WARNING LETTER
Veronvy
MARCS-CMS 694688 —
December 10, 2024
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Veronvy
3407 Felosa Drive
Rancho Dominguez
,
CA
90220
United States
service@obaskinec.com
service@Veronvy.com
service@herbaccouspf.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
WARNING LETTER
December 10, 2024
RE: 694688
Dear Veronvy:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.veronvy.com/ in October 2024 and has observed that your website offers “Elily Veronvy” and “Elily Veronvy 40+” products for sale in the United States. As described below, your “Elily Veronvy” and “Elily Veronvy 40+” 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). Furthermore, “Elily Veronvy” and “Elily Veronvy 40+” are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Drugs
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 that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:
Elily Veronvy and Elily Veronvy 40+
From your webpage https://www.veronvy.com/products/veronvy:
• “Veronvy Metabolic Boost Drops successfully helped people lose up to 52 pounds in 3 months during clinical trials and was approved by the Food and Drug Administration last year.”
• “Metabolism boost drops for weight management.”
• “The Science of GLP-1 . . . The effectiveness of the Veronvy Metabolic Boost Drops lies in its dual-action approach, addressing intake and expenditure. On one hand, it suppresses appetite, aiding in reduced food consumption and subsequent weight loss. It also slows gastric emptying, prolonging the feeling of fullness over an extended period. On the other hand, it accelerates the body's metabolism, promoting fat burning.”
On your webpage “Why Veronvy?,” https://www.veronvy.com/pages/why-veronvy%C2%AE:
• “You may have attempted to lose weight and keep it off many times in the past. The ups and downs can certainly be difficult, but you may finally be able to lose weight and keep it off with the help of Veronvy. . .. While taking Veronvy, people not only lost weight only lot weight [sic], but also kept it off[.] In addition to a reduced-calorie diet and increased physical activity, people in this study taking Veronvy lost more weight vs placebo”
Your “Elily Veronvy” and “Elily Veronvy 40+” 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 FDA-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).
Misbranded Drugs
Your “Elily Veronvy” and “Elily Veronvy 40+” products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product labels and/or websites include statements that misleadingly suggest that the drug products are approved or endorsed by FDA in some way. For example: the webpage for “Elily Veronvy” and “Elily Veronvy 40+” includes the image of a blue circle with the claim, “FDA APPROVED” along with the statement, “Veronvy Metabolic Boost Drops . . . was approved by the Food and Drug Administration last year.” As previously noted, there are no FDA-approved applications in effect for your “Elily Veronvy” and “Elily Veronvy 40+” products. Therefore, these products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded drugs are a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(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.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Content current as of:
12/17/2024
Regulated Product(s)
Drugs