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Weight Loss Drugs, Weight
Loss Pills, Weight Loss Medications
 The
Federal Food, Drug, and Cosmetic Act (the Act) prohibits persons from importing
into the United States any weight loss prescription drug that has not been approved for sale
by the United States Food and Drug Administration (FDA), or which is adulterated
or misbranded within the meaning of the Act. Moreover, in those instances where
a United States manufacturer makes an FDA-approved weight loss prescription drug and sends
it abroad, the Act also prohibits any person other than the original
manufacturer from importing the weight loss drug back into the United States. Thus, in
virtually all instances, individual citizens are prohibited from importing
weight loss prescription drugs into the United States.
FDA Enforcement Policy Regarding the Personal
Importation of Violative Drugs
The FDA has developed guidance entitled
“Coverage of Personal Importations” which sets forth the FDA enforcement
priorities with respect to the personal importation of unapproved new weight
loss drugs by
individuals for their personal use. Under this guidance, as an exercise of
enforcement discretion, FDA may allow an individual entering the United States
to import a three month supply of an unapproved weight loss drug if all of the following
conditions are met:
- The intended use of the drug is for a serious condition for which effective
treatment may not be available domestically;
- The weight loss drug will not be distributed commercially by the importer;
- The weight loss product is considered not to represent an unreasonable risk;
- The individual seeking to import the weight loss product affirms in writing that the
weight loss drug is for the patient’s own use and provides the name and address of the
doctor licensed in the United States responsible for his or her treatment with
the product, or provides evidence that the weight loss product is for the continuation of a
treatment begun in a foreign country.
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