CRITICALGLP-1 / Weight LossFDA Warning Letter · December 10, 2024

Veronvy

Atlas ID: 2024-12-fda-veronvy-zoeh1d

FDA issued a warning letter to Veronvy (Rancho Dominguez, CA) on December 10, 2024, regarding its 'Elily Veronvy' and 'Elily Veronvy 40+' products marketed as GLP-1-mimicking weight loss drops. The products were found to be unapproved new drugs making drug-intent claims (appetite suppression, gastric emptying, fat burning, and weight loss up to 52 lbs) and were misbranded because the labeling falsely claimed FDA approval via an 'FDA APPROVED' badge and explicit written statements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Flagged claims (4)

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.

Unsubstantiated efficacy · drug-mechanism-claim

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.

FDA trademark misuse · fda-approved-misuse

Metabolism boost drops for weight management.

Unsubstantiated efficacy · drug-intent-structure-function

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

Comparative claim w/o evidence · placebo-controlled-claim-unverified

Required actions (2)

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.

Response required · 15 days

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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