[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR250.12]

[Page 176]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 250_SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS--Table of Contents
 
                 Subpart A_Drugs Regarded as Misbranded
 
Sec.  250.12  Stramonium preparations labeled with directions for use in self-medication regarded as misbranded.

    (a) Stramonium products for inhalation have been offered for use in 
the therapy of the acute attacks of bronchial asthma for many years 
although their reliability and effectiveness are questionable. Recently, 
a significantly increased number of reports have come to the attention 
of the Food and Drug Administration showing that such products have been 
subject to abuse and misuse on a fairly large scale, mostly by young 
people, through oral ingestion for the purpose of producing 
hallucinations. Reports of such use have been received from physicians 
and police and other law enforcement authorities. Reports have also 
appeared in the public press and in medical journals.
    (b) Labeling these products with a warning that they are not for 
oral ingestion has not been effective in protecting the public. Misuse 
of stramonium preparations can cause serious toxic effects including 
toxic delirium, visual disturbances, fever, and coma. A number of 
serious reactions have already occurred from the oral ingestion of such 
products.
    (c) On the basis of this information, the Commissioner of Food and 
Drugs has concluded that such articles have a potentiality for harmful 
effect through misuse and are not safe for use except under the 
supervision of a physician. In the interest of public health protection, 
therefore, the Food and Drug Administration adopts the following policy:
    (1) Preparations containing stramonium supplied from the leaves, 
seeds, or any other part of the plant in the form of a powder, pipe 
mixture, cigarette, or any other form, with or without admixture of 
other ingredients, will be regarded as misbranded if they are labeled 
with directions for use in self-medication.
    (2) The Food and Drug Administration will, on request, furnish 
comment on proposed labeling limiting any such preparation to 
prescription sale.
    (d) The labeling or dispensing of stramonium preparations contrary 
to this statement after 60 days following the date of its publication in 
the Federal Register may be made the subject of regulatory proceedings.