Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (CPG 7132b.12)
BACKGROUND:
*When it was discovered that some glands produce hormones, a variety of glandular
products were placed on the market for OTC medicinal use. Many of these commercial
glandular preparations contained very little hormonal activity.
POLICY:
Our policy on inert glandular preparations is expressed in 21 CFR 201.300. It is our
policy that inert glandular preparations intended for medicinal use are not exempt from
Section 502(f)(1), that they bear adequate directions for use including indications for
use and any such representations offering these articles for use as drugs would be false
and misleading, and cause such articles to be unapproved new drugs*.
REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending legal action to the *Division of
Drug Labeling Compliance, HFD-310*.
Any desiccated whole or aqueous extracts of the following animal glands:
Adrena Orchic
Adrenal Cortex Parathyroid
Brain Parotid
Duodenum Pineal
Embryo Pituitary
Heart Placenta
Kidney Prostate
Liver Spleen
Lymph Stomach
Mammary Thymus
Ovary *Thyroid*
and
Such inert glandular preparation is offered for *OTC* drug use, other than, use limited
to vitamin content in the case of liver preparations; use limited to intrinsic factor
content in the case of stomach and duodenum, and parenteral use in the case of
parathyroid.
*Material between asterisks is new or revised*
Issued: 10/1/80
Revised: 5/22/87