Inspections, Compliance, Enforcement, and Criminal Investigations

Reishi D. International, Inc. 2/6/18

 

  

Black HHS-Blue FDA Logo

 

San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
 

 
 

 

WARNING LETTER
                                                                                                        
Via UPS Overnight
 
February 7, 2018                        
 
Mr. Zheng Xiong Li, CEO
Reishi D. International, Inc.
451 Victory Ave, Suite 3
South San Francisco, CA 94080
 
Dear Mr. Zheng Xiong Li:
 
On August 2nd – 7th, 2017, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 451 Victory Ave, South San Francisco, CA. The inspection revealed serious violations of the Current Good Manufacturing Practice (cGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Regulation Title 21 Code of Federal Regulations (CFR), Part 111, (21 CFR 111). These violations cause your Reishi D. dietary supplement product 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 product has been prepared, packed, or held under conditions that do not meet cGMP requirements for dietary supplements. 
 
Additionally, during the inspection of your facility, our investigator collected labels and brochures for your Reishi D. dietary supplement which contain violations of the Act and applicable regulations. We received your written response letter dated October 15, 2017. We have reviewed your response, and we address your proposed corrective actions below. You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.
 
Unapproved New Drugs
 
We have determined that the claims on your product brochures that are distributed with your Reishi D. product establish that your Reishi D. dietary supplement product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. 
 
Examples of some of the claims that provide evidence that your product is intended for use as a drug include the following:
  • “Chinese medicine ….”
  • “[H]as been used in Traditional Chinese Medicine for thousands of years ….”
  • “[B]ees use propolis to protect themselves from bacteria and diseases. Propolis has been around for over 40 million years and has been used by man for thousands of years ….”
  • “Propolis … contains more than 30 different flavonoids and antioxidants to help control free radicals. Free radicals are caused by waste from our body cells that increase with … infections … and toxins. The antioxidants help to neutralize the free radicals and prevent cell damage.” 
Your Reishi D. product is not generally recognized as safe and effective for the above-referenced uses and, therefore, the product is a “new drug” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce in the United States 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 based on scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
 
Adulterated Dietary Supplements
 
Even if your product labeling did not have therapeutic claims which make your Reishi D. product an unapproved new drug, it would still be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because the product has been held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). 
 
As a distributor that contracts with a manufacturer to manufacture, package, and label 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, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations; however, 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)). 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 with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
The significant violations documented during the inspection include, but are not limited to the following:
  1. Your quality control unit must approve for release, or reject any packaged and labeled dietary supplement, including a repackaged or relabeled dietary supplement, for distribution, as required by 21 CFR 111.127(h). You must also provide written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements, as required by 21 CFR 111.140(b)(2). Specifically, during the inspection you did not provide documentation of the approval for release of your dietary supplements by your quality control personnel.
We have reviewed your response dated October 15, 2017 in which you provided a copy of your Quality Control procedure. In your Quality Control procedure, you state that you inspect the packaging box, upon receipt, to ensure that there is no damage to the box before signing the delivery bill of lading. However, your response is inadequate because your written procedures for quality control operations do not include quality control functions such as reviewing documentation from the manufacturers with whom you contract relating to how the products you release into commerce are manufactured and whether they conform to established specifications.
  1. Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you distributed Reishi D., Lot #CC4020-6160 and failed to collect and hold a reserve sample. You also informed our investigator that you were not aware of the requirement to collect and hold reserve samples of finished dietary supplements you received from your contract manufacturer.
To fulfill the requirements for collecting and holding reserve samples, your firm must collect reserve samples for each lot of packaged and labeled dietary supplements that you distribute, and hold the samples in accordance with 21 CFR 111.83(b). Specifically:
 
o   Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)];
o   Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)];
o   Be retained for at least (l) year past the shelf life date (if shelf life dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(3)]; and
o   Consist of at least twice the quantity necessary for all tests or examinations to determine whether the dietary supplement meets product specifications [21 CFR 111.83(b)(4)].
 
We have reviewed your October 15, 2017 response. You provided a copy of the Procedure of Holding. In step 3 of the procedure you state “pull 3 bottles of products from each lot from the same container in different boxes of the last batch (must keep for at least one year after the expiration date).” Implementation of this corrective action will be verified during the next inspection.
  1. You failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you did not have written procedures for handling any returned dietary supplements, including when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520, or when a returned dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515. Specifically, you told our investigator that you did not have any written procedures for handling any returned dietary supplements.
We have reviewed your October 15, 2017 response and you have not provided documentation to support corrective action for this observation.
 
Misbranded Dietary Supplement
 
Based on labeling collected during the inspection of your firm, we note that several of your products are misbranded under section 403 of the Act and FDA’s labeling regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101), as follows:
 
1.    Your Reishi D. (60 Capsules) and (30 capsules) 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).  We note that all the ingredients (i.e., Ganoderma lucidum extract, Cordyceps sinensis, etc.) fail to comply with this requirement.
 
2.    Your Reishi D. (60 Capsules) and (30 capsules) product is 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 labels are incorrect. The terms "serving" or "serving size" for a dietary supplement are defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2, as the maximum amount recommended on the label for consumption per eating occasion. For example, the suggested use states “Take 1 capsule twice daily," but the serving size lists "2” capsules. The serving size listed should be one capsule. An incorrect serving size could lead a consumer to overconsume the product.
 
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or about your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are following all applicable statutes and regulations, including the Act and applicable FDA regulations. You should take prompt action to correct all the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to correct and prevent these violations, or similar ones, may result in FDA taking regulatory action, including, without limitation, seizure or injunction.
 
In addition, we note the following:
  • You make the following claim in your product brochure: “Propolis is a rich source of minerals, vitamins C, E, provitamin A, and B-Complex ….” To bear “rich in” claims, a product must contain 20% or more of the RDI or DRV of the nutrients that are the subject of the claim, in accordance with 21 CFR 101.54(c). The Supplement Facts label for your Reishi D. product (60 capsules) and (30 capsules) does not list any minerals or vitamin C, E, A or B vitamins. Furthermore, an RDI has not been established for “provitamin A.” We note that under 21 CFR 101.54(a) and 21 CFR 101.13(n), you must comply with the labeling provisions in 21 CFR 101.36 to make this nutrient content claim.    
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 after 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 mean 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.
 
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter.  In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones.  In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such corrective actions.  If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Please send your reply to the Food and Drug Administration, Attention: Matthew Walburger, Acting Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502. Please reference Case number 537352. If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737. 
 
 
Sincerely,
/S/ 
Darla Bracy, District Director
Office of Human and Animal Food
Division West 5  
 
 
 
Cc:
Shuo Lin Xu
Joy Summation Inc.
451 Victory Ave Suite 3
South San Francisco, CA 94080

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