WARNING LETTER
Far East Summit LLC
MARCS-CMS 681536 —
September 13, 2024
Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
William S. Martin
Recipient Title
President and Co-Owner
Far East Summit LLC
38903 Dexter Road
Dexter
,
OR
97431-9798
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
September 13, 2024
WARNING LETTER
Dear Mr. Martin:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, Far East Summit LLC, located at 38903 Dexter Road, Dexter, Oregon, from January 10, 2024, through February 14, 2024, during which FDA reviewed your product catalog, Far East Summit Product Listing and Order Form; and your website, www.fareastsummit.com. Based on our inspectional findings and our review of your product catalog and website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
During the inspection, we reviewed your website, www.fareastsummit.com, from which you take orders for your products Si Ni San, Du Huo Ji Sheng Tang, Ba Zheng Tang, and Xue Fu Zhu Yu Tang; and your product catalog, Far East Summit Product Listing and Order Form, which offers for sale your products Si Ni San, Bu Xue Tiao Jing Tang, Gan Mao Ling, Guan Jie, Huang Lian Shang Qing, Jin Gu Die Shang Wan, Shen Ling Bai Zhu San, Su Gan Wan, Tong Jing Tang, Xiao Jian Zhong Tang, and Xian Yao San. The claims on your website and product catalog establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the diagnosis, 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 claims on your product catalog, Far East Summit Product Listing and Order Form, that provide evidence these products are intended for use as drugs include:
Si Ni San
“Expels pathogens, resolves depression”
Bu Xue Tiao Jing Tang
“[R]esolves depression”
Gan Mao Ling
“Relieves cough”
Xian Yao San
“[R]esolves depression”
Guan Jie
“Disperses swelling, disinhibits the joints and relieves . . . pain”
Huang Lian Shang Qing
“Suppresses cough”
Jin Gu Die Shang Wan
“Staunches bleeding, disperses swellings, and relieves pain”
Shen Ling Bai Zhu San
“Arrests diarrhea”
Su Gan Wan
“[R]esolves depression”
Tong Jing Tang
“Relieves pain”
Xiao Jian Zhong Tang
“Moderates pain”
Examples of claims on your website, www.fareastsummit.com, that provide evidence these products are intended for use as drugs include:
Si Ni San
“Expels pathogens, resolves depression”
Ba Zheng Tang
“Frees strangury”
Xue Fu Zhu Yu Tang
“Relieves pain”
Du Huo Ji Sheng Tang
“Relieves impediment pain.”
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 based on 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 Si Ni San, Bu Xue Tiao Jing Tang, Xian Yao San, and Su Gan Wan 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, Si Ni San, Bu Xue Tiao Jing Tang, Xian Yao San, and Su Gan Wan 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
The inspection revealed significant violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations 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 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. You failed to establish the following specifications required by 21 CFR 111.70:
An identity specification for each component that you use in the manufacture of a dietary supplement [21 CFR 111.70(b)(1)]. Specifically, you purport to confirm the identity of the
(b)(4)
dietary ingredients
(b)(4)
, used to manufacture the dietary supplement products Emerald Energy Defense and Emerald Energy Original; the Eleuthero
(b)(4)
used to manufacture the dietary supplement product
(b)(4)
; the
(b)(4)
used to manufacture the dietary supplement Sage Calm Spirit; the
(b)(4)
used to manufacture the dietary supplement
(b)(4)
; and the
(b)(4)
used to manufacture the dietary supplement
(b)(4)
Awaken the Shen, by evaluating organoleptic properties (e.g., color, taste, smell, feel). However, all of the ingredients are
(b)(4)
. Because many
(b)(4)
share the same organoleptic properties, analysis of organoleptic factors does not provide unique information that is specific to each of these ingredients and thus cannot confirm the identity of each ingredient.
Component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)]. For example, you have not established component specifications for the
(b)(4)
dietary ingredients
(b)(4)
that are necessary to ensure the specifications for the purity, strength, and composition of
(b)(4)
and
(b)(4)
manufactured using these ingredients are met.
Component specifications for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)(3)]. For example, you have not established limits for contaminants for
(b)(4)
. Botanical dietary ingredients are frequently at risk for heavy metal, microbial, and pesticide contamination due to growing, harvesting, and processing factors.
Product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, to ensure the quality of the dietary supplement [21 CFR 111.70(e)]. Specifically, during the inspection you explained to the FDA Investigators that you did not currently have finished product specifications for the following dietary supplement products:
(b)(4)
, Chinese Classics Bu Zhong Yi Qi Tang, Chinese Classics Er Chen Tang,
(b)(4)
Restore the Heart,
(b)(4)
, and Herbalogic Quiet Mind. Furthermore, you provided copies of purported finished product specifications for the
(b)(4)
and
(b)(4)
dietary supplement products, which included physical and chemical parameters (appearance, odor, taste, % alcohol), heavy metals (lead, cadmium, mercury, arsenic), and microbial standards [total plate count (TPC), Coliform,
E. coli
, yeast and mold,
Salmonella
, and
Staphylococcus
]. The physical and chemical factors do not constitute unique criteria that can confirm the identity of these products and do not evaluate the purity, strength, or composition of these finished products. There are other substances that share the same appearance, odor, taste, and percent alcohol criteria.
In addition to establishing these specifications, you must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 111.75.
2. You failed to investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury, as required under 21 CFR 111.560(a)(2). Specifically, during the process of reviewing your returns records, our Investigators found Returned Material Authorization (RMA) 88030, for which the reason for return was documented as “adverse event.” RMA 88030, initiated on March 30, 2022, recorded an adverse event involving hallucinations and mood alterations as the reason for return for one bottle of
(b)(4)
. This bottle was subsequently discarded without further investigation to verify if the finished product or dietary ingredients used to manufacture the finished product met all required specifications.
3. You did not confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met by conducting appropriate tests or examinations or appropriately qualifying the supplier consistent with 21 CFR 111.75(a)(2)(ii), as required by 21 CFR 111.75(a)(2). Specifically, you did not conduct appropriate tests or examinations or verify the results for pesticides, heavy metals, and as applicable, sulfites and
Staphylococcus aureus
in the supplier Certificate of Analysis (COA) for components used in the manufacture of
(b)(4)
Lot 883056 (
(b)(4)
) and Chinese Classics Er Chen Tang Lot 883513
(b)(4)
.
4. You failed to use effective measures to protect against the inclusion of metal or other foreign material in components and dietary supplements, as required by 21 CFR 111.365(i). Specifically, during the inspection, the FDA Investigators observed gouges and scratches along the direct contact surfaces of the
(b)(4)
for the botanical material in your dietary supplements. The
(b)(4)
had visible areas where metal appeared to be missing. You do not have a method of preventing and detecting metal from being introduced into the components or dietary supplement products during processing using the
(b)(4)
.
5. Your master manufacturing records (MMR) failed to include written instructions and specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement products and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.210(h)(1). Specifically, your MMRs for
(b)(4)
Mind Lot 883634,
(b)(4)
Restore the Heart Lot 884086,
(b)(4)
Lot 884158, and
(b)(4)
Lot 883970 are lacking key critical in-process specifications. For example, your MMRs do not include in-process specifications for cook times, oven temperatures for drying, kettle temperatures, temperature and processing time for dehydration step, and for particle size and other parameters to ensure homogeneity of the powdered material after milling, grinding, blending, and sifting steps before encapsulation.
Misbranded Dietary Supplements
We reviewed product labeling on your website, www.fareastsummit.com, accessed through a practitioner account, and your product catalog, collected during the inspection, and have determined your Far East Summit Chinese Classics Bu Zhong Yi Qi Tang, and Er Chen Tang dietary supplement products you manufacture 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. In addition to being an unapproved new drug, your Ba Zheng Tang is also a misbranded dietary supplement because of the violations listed below. Specifically, we identified the following:
1. Your Far East Summit Chinese Classics Bu Zhong Yi Qi Tang, Ba Zheng Tang, and Er Chen Tang dietary supplement 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 names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36. For example:
“Ba Zheng Tang”, “Bu Zhong Yi Qi Tang”, and “Er Chen Tang” fail to declare the solvent used in the extract within the ingredient list.
“Bu Zhong Yi Qi Tang” and “Er Chen Tang” list “Citrus” which is not the common or usual name of an ingredient.
2. Your Far East Summit Chinese Classics Ba Zheng Tang, Bu Zhong Yi Qi Tang, and Er Chen Tang dietary supplement products are misbranded within the meaning of sections 403(s)(2)(A)(ii) and 403(q)(5)(F) of the Act [21 U.S.C. §§ 343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36. For example, your labels fail to present nutrition information on the nutrition label using the title, “Supplement Facts,” and your labels fail to include the quantitative amount by weight per serving of each dietary ingredient in accordance with 21 CFR 101.36.
3. Your Far East Summit Chinese Classics Ba Zheng Tang dietary supplement 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). For example, “herb” does not identify the plant part used in the product. If the whole or entire plant is used, that information must be listed.
4. Your Far East Summit Chinese Classics Bu Zhong Yi Qi Tang dietary supplement product is misbranded within the meaning of section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] because the product label makes structure/function claims that are not linked to the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(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.
We also offer the following comments:
1. Your firm includes “best by date” for the dietary supplement product bulk Chinese Classics Dianthus, FES Lot 883249. During the inspection, our Investigators observed that the bulk Chinese Classics Dianthus, FES Lot 883249, was originally encoded on the product label with “Lot 883249 Best By: 08/24.” Your firm printed new labels and you did not only change the lot number but also extended the product’s expiration date to “Lot 883249-1 Best By: 09/26.” You informed our Investigators that you did not conduct or have any data supporting the expiration dates listed on the product labels. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [see 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
2. You did not submit an update to your facility's registration within 60 calendar days of changes to the registration information previously submitted. As of September 12, 2024, your firm’s food facility registration listed your old address at 38880 Skeeter Bee Loop, and you have not submitted an update to your food facility registration to reflect the accurate address. Also, you have not updated your registration to indicate that you manufacture food for animal consumption.
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.
Please send your reply to the Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021-4421, to the attention of Jinkee M. Vila-Binayug, Compliance Officer. Refer to Unique Identification Number CMS #681536 when replying.
If you have any questions concerning this letter, you can contact Jinkee M. Vila-Binayug at (425) 302-0413, or by email at Jinkee.vilabinayug@fda.hhs.gov.
Sincerely,
/S/
Miriam R. Burbach
Program Division Director
Office of Human and Animal Food Operations
West - Division 6
Content current as of:
10/01/2024
Regulated Product(s)
Dietary Supplements
Food & Beverages