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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims

 

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