FDA Issues Import Alert Against Unapproved Mail-Order Drugs from Overseas

News 01/30/1992 FDA Issues Import Alert Against Unapproved Mail-Order Drugs from Overseas

P92-3                                           Food and Drug Administration
FOR IMMEDIATE RELEASE                           Brad Stone -- (301)443-3285


    The Food and Drug Administration announced today it has issued an import  
alert against unapproved mail-order drugs promoted by six overseas companies.
    Many of these drugs are illegally advertised in periodicals and through   
direct mail, as foreign versions of approved prescription drugs.  The         
promotion and distribution of unapproved drug products within the United      
States is illegal.
    "In some cases, the drugs are counterfeit -- lacking any real similarity  
to the approved drug.  The uncertain character and quality of these drugs     
constitute an unreasonable risk to the public health," FDA Commissioner       
David A. Kessler, M.D., said.
    The import alert instructs FDA field offices to automatically detain all  
imported unapproved prescription products manufactured by six overseas        
companies which have promoted their products in this country. The companies   
cited are Interpharm, Inc., of Nassau, Bahamas; Northam Medication Service    
International Pharmacy of Nassau, Bahamas; Inhome Services of Delemont,       
Switzerland; International Products of Hannover, Germany; Azteca Trio         
Internacional, S.A. de C.V., of Zona Rio Tijuana, Mexico; and Interlab of     
London, England.  
    These companies have been promoting a wide variety of products purported  
to treat various conditions, including depression, high blood pressure,       
fungal infections, fatigue, chronic bronchitis and hair loss.
                                   -MORE-


                                            Page 2, P92-3, Import Alert
    Many of the ads for these unapproved drugs claim that people can save     
money on the costs of prescription drugs, but in reality the drugs may pose   
a risk to the patient's health.  Dr. Kessler said so-called "foreign          
versions" of prescription drugs are often of unknown quality with inadequate  
directions for use.
    For many years FDA has permitted -- and will continue to permit -- its    
field offices to exercise discretion regarding the release for entry into     
the United States of small "personal-use" quantities of drugs sold abroad     
but not approved in the United States -- provided that the drugs do not pose  
unreasonable safety risks, that their use is not promoted in the United       
States and that they are for a serious condition for which there is no        
satisfactory treatment available in this country.  The policy was designed    
to give FDA field offices discretion to release small quantities of           
medicines with which individuals returning to the United States may have      
been treated while traveling abroad and to allow individuals with serious     
conditions the ability to import, under certain limited conditions,           
personal-use quantities of unapproved drugs that they believe might be        
helpful in treating their conditions.
    Personal-use quantities are generally considered to be amounts for a      
patient's treatment for three months or less.  Imports involving larger       
quantities are not permitted as they lend themselves to commercialization.
    FDA approves drugs on the basis of scientific data proving them to be     
safe and effective.  FDA-approved labeling provides information on how and    
when the drugs can be used to maximize their effectiveness and minimize       
their harmful side effects.  The manufacturing facilities and procedures for  
approved products are also carefully regulated by FDA to ensure product       
integrity.
                                   -MORE-


                                            Page 3, P92-3, Import Alert
    The unapproved drugs promoted by these overseas operations lack these     
safeguards and quality assurance standards.  
    Consumers should also be aware that the acquisition and use of            
prescription drugs without the valid prescription of a physician or other     
licensed health professional may violate state or local laws.  FDA warns      
that severe adverse reactions, including death, can result from the improper  
use of prescription drugs.
    Persons with questions about importation of drugs for personal use        
should consult with their local FDA district office or the FDA Imports        
Operations Branch in Rockville, Md., at (301) 443-6553.
    The Food and Drug Administration is one of the eight Public Health        
Service agencies within HHS.
                                    ###