The new effort is part of a broader program called the Dietary Supplements Laboratory Quality Assurance Program (DSQAP), coordinated by National Institute of Standards and Technology (NIST) and the National Institutes of Health Office of Dietary Supplements (NIH-ODS). The voluntary DNA study is intended to look at effectiveness of currently used DNA sequencing techniques for botanical ingredient identification. The data gathered from this exercise will be used to establish resources and provide recommendations to help the industry effectively develop this emerging technology.
“It is an interesting study and we hope by the end we will have some idea about how reliable DNA testing is,” Maged Sharaf, chief scientific officer of AHPA, told NutraIngredients-USA.
“So far we have eight organizations signed up for the study and we expect to have a few more,” he said.
Making fine distinctions key to reliability
The study will begin with what Sharaf called a fairly straightforward botanical identification, one that shouldn’t present too much of a challenge for the labs. The second part of the exercise will be a more challenging sample, one that is expected to more fully test the labs’ capabilities.
Sharaf said being able to reliably used DNA to ID very similar samples is a key to its reliability. After all, in some cases very similar botanicals appear in the trade, such as the three species of Echinacea: E. purpurea, E. augustifolia and E. pallida. While the mixture of these species might merely serve to accentuate or blunt the effects consumers expect from consuming these products, the similar species question can have more serious consequences. In the case of black cohosh, for example, this botanical has been linked in some reports with cases of hepatotoxicity. However, according to the American Botanical Council, there have been no demonstrated cases of liver damage connected to authentic black cohosh, or Actaea racemosa. Similar species of Chinese origin, namely A. cimicifuga, A. dahurica, A. heracleifolia, and A. simplex, have been included in products sold as black cohosh as adulterants, and it may be these that are responsible for whatever level of liver injury that can be connected to this botanical.
Methods not specified
Sharaf said that the samples will be sent to the labs in a blinded fashion. And NIST is not specifying which techniques should be used; each lab will be free to use the method it is most familiar and comfortable with so that the study can assess the true state of efficacy for these tests as they stand in the marketplace.
“The intent here is to look at the reality of the current DNA testing technologies and methods to see how successful they are. The only common thing will be the blinded material,” he said.
Sharaf said that the idea was hatched in an AHPA working group about six weeks ago, when a tentative study design was put forward. NIST agreed to house the study, and a meeting on July 6 will formalize the procedure. He said he didn’t know how long it would take to finish the entire two rounds of the test, as each lab will have to fit the work in around its existing schedule. But Sharaf did note that the tests themselves, unlike running a clinical trial on an ingredient, will only take a day or two to complete by each lab.
Standards development
Another parallel effort taking place at NIST is the development of a library of standards to use in DNA identification. When New York Attorney General Eric Schneiderman took the industry to task for failing to more fully employ DNA barcoding technology, he glossed over the fact that there were very few DNA standards for botanical materials then in existence.
“They are looking to develop suites of standards for each botanical,” Sharaf said.
The identity of all participating laboratories will remain confidential, Sharaf said. For more information on the program or to volunteer to participate, click here.