Vacation Inc.

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 products were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not new drugs under section 505G(a)(1), they do not comply with the requirements under section 505G. Accordingly, your “Classic Whip Sunscreens” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Passage 2

Furthermore, your “Classic Whip Sunscreens” are misbranded under Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), which provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading,” because they are packaged in containers that resemble food canisters customarily purchased by U.S. consumers.