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  1. Warning Letters

WARNING LETTER

Julian Naya Beauty LLC MARCS-CMS 699782 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Julie Ellis
Julian Naya Beauty LLC

1298 Antwerp Lane
San Jose, CA 95118
United States

Info@juliannayabeauty.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

March 3, 2025

RE: 699782

Dear Julie Ellis:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://juliannayabeauty.com/ in January 2025 and has observed that your website offers various injectable lipolytic products such as “Kabelline,” “Lipo Lab PPC Solution,” “Lipo Lab V-Line,” “LemonBottle Ampoule Solution,” “Lipo Vela,” and “Neobella” for sale in the United States. We have also reviewed your social media websites at https://www.facebook.com/juliannayabeauty/ and https://www.instagram.com/juliannayabeauty/. Your social media websites direct consumers to your https://juliannayabeauty.com/ website to purchase your products. As
described below, your “Kabelline,” “Lipo Lab PPC Solution,” “Lipo Lab V-Line,” “LemonBottle Ampoule Solution,” “Lipo Vela,” and “Neobella” 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 website and social media websites that establish the intended use of your products as drugs for human use include, but may not be limited to, the following:

On your “Kabelline” webpage https://juliannayabeauty.com/product/kabelline/:

􀁸 “Kabelline is one of the highest-rated fat dissolver [sic] on the market. Kabelline Fat Reduction Solution is a contouring solution that helps to improve the appearance and profile of moderate to severe fat on the body. Kabelline products include the active ingredient synthetic deoxycholic acid. Deoxycholic acid aids in the breakdown of fat and its absorption; it is a naturally occurring body molecule.”
􀁸 An image of application sites on a woman’s body with the quote “Point Injection Apply 0.2-0.3ml at each point.”

On your “Lipo Lab PPC Solution” webpage https://juliannayabeauty.com/product/lipolab/:

􀁸 “It efficiently eliminates fat deposits and cellulite in different parts of the body. LipoLab is one of the safest and most effective fat dissolving products in existence today. It offers fast subcutaneous fat removal. It fights obesity in two main ways – by speeding up metabolism and melting the fat tissues in a natural and health-friendly manner.”
􀁸 “Areas recommended for injection are: - double chin - shoulders and forearms - armpits - back and abdomen - lateral folds - buttock - knees”

On your “Lipo Lab V-Line” webpage https://juliannayabeauty.com/product/lipo-lab-vline/:
􀁸 “This advanced product helps redefine facial contours by breaking down fat cells”
􀁸 “Benefits and Effects . . . Facial fat reduction”
􀁸 “Inject into the subcutaneous fat layer: Use a thin needle to inject the solution into the subcutaneous fat layer”

On your “LemonBottle Ampoule Solution” webpage https://juliannayabeauty.com/product/lemonbottlefat/:
􀁸 “LEMONBOTTLE is a high-concentration, premium solution combining Riboflavin (Vitamin B2) with advanced fat-decomposition ingredients. This innovative formula boosts fat cell metabolism, accelerates their breakdown, and enhances lipase activity, all while soothing inflammation.”
􀁸 Image of a syringe and human arm with the quote “Under Arms.” Similar images for “Abdomen,” “Love Handle,” “Outer Thighs,” and “Inner Thighs.”

On your “Lipo Vela” webpage https://juliannayabeauty.com/product/lipo-vela/#:
􀁸 “LIPO VELA is a high-purity PPC solution designed for enhanced fat reduction. Enriched with Sodium Deoxycholate, L-carnitine, and vitamin B12, it accelerates lipolysis, effectively and safely dissolving fat cells while promoting fat cell metabolism.”
􀁸 “Permanently Eliminates Fat Cells”

On your “Neobella” webpage https://juliannayabeauty.com/product/neobella/:
􀁸 “Permanent fat removal and skin tightening in one system. Dissolve localized fat and cellulite.”
􀁸 “With the help of Deoxycholic Acid, the Neobella injection triggers a natural lipolytic process, encouraging the organism to dissolve fatty acids stored in the target treatment zones.”

On your Facebook social media website at https://www.facebook.com/juliannayabeauty/:
􀁸 November 15, 2024 post: “V-Line Solution Premium Lab V-Line is an advanced, non-surgical treatment designed for facial contouring and lifting, specifically optimized for facial applications. This innovative fat-dissolving lipolysis solution delivers superior results compared to traditional liposuction surgery.”

On your Instagram social media website at https://www.instagram.com/juliannayabeauty/:
􀁸 April 4, 2022 post: “Kabeline Fat Dissolver Get Rid of Fat, Permanently!”

On your Facebook and Instagram social media websites at https://www.facebook.com/juliannayabeauty/ and https://www.instagram.com/juliannayabeauty/:
􀁸 September 12, 2024 post: “Lemon Bottle Fat Dissolving Injections”

Your “Kabelline,” “Lipo Lab PPC Solution,” “Lipo Lab V-Line,” “LemonBottle Ampoule Solution,” “Lipo Vela,” and “Neobella” 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 “699782” 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
U.S. Food and Drug Administration

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