10 questions we need answered regarding the NY AG’s botanical action

By Stephen Daniells

- Last updated on GMT

Barcodes are short genetic markers or signatures in DNA that identify which particular species it belongs to
Barcodes are short genetic markers or signatures in DNA that identify which particular species it belongs to

Related tags Cease and desist

You couldn’t make it up: DNA barcoding is used to test products that appear to be predominantly extracts by a researcher who is more comfortable with reptiles and dinosaurs and the results have not been made public. But the NY Attorney General is using the data to issue cease and desist letters to four major retailers.

There are more questions than answers at this point and the Attorney General needs to be totally transparent with the data. Here are our key questions – feel free to add you own in the comments section.

1. DNA barcoding is “seldom able to properly identify chemically-complex herbal extracts as little or no DNA is extracted in many commercial extraction processes”​, says Stefan Gafner, PhD, Chief Science Officer for the American Botanical Council (ABC).
Question 1: DNA barcoding is not an established method for extracts. Why did the AG and the researcher choose this method?

2. We know that we don’t know anything about the methodology and testing used. The data has not been published in a peer-review journal and it is not known if it will be subjected to peer-review.
Question 2: Why is the Attorney General withholding the data?

3. The AG’s action relates to 24 products from four retailers. According to the descriptions from the NY AG’s office and data available from the retailer websites, 66% of the products tested were extracts, with a further 8% available as both whole herbs and extracts. That’s a potential 74% of products tested being extracts, and yet data from the AG says that 79% of the products tested “came up empty for DNA related to the labeled content or verifying contamination with other plant material, ”​ said the AG’s statement.
Question 3: My calculations are based on data from the retailers’ websites, not from the researcher. What are the labels of the products tested?

4. The researcher commissioned to do the DNA analysis specializes in reptilian and evolutionary biology. That’s right, reptiles and dinosaurs. Based on details from his bio on the Clarkson University website, Dr James Schulte has not published any papers on DNA barcoding of botanicals or botanical extracts.
Question 4: How qualified is Dr Schulte to be testing botanical products?

5. Regarding the contaminants, we have no data about the quantities found, only that some contaminants were detected. Without knowing quantities, it is not known if these trace amounts are large enough to trigger label requirements.
Question 5: What were the quantities of the contaminants detected?

6. The four retailers in question are reacting differently to the news: According to the New York Times, Walgreens has said it will remove the products from its shelves nationwide, while Walmart said it is contacting its supplement suppliers “and take appropriate action.” GNC said it would work with the AG but stood by its products. Target didn’t comment. Industry sources indicate that some of the retailers only found out about the investigation when they received the cease and desist letters.
Question 6: Why were the retailers/manufacturers not shown the data and given the opportunity to respond and defend themselves?

7. This all links back to the controversial 2013 study from Steven Newmaster at the University of Guelph, which was widely criticized by industry. The ABC called for the paper to be retracted given its limitations and flaws​. According to the New York Times​, their early coverage of the Newmaster paper prompted the AG’s investigation.
Question 7: This paper was widely criticized – were these criticisms known to the AG and the researcher?

8. DNA barcoding is a powerful tool for testing botanicals, but is severely limited for extracts. Every expert I have spoken to says the same thing – there’s little to no cellular material left in an extract, and yet this technique is being used (again!) to test herbal supplements. There are established/accepted methods to test for herbals.
Question 8: Why did the researcher not use the accepted methods (with monographs)?

9. GMPs require 100% identity testing of materials. There is no public record of problems with the products from any of the four retailers.
Question 9: Is the AG aware of DSHEA and cGMP requirements for dietary supplements?

10. As expected, the mainstream media coverage has been negative and one-sided. The American Botanical Council provided a comment to the New York Times​, which the paper chose to not use, instead quoting several industry critics.
Question 10: Will the industry response be heard?

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Robert D

Posted by AJ Swan,

Comparing the side effects and adverse events for pharmaceuticals as a rebuttal for the quality of dietary supplements is a false comparison. Either the herbal dietary supplements in question are made with quality or they are not. The liver-related deaths of acetaminophen in 2014 is irrelevant to this very real issue in our industry.

This is a real issue and I am not at all surprised if it proves out that major herbal manufacturers are not manufacturing to label claim. We all know of or have worked with DS manufacturers that intentionally made products with inferior quality. I personally worked with one that regularly left out ingredients that were supposed to be included in their products and eventually voluntarily left when I was asked to falsify a couple of supplement batch records during an FDA audit that the FDA auditor randomly requested to review.

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I got no skin in this game

Posted by Walter Bazella,

but I'm being called gullible because I don't believe the tests. In most cases the ingredients are inexpensive and readily available. Why wouldn't the manufacturers use them? This doesn't smell right.

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Do I Smell a Lawsuit in the Air?

Posted by Martha W.,

If the sellers of the supplements prevail in this action, and they show that the AG used methods that are unreasonably inaccurate to justify his actions, we may see an Malicious Prosecution lawsuit in the future. This will be interesting.

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