WARNING LETTER

GC Natural MARCS-CMS 547463 — July 13, 2018

Recipient:: Recipient Name

Ms. Chun H. Guo/Mr. Wen Zhe Guo; GC Natural; 6081 Dale St. Suite B
Buena Park, CA 90621
United States

Issuing Office:: Los Angeles District Office; United States

OHAFO West Division 5
19701 Fairchild
Irvine, CA 92612-2506

WARNING LETTER

VIA UNITED PARCEL SERVICE

SIGNATURE REQUIRED

7/13/18
WL #547463

Ms. Chun H. Guo, Secretary and Owner

and

Mr. Wen Zhe Guo, CEO, President, and Owner

Dear Mr. and Ms. Guo:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, GC Natural, located at 6081 Dale St. Suite B, Buena Park, CA,on November 28-29 and December 4, 2017, and January 12 and 19, 2018. The inspection revealed serious violations of FDA’s regulation 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). These violations cause your dietary supplement products 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 they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Additionally, FDA reviewed your product labels collected during our inspection and your website at www.gcnatural.com. Based on our review, we have determined that certain of your products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.

You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New Drugs and Misbranded Drugs

FDA reviewed your website at the Internet address www.gcnatural.com in June 2018 and has determined that you take orders there for your Red Pyrola Plus + Advanced Joint Formula Capsules, CSDP GOLD Capsules, Rejeune Optimal Kidney & Liver Support Extract balls, C. Mori Optimal Respiratory System Support Extract balls, and Evodia Extract Powder. FDA also reviewed labels for these products that we collected during the inspection of your facility. The claims on your website and your product labels establish that the 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 claims found in your website include:

Product	Website
Red Pyrola Plus + Advanced Joint Formula Capsules	“Red Pyrola’s Main Ingredients” - “Red Pyrola - Relieves pain…” - “Du Huo - Relieves back pain, knee pain, and muscle aches. Great for inflammation in joints and chronic pain.” - “Mo Yao-Promotes tissue regeneration and healing. Great for inflammation and swelling.” “How to use Red Pyrola” - “For pain” - “For extreme pain” “Red Pyrola” - “Joint Pain, Back Pain, Knee Pain.”
CSDP GOLD Capsules	“CSDP Gold is especially good for those who:” - “Have a hard time cholesterol, blood pressure, and diabetes.” - “Have a long history of circulation problems.” - “Want a natural way to treat circulation problems” “CSDP Gold” - “Great for circulation problems.”
Rejeune Optimal Kidney & Liver Support Extract balls	“Rejeune’s Main Ingredients” - “Shan Zhu Yu - … helps with lumbar problems. Great for bladder problems and sexual problems.” - “Shan Yao - … great for Lumbar, Knee, and sexual problems.”
C. Mori Optimal Respiratory System Support Extract balls	“C. Mori” - “Coughing, Phlegm, Mucus. Great for problems of the Lungs.” “C. Mori is” - “[T]his formula is . . . great for relieving symptoms of coughing… excessive phlegm and mucus.” “C. Mori’s Main Ingredients” - “Chen Pi – Dissolves phlegm and stops cough.” “How to use C. Mori” - “For coughing and phlegm…” - “For serious coughing and phlegm…”
Evodia Extract Powder	“Evodia Extract’s Main Ingredients” - “Evodia – Relieves stomach pain and helps protect the stomach from ulcers and helicobacter infections.” - “Jiu Li Xiang – Great for stomache [sic] aches and relieves pain.” - “Bai Shao – Great for relieving stomach pain…” “Evodia Extract” - “Indigestion, Diarrhea. Great for stomach problems.” “How to use Evodia Extract” - “For stomach pain …” - “For extreme stomach pain or acid..” Label reads: “*Good for * Heartburn & Acid Reflux***”

Your products listed above are not generally recognized as safe and effective for the above referenced uses and, therefore, they 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 sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 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 CSDP Gold Capsules and Evodia Extract Powder 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, these products 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)].

Dietary Supplement CGMP Violations

Your dietary supplement products are 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 that do not meet CGMP regulations for dietary supplements. Additionally, even if your Red Pyrola Plus + Advanced Joint Formula Capsules, CSDP GOLD Capsules, Rejeune Optimal Kidney & Liver Support Extract balls, C. Mori Optimal Respiratory System Support Extract balls, and Evodia Extract Powder products did not have therapeutic claims which make them drugs, these products would be adulterated within the meaning of 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 regulations for dietary supplements (21 CFR Part 111).

We understand that your firm receives packaged and labeled dietary supplement products from one or more co-manufacturers, labelers, or packagers and that your firm holds and distributes these dietary supplement products. During the inspection, you told our investigator that your firm develops the formulation for some of your dietary supplement products and purchases raw materials and finished bulk products that your firm then delivers to your co-manufacturer. You also told our investigator that your firm designs and creates finished product labels, including the artwork and content; orders those labels to be printed by another firm; and delivers the finished product labels to your co-labeler.

1. 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you did not establish written procedures for the responsibilities of the quality control operations.

To the extent that another firm manufactures, packages, and/or labels your dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether the packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [see 72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). You must implement quality control operations in accordance with 21 CFR 111.65 to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. Your firm’s quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Further, your firm must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 21 CFR 111.140(b)(2)).

We have reviewed your response, received on January 30, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states you will establish and follow written procedures for the responsibilities of the quality control operations. We will evaluate the adequacy of your procedures for quality control operations at our next inspection.

2. You failed to establish specifications for dietary supplement labels (label specifications), as required by 21 CFR 111.70(d). Specifically, you did not establish label specifications.

We have reviewed your response, received on January 30, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states you will establish label specifications. We will evaluate the adequacy of your specifications for dietary supplement labels at our next inspection.

3. You failed to establish and follow written procedures for holding operations, as required by 21 CFR 111.453. Specifically, your firm has not established written procedures for holding operations. Once you establish these procedures, you must make and keep the records of such procedures, as required by 21 CFR 111.475(b)(1).

We have reviewed your response, received on January 30, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states you will establish written procedures for holding operations. We will evaluate the adequacy of your written procedures for holding operations at our next inspection.

4. You failed to establish and follow written procedures to fulfill the requirements for returned dietary supplements as required by 21 CFR 111.503. Specifically, your written procedure titled “Returns Policy” does not include all required information for identifying and quarantining returned dietary supplements until quality control personnel conduct a material review and make a disposition decision (see 21 CFR 111.510).

5. You failed to establish and follow written procedures to fulfill the requirements that apply to product complaints, as required by 21 CFR 111.553. Specifically, your written procedure titled “Complaint Handling Procedure” does not include the following requirements related to the review and investigation of product complaints, in accordance with 21 CFR 111.560:

(a) A qualified person must:

(1) Review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; and

(2) Investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury.

(b) Quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed.

(c) The review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and follow up action of any investigation performed, must extend to all relevant batches and records.

Misbranded Dietary Supplements

Your Youth Factor + for Women is 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 the 21 CFR part 101, as discussed further below. Additionally, even if your Red Pyrola Plus + Advanced Joint Formula Capsules, CSDP GOLD Capsules, Rejeune Optimal Kidney & Liver Support Extract balls, C. Mori Optimal Respiratory System Support Extract balls, and Evodia Extract Powder products did not contain therapeutic claims which make the products unapproved new drugs and/or misbranded drugs, your products would be 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 the 21 CFR part 101, as discussed further below.

1. Your Red Pyrola Plus +, Red Pyrola, Youth Factor+ for Women, CSDP Gold, CSDP, C. Mori, Evodia Extract, Rejeune and Sinus Health products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail 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). Furthermore, the identification of plant parts (when listed) must be in English and not Latin.

2. Your Evodia Extract product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

3. Your Red Pyrola, Evodia Extract, and Red Pyrola Plus+ products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example, the following botanical dietary ingredients fail to use the Latin binomial name or the standardized common name as stated in the reference Herbs of Commerce:

Red Pyrola and Red Pyrola Plus+: Safflower Pyrolae, Angelica Laxiflora, Paeoniae Rubra, Glycyrrhiza, Piper Futokadsura.
Evodia Extract: Foliument cacumen murrayae, Paeoniae Alba, Indian bread.
Rejeune: Discorea oppositae, Cortex Moutan, Phizoma Alismatis, Ramulus Cinnamorni, Semen Plantaginis.
C. Mori: Cortex Mori, Tussilanginis Farfaraeflos, Glycyrrhizae.
CSDP: S. miltiorrhiza.
Youth Factor+: Chuanxiong, Cortex Moutan, Leonuri.
Sinus Health: Saposhnikoviae.

4. Your Red Pyrola, Youth Factor+, Evodia Extract, and Rejeune products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. An incorrect serving size could cause a consumer to overconsume your product.

Your Red Pyrola, Rejeune, and Youth Factor+ product labels indicate a range for the serving size rather than the maximum amount recommended per eating occasion.
Your Evodia Extract product label declares a serving size of 10 g which is equivalent to 1 bag. The serving directions instruct the consumer to mix 1-2 bags with water. Therefore, the correct serving size is 20 g, and the number of servings per container and quantitative amounts of the dietary ingredients will consequently require adjustment.

5. Your Red Pyrola, Rejeune, and Youth Factor+ products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343 (q)(1)(B)] because the label fails to declare the correct number of servings per container in accordance with 21 CFR 101.36(b)(1)(ii). Specifically, the number of servings is stated as a range instead of one value.

6. Your Red Pyrola, Red Pyrola Plus+, CSDP and Youth Factor+ 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 presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, your CSDP and Youth Factor+ product labels fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed [21 CFR 101.36(b)(3)(iv)].

7. Your CSDP and Youth Factor+ products are misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act [21 U.S.C. § 343 (s)(2)(A)(ii)(I)] in that the label fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36.

8. Your Evodia Extract and Youth Factor+ products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

9. Your Red Pyrola, Evodia Extract, Rejeune, CSDP, CSDP Gold, Youth Factor+, C. Mori, Sinus Health, and Red Pyrola Plus+ products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include a complete address or phone number.

This letter is not an intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. It is your responsibility to ensure that your firm and your products comply with the Act and all implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and injunction.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. 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 the 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, the FDA may assess fees to cover any reinspection-related costs.

Your response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Compliance Branch, HAF Division West 5, HFR-PA150

Los Angeles District

19701 Fairchild
Irvine, CA 92612

If you have any questions about the content of this letter, please contact Sara J. Dent Acosta, Compliance Officer, at 619-941-3767. Include Special Identifier “Dent Acosta FEI # 3011411645” on all correspondence.

Sincerely,

/S/

Darla Bracy, Director

Office of Human and Animal Foods

Division 5 West

US Food and Drug Administration