Compliance Policy Guide  
Sec. 335.300 Hypnotherapy Devices - Self Hypnotic Tape Recordings  
Guidance for FDA Staff  
This document supersedes Sec. 335.300, Hypnotherapy Devices  Self Hypnotic Tape Recordings, 
previously revised on 02/1995.  
Issued by:  
U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Devices and Radiological Health  
08/28/2012  
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the 
public. You can use an alternative approach if the approach satisfies the requirements of the applicable 
statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the 
telephone number listed on the title page of this guidance.  
I. Introduction:  
This CPG provides guidance to FDA staff on the submission of regulatory action recommendations for 
self-hypnotic tape recordings which are misbranded because of false or misleading medical claims in the 
accompanying promotional literature, and the lack of adequate directions for lay use on these 
prescription devices.  
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. 
Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited. The use of the word 
should in Agency guidance means that something is suggested or recommended, but not required.  
II. Background:  
FDA has both seized self-hypnotic tape recordings and issued regulatory letters to manufacturers 
concerning such recordings because the intended use of the tapes (gathered from both the tapes and 
their labeling) made them devices within the Federal Food, Drug, and Cosmetic Act's definition of a 
device. The Center's position is that the tapes are misbranded because of false or misleading medical 
claims in the accompanying promotional literature. Furthermore, the center *affirms* that these tapes 
are prescription devices and adequate directions for lay use cannot be written for these devices.   Hypnotherapy is a recognized medical modality useful for diagnostic and therapeutic purposes. Tape 
recordings used in conjunction with hypnotherapy which are intended for use in the mitigation, 
treatment, and cure of disease and other medical conditions are "devices" as that term is defined in 
Section 201(h) of the act.  
Tape recordings labeled only for behavior modification, self-improvement, habit correction, learning 
techniques, and simple relaxation are not considered to be devices unless they are also labeled for 
medical or therapeutic use.  
III. Policy:  
The Agency will not object to the distribution of tape recordings provided the labeling and the text of 
the recordings do not contain claims for specific disease conditions or therapeutic use. The intended use 
of the tape recordings as medical devices can be established from the labeling and statements made in 
the tapes themselves that the tapes have therapeutic and medical usefulness.  
Tape recordings, the labeling and text of which claim that the tapes are effective as a form of 
hypnotherapy (including self-hypnosis) and are intended for use in the mitigation, treatment or cure of a 
specific disease or medical condition, will be regarded as misbranded devices when sold for lay use.  
Examples of objectionable claims for lay use are listed below:  
Acne and skin problems Birth Control of Allergies Emotional health Enuresis Hair loss Hearing Loss High 
blood pressure Hyperactive children *or Adults* Improving vision Insomnia Menstrual Control Migraine 
headaches Pain Control Psychic healing Wart Removal  
IV. Regulatory Action Guidance:  
Refer to Compliance Policy Guide *120.500*, Health Fraud - Factors in Considering Regulatory Action. 
Please Note: The Health Fraud definition includes the "... promotion, advertisement, distribution or sale 
of articles, intended for human or animal use ...") for guidance. The appropriate division within the 
Office of Medical Device and Radiological Health Operations (OMDRHO) program should consider 
submitting a recommendation for misbranding to the *Center for Devices and Radiological Health 
(CDRH), Office of Compliance* when tapes with such claims are offered for lay use.  
V. Specimen Charges:  
The appropriate charges are 502(a), in that the labeling is false or misleading because the articles are 
not effective for such use and 502(f)(1) in that the articles fail to bear adequate directions for use since 
adequate directions for use cannot be written for use by laymen of the articles for the purposes for 
which the devices are intended and they are not exempt from the requirements of section 502(f)(1) of 
the act and 21 CFR 801.109.  
For Rx use, appropriate division within OMDRHO should contact the CDRH, Office of Compliance for 
guidance before submitting a recommendation.   *Material between asterisks is new or revised*  
Issued: 11/01/81 Revised: 11/21/88, 03/95, 08/28/12