BGP, LLC

Selected passages from the FDA letter

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

Passage 1

Accordingly, this product is an unapproved new drug 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

Thus, “BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because its labeling is false or misleading in any particular.

Passage 3

Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. § 352(ee), because “BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug” is subject to section 505G of the FD&C Act, 21 U.S.C. § 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. § 355.

Passage 4

Because “Biocence Botanical Complex” was not a proposed active ingredient in the rulemaking for topical antiseptic drug products your product is not in conformity with the relevant conditions of use outlined in the 1994 TFM and its subsequent amendments.

Passage 5

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 the 2015 Health Care Antiseptic Proposed Rule.