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Economically Motivated Adulteration in the Dietary Supplement Market Place


... from simple addition of stones or thumbs on the butcher scale to more current ... Indications of idebenone substitution in Asian market place ... – PowerPoint PPT presentation

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Title: Economically Motivated Adulteration in the Dietary Supplement Market Place

Economically Motivated Adulteration in the
Dietary Supplement Market Place
  • William Obermeyer Ph.D.,
  • VP Research,
  • Pasadena, MD 21122 USA

Economic Adulteration
  • Historically, economic adulteration ranges from
    simple addition of stones or thumbs on the
    butcher scale to more current sophisticated
  • 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

CL Testing of Finished Products
  • Product Testing
  • Identity
  • Quality
  • Consistency
  • Impurities
  • Disintegration/Dissolution

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

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
  • Clinically tested
  • Typically 1500 mg G/1200 mg C daily

CL Joint Supplement Results
  • Chondroitin Sulfate Scientific Committee (CSSC)
  • Raw material manufacturers gather to establish
    chondroitin monograph and assess analytical
  • 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
  • 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

Persistent Problems with Chondroitin
  • Using the wrong method for analysis
  • Lack of knowledge of adulteration or proper
  • 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
  • Didnt see the potential for abuse
  • Depending on C of A for identity
  • No testing
  • Will go away in June 2009 with GMPs ?

Other Examples of Adulterated Products
  • Ginkgo
  • Conducted 4 surveys in last 10 years with results
    indicating a subtle progression of sophisticated
  • 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
  • Sold to unsuspecting manufacturers until supply

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
  • In conjunction with several labs CL sent out
    idebenone standards and developed method for
  • Herbal ED supplements (Flora Research)

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
Media coverage has not been effective at reducing
the number of illegal products on the market or
sales. DS quality issues are enormous and
API Story ran in hundreds of papers globally.
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
1990s and over 90 are adulterated with some
analogue drug and the problem is getting
worse. Now they are seeing other APIs in DS
products. We are Phytoforensic scientists
looking for unknowns missed by numerous labs.
The complexity of adulteration is mind boggling.
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
  • ??
  • Chinese acai in market
  • No quality markers, ripe for adulteration

  • 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.

  • Jim Kababick at Flora Research for allowing me to
    present a summary of his work on herbal ED
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