Captain's Cloth LLC

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WARNING LETTER

DATE: July 2, 2021

Re: “KN95 Face Mask”

Dear Brian Eckert:

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://captainscloth.com/ on June 10, 2021, where you offer the “KN95 Face Mask” for sale in the United States. We also reviewed your social media page at https://www.facebook.com/Captains-Cloth-140013110203384/ where you direct consumers to your website to purchase the KN95 Face Mask. Based on our review, these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).

FDA’s review of your website revealed the following statements that establish that the KN95 face masks are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, including but not limited to:

• Statements alongside an image of the KN95 Face Masks that they “filter out 95% of particles” and that your firm is “working primarily with medical distribution companies … to support those on the front lines” [https://captainscloth.com/products/kn95-face-masks-5-pack]
• Statements made on the KN95 Face Mask packaging that “This product can filter air particulates, dust, smoke, mist, microorganisms, block droplets, body fluids, secretions…” and “Prevent Virus” [https://captainscloth.com/products/kn95-face-masks-5-pack]

The KN95 Face Mask, which your website represents is manufactured by “Lianyungang Manai Protective Equipment Co. Ltd.” (Lianyungang) is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, this product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). This product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

In addition, the KN95 Face Mask is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. Specifically, your websites contain false or misleading representations, including but not limited to:

• Representations that the KN95 Face Masks “have an active status with the FDA…” [https://captainscloth.com/products/kn95-face-masks-5-pack]
• Unauthorized display of what appears to be FDA’s logo¹ on the front and back of the product’s labeling [https://captainscloth.com/products/kn95-face-masks-5-pack]

Display of the FDA logo on packaging and near images of and information about the respective products, combined with statements about having active status with the FDA, is misleading because such information implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by FDA.

This letter is not meant to be an all-inclusive list of violations that exist in connection with the products or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you do not make representations that misbrand the product(s) in violation of the Act.

This letter notifies you of our concerns and provides you with an opportunity to address them. Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of any actions your firm has taken. If your firm’s planned actions will occur over time, please include a timetable for implementation of those activities. Your firm’s response should be comprehensive and address all violations included in letter. If you believe that the products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993

Refer to the Document number CMS Case# 611829 or CTS Number CPT2001007 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Assistant Director, Paola Barnett at 301-796-5462 or Paola.Barnett@fda.hhs.gov.

Sincerely,
/S/

Donna Engleman, MS, BSN
Director
Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Cc:
Youbiao Wei
Lianyungang Manai Protective Equipment Co., Ltd.
Jinshan Town Industrial Park, Ganyu District
Lianyangang, Jiangsu CN 222002

US Agent:
Hong
38 South 18th Avenue, Suite A Brighton, CO 80601
Email: abmedservice@outlook.com

Lianyungang Manai Protective Equipment Co., Ltd.
No. 6 Building, 1-8 North Street, Sanyuanli Yaochi, Yuexiu District
Guangzhou, Guangdong CN 510030

Official Correspondent:
Shuo Wang
Lianyungang Manai Protective Equipment Co., Ltd.
Kuangquan Street Yaochi North Street Community
Guangzhou, Guangdong CN 510030

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1 The FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy).

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Dear Mr. Eckert:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613965, July 2, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
/S/
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health