Scope Health Inc

Selected passages from the FDA letter

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

Passage 1

your MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray products are intended for use as topical ophthalmic drug products. As described below, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Passage 2

sacha inchi seed oil, trehalose, sodium hyaluronate, and Ectoin® are not active ingredients permitted for ophthalmic demulcent drug products under M018.12.

Passage 3

vitamin A is not an active ingredient that is permitted for ophthalmic emollient drug products under M018.14.

Passage 4

the warning described in M018.60, “If solution changes color or becomes cloudy, do not use”, is required for ophthalmic demulcent drug products, such as your Dry Eye Intense Drops (multi-use bottle) product, to be legally marketed under section 505G of the FD&C Act. This monograph warning also falls within the scope of the warnings described in section 502(f)(2) of the FD&C Act. Thus, omission of this monograph warning from the product labeling renders the product misbranded under section 502(f)(2).

Passage 5

your Allegro Eye Drops, MGD Advanced Dry Eye Drops, Dry Eye Intense Drops, (multi-use bottle and single dose), and HYLO Night Eye Ointment products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section (as described above) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.