Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
October 15, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 13 - 02
Ortho Molecular Products Inc.
1991 Duncan Place
Woodstock, Illinois 60098
Dear Mr. Powers:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 3017 Business Park Drive, Stevens Point, Wisconsin, on April 3-5, 2012. During our inspection we collected samples of labeling for several of your products including Candicid Forte, Inflamma-bLOX, Lipitrol, Mucosagen, Prostatrol Forte, and Resvoxitrol. In addition, we conducted a review of your website www.orthomolecularproducts.com in October 2012.
Our review of your product labels, website, and other labeling materials establishes that your products Candicid Forte, Inflamma-bLOX, Lipitrol, Mucosagen, Prostatrol Forte, Resvoxitrol, Paracid Forte, VascuPak HTN, and Lithium Orotate are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your product labels and on your website establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You may find the Act and related regulations through links on our website www.fda.gov.
We received your firm's response to the FDA Form-483, dated April 23, 2012, which promised corrections to adverse event reporting issues identified during the inspection. However, because the violations discussed below were not identified in the FDA Form-483, your response did not address these violations. Examples of some of the claims found in your labeling on your website www.orthomolecularproducts.com include:
- Candicid Forte:
o “Your doctor may recommend Candicid Forte if they suspect dysbiosis due to yeast overgrowth.”
o “Candicid Forte was developed to support those with Candida and related yeast infections.”
o “The ingredients in Candicid Forte help to eliminate Candida and its related effects by supplying natural herbs…with antifungal and antibacterial properties.”
o “Designed for Prostatitis, this formula has shown potential for all inflammatory conditions, including inflammatory bowel conditions, chronic inflammation, prostatitis and injury related inflammation.”
o “Skullkap root has been used for allergies, inflammatory diseases and other conditions.”
o “BeePropolis [a component in your product]…Caffeic acid phenethyl ester (CAPE) is an important component in propolis, acting with anti-inflammatory…activities.”
o “Sytrinol [an ingredient in your product] lowers total cholesterol, LDL-C…in men and women with hyperlipidemia.”
o “Components in the resin…give gugul resin [an ingredient in your product] its cardiovascular benefits.”
o “Glutamine [an ingredient in your product] plays a role in inhibiting inflammatory cytokines….”
o “Lactoferrin [an ingredient in your product] has antibiotic and anti-inflammatory properties.”
- Prostatrol Forte:
o “Studies have shown Saw Palmetto has been shown to increase urinary tract function, reducing symptom scores, nocturia, and improving peak urine flow rate.”
o “Nettles may also decrease the negative effects of androgens on the prostate while inhibiting prostate cell growth.”
o “Pygeum has [been] shown to…reduc[e] prostatic inflammation...”
o “One study on men with BPH showed prostate symptom scores reduced by 40%…all with 50mg of Pygeum [an ingredient in your product]….”
o “[P]terostilbene [an ingredient in your product] has strong…anti-inflammatory properties, as well as anti-cancer and anti-fungal activities.”
o “[R]esveratrol [an ingredient in your product] has…anti-inflammatory, anti-cancer and anti-aging benefits.”
o Sulforphane [a component of broccoli seed extract which is an ingredient in your product]…has…anti-inflammatory, and chemoprotective…properties.”
o “Quercertin [an ingredient in your product]…has…anti-inflammatory, and anti carcinogenic activities.”
o “Pomegranate byproducts [ingredients in your product]…have…anticarinogenic[sic], and anti-inflammatory properties.”
- Paracid Forte:
o “The herbal agents in Paracid Forte including sweet wormwood, olive leaf, and black walnut hulls all have anti-parasitic and antimicrobial properties.”
o “Artemisinin is an active constituent of Wormwood that…is frequently used…for the treatment of malaria….”
o “[A]rtemisinin has anti-parasitic activity against a number of parasites including: Babesia species, Schistosoma species, Leishmania species, Toxoplasma gondii, and Plasmodium species.”
o “Bot olive leaf and black walnut hulls have…been used to support the removal of parasites.”
o “Besides having anti-parasitic properties, olive leaf and black walnut hulls also have antibacterial and antifungal….”
o “[B]erberine has anti-parasitic actions against strains of malaria, Entamoeba histolytica, Giardia lamblia, Leishmania donovani, and Trichomonas vaginalis.”
o “Studies using berberine sulfate in children with a giardia infection, show berberine sulfate can eliminate the presence of giardia cysts.”
o “Berberine also has antibacterial and antifungal properties.”
- VascuPak HTN:
o “VascuPak provides comprehensive nutritional support for hypertensive or prehypertensive patients.”
- Lithium Orotate:
o “Lithium Orotate has traditionally been used for mood disorders.
These products are not generally recognized as safe and effective for the above referenced uses 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.
Furthermore, because these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing these products to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not meant to be an all-inclusive list of violations at your facility or that may exist in any of your product labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations. Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include seizure and/or injunction.
In addition, during the April 2012 inspection, FDA collected various marketing materials from your facility, including your “Pillars of G.I. Health Inflammatory Bowel Disease Patient Guide.” We note that this document promotes your Alpha Base, Mucosagen, Orthomega, InflammaCORE, and OrthoBiotic products for use in various “protocols” to treat Inflammatory Bowel Disease.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, explain the reason for the delay and state when you will correct any remaining violations.
Your reply should be sent to the attention of Compliance Officer Demetria L. Lueneburg at the address on the letterhead.
Michael Dutcher, DVM