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WARNING LETTER

Flawless Beauty and Skin MARCS-CMS 630567 —

Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Jack H. Gindi
Recipient Title
Owner
Flawless Beauty and Skin

1750 Brielle Ave, Suites A3, A4, and A6
Ocean, NJ 07712
United States

Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER
CMS# 630567


August 5, 2022

Dear Mr. Gindi:

During an inspection of your firm located at 1750 Brielle Ave, Suites A3, A4, and A6, Ocean, NJ, on November 16, 2021 through January 19, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm, under 21 CFR 807.3(g), is an initial importer of the Relumins Premium Derma Pen (SKU: RL-DERMAPEN), Relumins Premium Derma Pen Plus (SKU: RL-DERMAPENPLUS), MESOpower pen and needle modules (SKU: MS-POWERPEN), Relumins Branded 35 needle Dermastamper (SKU: RL-STAMPER-35), Relumins Branded 80 needle Dermastamper (SKU: RL-STAMPER-80), Relumins branded 1200 needle Dermaroller 1.0 mm (SKU: RL-DERMROLLER1200-1.00mm, Relumins branded 1200 needle Dermaroller 2.0 mm (SKU: RL-DERMROLLER1200-2.00mm), and Relumins Intense Glow Beauty Care Tool (SKU: RL-BEAUTYTOOL).

Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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.1

Based on our review of evidence collected during the inspection, including product packaging and labels, user manuals, brochures, and product labeling on your firm’s website at http://www.flawlessbeautyandskin.com, FDA has determined that the Relumins Premium Derma Pen (SKU: RL-DERMAPEN), Relumins Premium Derma Pen Plus (SKU: RLDERMAPENPLUS), Mesopower Pen (SKU: MS-POWERPEN), Relumins Branded 35 needle Dermastamper (SKU: RL-STAMPER-35), Relumins Branded 80 needle Dermastamper (SKU: RL-STAMPER-80), Relumins Branded 1200 needle Dermaroller 1.0 mm (SKU: RLDERMROLLER1200-1.00mm) and Relumins Branded 1200 needle Dermaroller 2.0 mm (SKU: RL-DERMROLLER1200-2.00mm), and the Relumins Intense Glow Beauty Care Tool (SKU: RL-BEAUTYTOOL) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because, for each of the above listed devices, an approved application for premarket approval (PMA) is not in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), nor has an application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) been approved. The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because, for each of the above listed devices, a notice or other information respecting the devices was not provided as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm could submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.

A review of your firm’s website, http://www.flawlessbeautyandskin.com (last accessed on July 26, 2022), revealed the following claims:

Relumins Premium Derma Pen (SKU: RL-DERMAPEN) & Relumins Premium Derma Pen Plus (SKU: RL-DERMAPENPLUS)

  • “Can help to lighten the appearance of hyper-pigmentation.”\
  • “Use the pen on your face or body to reduce the appearance of acne scars, fine lines, wrinkles and stretch marks.”
  • “You can even use it on your scalp to stimulate hair growth.”
  • “We suggest using with Relumins Intensive Brightening Serum to treat stretch-marks”
  • “1 PIN TIPS: 5 PACK – This single needle tip allows precise treatment of deep lines or wrinkles”
  • “What makes this pen stand apart from the rest is the adjustable needle head (varying in length from 0.25 mm to 2 mm), and the built-in vibration mechanism that provides deeper needle penetration.”

Claims or statements of penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to affect the structure or function of the body. See FD&C Act § 201(h)(3). Based on these claims, the Relumins Premium Derma Pen (SKU: RLDERMAPEN) and Relumins Premium Derma Pen Plus (SKU: RL-DERMAPENPLUS) are devices because they are “intended to affect the structure or function of the body” (e.g., the adjustable needle head, which varies “in length from 0.25 mm to 2 mm”, penetrates the skin “to lighten the appearance of hyper-pigmentation” and “to reduce the appearance of acne scars, fine lines, wrinkles, and stretch marks”) under section 201(h) of the Act.2

MESOpower Pen and Needle Modules (SKU: MS-POWERPEN) (with needle lengths from 0.25 mm – 1.00 mm)

  • “Various needle modules to stimulate skin: for treating fine lines, scars or large areas”
  • “More than 50% of stretch marks and acne scar improvement”

Claims or statements that indicate penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to affect the structure or function of the body. See FD&C Act § 201(h)(3). Based on these claims, the MESOpower Pen and Needle Modules (SKU: MS-POWERPEN) is a device because it is “intended to affect the structure or function of the body” (e.g., treats “fine lines, scars or large areas” and improves stretch marks and acne scars by “more than 50%”) under section 201(h) of the Act.

Relumins Branded 35 Needle Titanium Needle Dermastamper (SKU: RL-STAMPER-35) and Relumins Branded 80 Needle Dermastamper (SKU: RL-STAMPER-80)

  • “Reduce the Appearance of Indented Acne Scars, Wrinkles and Lines”
  • “Clinically shown to be effective in reducing scarring in 94% of patients”
  • “Anti-aging, skin regeneration and skin tightening”
  • “Improves skin texture and reduces the appearance of wrinkles”
  • “Reduces the appearance of hyperpigmentation and scars, creating smooth, even skin”

Under the statement, “How to Determine What Size Needle is Right for You:” for these products are the following claims:

  • “0.05mm (click for Relumins Roller in this size!)- Fine lines, Light Wrinkles, Open Pores, Pigmentation Marks, Acne Scars, Mild Ice Pick Scars, Face Rejuvenation”
  • “1.00mm (click for Relumins Roller in this size!)- Mild Wrinkles, Deep Acne Scars, Surgery Scars, Chicken Pox Scars, Ice Pick Scars, Strong Black Heads”
  • “1.5mm - Deep scars, Deep stretch marks”

Claims or statements that indicate penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to affect the structure or function of the body. See FD&C Act § 201(h)(3). Based on these claims, the Relumins Branded 35 Needle Titanium Needle Dermastamper (SKU: RL-STAMPER-35) and Relumins Branded 80 Needle Dermastamper (SKU: RL-STAMPER-80) are devices because they are “intended to affect the structure or function of the body” (e.g., to “reduce the Appearance of Indented Acne Scars, Wrinkles and Lines”, to improve “skin texture” and reduce “the appearance of wrinkles”, and to reduce “the appearance of hyperpigmentation and scars, creating smooth, even skin”) under section 201(h) of the Act.

Relumins Branded 1200 Needle Dermaroller 1.0 mm (SKU: RL-DERMROLLER1200-1.00 mm) and Relumins Branded 1200 Needle Dermaroller 2.0 mm (SKU: RLDERMROLLER1200-2.00mm)

  • “Lighten Acne Scar Hyper-pigmentation to Reduce the Appearance of Indented Acne Scars, Wrinkles and Lines”
  • “Clinical studies have shown that over 94% of patients using the DermaRoller/MicroNeedling Treatment System achieved a reduction in the severity of their scarring by one or two grades. More than 80% of patients assessed their treatment as ‘excellent’ on a 10-point scale.”

Claims or statements that indicate penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to affect the structure or function of the body. See FD&C Act § 201(h)(3). Based on these claims, the Relumins Branded 1200 Needle Dermaroller 1.0 mm (SKU: RL-DERMROLLER1200-1.00 mm) and Relumins Branded 1200 Needle Dermaroller 2.0 mm (SKU: RL-DERMROLLER1200-2.00mm) are devices because they are “intended to affect the structure or function of the body” (e.g., they “Lighten Acne Scar Hyper-pigmentation to Reduce the Appearance of Indented Acne Scars, Wrinkles and Lines” and reduce “the severity of their scarring by one or two grades”) under section 201(h) of the Act.

Relumins Intense Glow Beauty Care Tool (SKU: RL-BEAUTYTOOL)

  • “Target areas include under-eye pouches, crow’s feet, wrinkles around the nose and mouth, chin skin, frown lines and improving the appearance of neck wrinkles”
  • “Solar panel provides microcurrent to stimulate the body’s tissue”

The product claims to contain a solar panel that provides micro current to “stimulate the body’s tissue[s]” that will “target” various areas on the face and neck. Based on these claims, the Relumins Intense Glow Beauty Care Tool (SKU: RL-BEAUTYTOOL) is a device because it is intended to affect the structure or function of the body (e.g., the Relumins Intense Glow Beauty Care Tool is intended to stimulate the body’s tissues with a microcurrent in order to improve the appearance of areas on the face and neck) under section 201(h) of the Act.

Under section 510 of the Act (21 U.S.C. § 360), initial importers of medical devices are required to annually register with the FDA (see 21 CFR 807.3(g); 21 CFR 807.20(a)(5)). In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. As of this date, our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2022.

Therefore, the listed devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).

In your response dated February 9, 2022, your firm states that the investigator indicated that your firm did not distribute devices. However, your response is inconsistent with the FDA Form 483, observations 8-9 issued to your firm by the investigators on January 19, 2022. Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen 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 the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Gina Brackett, Director of Compliance Branch, at oradevices1firmresponse@fda.hhs.gov. Refer to CMS # 630567 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer Sean Moynihan at 410-779-5134 or sean.moynihan@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Binita S. Ashar, MD, MBA, FACS
Director
OHT 4: Office of Surgery and Infection Control
Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

/S/

Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
    Operations
Division 1 - East

____________________

1 As discussed further below, our inspection found that your firm is also marketing other products that are drugs, biological products, and/or combination products, which are subject to additional/different requirements from those discussed in this letter. This letter only pertains to products that are not subject to the Consent Decree of Permanent Injunction entered by the United States District Court on September 26, 2017 in United States v. Flawless Beauty LLC, et al., No. 17-7091 (D.N.J.). You may receive additional, separate communication from FDA regarding products that are or may be subject to that decree.

2 We note that FDA issued the “Regulatory Considerations for Microneedling Products - Guidance for Industry and Food and Drug Administration Staff” (November 2020) to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Act. The guidance discusses a firm’s claims and statements associated with a microneedling product that FDA believes would generally cause the product to meet the device definition (e.g., it treats scars, treats wrinkles and deep facial lines, treats acne, treats alopecia, stimulates collagen production, and promotes wound healing). The guidance also states that FDA may consider the design and technological characteristics/features of a microneedling product in determining whether it is a device under the Act. As noted in the guidance, microneedling products that are combination products are outside the scope of the guidance.

 
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