On February 3, 2015, Eric Schneiderman, the State of New
York Attorney General, pulled off his glove and slapped the supplement industry
in the face. His office sent out cease and desist letters to GNC, Walmart,
Target and Walgreens asking them to stop selling certain supplements in New
York. His office issued a press release revealing the results of an
investigation into the authenticity of common store brand supplements purchased
at GNC, Target, Walgreens, and Walmart stores throughout New York. The Attorney
General had hired a population and evolutionary biologist - James Schulte, PhD
of Clarkson University - to analyze the samples. Dr. Schulte was hired because
of his expertise using a technique called DNA barcoding.
Resources:
DNA barcoding – what it is and what it is not
What it is
The technology of DNA barcoding emerged in 2003. Originally
created to help taxonomists identify and classify new species, DNA barcoding takes
a small specific region of DNA and basically makes a barcode out of the nucleotides.
The developers of the technology soon realized broader applications for its use and it is now
a tool used by a variety of
disciplines, including evolutionary biology. The DNA barcode information is
maintained in an open-source database and is available for other users to
access. Dr.
Schulte, an evolutionary biologist, uses this technology is his research and his
expertise with this method is part of why the NY Attorney General’s office hired him to analyze dietary
supplements. One of the outpourings of DNA barcoding is that it is user
friendly – non-experts can use the technology and information.
What it is not
DNA barcoding is not a standard method used in phytochemical
(plant chemical) research, in clinical testing related to phytochemicals, or as
a lab test to detect for the use of dietary supplements as performance enhancement
aids. The standard, most common, and recognized techniques used in dietary
supplement research including clinical and lab testing are high performance
liquid chromatography (HPLC), nuclear magnetic resonance (NMR), mass
spectrometry (MS) and different types of MS like MS/MS and gas chromatography-mass spectrometry
analysis (GC/MS). If you read literature about phytochemicals these are the
methods used to determine the presence
and quantity of phytochemicals in products as well as in biological samples (Hoggan, Shelby, Crouch, Borges, & Slawson, 2007; Li & Seeram,
2011; Ma et al., 2012; Prior, Wu, & Schaich, 2005; Thomas et al., 2010;
Vaclavik, Krynitsky, & Rader, 2014).
Resources
The results
Six herbal samples were identified and selected for the
study. The 6 dietary supplements were selected because they are samples that
can be identified by DNA barcoding technology. As I said before, this is a new technology
and not everything in the world (not every plant species) is included in the
database. If it does not exist in the DNA database, it cannot be detected. Of
the possible herbal supplements that they could select from, they focused on more
popular dietary supplements. The researchers tested 3-4 samples from each of
the stores and they tested each sample multiple times. In total, the
researchers had 78 samples and they performed 390 DNA tests on those 78
samples. I have not read the full report of the research (I have not come across
it in my research and I do not know if it is publicly available yet). Here is a
summary of what the Attorney General’s office has released.
When Dr. Schulte looked at all the data from all the stores together
it showed that:
- 21% contained DNA for the ingredients listed on the label (they contained what they advertised – at least by name, do not know about quantity);
- 79% contain DNA evidence of plant-based ingredients not listed on the label – these are considered filler ingredients and contaminated ingredients;
- A “large number” of samples (percent not provided by AG’s office) contained no DNA at all – whatever is in the product could not be identified by DNA barcoding analysis.
More specifically:
Store brand
|
Supplements tested
|
Overall results of DNA barcoding tests
|
Ingredients detected but not listed on the label
|
|
Walmart
|
Spring Valley
|
Gingko biloba
St. John’s Wort
Ginseng
Garlic
Echinacea
Saw palmetto
|
4% of the contained DNA matches for the ingredients listed on the product
label
|
Allium
Pine
Wheat/grass
Rice mustard
Citrus
Houseplant
Cassava
|
GNC
|
Herbal
Plus
|
Gingko
biloba
St. John’s
Wort
Ginseng
Garlic
Echinacea
Saw
palmetto
|
22% contained DNA matches for the labeled ingredients
|
Allium
Asparagus
Rice
Houseplant
Saw
palmetto
Primrose
Alfalfa/clover
Echinacea
Spruce
Legume
|
Walgreens
|
Finest Nutrition
|
Gingko biloba
St. John’s Wort
Ginseng
Garlic
Echinacea
Saw palmetto
|
18% contained DNA matches for
labeled ingredients
|
Allium
Rice
Wheat
Palm
Daisy
Houseplant
|
Target
|
Up &
Up
|
Gingko
biloba
St. John’s
Wort
Valerian
Root
Garlic
Echinacea
Saw
palmetto
|
41% contained DNA matches for labeled
ingredients
|
Allium
Asparagus
French
bean
Wild
carrot
Pea
Saw
palmetto
|
Allium atropurpureum. Photo: JLPC / Wikimedia Commons, via Wikimedia Commons |
Walmart, GNC, Walgreens and Target received cease and desist
letters from the State of New York’s Office of the Attorney General. The
companies were informed that the state was unable confirm the content of some
of their store brand dietary supplements, that they found evidence of product adulteration,
and that some products needed to be removed from store shelves within the state
of New York. Additionally, each company was asked to provide the Attorney General’s office with information
and documentation about the procedures for manufacturing, processing, testing,
and quality control of their store brand dietary supplements.
Needless to say, companies were not thrilled to receive with
this correspondence.
A GNC spokesperson stated that the company stands by the
herbal products and that DNA barcoding may not be the best test method to use
for phytochemicals. Target has replied with a comment regarding that they aim
for high quality and safe products. Walgreens is working to remove the
supplements from their shelves and will review the process and procedures for
their store brand herbal supplements, and Walmart states it is reaching out to
its suppliers.
Final thoughts
I am not surprised that they found unexpected and
potentially dangerous ingredients in supplements. Supplement manufacturers are
required to list all active and inactive ingredients on the label and they failed
to comply with this requirement. Every company tested showed that their
supplements contained unlisted ingredients, some of which are known allergens. This
is a health concern and a serious problem. It does not matter how they tested
for it. These ingredients were probably cheap and made good fillers. Just like
with medications and with foods, manufacturers must disclose all ingredients and supplement
manufacturers need to be held accountable when they do not comply. I believe what has
been shared with the public so far is a list of the most prevalent unlisted
ingredients. Also, only plant-based DNA included
in the DNA barcode database are part of this study. This is probably just the
tip of the list because unlisted pharmaceutical ingredients and plants not yet
part of the database have not been considered.
Supplement manufacturers often extract the
active component(s) from the whole plant and include the extracted part in the supplement.
It is unrealistic to use whole plants to make supplements (the volume
needed would be immense, there could be spoilage issues, there would not be enough
plants, and the whole point – theoretically – is to deliver a concentrated dose
of a phytochemical beyond that which you get in a complex food item where it is
diluted with other components). The DNA barcode is derived from a section of
DNA taken from the whole plant but most herbal supplements contain extracts. I
have no idea if any changes occur to DNA during extraction procedures. More
importantly, I have no idea if they tested and controlled for this in any sort
of way when they did they NY study. For example, did they purchase any pure and
validated St. John’s Wort and then examine that with DNA barcoding to determine
that it can be detected using this method? Have they verified their results using
standard methods of detection like HPLC and MS?
DNA barcoding is interesting and we will encounter more of it in the
future. As with any new method, it has to be validated. To do that, results
need to be compared to existing gold standard methods. I hope that as this
issue moves forward, we can see that happen with DNA barcoding and
currently used methods in phytochemical research.
I am passionate about the potential of phytochemicals (plant
chemicals) to impact health. I am very interested in the differences between
how phytochemicals work when they are part of food versus how they may function
when they are extracted and taken as supplements. That is, of course, assuming
the supplements contain what they should. Phytochemical research is a new discipline
and much remains unknown about if and how phytochemicals function, and yet in
2009 Americans spent over $25 billion dollars on all types of supplements,
according to Consumer Reports.
We seem to be more interested in the possibility than the science and that
fuels their fire. They are taking advantage of us, but we are letting them. It is
time for this to stop and the New York Attorney General is paving the way.
Other Posts on this Blog
about Dietary Supplements:
Other Resources
Literature Cited
Hoggan, A. M., Shelby, M. K., Crouch, D.
J., Borges, C. R., & Slawson, M. H. (2007). Detection of bumetanide in an
over-the-counter dietary supplement. J
Anal Toxicol, 31(9), 601-604.
Li, L., &
Seeram, N. P. (2011). Further investigation into maple syrup yields 3 new
lignans, a new phenylpropanoid, and 26 other phytochemicals. J Agric Food Chem, 59(14), 7708-7716.
doi: 10.1021/jf2011613
Ma, H., Yuan, T.,
Gonzalez-Sarrias, A., Li, L., Edmonds, M. E., & Seeram, N. P. (2012). New
galloyl derivative from winged sumac (Rhus copallinum) fruit. Nat Prod Commun, 7(1), 45-46.
Prior, R. L., Wu,
X., & Schaich, K. (2005). Standardized methods for the determination of
antioxidant capacity and phenolics in foods and dietary supplements. J Agric Food Chem, 53(10), 4290-4302.
doi: 10.1021/jf0502698
Thomas, A.,
Kohler, M., Mester, J., Geyer, H., Schanzer, W., Petrou, M., & Thevis, M.
(2010). Identification of the growth-hormone-releasing peptide-2 (GHRP-2) in a
nutritional supplement. Drug Test Anal, 2(3),
144-148. doi: 10.1002/dta.120
Vaclavik,
L., Krynitsky, A., & Rader, J. (2014). Mass spectrometric analysis of
pharmaceutical adulterants in products labeled as botanical dietary supplements
or herbal remedies: a review. Analytical
and Bioanalytical Chemistry, 406(27), 6767-6790. doi:
10.1007/s00216-014-8159-z