Economically Motivated Adulteration in the Dietary Supplement Market Place

William Obermeyer Ph.D., VP Research,

ConsumerLab.com, Pasadena, MD 21122 USA

william.obermeyer@consumerlab.com

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

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 cartilage

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

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

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

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

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)

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.

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.

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

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.

Acknowledgment

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