Feb. 3, 2010
Antimony Update
What is the latest information?
Kirkman® continues to work with the
FDA and a toxicologist to identify the type of antimony compound present
as a contaminant in our recalled products. Depending on the identity,
there may not be any long term effects or medical intervention required.
Certain organic types of organic antimony compounds are not likely to
cause any medical issues and should be harmlessly eliminated by the
body. We all hope that this is the case on the recalled products.
Until the contaminating compound is
identified, Kirkman® is unable to make any further recommendations.
Thank you for your patience in this
matter.
Jan. 12, 2010
What are the effects of ingesting antimony?
There are still unknowns regarding the ingestion of
antimony. Antimony is not
typically a contaminant in raw materials.
It is not part of the USP heavy metal screening that raw materials are
typically tested for by importers or food and supplement manufacturers. Furthermore, there are very few studies
that define what are safe or potentially harmful levels of antimony. Kirkman® has spoken with government regulatory
agencies regarding safety issues from the use of antimony. Their response is still
forthcoming. As a result, we don’t
have all the answers currently.
Orally consumed antimony is typically eliminated by the body through urine and feces in several weeks and probably isn't bio-accumulated. If this is the case, the levels in Kirkman's products would pose no risks. The few clinical studies reported in the literature tend to indicate that levels less than 1 mg. of antimony per kg. of body weight are eliminated without side effects. Kirkman® will continue to update our website as more information becomes available. Thank you for your patience in this matter.
Larry Newman
Chief Operating Officer
Technical and Regulatory Affairs
Kirkman Group, Inc.
NOTICE TO OUR CUSTOMERS:
Jan. 7, 2010
Dear Kirkman Customer and Distributor,
It has come to Kirkman’s attention, that a raw material vendor has supplied Kirkman with stevia that has a higher content of antimony than may be acceptable for our special needs customers.
The problem is limited to only two lots of stevia, which were used in several Kirkman® products. These products affected by the high antimony levels are:
1. Zinc Liquid - - Product # 387/8 and 387/16
2. Super Nu-Thera® w/o A and D Powder - - Product # 447/454
3. DMAE 50 mg. Chewable - - Product # 489/90
4. Super Nu-Thera® Powder Orange - - Product # 410/454
5. B Complex with CoEnzymes Pro-Support Powder - - Product #399/7
6. TMG w/Folic and B-12 Powder - - Product #413/4 and 413/8
7. Vitamin C 250 mg Chewable Tablets - - Product #389/100 and 389/250
8. Trial sizes of the above seven products
You should stop using these products, destroy them and request a credit or replacement from Kirkman®. Please call our customer service department to make this request.
Raw material suppliers or nutraceutical companies are not required to test for antimony levels, so Kirkman® was not aware of this problem until two of our physician customers brought the issue to our attention as a result of their metal testing. We immediately had our laboratory research the issue. They quickly isolated the problem to two specific lots of stevia leaf extract. Kirkman® immediately stopped using the affected stevia and stopped shipping products that tested out at high antimony levels.
So that this situation does not reoccur, we have implemented a new policy that every raw material we use in our products will be tested for antimony.
Kirkman® apologizes for any inconvenience we may have caused because of this issue. We have instituted this voluntary action regarding the suspect products because we feel it’s the right thing to do. Kirkman® will not compromise on the quality standards we have been known for throughout our more than 60 years of business.
Sincerely,
Larry Newman
COO Technical and Regulatory Affairs
Kirkman Group