BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Drugs

Fallien Cosmeceuticals Ltd. dba Fallene Ltd.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Thus, even if your product was in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “TiZO® SHEERFOAM™ SPF 30” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.128
  • 21 CFR 207