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  5. Filler Lux dba Filler Lux USA - 699221 - 03/03/2025
  1. Warning Letters

WARNING LETTER

Filler Lux dba Filler Lux USA MARCS-CMS 699221 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Boris Kalashnikov
Recipient Title
CEO
Filler Lux dba Filler Lux USA

800 3rd Avenue
New York, NY 10022
United States

info@fillerlux-usa.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

March 3, 2025

2385 3rd Avenue #1601
Bronx, NY 10451

RE: 699221

Dear Boris Kalashnikov:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://fillerx.com in December 2024 and has observed that your website offers various injectable lipolytic products such as “LemonBottle Ampoule Solution,” “Dr. Lipo+,” “Lipo Lab PPC Solution,” “DermaHeal LL,” and “Wonderfit” for sale in the United States. We have also reviewed your social media website https://www.instagram.com/fillerlux_usa/, which directs consumers to your https://fillerx.com website to purchase your products. As described below, your “LemonBottle Ampoule Solution,” “Dr. Lipo+,” “Lipo Lab PPC Solution,” “DermaHeal LL,” and “Wonderfit” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.

Your products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Examples of claims observed on your websites that establish the intended use of your products as drugs for human use include, but may not be limited to, the following:

LemonBottle Ampoule Solution

On your webpage https://fillerx.com/products/lemonbottle-lipolysis-solution:

  • “Lipolysis Solution”
  • “Even without Lipase (Hyaluronidase), the lipolytic effect of Lemon Bottle is already excellent.”
  • “KEY INGREDIENTS
    1. Riboflavin, Vitamin B2 induces activation of fat metabolism
    2. Bromelain, Bromelain helps to break down fat and Remove inflammation
    3. Lecithin, Lecithin destroys and transports unnecessary fat cells.”
  • Before and after FACE and BODY photographs depicting visible fat reduction in the chin, jaw, abdomen, and flank.
  • "Result After 24hours [sic]
    o Powerful Fat-dissolving Solution”
  • “When the part you want to lose weight is holding you back, Lemonbottle comes to the rescue!”

Dr. Lipo+

On your webpage https://fillerx.com/products/dr-lipo:

  • “Dr.LIPO+ PPC solution is developed for reducing body fat and tightening skin.”
  • “Dr.Lipo + New generation lipolytic”
  • “Dr.Lipo + is a direct lipolytic and acts on the adipocyte cell by destroying it.”
  • “Mechanism of action
    After the injection of the solution, the adipocyte cell (fat cell) dissolves and turns into a liquid emulsion.”

On your social media website https://www.instagram.com/fillerlux_usa/:

  • June 28, 2024 post:
    o “Doctor Lipo+ - Direct Lipolytic”
    o “Areas of Application:
    􀂃 Chest: Anterior axillary fold in women, fat in men
    􀂃 Cellulite Treatment
    􀂃 Back: Isolated fat deposits
    􀂃 Abdomen: Fat deposits on the ribs, lower abdomen, and thighs
    􀂃 Lipomas”
    o “Composition: Phosphatidylcholine: Ensures fat absorption and transportation.”

Lipo Lab PPC Solution

On your webpage https://fillerx.com/products/lipo-lab-lipolytic:

  • "Try this efficacious PPC solution for fitter body. . .. This combined substance safely dissolves fat cells through interaction and consequently results in destruction of fat cells or minimizes the size of fat cells.”

DermaHeal LL

On your webpage https://fillerx.com/products/dermaheal-ll:

  • “Lipolytic Solution”
  • “[T]his fat-dissolving treatment reduces stubborn fat pockets, minimizes cellulite.”
  • “Reduces Stubborn Fat: Effectively targets and eliminates localized fat deposits.”

Wonderfit

On your webpage https://fillerrx.com/producs/wonderlift:

  • “Injectable for localized fat reduction[,] Effectively breaks down adipocyte cells”
  • “Usage
    Every part of the face and body.
    Specifically where difficult to get removed by exercise and diet”

Your “LemonBottle Ampoule Solution,” “Dr. Lipo+,” “Lipo Lab PPC Solution,” “DermaHeal LL,” and “Wonderfit” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

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.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 699221” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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