1500.128—Label comment.
The Commission will offer informal comment on any proposed label and accompanying literature involving a hazardous substance if furnished with:
(c)
Adequate clinical pharmacological, toxicological, physical, and chemical data applicable to the possible hazard of the substance.
(d)
Any other information available that would facilitate preparation of a suitable label, such as complaints of injuries resulting from the product's use or other evidence that would furnish human-experience data.