WARNING LETTER

March 3, 2025

RE: 699226

Dear Lisa Currin:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.vividscientific.com/ in January 2025 and has observed that your website offers various injectable lipolytic products, such as “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution,” “Neobella Extreme,” and “Deoxycholic Acid Booster,” for sale in the United States. As described below, your “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution,” “Neobella Extreme,” and “Deoxycholic Acid Booster” 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:

On your “LemonBottle Ampoule Solution” webpage https://www.vividscientific.com/lemonbottle-fat-dissolver-5-vials--no-kit.html:

􀁸 “FAT DISSOLVER”
􀁸 “The plant and vitamin based formulation dissolves localized cellulite and fat, tightens skin, and improves overall health.”
􀁸 “Dissolve Fat & Cellulite - immediately breaks down fat cells (including cellulite) and speeds up metabolism.”
􀁸 “Anti Aging – Centella Asiatica extract stimulates collagen, has anti-inflammatory properties, and is an excellent antioxidant”
􀁸 “Increased Metabolism & Energy – Riboflavin (Vit B2) specializes in extracting energy from food while burning fat + functions as an antioxidant supporting the immune system, healthy skin, and hair.”

On your “Lipo Lab PPC Solution” webpage https://www.vividscientific.com/LipoLab-Max-NO-KIT_p_57.html:

􀁸 “Permanently dissolve fat and cellulite while increasing collagen and elastin with Lipo Lab's proprietary lipolysis formula.”
􀁸 “Treatment with Lipo Lab produces rapid fat loss and prevents wrinkles and sagging as the fat layer shrinks.”
􀁸 “Dissolve stubborn fat and cellulite”
􀁸 “Increase metabolism”
􀁸 “Boost energy levels”
􀁸 “[S]odium deoxycholate breaks down the membranes of fat cells allowing phosphatidylcholine (PPC) to enter and dissolve fatty acid molecules.”
􀁸 “L-carnitine, the third active ingredient, acts as a carrier molecule, facilitating the transport of fatty acids into the mitochondria, where they are converted into energy.”
􀁸 “The active ingredients are naturally occurring molecules that dissolve fat and cellulite permanently. Treated fat cells can no longer store fat.”

On your “Neobella Extreme” webpage https://www.vividscientific.com/NEOBELLAEXTREME-5-VIALS-NO-KIT_p_64.html:

􀁸 “Target stubborn cellulite and fatty problem areas. . . . Results are permanent! Once the fat cells are dissolved, they are gone for good.”
􀁸 “PERMANENT FAT REMOVAL + SKIN TIGHTENING IN ONE SYSTEM.”
􀁸 “Fat dissolving injections provide a non-surgical, gentle method of sculpting the body gradually and artistically.”
􀁸 “The main active ingredient is deoxycholic acid, a naturally occurring molecule that breaks down and destroys fat.”

On your “Deoxycholic Acid Booster” webpage https://www.vividscientific.com/deoxycholic-acid-fat-dissolving-booster-10ml.html:

􀁸 “DEOXYCHOLIC ACID FAT DISSOLVING BOOSTER contains the same deoxycholic acid formulation as KYBELLA.”
􀁸 “The BOOSTER can be added to lipolysis serums (Neobella, LipoLab, etc.) to increase efficacy and accelerate results.”

Your “LemonBottle Ampoule Solution,” “Lipo Lab PPC Solution,” “Neobella Extreme,” and “Deoxycholic Acid Booster” 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 “699226” 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