PurePurge Inc.

Selected passages from the FDA letter

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

Passage 1

Based on our review, MEDPURE HAND SANITIZERS are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and are misbranded under sections 502(ee) and (o) of the FD&C Act, 21 U.S.C. 352(ee) and (o).

Passage 2

These products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because MEDPURE HAND SANITIZERS 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 and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 3

A review of FDA’s establishment registration and drug listing database confirms that PurePurgeTM, located at 2630 Homestead Place, Rancho Dominguez, CA 90220, is not registered as a drug manufacturing facility and MEDPURE HAND SANITIZERS are currently not listed with FDA as required by section 510 of the FD&C Act.

Passage 4

Neither hydrogen peroxide nor PurePurge™ is permitted as an active ingredient for use as consumer antiseptic hand rub drug products under the 1994 TFM. Such products do not conform to the TFM***2***, nor are they consistent with the formulations described in FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency***3***.

Passage 5

In addition, the labeling of MEDPURE HAND SANITIZERS indicates that the products eliminate more than 99.99% of viruses in as little of 15 seconds and are proven to kill enveloped viruses, non-enveloped viruses, fungi, mold and spores. These labeled, intended uses go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, and FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency.***4***