WARNING LETTER

Kamerycah, Inc. MARCS-CMS 589373 — December 02, 2019

Delivery Method:: VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:: Food & Beverages

Recipient:: Recipient Name

Mr. Hideaki Takeuchi; Recipient Title

CEO; Kamerycah, Inc.; 3878 W. Carson St., Suite 101
Torrance, CA 90503-6707
United States

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

WARNING LETTER

December 2, 2019

WL # 589373

Dear Mr. Takeuchi:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, Kamerycah Inc., located at 3878 W Carson St, Suite 101, Torrance, CA on May 1, 3, and 20, 2019. Based on our inspection and subsequent review of your product labeling, including product labels, a brochure that accompanies your product, and claims on your Amazon storefront, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable FDA 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 and Misbranded Drugs

FDA reviewed your product labeling, including the booklet Essential Nutrition Umi No Shizuku fomulated [sic] by Dr. Daisuke Tachikawa, and your www.Amazon.com storefront, Kamerycah Inc., where you take orders for your products, including Umi No Shizuku Fucoidan products. The claims on your product labeling 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 claims that provide evidence that your products are intended for use as drugs include:

Your Korean language booklet Essential Nutrition Umi No Shizuku fomulated [sic] by Dr. Daisuke Tachikawa includes the statements:

Additionally, your Amazon storefront Kamerycah Inc. lists your Umi No Shizuku Fucoidan products for sale alongside the book, The Amazing Power of Fucoidan – The Key to Conquering Cancer. In addition to the title of the book, other claims include “Fucoidan . . . has been shown in clinical trials to support the body against cancer. Fucoidan has been found to have three main anti-cancer powers. First it induces Apoptpsis, or cell self-destruction. Second, it prevents Angiogenesis, or the outgrowth of new blood vessels from the tumor. Lastly, Fucoidan rallies to the immune system to fight against cancer,” and “The medical community worldwide has put out study after study testifying to its anticancer abilities . . . fucoidan destroy[s] cancer cells and prevent[s] the formation of blood vessels from the tumor . . . fucoidan is poised to become the new standard in cancer treatment.”

Your Umi No Shizuku Fucoidan and Umi No Shizuku Essential Nutrition 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 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 Umi No Shizuku Fucoidan and Umi No Shizuku Essential Nutrition products 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, the 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

Additionally, even if your Umi No Shizuku and Umi No Shizuku Essential Nutrition products did not have therapeutic claims which cause them to be drugs, our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements.

We understand that your firm receives packaged and labeled dietary supplement products from one or more co-manufacturers and that your firm holds and distributes these dietary supplement products. During the inspection you told our investigator (b)(4).

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 do not have written procedures for responsibilities of the quality control operations, and you do not document any of the required quality control operations for the processes you perform, such as approval of contract manufacturers and approval of labels.

As a distributor that contracts with other manufacturers to manufacture, package, and label dietary supplements 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. During the inspection, management stated that your firm distributes proprietary dietary supplement products under your brand names and that these dietary supplement products are contract-manufactured for your firm. Although a firm may contract out certain dietary supplement manufacturing 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)).

We have reviewed your response to the FDA 483, received on June 5, 2019, which states (b)(4). However, we are unable to evaluate the sufficiency of your corrective actions because you have not provided copies of new procedures or examples of implementation.

2. You failed to establish specifications for dietary supplement labels (label specifications), as required by 21 CFR 111.70(d). Specifically, your firm designs the finished product labels which you then provide to your manufacturers. However, you have not established label specifications.

We have reviewed your response, received on June 5, 2019, which states (b)(4). However, we are unable to evaluate the sufficiency of your corrective actions because the response does not include copies of specifications, procedures, or examples of implementation.

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. In addition, as a distributor, you are also subject to the requirements under 21 CFR 111.470 in that dietary supplements must be held under conditions that will protect the dietary supplements against contamination and deterioration.

We have reviewed your response, received on June 5, 2019; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states (b)(4). However, we are unable to evaluate the sufficiency of your corrective actions because the response does not include copies of procedures, or examples of implementation.

4. You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements as required by 21 CFR 111.503. Specifically, your return policy is only for handling monetary refund to the customer. The procedure does not include instructions pertaining to the identification, and quarantine, or material review and disposition of returned dietary supplements in accordance with 21 CFR 111.510. Further, your firm does not maintain records of material reviews and disposition decisions for returned products in accordance with 21 CFR 111.535(b)(2).

5. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you don’t have a procedure for handling, reviewing, or investigating product complaints.

Misbranded Dietary Supplements

1. Your Fucoidan Capsule Dietary Supplement, Fucoidan Liquid Dietary Supplement, and Fucoidan Powder Dietary Supplement products are misbranded within the meaning of section 403(q) of the Act (21 U.S.C. 343 (q)) in that the presentation of the nutrition information on the label does not comply with 21 CFR 101.36 and 21 CFR 101.9. For example:

a. The Umi No Shizuku Fucoidan Supplements page on your website www.kfucoidan.com, where your products are sold, depicts the Fucoidan Capsule Dietary Supplement, Fucoidan Liquid Dietary Supplement, and Fucoidan Powder Dietary Supplement products next to the claim, “High . . . potency.” “High potency,” is defined in 21 CFR 101.54(f) as a food with a vitamin or mineral that is present in the food at 100% of the Reference Daily Intake per Reference Amount Customarily Consumed. However, the Supplement Facts label on the product label of the Fucoidan Capsule Dietary Supplement does not list any vitamins or minerals, and the Supplement Facts label on the web page for the Fucoidan Powder Dietary Supplement also does not list any vitamins or minerals.
In addition, the claim fails to clearly identify which vitamins or minerals in the Fucoidan Liquid Dietary Supplement product are described by the claim, as required by 21 CFR 101.54(f)(1)(ii).

b. Your Fucoidan Liquid Dietary Supplement (30--1.7 fl. Oz. (50ml) failed to declare the correct %DV for Vitamin B6 to the nearest whole percent on the Supplement Facts label, as required by 21 CFR 101.36(b)(2)(iii)(C).

c. Your Fucoidan Capsule Dietary Supplement declares calories as zero on the Supplement Facts label. Any (b)(2)-dietary ingredient that is not present or that is present in amounts that can be declared as zero in 21 CFR 101.9(c), must not be declared, as required by 21 CFR 101.36(b)(2)(i).

d. Your Essential Nutrition Nutritional Supplement fails to declare on the Supplement Facts label the correct %DV for Vitamin B6, riboflavin, and thiamine to the nearest whole percent. Furthermore, the levels of significance for the listed quantitative amounts are not correctly declared for Vitamin A, Vitamin C, Vitamin D, Vitamin E, niacin, zinc, and selenium, as required by 21 CFR 101.36(b)(2)(iii)(C) and 21 CFR 101.9(c)(8)(iii).

e. Your Essential Nutrition Nutritional Supplement product’s Supplement Facts label bears the following or similar statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).

2. Your Fucoidan Capsule Dietary Supplement, Fucoidan Liquid Dietary Supplement, and Essential Nutrition Nutritional Supplement products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in two languages but do not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, 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. However:

a. The Fucoidan Capsule Dietary Supplement and Fucoidan Liquid Dietary Supplement labels do not include the Japanese common or usual product name on the principal display panel, the Supplement Fact labels do not include nutrition information in Japanese, and the Japanese net quantity of contents statements are not on the principal display panels.

b. The Essential Nutrition Dietary Supplement label does not provide the Japanese common or usual name of the product and the label fails to bear the net quantity of contents, Supplement Facts, ingredients, and name and address of the responsible party in Japanese.

3. Your Essential Nutrition Nutritional Supplement is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the product label does not include a statement of identity as a “dietary supplement” or an appropriately descriptive term indicating the type of dietary ingredients that are in the product, as required by 21 CFR 101.3(g).

4. Your Fucoidan Liquid Dietary Supplement and Fucoidan Capsule Dietary Supplement products are each misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)] . In particular, the Fucoidan Liquid Dietary Supplement (outer box and bottle) and Fucoidan Capsule Dietary Supplement product labels each declare the following claim: “rich Agaricus mycelium extract.” Furthermore, your website www.kfucoidan.com contains the following statements in reference to Fucoidan Umi No Shizuku: “high Concentration of High Purity Fucoidan”, “… high content of Glucose in the form of β-glucan.” and “excellent nutritional supplement because it contains not only Fucoidan …but also Agaricus blazei mycelia extract …”

To bear the claim “rich”, “high”, or “excellent” as it relates to a nutrient, the product must contain 20% or more of the RDI or DRV for nutrients under 21 CFR 101.54(b). However, an RDI or DRV has not been established for fucoidan, glucose (in the form of β-glucan), or Agaricus mycelium extract. The products do not qualify to bear this claim under 21 CFR 101.54(b) because there is no established RDI or DRV for fucoidan, glucose (in the form of β-glucan), or Agaricus mycelium (or mycelia) extract. We note that there are alternative ways to convey the amount of the nutrients in your product to consumers. For example, the amount of a nutrient in a food may be stated in the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). Percentage claims for dietary supplements may be stated in accordance with the requirements in 21 CFR 101.13(q)(3)(ii)(A) and (B). If you want to seek authorization to use your current claim, you may submit a petition requesting FDA to authorize a new nutrient content claim for one or more of the nutrients in your product (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.

5. Your Fucoidan Liquid Dietary Supplement’s outer box label is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to adequately declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7 and 16 CFR §§500.8 and 500.10 (relative to the Fair Packaging and Labeling Act (FPLA)). Specifically, the net quantity of contents fails to include the metric measure.

This letter is not an intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and its 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 without further notice, including, without limitation, seizure and/or injunction.

Please 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 cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. 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 92612

Refer to Unique Identification Number CMS# 589373 when replying. If you have any questions regarding this letter, please contact Sara J. Dent Acosta, Compliance Officer, at sara.dent@fda.hhs.gov or (619) 941-3767.

Sincerely,
/S/

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