WARNINGPharmacy / CompoundingFDA Warning Letter · September 9, 2025

Dermacare LLC dba BlueChew

Atlas ID: 2025-09-fda-dermacare-llc-dba-bluechew-8bd8w3

FDA's Center for Drug Evaluation and Research issued a warning letter to Dermacare LLC dba BlueChew in September 2025 after reviewing the bluechew.com website and finding that marketing claims for compounded sildenafil and tadalafil products falsely implied equivalence to FDA-approved drugs such as Viagra and Cialis. The agency determined these claims constitute misbranding under FDCA sections 502(a) and 502(bb) because compounded drugs are not FDA-approved and cannot lawfully be promoted as equivalent to approved products. FDA directed BlueChew to immediately cease using the offending language and to provide a written corrective response within 15 working days. Failure to comply could result in seizure or injunction without further notice.

Flagged claims (4)

SIL: Same active as Viagra

FDA trademark misuse · compounded-drug-equivalence-implication

The chewable tablets offered through BlueChew work for most patients. They are compounded medications made with the same active ingredients (Sildenafil, Tadalafil, and Vardenafil) used in Food and Drug Administration (FDA) approved erectionenhancing medications such as Viagra, Cialis….

FDA trademark misuse · compounded-drug-fda-approved-equivalence

The chewable tablets offered through BlueChew contain the same active ingredients - Sildenafil, Tadalafil, and Vardenafil - that are used in FDA-approved drugs like Viagra, Cialis….

FDA trademark misuse · compounded-drug-fda-approved-equivalence

TAD: Same active as Cialis

FDA trademark misuse · compounded-drug-equivalence-implication

Required actions (2)

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).

Claim removal

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.

Response required · 15 days

Source

www.fda.gov · FDA Warning Letter

Does your site contain similar claims?

The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.

Run my free site audit

Worried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.

Check specific copy in the Claim Checker