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Slide 1 - Economically Motivated Adulteration in the Dietary Supplement Market Place William Obermeyer Ph.D., VP Research,, Pasadena, MD 21122 USA
Slide 2 - Economic Adulteration Historically, economic adulteration ranges from simple addition of stones or thumbs on the butcher scale to more current sophisticated approaches Plantain/digitalis case Plantain adulteration described in the literature and diminished with invention of microscope Inability to prevent adulteration without sufficient testing for identity Was in market place for several years before being identified 1997 ANPR cGMP for dietary supplements Insufficient testing to prevent adulteration
Slide 3 - CL Testing of Finished Products Product Testing Identity Quality Consistency Impurities Disintegration/Dissolution
Slide 4 - Current Adulteration Issues Simple adulteration Addition of inert material to add fill weight Maltodextrin Extracted marc Sophisticated adulteration Deliberate substitution with selected ingredients specifically designed to manipulate tests to “enhance” ingredient quality Premium orange juice Melamine Examples of Economic Adulteration 10 years of CL survey work of the most commonly purchased categories of products in the US Potential adulteration leads from inside the industry and from international sources Quick overview of our observations of economic adulteration in the US market place Many examples; each one could be its own full length technical presentation
Slide 5 - Joint Supplements Glucosamine/Chondroitin products One of the larger consumer product categories Osteoarthritis affects an est. 20.7 million people in the US In the “top 10” (NBJ) Annual sales in 2007 were $831 M (NBJ 2008) Glucosamine (HCl, Sulfate) Relatively inexpensive raw material From shellfish and corn Chondroitin Sulfate Expensive material From bovine, porcine trachea, shark or chicken cartilage Clinically tested Typically 1500 mg G/1200 mg C daily
Slide 6 - CL Joint Supplement Results Chondroitin Sulfate Scientific Committee (CSSC) 1999 Raw material manufacturers gather to establish chondroitin monograph and assess analytical methods Products containing glucosamine (G) only, glucosamine/chondroitin (G/C), chondroitin (C) only and MSM Snapshot surveys completed in 2000, 2003, 2007 and an upcoming 2009 2000: 25 products (10 G, 13 G/C, 2 C) 6/13 GC and 2/2 C failed for low C 3 products <10% label claim for C 2003: 49 products, 4/24 with C failed for C 2 of 4 had no detectable levels of C 2007: 29 G and/or C products, 18 containing C 7 failed for C content; 4/7 with 0-8% of C, 3/7 51-75% of C 2009: > 50 G and/or C products Approx. 5 C containing products had little or no C
Slide 7 - Persistent Problems with Chondroitin Identification Using the wrong method for analysis Lack of knowledge of adulteration or proper testing Non-specific tests for “identity” without doing additional confirmatory tests (CPC, CE, size-exclusion chromatography, carbozole) Need to use specific method developed for chondroitin (enzymatic digestion with HPLC) Sophisticated adulteration Tricking CPC (cetylpyridinium chloride) titration method with other sulphated materials (alginates) CSSC “approved” CPC method for C raw material Didn’t see the potential for abuse Depending on C of A for identity No testing Will go away in June 2009 with GMPs 
Slide 8 - Other Examples of Adulterated Products Ginkgo Conducted 4 surveys in last 10 years with results indicating a subtle progression of sophisticated adulteration Addition of rutin/quercitin from buckwheat approx. $10/kg Fructus sophorae additions to enhance Q/K ratio GBE cost $35-90/kg Saw Palmetto Shortage of raw material due to hurricanes and lack of workers Chinese SP in market place Actually palm oil $130/kg vs $160/kg for real material Well known US lab “certifies” material based on total fatty acids and not specific FA profile for SP Sold to unsuspecting manufacturers until supply gone
Slide 9 - Other Examples of Adulterated Products Hoodia Weight loss “fad” ingredient Much of material sold was an ext. from cacti and not Hoodia CoQ10 Shortage of raw material Indications of idebenone substitution in Asian market place Not detected with non-specific spectrophotometric methods In conjunction with several labs CL sent out idebenone standards and developed method for detection Herbal ED supplements (Flora Research)
Slide 10 - Media Coverage & Sales Grow Together! It is theorized that there are more men in China now seeking treatment for ED than there are people in the US. This has driven the demand for TCM ED treatments combined with the push for more potent and effective analogues. Deaths have been reported. Media coverage has not been effective at reducing the number of illegal products on the market or sales. DS quality issues are enormous and growing. API Story ran in hundreds of papers globally.
Slide 11 - Big 3, Analogues, Analogues of Analogues & now Pro-Drug Analogues! Here is a partial list of PDE-5 inhibitors and their analogues. Since this list was published, several more compounds have emerged (~20) Flora has tested thousands of samples since the late 1990’s and over 90% are adulterated with some analogue drug and the problem is getting worse. Now they are seeing other API’s in DS products. We are Phytoforensic scientists looking for unknowns missed by numerous labs. The complexity of adulteration is mind boggling.
Slide 12 - Potential Products for Adulteration Superfruit juices and supplements Noni juice $277M in sales in 2007 (NBJ) Mangosteen juice $191M in sales in 2007 (NBJ) Gogi juice $98M with a 50% increase in sales in 2007 (NBJ) Acai juice and weight loss supplements Eight species of palm native to Central and South America $?? Chinese acai in market No quality markers, ripe for adulteration
Slide 13 - Conclusions Economic adulteration is highly likely to occur with fad and expensive ingredients, or during times of shortage. Intentional or unintentional Nonspecific testing Knowingly using “dry” labs Once adult ingredients are introduced in the market place there is currently no meaningful way to remove them.
Slide 14 - Acknowledgment Jim Kababick at Flora Research for allowing me to present a summary of his work on “herbal” ED products