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BACKGROUND:
There are a number of ion generating devices, both negative and positive, which are
being promoted for the treatment of various diseases. When medical claims are made for
these ion generating devices, they are subject to the *Federal* Food, Drug, and Cosmetic
Act. Until the medical claims can be supported with well controlled and valid scientific
studies, these devices are considered misbranded. Should the ion generator produce ozone,
it would be subject to 21 CFR 801.415, provided the intended use brings it within the
definition of a device. For the most part labeling for ion generators currently being
marketed claim the absence of, or very low levels, of ozone production. Truthfulness of
such claims require verification.
POLICY:
Ion generating devices promoted for medical use are subject to the requirements of the
Federal Food, Drug, and Cosmetic Act. Such devices labeled with unsupported medical claims
are in violation of 502(a) and 502(f)(1). If encountered, follow 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 animals use ...")*.
*Material between asterisks is new or revised*
Issued: 12/16/74
Reissued: 10/1/80
Revised: 9/24/87, 3/95