Economically Motivated Adulteration in the Dietary Supplement Market Place

1
Economically Motivated Adulteration in the
Dietary Supplement Market Place

• William Obermeyer Ph.D.,
• VP Research,
• ConsumerLab.com,
• Pasadena, MD 21122 USA
• william.obermeyer_at_consumerlab.com

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

3
CL Testing of Finished Products

• Product Testing
• Identity
• Quality
• Consistency
• Impurities
• Disintegration/Dissolution

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

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

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
• 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

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
• Didnt see the potential for abuse
• Depending on C of A for identity
• No testing
• Will go away in June 2009 with GMPs ?

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

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)

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.
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
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.
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

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.

14
Acknowledgment

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