The Commission will offer informal comment on any proposed label and accompanying literature involving a hazardous substance if furnished with:

Terms Used In 16 CFR 1500.128

  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.

(a) Complete labeling or proposed labeling, which may be in draft form.

(b) Complete quantitative formula.

(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.