October 11, 2002
FDA Issues Cyber Letter to Yellow
- FDA announced that it has issued a Cyber Letter (a letter sent via email
to notify a company of potential violations) to the operator of an internet
web site for promoting and selling Yellow Jackets, an herbal product, as an
alternative to illicit street drugs.
Yellow Jackets are promoted as a substitute for controlled substances.
According to the promoter's web site, they contain ephedra and other herbal
ingredients, including kola nut extract (a source of caffeine). There does
not appear to be any legitimate drug use for this product, and its sale as a
substitute for controlled substances would be illegal.
FDA is aware that some street drug alternatives are being marketed as
dietary supplements. FDA does not believe that street drug alternatives are
intended to be used to supplement the diet. Accordingly, street drug
alternatives do not meet the definition of a dietary supplement.
Yellow Jackets, described on the web site as herbal XTC, could pose a
serious risk to consumers.
"Consumers should not purchase or use these or similar products available
through the Internet or elsewhere," said FDA Deputy Commissioner, Dr. Lester
M. Crawford. "FDA will continue its efforts to protect American consumers
from dangerous and fraudulent internet companies who would sell illegal
products that present risks to public health."
FDA has issued this "cyber" letter to the internet address of Yellow Jackets
promoter, Mr. Xoch Linnebank of the Netherlands and noted that the continued
sale of Yellow Jackets and other products as substitutes for controlled
substances to U.S. citizens may be illegal.
FDA's "cyber" letters provide 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 detained at the border and subject to refusal of entry.
Copies of each "cyber" letter are sent to regulatory officials in the
country in which the operator is based and to other individuals and
companies involved in the operation of the web site.
In March of 2000, FDA made available the document, "Guidance for Industry
Street Drug Alternatives." This document is available at the Internet web
site, http://www.fda.gov/cder/guidance/3602fnl.htm. It explains FDA's policy
on products that are promoted as street drug alternatives.
Consumers who want information about online drug sales, or, who wish to
report web sites that they believe are promoting illegal products, can
contact the FDA through its Web site at www.fda.gov/oc/buyonline/.