15 U.S.C. § 2604 - U.S. Code - Unannotated Title 15. Commerce and Trade § 2604. Manufacturing and processing notices

(1) The nature and seriousness of the person's illness, disorder or defect.

(2) The nature of the proposed organic therapy and its intended duration.

(3) The likelihood of improvement or deterioration, temporary or permanent, without the administration of the proposed organic therapy.

(4) The likelihood and degree of improvement, remission, control, or cure resulting from the administration of such organic therapy, and the likelihood, nature, and extent of changes in and intrusions upon the person's personality and patterns of behavior and thought or mentation and the degree to which these changes may be irreversible. This information shall indicate the probable duration and intensity of such therapy and whether such therapy may have to be continued indefinitely for optimum therapeutic benefit.

(5) The likelihood, nature, extent, and duration of side effects of the proposed organic therapy, and how and to what extent they may be controlled, if at all.

(6) The uncertainty of the benefits and hazards of the proposed organic therapy because of the lack of sufficient data available to the medical profession, or any other reason for such uncertainty.

(7) The reasonable alternative organic therapy or psychotherapeutic modality of therapy, or nonorganic behavior modification programs, and why the organic therapy recommended is the therapy of choice. These alternatives shall be described and explained to the person in the manner specified in this section.

(8) Whether the proposed therapy is generally regarded as sound by the medical profession, or is considered experimental.