Regarding to “Urgent Recall Xuduan concentrated herbal granules” ,We respect of this recall and
wish to communicate some key facts:
1. The manufacturer claims all their products including Xuduan are pure natural products.
According to the scientific literature, there is no researches that reports they have found drug
Mycophenolat in Xuduan itself; but Xuduan contains many natural compounds with medicinal
2. The manufacturer strictly follows standard manufacturing procedure to prepare the tea or
powdered granules. No Mycophenolate is added to the Du Xuan herbal granule product at any point
of the manufacturing process. It should be noted that the manufacturer does not manufacture any
Mycophenolate products either;
3. No evidence has been shown to us or the public to demonstrate that the tea contains
MYcophenolate except the conclusive statements posted on the Health Canada website and officer
Ms. Inessa’s email which the manufacturer respectfully disagree with.
4. Xuduan granules products which are sold for compounding purposes and not marketed as a NHP
is treated as a raw material and as per Health Canada's Raw Material and compounding policies.
Raw materials do not require DIN or NPN for importing or distributing in Canada. The your notice
wrongly states that the Du Xuan product is an unauthorised product on the market.
5. This Efong granule herbal tea has been used for 25 of years and 9010,000 sachets have been
produced and sold in 2016 .We have not received any reports or complaints of miscarriage due to
the use of this product. But in fact this herb is well known used for treating miscarriage as you know
as a TCM practitioner .
6. A third party Lab has proved that a trace amounts of mycophenolic acid (“MPA”) in all the
tested samples.The finding of MPA in the raw herbal form of Xu Duan confirms that the trace
amounts of MPA found in all the manufactured granules originates from the natural plant itself and
not due to contamination with or addition of the prescription drug mycophenolate by Yifang and
7. Studies have shown that MPA originates from Penicilium which exist widely in the natural
environment. Thus MPA can be found widely in soil ,water, plants roots, fruits, dry fruits, cereals,
animal feeds , silages , meats and foods especially in blue cheeses.
8. According Health Canada regulation of “Natural Toxins”:
a).“Natural toxins are chemicals that are naturally produced by living organisms. ”
b).“Mycotoxins are another group of natural toxins.
The word mycotoxin is derived from the Greek word for fungus 'mykes' and the Latin word 'toxicum'
meaning poison. Mycotoxins are toxic chemical products formed by fungi that can grow on crops in
the field or after harvest. The foods that can be affected include cereals, nuts, fruit and dried fruit,
coffee, cocoa, spices, oilseeds and milk. There are now more than 300 known mycotoxins of
widely different chemical structures and differing modes of action.Common mycotoxins include
aflatoxins, ochratoxin A, ergot alkaloids, fumonisins, Patulin, trichothecenes (such as
deoxynivalenol which is also known as vomitoxin) and zearalenone
We look forward to providing you with additional information as we continue our ongoing
discussions with Health Canada on this matter. Should you have any questions, please feel free to
Thank you for your consideration and support!