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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* contends 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.
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
Control of Allergies
Emotional health
Enuresis
Hair loss
Hearing Loss
High blood pressure
Hyperactive children
Improving vision
Insomnia
Menstrual Control
Migraine headaches
Pain Control
Psychic healing
Wart Removal
*The district should consider submitting a recommendation for misbranding to the
*Office of Compliance (HFZ-300)* when tapes with such claims are offered for lay use.
Refer to Compliance Policy Guide 7150.10, 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 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, district offices should contact the *Office of Compliance (HFZ-300)* for
guidance before submitting a recommendation.
*Material between asterisks is new or revised*
Issued: 11/01/81
Revised: 11/21/88, 3/95