*EPF311 02/02/00
Text: FDA Launches Campaign Against Foreign Online Drug Sites
(Campaign targets foreign-based Web sites) (600)

The U.S. Food and Drug Administration (FDA) has launched a "cyber" campaign to stop foreign-based online operators from selling prescription drugs that may be illegal through the Internet to consumers in the United States.

The FDA began sending out "cyber" letters to a dozen potentially illegal, foreign-based online drug sites in recent weeks, the agency said February 2. The FDA has determined that some of these online drug distributors may be engaged in illegal activity such as selling prescription drugs to U.S. citizens without valid prescriptions, or in some cases without any prescriptions, the agency said.

At least one online distributor has already indicated to the FDA that it will stop its illegal activities, the agency announcement said.

The FDA also said it may extend its cyber campaign to prevent illegal prescription drug sales by domestic Web sites.

Following is the text of the FDA announcement:

(begin text)

[U.S. Food and Drug Administration
Washington, D.C.
February 2, 2000]

FDA LAUNCHES "CYBER" LETTERS AGAINST POTENTIALLY ILLEGAL, FOREIGN-BASED ONLINE DRUG SITES

In recent weeks FDA has issued "cyber" letters -- letters sent electronically via the Internet -- to a dozen operators of foreign-based internet sites that offer to sell online prescription drugs that may be illegal. The letters warn these website operators that they may be engaged in illegal activities, and informs them of the laws that govern prescription drug sales in the United States. This is the first time the FDA has used the Internet as a means for reaching those who are potentially violating the Federal Food, Drug, and Cosmetic Act, and it represents a new stage in the agency's efforts to protect the public against illegal and potentially dangerous products sold through websites.

In each of these internet cases, FDA sent letters electronically to the domain holders for sites it had determined may be engaged in illegal activity such as offering to sell prescription drugs to U.S. citizens without valid (or in some cases without any) prescriptions. Through various means, the agency has gained the ability to identify and monitor these sites. These drugs could pose a serious risk to patients, particularly if used without proper medical supervision.

The "cyber" letters sent are electronic versions that are similar to traditional "warning" or "untitled" letters, which the agency has long sent to organizations or individuals it believes are engaged in violative activities. These letters usually outline the nature of the alleged violation and request a formal response.

The "cyber" letters also provided these foreign operators with an explanation of the statutory provisions that govern interstate commerce of drugs in the United States, as well as a warning that future shipments of their products to this country may be automatically detained and subject to refusal of entry.

Hard copies of each "cyber" letter are sent to the website operator, the U.S. Customs Service and to regulatory officials in the country in which the operator is based.

To date, FDA has already received one response from a "cyber" letter recipient indicating that it will cease its illegal activities.

FDA may also use this approach in its ongoing efforts to prevent illegal sales of prescription drugs by domestic websites.

Consumers who want information about online pharmacies, or who wish to report websites that they believe may be acting illegally, can contact the FDA through its Website at www.fda.gov/oc/buyonline/.

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(Distributed by the Office of International Information Programs, U.S. Department of State.)
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