- Delivery Method:
- United Parcel Service
- Medical Devices
Recipient NameSobin Chang
Recipient TitleChief Executive Officer
- Aquavit Pharmaceuticals, Inc
145 W 57th Street, 15th Floor
New York, NY 10019
- Issuing Office:
- Office of Medical Device and Radiological Health Division 1 – East
CMS # 607150
Dear Ms. Chang:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the AQUAGOLD® fine touch and the Advanced Skin Application Platform (A.S.A.P!) Micro Infusion System in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).1 Under section 201(h) of 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.2
According to your firm’s websites, https://aquagoldfinetouch.com and https://skinworkout.com, the AQUAGOLD® fine touch is a microchannel microinjector available for physician and clinical practitioner use that delivers “specially selected therapeutics” into the dermis to address a wide range of skin concerns, and the A.S.A.P! Micro Infusion System is a microchannel applicator designed for at-home use to deliver microdroplets of treatment solutions directly into the skin. Based on our review of your firm’s websites, FDA has determined that the AQUAGOLD® fine touch and A.S.A.P! Micro Infusion System are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify FDA 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).3
A review of your firm’s websites, https://aquagoldfinetouch.com and https://skinworkout.com (last accessed March 22, 2021), revealed the following claims:
AQUAGOLD® fine touch:
• “When you want to look your best, the professionals turn to AQUAGOLD® fine touch™, the world’s foremost revolutionary microinjector device. Our patented applicator uses microchannel technology to precisely administer your personalized treatments. AQUAGOLD® fine touch™ delivers low dose microinjections with 24K pure gold-plated surgical-grade (SUS 316L) stainless steel microchannels, each thinner than a human hair. AQUAGOLD® fine touch™ is the perfect solution for painless treatment of sensitive areas including peri-oral (around the mouth), peri-orbital (around the eyes), forehead, neck, back of hands, and décolletage. AQUAGOLD® fine touch™ is available only for physicians and clinical practitioners.”
• “What are the advantages of AQUAGOLD® fine touch™?The AQUAGOLD® fine touch™ has the proven ability to deliver micro-doses of a drug or biologic just under the dermis at a consistent depth and pain-free. This is a major advantage over the conventional syringe approach.”
• “How is AQUAGOLD® fine touch™ different from microneedle devices? The intended use of AQUAGOLD® fine touch™ is to microdose and microinject, whereas the intended use of other common microneedle devices is to puncture or wound the skin.”
• “MORE THAN JUST NEEDLING[:] The microchannel screw-like design safely and consistently delivers therapeutics at a consistent depth with minimal damage to the dermis, targeting all layers of the skin while stimulating collagen and elastin production.”
• “UNIQUE 2-IN-1 TREATMENt[:] Targeted treatments that include a wound-healing response, and simultaneously stimulate collagen and elastin production.”
• “PERSONALIZED MEDICINE[:] Specially selected therapeutics for a treatment customized just for you. Address a wide range of skin concerns from acne scars and fine lines to hyperhydrosis and alopecia.”
Based on these claims, the AQUAGOLD® fine touch is a device because it is intended to deliver microdoses and microinjections of products into the skin for various medical purposes (e.g., stimulating collagen and elastin production, promoting wound healing, treating acne scars, hyperhidrosis, and alopecia).4 The risks of AQUAGOLD® fine touch use may include, but are not limited to: severe skin reactions and inflammation; allergic reactions; bleeding; infection from zoonotic or other human materials; adverse reactions relating to contamination with bacteria or viruses, exposure to heavy metals and toxins or cross-contamination; scarring; keloid formation; undesired skin pigment changes; granuloma formation; nerve and blood vessel damage; and overdosage. Many of these risks may be severe and permanent.
A.S.A.P! Micro Infusion System:
• “A.S.A.P! is designed to work with our SKINWORKOUT program of specially formulated pharmaceutical grade pure sterilized hyaluronic acids and proprietary compounds to support your skin health . . . The program features two specially formulated skin health serums, U.R. (Ultimate Radiance and T.T. (Targeted Toning). U.R. is a high-performance sterilized serum with the purest hyaluronic acid, PDRN, and growth factors. It’s a rejuvenating blend that treats signs of aging and helps to regenerate damaged skin. T.T. is an intensely hydrating sterilized serum with the purest hyaluronic acid, Glutathione, Niacinamide, and Tranexamic Acid. This gentle yet effective serum helps even out skin tones, brightens skin, and reduces inflammation. Glutathione prevents dark spots and brightens the skin. Niacinamide helps with skin brightening and the enhancement of skin tone to even out your complexion. Tranexamic Acid is a nice treatment for freckling.”
• “For consumers, we introduced the SKINWORKOUT®. This system includes the first in the US, sterilized pharmaceutical grade HA serums (U.R. and T.T.) for after-care and maintenance for any in-office treatments. The A.S.A.P.!™ Microinfusion system allows the optimal infusion of any valuable serums we use at home. A perfect match with U.R. and T.T.!”
• “SKINWORKOUT® features our revolutionary micro infusion applicator, A.S.A.P.!™ (Advanced Skin Application Platform), designed to infuse specialized, pharmaceutical grade serums into the skin using our patented repeated motion called Microchannel Technology®. Unlike traditional skin care applications, microinfusion allows skin health serums to be infused directly into your skin rather than sitting on the surface.”
Based on these claims, the A.S.A.P! Micro Infusion System is a device because it is intended to deliver micro-droplets of serums into the skin for various medical purposes (e.g., helping to regenerate damaged skin, reducing inflammation). The risks of A.S.A.P! Micro Infusion System use include, but are not limited to, all of the risks associated with AQUAGOLD® fine touch use (see above).
In addition, the AQUAGOLD® fine touch and the A.S.A.P! Micro Infusion System are devices because they are intended to affect the structure or any function of the body. The AQUAGOLD® fine touch and A.S.A.P! Micro Infusion System include microchannels (needles) that are 0.6mm and 0.2mm in length, respectively. Thus, these penetrate well beyond the stratum corneum (which is typically 0.02-0.04mm thick5). Based on the design and technology of these products, the entire microchannel is inserted into the skin and there is no mechanism that would prevent the user from inserting the entire microchannel into the skin. Therefore, your devices result in needle penetration beyond the stratum corneum and into the living layers of the skin (epidermis and dermis), showing that they are “intended to affect the structure or any function of the body” under section 201(h) of the FD&C Act.
Microneedling devices for aesthetic use are Class II devices regulated under 21 CFR 878.4430 and require premarket notification [510(k)]. At this time, no microneedling device has been cleared for over-the-counter (OTC) or home use. Additionally, devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biological products are not included in this classification and may need to be evaluated by the Center for Biologics Evaluation and Research (CBER) and/or the Center for Drug Evaluation and Research (CDER).
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the FDA. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices 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.
We note that your firm is also marketing other products that are drugs, biological products and/or combination products, which are subject to additional/different requirements than those discussed above. For example, you are marketing the SKINWORKOUT® U.R. (Ultimate Radiance) and the SKINWORKOUT® T.T. (Targeted Toning) as serums that are intended to be injected into the human body for various medical purposes. On your firm’s website (https://skinworkout.com), you state that the SKINWORKOUT® U.R. (Ultimate Radiance) is a serum containing hyaluronic acid, “growth factors,” polydeoxyribonucleotide, and tri-peptides, among other things, and that it promotes the formation of collagen and elastin, stimulates cellular renewal, and helps regenerate damaged skin. You also state that the SKINWORKOUT® T.T. (Targeted Toning) is a serum containing hyaluronic acid, glutathione, and niacinamide, among other things, and that it activates a metabolic process to brighten the skin and reduces inflammation. You also are marketing the A.S.A.P! + Two Serums Skin Care Gift Set, which is a set that includes the Ultimate Radiance Serum, Targeted Toning Serum, A.S.A.P! Microinfusion System, and a cap.
We note that for combination products (see 21 CFR 3.2(e)), the regulations at 21 CFR Part 4 also apply. The appropriate marketing application for a combination product generally depends on which agency component (i.e., CBER, CDER or the Center for Devices and Radiological Health) has the lead responsibility for the premarket review and regulation of the combination product. Your firm may obtain formal or informal determinations regarding the assignment (the agency component with the lead regulatory responsibility), as well as the classification, of products by submitting RFDs or pre-RFDs, respectively, with the FDA’s Office of Combination Products (OCP). For further information about the RFD and pre-RFD processes, you may visit OCP’s website at http://www.fda.gov/CombinationProducts/default.htm or contact OCP at 301-796-8930 or firstname.lastname@example.org. You should also review the following guidances for additional information: How to Write a Request for Designation (RFD): Guidance for Industry (fda.gov) and How to Prepare a Pre-Request for Designation (Pre-RFD) (fda.gov).
Your firm should take prompt action to address the violations described in this letter. Failure to adequately address any violations may lead to regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Also, other federal agencies may take your compliance history into account when considering the award of contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
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 correct 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 you have complied with the Act and FDA regulations, please provide your reasoning and any supporting information for our consideration as part of your response to FDA within fifteen business days.
If you have any questions about the contents of this letter, please contact Compliance Officer, Sean Moynihan at 410-779-5134 or email@example.com. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at firstname.lastname@example.org.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division 1 – East
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc: Aquavit Life Sciences, Inc.
145 W 57th Street, Floor 15
New York, NY 10019
1 FDA has had previous interactions with your firm regarding these products, including in correspondence related to: (1) It Has Come To Our Attention (IHCTOA) letters sent to your firm on May 10, 2016 and July 18, 2016, (2) a Request For Designation (RFD) your firm submitted to FDA on April 10, 2017, and (3) FDA’s inspection of your firm from October 23, 2019 to December 19, 2019.
2 As discussed further below, 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. Please refer to page 4 of this letter for additional information on these issues.
3 The AQUAGOLD® fine touch has been listed with product code GAA (Needle, Aspiration And Injection, Disposable) under 21 CFR 878.4800. Based on the claims discussed further below, the device does not fall under that product code or regulation. We note that the A.S.A.P! Micro Infusion System has not been listed. Under section 502(o) of the Act, 21 U.S.C. § 352(o), a device that is not listed as required by section 510(j) is deemed to be misbranded.
4 We note that FDA issued the Regulatory Considerations for Microneedling Products - Guidance for Industry and Food and Drug Administration Staff (fda.gov) (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.
5 Haftek M. (2017) Stratum Corneum Histopathology. In: Humbert P., Fanian F., Maibach H., Agache P. (eds) Agache's Measuring the Skin. Springer, Cham. https://doi.org/10.1007/978-3-319-32383-1_23.