DNA vs HPTLC for Testing Identity and Potency of Botanical Extracts?
NY Attorney General vs Science
PureNSM is in the process of installing an HPTLC from CAMAG.
In the light of recent news why are we not installing DNA testing equipment?
I completely understand your concern as the recent headlines have caused much consternation in the dietary supplement industry. We are here to work with you so that you will be fully compliant with the GMPs set forth by the FDA for 100% identification of botanical raw ingredients. As an example of the type of analyses that can be performed with HPTLC on botanicals, I have attached a document from the HPTLC Association (http://www.hptlc-association.org/).
HPTLC is the industry standard, proven way to perform 100% identity testing on botanical raw materials and is supported by the FDA and pharmacopeias worldwide (including the USP). DNA testing cannot make that claim.
To prove my point, here are several items regarding the recent news of the NY Attorney General investigation and the subsequent announcement by GNC:
– GNC’s products, through independent testing both by their own lab and by 3rd party labs, were shown to be within specification. Their announcement is clearly a public relations move aimed at appeasing the NY AG and the general public.
– The findings of the entire investigation have been called into question because DNA is NOT an appropriate method for identity testing in extracts, and extracts are the primary source of most of the supplements on the market. In fact, one of the biggest opponents of the dietary supplement industry, Dr. Pieter Cohen, has called the results of the DNA testing into question. When one of your biggest enemies comes to your defense, you know something is amiss.
– Many respected news outlets have called the results into question because of the use of DNA testing:
– I have attached two PDFs for your review. One is a letter written by Roy Upton, the highly respected director of the American Herbal Pharmacopoeia, while the other document is a list of very relevant quotes from various sources. You will note that one of the quotes is from the FDA and one is from Danica Harbaugh Reynaud, CEO of AuthenTechnologies (the industry leader in DNA testing on botanicals). Her quote is “My suspicion is that inappropriate methods were used to assess these products, leading to some false-negative results,” and “A lack of DNA … is not necessarily indicative” of a mislabeled supplement”. That’s right, the CEO of a company that prides itself in being the “world leader in DNA botanical testing” and thus has much to gain from DNA’s use, says that using DNA for this investigation was inappropriate.
– You will notice that the FDA has yet to weigh in on this issue. The only news that has come out of this has been from the NY AG’s office and mostly the NY Times. Both of these organizations stand to lose much face if it is shown that the entire investigation was based on faulty science. And the lack of response from the FDA is very telling in my opinion, as there are already established regulations in place to monitor the quality of dietary supplements, and the FDA has stepped up enforcement of these regulations as of late.
– The FDA does not recommend the use of DNA testing as a primary technique for identity testing. NSF does not recommend the use of DNA testing as a primary technique for identity testing. The USP does not recommend the use of DNA testing as a primary technique for identity testing. No other pharmacopeia around the world recommends the use of DNA testing as a primary technique for identity testing. However these organizations DO recommend HPTLC as one of the primary testing techniques.
– Most of the major dietary supplement manufacturers use HPTLC as the primary identity tool. ALL major dietary supplement contract labs use HPTLC as the primary identity tool, and they do not use DNA. Why? Because HPTLC works for whole plants, plant parts, powders, and extracts. DNA testing cannot make the same claim.
DNA is a highly useful tool and may have a place in botanical labs for other purposes, but not for identifying the botanicals in extracts. That’s not a sales pitch from me, that’s proven science. I know that you must listen to your customers, but if they say that HPTLC is “old school” then they have no clue of what they are talking about. Your customers only care that you are providing them with a quality product, so as long as you can convince them of that then they will be happy. I think you will be better off listening to the FDA and USP when it comes to the scientific aspects of your QC program, versus relying on public opinion (which is fleeting and apt to change from day to day). The NY AG has no choice at this point but to push ahead, even though in a court of law his findings have ZERO chance of holding up, since it was based on inappropriate science. But the NY AG is an elected official and has a vested interest in keeping public opinion on his side.
So the simplest response I can give you is that if you rely on extracts to manufacture your products, and you choose DNA testing as your primary identity tool, you will be wasting your time and money AND you will fail any FDA audit that comes your way. If you use HPTLC as your primary identity tool, and you follow the established methods and procedures to do so, you will be in full compliance of the FDA’s GMPs regarding identity of botanical raw materials. Don’t let the politics and sensational headlines of this issue cloud your judgement when it comes to doing what’s best for your company and your customers.