EA WORKS Limited Liability Company dba Trust Labs

Selected passages from the FDA letter

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

Passage 1

Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503A, because retatrutide is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list.

Passage 2

Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503B, because retatrutide does not appear on the 503B bulks list, and is not used to compound a drug that appears on the drug shortage list.

Passage 3

There are no FDA-approved applications on file for your compounded retatrutide drug products.

Passage 4

your compounded retatrutide drug products are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended use.

Passage 5

Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.