Inspections, Compliance, Enforcement, and Criminal Investigations
JHS Natural products 20-May-08
Department of Health and Human Services
Public Health Service
May 20, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-16
John Seleen, President
JHS Natural Products
1025 Conger Street, Suite 6
Eugene, Oregon 97402-6937
Dear Mr. Seleen:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.jhsnp.com and www.medicinalmushrooms.com and has determined that the product "Pectasol" is promoted for conditions that cause the product to be a drug under section 201(g)(1)(13) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(13)]. The therapeutic claims on your websites establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the product with these claims violates the Act.
Examples of some of the claims observed on your websites include:
Pectasol (Pecta-Sol Modified Citrus Pectin)
• "This galactosyl component of Pecta-Sol Modified Citrus Pectin is . . . k]nown for its ability to interfere with the binding properties of cancer cell-surface proteins called galectins [sic]. This prevents tumor cells from adhering to each other or to the inner wall of blood vessels."
• "Pectin supplementation causes significant decreases in total cholesterol . . ."
Further, your websites cite articles under "Scientific References" for treatment or prevention of cancer. When scientific publications are used commercially by the seller or a product to promote the product to consumers, such publications may become evidence of the product's intended use: For example; under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
The following reference citations are used to market "Pectasol" for disease treatment and prevention on your websites:
• "Pienta, KJ et al. J Natl Cancer Inst 1995 Mar 1; 87(5):331-2."
• "Naik, H et al. Proc Ann Meet Am Assoc Cancer Res; 36:A377 1995."
• "Platt D. J Natl Cancer Inst 1992 Mar 18; 84(6):438-42."
• "Zhu HG, et al. J Cancer Res Clin Oncol 1994; 120(7):383-8."
These reference citations and other claims quoted above are supplemented by one of the the metatags used to bring consumers to your websites through Internet searches. The metatag is "alternative cancer treatment."
Your product is not generally recognized as safe and effective for the above referenced conditions and therefore; the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your product "Pectasol" is also misbranded within the meaning of section 502(f)(1) of the Act; in that labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in "Pectasol" and its labeling. It is your responsibility to ensure that all FDA regulated products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
CC: Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580