Elevate Your Wellness LLC, dba Elevated
FDA issued a warning letter to Elevate Your Wellness LLC (dba Elevated) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide products falsely implied equivalence to FDA-approved drugs. The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (2)
Compounded GLP-1 medications are personalized versions of treatments like Semaglutide or Tirzepatide. They're made by licensed compounding pharmacies based on a prescription from a qualified healthcare provider. They contain the same active ingredient as the branded medications, but are compounded to offer a more personalized and often more accessible option.
Semaglutide ODT is a custom-formulated, dissolvable tablet that delivers the same active ingredient found in the leading GLP-1 weight loss medications – without the need for injections.
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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