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WARNING LETTER

Fox Pharma LLC MARCS-CMS 699225 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Fox Pharma LLC

2401 Frankford Ave, Ste 4B
Philadelphia, PA 19125
United States

info@foxpharma.us
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

March 3, 2025

RE: 699225

Dear Fox Pharma LLC:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://foxpharma.us in January 2025 and has observed that your website offers various injectable lipolytic products, such as “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution (brown vial),” “Lipo Lab PPC Solution,” “Lipo Vela,” “Lipo Lab V-Line,” “Kabelline,” and “Super V-Line Sol,” for sale in the United States. We have also reviewed your social media websites at https://www.facebook.com/foxpharma.us/ and https://www.instagram.com/foxpharma_us/. Your social media websites direct consumers to your https://foxpharma.us website to purchase your products. As described below, your injectable lipolytic products including “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution (brown vial),” “Lipo Lab PPC Solution,” “Lipo Vela,” “Lipo Lab V-Line,” “Kabelline,” and “Super V-Line Sol” 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://foxpharma.us/products/lemon-bottle:
􀁸 “[F]or fat decomposition to increase metabolism of fat cells and accelerate it.”
􀁸 “[M]etabolic activation effect of Riboflavin separate and send out the fat cell fast lipase activity and inflammation relief”
􀁸 “[A]ctivation of fat metabolism”

On a May 16, 2024, post on your Facebook and Instagram social media websites at https://www.facebook.com/foxpharma.us/ and https://www.instagram.com/foxpharma_us/:
􀁸 “Lecithin destroys and transports unnecessary fat cells”
􀁸 “Bromelain (Ananas Sativus (Pineapple)) helps to break down fat and remove inflammation”
􀁸 “[I]f you [sic] uncomfortable with liposuction[,] diet does not help”
􀁸 “[I]f you want to lose weight quickly in a short time”

Lipo Lab PPC Solution (brown vial)

On your webpage https://foxpharma.us/products/lipo-lab-10x10ml-brown-vial:
􀁸 “Lipo Lab 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.”
􀁸 “[R]emove[s] cellulite.”

Lipo Lab PPC Solution

On your webpage https://foxpharma.us/products/lipolab-ppc-10-ml-10-vials:
􀁸 “With the combination of the best PPC ingredients and PLLA and PDRN, LipoLine products will reduce fat and, at the same time, increase the skin's own collagen production and elasticity, creating a resilient body line.”
􀁸 “PPC(PhosphatidylCholine) [sic] spotlighted as the latest solution to obesity”
􀁸 “Reduces the storage of fat layer”

Lipo Vela

On your webpage https://foxpharma.us/products/lipo-vela-10x10ml:
􀁸 “Effective & Safe Lipolisys [sic] Solution”
􀁸 “Combined with Sodium Deoxycholate, L-carnitine and Vitamin B12, which further accelerates lipolysis, it promotes the metabolism of fat cells and dissolves lipolysis safely and effectively.”
􀁸 “It contains cell growth factors, collagen promotion, and skin antioxidants that help to prevent wrinkles and maintain elasticity during the lipolysis process.”
􀁸 “LIPOLISYS [sic] ACCELERATOR[:] Effective ingredients to promote the dissolution of fat cells, Energy metabolism and activation”

Lipo Lab V-Line

On your webpage https://foxpharma.us/products/lipo-lab-v-line-5x10ml:
􀁸 “Lipo Lab V-line is a premium-class lipolytic for the elimination of excessive fat tissue and non-surgical face contouring.”
􀁸 “Facial fat reduction”

On a February 9, 2024, post on your Facebook social media website https://www.facebook.com/reel/6887553201356719:
􀁸 “Skin cell activation”
􀁸 “Your insecurity about your saggy skin and uneven face shape will be solved with a few treatment sessions with this fat-reducing injectable.”

Kabelline

On your webpage https://foxpharma.us/products/kabelline-box-5x8ml:
􀁸 “Kabelline destroys fat cells in the chin area, which results in a noticeable and satisfactory reduction of redundant fat cells.”
􀁸 “Once these adipocytes (fat cells) are destroyed, these cells no longer can store and accumulate fat.”
􀁸 “Deoxycholic acid aids in the breakdown of fat and its absorption; it is a naturally occurring body molecule.”
􀁸 “Non-invasive treatment to destroy fat cells without the use of surgeries”

Super V-Line Sol

On your webpage https://foxpharma.us/products/super-v-line-sol-5x10ml:
􀁸 “[A] safe and efficient lipolytic solution that specifically targets facial fat deposits.”
􀁸 “It contains a lipolytic complex composed of natural ingredients that help reduce excessive facial fat and age-related changes in facial contour.”
􀁸 “Reduces facial fat deposits”
􀁸 “[R]emoves cellulite”
􀁸 “More effective and accessible than traditional liposuction surgery”

Your “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution (brown vial),” “Lipo Lab PPC Solution,” “Lipo Vela,” “Lipo Lab V-Line,” “Kabelline,” and “Super V-Line Sol” 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 “699225” 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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