DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996
July 14, 2006
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
John D. Seleen, President
JHS Natural Products, LLC
P.O. Box 50398
Eugene, Oregon 97405
Ref. No. CL-06-HFS-810-231
Dear Mr. Seleen:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the
Internet address http://www.mushroomscience.com and has determined that the products “Coriolus-
PSP” and “Coriolus VPS” are promoted for conditions that cause the products to be drugs under
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].
The therapeutic claims on your web site establish that the products are drugs because they are
intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these
products with these claims violates the Act.
Examples of some of the claims observed on your web site include:
Coriolus-PSP
• “PSP is used to stimulate immune function and to support immune health, both
before and/or after surgical treatment for cancer, and to support immune health
during conventional cancer treatment.”
Coriolus VPS [also referred to on your web site as VPS® Coriolus]
• “In traditional herbalism hot water extracts of Coriolus were used to … treat
pulmonary infections ….”
• “[I]t was … success in using Coriolus for stomach cancer that … subsequently
launched the research and development of what came to be known as PSK” [your
web site states elsewhere that the hot water extract of Coriolus is "[k]nown as …
PSK in Japan" and describes your product