February 14, 2012
PARSIPPANY, N.J.FDA said marketing material the agency collected from Mushroom Wisdom Inc. at the Natural Products Expo East trade show in Baltimore and on the company's website brand some of its products as drugs, according to the Federal Food, Drug, and Cosmetic Act.
The agency sent a warning letter to Mike Shirota at Mushroom Wisdom Inc. saying the company's Maitake D-Fraction, Maitake SXFraction and Brain-Mate products are promoted for use in the cure, mitigation, treatment or prevention of disease. The day before sending this letter to Mushroom Wisdom, FDA sent a warning letter to Almased USA Inc. for a similar situation. FDA said booklets handed out at Expo East contained drug claims for the company's Almased® supplement.
In response to the warning letter, Mushroom Wisdom said it is working with FDA to respond to the concerns the agency raised. "We respect the agencys analysis of our materials, and it is not our intention to sell our products as drugs," the company said it a statement. "Thus, we are addressing all of the points raised by the agency. Mushroom Wisdom believes the agency will be completely satisfied by our response and the steps we are implementing to ensure all of our products are in compliance."
In the warning letter to Mushroom Wisdom, FDA offered the following examples from promotional materials distributed at the Expo East seminar "Ancient Remedies Revisited," sponsored by Mushroom Wisdom:
"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 .... "
FDA also cited the following examples from the company's website:
"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 SX-Fraction, a proprietary Maitake fraction with established applications ... including insulin resistance linked to ... Type 2 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."
FDA also noted the metatags used on the website to draw consumers and search engines, included "Cancer Fighting" and "Gene Activator that Induces Cancer Cell Apoptosis."
While Mushroom Wisdom's products do have scientific backing showing it combats breast cancer cells, reduces symptoms of PCOS and helps manage diabetes, FDA's warning letter says making such claims causes these supplements to drift into the drug realm, which is illegal.
FDA gave the company 15 working days to respond with documentation showing how the company has corrected these violations and what steps it will take in the future to repeat such mistakes.
Find out was industry experts say about legal and illegal product claims from INSIDER's slide show "Exploring Product claims."
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