Walmart, Inc.
3 extracted findings
FDA source excerpt, selected passage
“HClear for him,” “Herstat GST,” and “Terragen HG Formula” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
“HClear for him,” “Herstat GST,” and “Terragen HG Formula” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.
Source passage selected by the model
02
No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.
Source passage selected by the model
03
The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.