BotanicLab Urges Recall, Hires Agency to Check Returned Samples for "Packaging Integrity"
BY JACQUIE STRAX ©
New York: PSA Rising, September 7, 2001 : 9:41 PM EST. BotanicLab Inc., the Brea, CA herbal supplement manufacturer, is urging customers to return any unopened bottles of two lots of PC SPES.
BotanicLab wants customers to mail the PC SPES to a forensics laboratory in Arizona, which will check the returned samples for package tampering.
"In pursuing BotanicLab's promise to follow the trail of PC SPES product recently reported to contain traces of DES," the company said today in an e-mail to the PC SPES mailing list, "we are following up with our offer for you to send unopened bottles of PC SPES with seals intact from lots #5430125, exp. '06/'02 and #5436285, exp. '03/'00 to Forensic Science Associates," located in Scottsdale, AZ.
Forensic Science Associates is listed as an investigation agency in the Yellow Pages under Handwriting Experts, Investigators and Polygraph & Lie Detection. Rosemary Oblansky, a representative, confirmed tonight that the company takes on industrial projects, but had no further comment.
BotanicLab says they selected Forensic Science Associates "as a first step, because they regularly deal with matters requiring utmost prudence and precision in handling products, samples." Botaniclab says Forensic Science Associates have been hired to "log in sender and lot/expiration date information, and test incoming bottles for packaging integrity. Their findings regarding packaging integrity will be published."
"When Forensic Science Associates has completed its assignment," BotanicLab says, "the PC SPES product lots will be forwarded, by them, to an FDA-approved laboratory to be agreed upon by BotanicLab and two representatives -- selected by PC SPES E-Mail List Members themselves -- from the PC SPES E-Mail Member List."
"This FDA-approved testing laboratory will assay product from the above-referenced PC SPES lots for DES. The actual number of PC SPES pills that will be tested will be determined by the above-referenced laboratory."
"Forensic Science Associates must receive PC SPES product meeting the above guidelines by 5:00 p.m. Wednesday, September 26, 2001. As mentioned in our previous correspondence, in exchange for your cooperation, BotanicLab will replace, free of charge, any product returned from the above-referenced lots with a bottle of the current product, plus a coupon redeemable for a free bottle of PC SPES at the time you next purchase PC SPES. As you know, no question has been raised about the presence of DES in recent lots of PC SPES."
BotanicLab says it will establish a hotline - a toll-free telephone number -- within the next few days "to answer all your questions about the matter at hand. As soon as the number is in place, it will be published." Patients began asking for a hotline several weeks ago.
The PC SPES recall comes almost two weeks after Rocky Mountain Instrumental Laboratories Incorporated, Fort Collins, Colorado reported finding DES in old lots of the supplement. RMIL's was the second patient-sponsored laboratory test run in just over a month. In July, a Connecticut couple, David and Susan Domizi, announced that a laboratory they had hired had found DES in samples from older lots of the product.
Last week BotanicLab posted an FDA report of an August 2000 test, which found PC SPES contained no DES.
Earlier reports and commentary:
BotanicLab Recalls Samples of Herbal Supplement After Second Lab Finds Diethylstilbestrol (DES) BY JACQUIE STRAX © September 7, 2001.
BotanicLab,Inc. Posts Copy of FDA Test That Found No DES in PC SPES Aug 23 2001
Second Lab Finds Artificial Estrogen Profile in Samples of Herbal Supplement for Prostate Cancer BY JACQUIE STRAX August 22, 2001
PC SPES, One Man's Story BY BOB ANDERSON © Raleigh, N.C. July 19, 2001
PC SPES Puzzle July 16, 2001
Botaniclab CEO "Stands Firm" Against PC SPES Allegations: July 14 2001
Synthetic Estrogen (DES) Reported in 2 Samples of "Natural" Herbal Compound PC SPES July 14, 2001
No DES in Prostate Cancer Herbal Supplement, BotanicLab Vouches July 10, 2001
Turmoil Over Prostate Cancer Supplement -- Estrogen Added or Missing? July 9, 2001
Prostate Cancer Herbal Mixture Avoids Osteoporosis of Chemical Hormonal Blockade May 13, 2001
PC SPES, Herbal Compound, Lowers PSA in Men With Advanced Prostate Cancer, UCSF Study Finds: October 28, 2000
PC-SPES Effects on Patients With Androgen Dependent Prostate Cancer: May 20, 2000
PC-SPES Update The Herbal Therapy Lowers PSA in Men With Advanced Prostate Cancer, UCSF Study Shows: May 6 - July 9, 1999.
PC-SPES Contains Estrogen, Lowers Testosterone and PSA: November 26, 1998
Test Report, DiPaolo (1998)
Figure 3. Results of High-Performance Liquid Chromatography, Gas Chromatography, and Mass Spectrometry of PC-SPES and the Estrogens Estrone, Estradiol, and Diethylstilbestrol (DES). The results of high-performance liquid ...