This guidance document is intended to assist persons submitting to FDA certain documents identified in section 904(a)(4) of the act (referred to in this guidance as “tobacco health documents”). The guidance document explains, among other things:
- The statutory requirement to submit tobacco health documents;
- Who submits health documents;
- What information is included in the submissions;
- How to submit the information;
- When to submit the information; and
- FDA’s compliance policies.