Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-8 Print Media: 301-827-6242
February 2, 2000
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/.