Hyaluron Pen Store, LLC dba Glow Nest Beauty

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the internet addresses https://www.glownestbeauty.com/ and https://www.hyaworld.store/ in January 2025 and has observed that your websites offers various injectable lipolytic products such as “PineBottle,” “Super V-Line Sol,” “LipoLab PPC Solution (brown bottle),” and “Deolipo” for sale in the United States. We have also reviewed your social media websites at https://www.facebook.com/hyaluronpenoriginal/ and https://www.instagram.com/glownestbeauty/. Your social media websites direct consumers to your https://www.glownestbeauty.com/ and/or https://www.hyaworld.store/ websites to purchase your products. As described below, your injectable lipolytic products including “PineBottle,” “Super V-Line Sol,” “LipoLab PPC Solution (brown bottle),” and “Deolipo” 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 webpage https://www.glownestbeauty.com/product-page/pinebottle-fat-burber:􀁸 “Enhance Skin Elasticity, Reduce Wrinkles. Pine Bottle enhances skin elasticity and reduces wrinkles. Unlike typical lipolysis products that can cause wrinkles”􀁸 “During fat dissolution, our solution, combined with Riboflavin, Cyanocobalamin, and L-Carnitine, accelerates lipolysis, [s]afely dissolving fat cells and addressing potential wrinkles.”

On your webpages https://www.glownestbeauty.com/product-page/super-v-line-sol and https://www.hyaworld.store/shop#!/Super-V-Line-Sol/p/586905325:􀁸 “[I]ntended for removing fat deposits from different facial zones. After the procedure the skin gets lifted and facial contours obtain delicate V-shape.”􀁸 “Removes fat deposits and lifts the skin simultaneously.”􀁸 “Speeds up regeneration and skin renewal processes.”􀁸 “It is used on contour plastics for correcting facial contours.”

On a February 19, 2024 post on your Instagram social media website at https://www.instagram.com/glownestbeauty:􀁸 “Lipolytic”􀁸 “Tightens the skin and improves elasticity.”􀁸 “Removes the formation of fat in the chin, cheeks, ears, nose, hernias around the eyes.”􀁸 “Promotes skin regeneration, creates a lifting effect.”

On your webpages https://www.glownestbeauty.com/product-page/+ LipoLab-fatdissolver and https://www.hyaworld.store/#!/+ LipoLab/p/610135630:􀁸 “[O]ne 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. This PPC (Phosphatidyl Choline) solution can also increase the elasticity of the skin and remove cellulite.”􀁸 “More efficacious, easier treatment and cheaper than liposuction surgery.”􀁸 “Unlike existing methods such as mesotherapy which only reduces the size of fat cells, Lipo Lab PPC dissolves, destroys fat cells and exhausts them out of the body through sweat, urine and internal combustion.”􀁸 “Effective for removing cellulites and enhances skin elasticity”􀁸 “Promotes adipocytes”

On a November 13, 2024 post on your Instagram social media website at https://www.instagram.com/glownestbeauty:􀁸 “[L]ipolytic”􀁸 “[D]rugs for correction of excess adipose tissue.”􀁸 “They are injected under the skin and allow you to remove fat deposits locally.”􀁸 “The technique itself can not only get rid of excess, but also improve the condition of the skin, restore metabolism in tissues.”􀁸 “Fat is converted into an emulsion, then into water and the body easily removes it naturally.”

On a February 9, 2022 post on your Facebook social media website at https://www.facebook.com/hyaluronpenoriginal/:􀁸 “Lipo Lab is a safe and effective lipolytics [sic] designed to activate the breakdown of fat cells and remove them from the body.”􀁸 “A lipolytic destroys cell membranes by converting the fat in the cells into an emulsion.”

On a July 10, 2023 post on your Facebook social media website at https://www.facebook.com/hyaluronpenoriginal/:􀁸 “The Ultimate Fat Burner! Ignite Your Fat Burning Potential! Are you tired of struggling with stubborn fat that just won’t budge? Say goodbye to your worries because Lipolab is here to rescue you!”􀁸 “[R]amp up your metabolism, turning your body into a fat-burning machine . . . excess pounds melt away!􀁸 “[H]elps enhance endurance and stamina.”

On your webpages https://www.glownestbeauty.com/product-page/deolipo and https://www.hyaworld.store/#!/Deolipo/p/586901883:􀁸 “DEOLIPO is an innovative contouring serum that's specifically designed to enhance the appearance and profile of moderate to severe fat on the face or body. By inducing a reduction in redundant lipids or fat, DEOLIPO helps provide a natural and well-defined line that complements your facial features or body shape.”􀁸 “DEOLIPO serves as a supportive aid for the treatment of various forms of obesity, including the most common dyslipidemias that often accompany this condition. Its main ingredient, deoxycholic acid, is an FDA-approved fat dissolving material and a human bile acid that's produced by intestinal bacteria in the human body.”

On a February 15, 2024 post on your Instagram social media website at https://www.instagram.com/glownestbeauty:􀁸 “Completely removes excess fat without the need for any operations”

Your “PineBottle,” “Super V-Line Sol,” “LipoLab PPC Solution (brown bottle),” and “Deolipo” 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).

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 “700256” in the subject line of the email.