References: § 342
 § 321
 § 343
 § 321
 § 355
 § 331
 § 352
 § 331
 § 342
 § 355
 § 343
 § 343
 § 343
 § 343
 § 343