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U.S. Department of Health and Human Services

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Enforcement Actions

Mushroom Wisdom, Inc. 1/19/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4902

January 19, 2012

WARNING LETTER

VIA UPS

Mr. Mike Shirota
Mushroom Wisdom, Inc.
1 Madison Street, Building F6
East Rutherford, NJ 07073

File#: 12-NWJ-07

Dear Mr. Shirota:
 

The U.S. Food and Drug Administration (FDA) reviewed your website at www.mushroomwisdom.com (formerly www.maitake.com) in January 2012, and collected promotional materials associated with your products on September 23, 2011 at the Natural Products ExpoEast trade show at the Baltimore Convention Center. Based on our review of your website and these materials, we have determined that your "Maitake D-Fraction," "Maitake SXFraction," and "Brain-Mate" products 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 claims on your website and in the promotional materials establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.

On your home page, the tab labeled "PRODUCTS" lists products "BY ITEM" and numerous diseases "BY SUPPORT AREA" that link to webpages that list the products you recommend for each condition.

Examples of some of the claims observed on your website www.mushroomwisdom.com, from the tab labeled "NEWS," include:

Maitake D-Fraction:

• "Maitake D-Fraction Induces Apoptosis in Breast Cancer Cells.
• "[R]esearchers ... examined the direct anti-tumor effect Maitake D-Fraction has against breast cancer cells."
• "[Maitake D-Fraction's] activity of inducing apoptosis in prostatic cancer has already been reported by researchers .... "

Maitake SX-Fraction:

• "Maitake SX-Fraction, a proprietary Maitake fraction with established applications ... including insulin resistance linked to ... Type 2 diabetes .... "
• "[A] study that demonstrates that SX-Fraction also holds promise for Type 1 diabetes."
• "[S]X-Fraction induces ovulation in patients with PCOS (Polycystic Ovary Syndrome) .... "
• "SX-Fraction ... a natural treatment for PCOS (Polycystic Ovary Syndrome .... "
• "SX-Fraction ... showed antidiabetic, antihypertensive, antiobesity, and antihyperlipidemic effects."
• "[SX-Fraction] has been known ... to be heavily associated with diverse and serious diseases such as diabetes, ... cancer, Alzheimer's disease .... "

The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include "Cancer Fighting" and "Gene Activator that Induces Cancer Cell Apoptosis."

Examples of some of the claims in the promotional materials distributed with your "Brain-Mate" product (which includes "LION'S MANE" and "Maitake SX-Fraction") to attendees of your "Ancient Remedies Revisited" seminar at the Natural Products ExpoEast trade show include:

In "Maitake Mushroom":

• "Maitake may also be useful as a complementary cancer therapy .... [I]t can significantly decrease many side effects of chemotherapy, including ... pain, nausea, vomiting, and the decrease in white blood cells."
• "Maitake has shown positive direct actions ... for hepatitis B and HIV."
• "[S]X fraction shows a range of actions that makes it uniquely suited for ... Type 2 diabetes. These include lowering high blood pressure, cholesterol, and triglycerides; ... significantly lowering blood glucose levels .... "

In "Anti-Dementia and Beyond: AMYLOBAN 3399 Applications Expanded":

Under the heading "Nerve Growth Factor":

• "Hericenones and other bioactive substances in Lion's Mane are believed to have great potential for ... preventing and treating Alzheimer's disease."

Under the heading "Anti-Dementia Studies":

• "[A] ... man ... began experiencing hand tremors and noticed that he was forgetting appointments and conversations with employees. As symptoms became worse ... [he] was diagnosed with early-onset dementia .... [A] friend informed him about Alzheimer's medications and Lion's Mane extract. After three to four months, the hand tremors disappeared and his concentration and retention gradually improved .... [T]he . .. man made a decision to try the natural mushroom extract. ... After six months, he was able to recall complete agendas, not only for the week but also from the week before."

In "Maitake D-Fraction Apoptosis Inducer and Immune Enhancer":

• "[B]enefits of maitake have been postulated, ranging from antitumor effects to treatment for hypertension, diabetes, hypercholesterolemia, obesity, and hepatitis-B infection. Maitake's antiviral activity against human immunodeficiency virus (HIV)/autoimmune deficiency syndrome (AIDS) was confirmed .... "
• "D-Fraction may have a chemosensitizing activity on certain anticancer drugs, helping to improve the efficacy of chemotherapy."
• "The results showed that tumor regression or significant symptomatic improvements with D-fraction were observed in ... patients with breast cancer, .. . patients with lung cancer, and ... patients with liver cancer. When D-fraction was given with chemotherapy, the response rates improved from 12 percent to 28 percent."
• "[M]aitake D-fraction was able to prevent the HIV-mediated destruction of T-helper lymphocytes up to 97 percent in vitro. These findings suggest that D-fraction may even help to prevent or slow down the progression of HIV to full-blown AIDS. Several physicians who used D-fraction for the treatment of patients with HIV I AIDS have also reported that oral administration of D-fraction had significantly improved the clinical conditions of patients with Kaposi's sarcoma (even those who were undergoing radiotherapy) and other AIDS-related symptoms."
• "Maitake D-Fraction: Powerful Against Prostate Cancer."

In "ADVERTORIAL The Great Brain Regenerator: Lion's Mane":

• "[C]ompounds in Lion's Mane called hericenones . . .. offer a potential treatment for Alzheimer's disease."

Your "Maitake D-Fraction," "Maitake SX-Fraction," and "Brain-Mate" 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, your "Maitake D-Fraction," "Maitake SX-Fraction," and "Brain-Mate" products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. 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 intended to be an all-inclusive list of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. We advise you to review your website, 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 noted above. Failure to correct these violations promptly may result in regulatory action such as seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days from your receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrective actions within 15 working days, state the reason for the delay and the date by which the corrections will be completed.

Please send your reply to the attention of Mr. Andrew Ciaccia, Compliance Officer, Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. If you have any questions regarding any issue in this letter, please contact Mr. Ciaccia at 973-331-4904 or
Andrew. Ciaccia@fda.hhs.gov.

Sincerely,

/s/

Diana Amador-Toro
District Director
New Jersey District Office