The natural products industry isn’t the type to roll over when it’s accused of producing shoddy products. Especially when the accuser isn’t willing to pony up the evidence for its negative claims.
Last week, New York Attorney General Eric Schneiderman sent cease-and-desist letters to four major retailers telling them to remove store brand botanical products because tests showed they did not contain the botanicals noted on labels. The Attorney General followed up with a press release that led to a New York Times article as well as other media reports.
However, the supplement industry has questioned Attorney General Schneiderman’s use of DNA barcoding as the test method that substantiated his claims. To add to the rub, Schneiderman’s office said it won’t release the data to the public because it is part of an ongoing investigation.
To that, industry says “#ReleaseTheReport," and it has demanded “#transparency" from Attorney General Eric Schneiderman on Twitter. In addition, several trade organizations have spearheaded email and telephone campaigns to the Attorney General’s office urging it to reveal the data.
“The Attorney General needs to release these results," said Marc Ullman, partner, Ullman, Shapiro and Ullman. “If you look at the mainstream media, this report is being touted as proof that the supplement industry is unreliable, unregulated and filled with charlatans, and the Attorney General owes it to the public to release this data."
Daniel Fabricant, Ph.D., CEO and executive director, Natural Products Association (NPA), said certain principles apply to peer-reviewed research, such as scientific methodology, transparency, robustness, repeatability and freedom from bias. “These needs to be on free display so people know that confounders aren’t present," he said. “It’s the key to any good study."
What’s Not Revealed?
By not releasing the data, Attorney General Schneiderman’s office leaves unanswered questions about the research they used to question the botanical products. A major sticking point is if the DNA testing was appropriate for the products testing.
DNA testing is appropriate for raw botanical materials, as noted by Mark Blumenthal, founder and executive director or the American Botanical Council (ABC), in an INSIDER interview. But DNA is not a good way to test products created from botanical extracts, especially when used alone. The extraction process denatures and removes botanical DNA while still providing the phytochemicals associated with health benefits.
If there’s no DNA in the store-brand products, and the Attorney General is evaluating DNA, then it makes sense that the test results fell short. “The Attorney General is using what’s generally viewed as cutting-edge—but not reliable—technology to do this testing," Ullman said. “When you’re using a test methodology that has a high potential for error, and you’re not using back-up testing to validate results, it’s extremely important to provide the data."
With any assay, reference material is an important part of methodology. In order to determine identity, researchers must compare test results with an established reference.
“Just like with chemical analysis, you have to have a reference materials that you take your results and compare it against," said Steve Mister, president and CEO, Council for Responsible Nutrition (CRN). “DNA testing is such an emerging science that there are not complete libraries of DNA barcodes. If they weren’t comparing it to a validated library of material, how do we have confidence in what they are looking for?"
Fabricant pointed out the Attorney General examined Echinacea, a botanical with three species. “So, which one did they use?" he asked. “It’s not comparing apples to oranges, but it’s comparing gala apples to granny smith apples to Honeycrisp apples."
Other items in the data that should be revealed include if the tests were confirmed by more than one lab, if the contaminates levels were under legal limits, and if any of the researchers were experts in botanical identity testing.
And before even discussing the testing validity, Fabricant said chain of custody is the easiest thing to question. “We would get cases thrown out of chain of custody all the time [when I was at FDA]," he said. “Was there a possibility that the sample was tampered with, or was the sample held in conditions that wouldn’t keep it intact? Those types of things happen more often than people are aware of."
‘Under Investigation’ Privacy Shield
It is not uncommon for the government to refuse to release materials in an investigation, according to Mister, “But usually an investigation doesn’t begin with a press release to the New York Times," he said. “They went about it in a very public way in order to embarrass those retailers. If you’re going to take that kind of approach, then you should put your data out there for public review."
Anthony L. Young, partner, Kleinfeld, Kaplan and Becker LLP, noted it’s common in criminal actions to hide the evidence in order to spring it on the accused, but it’s uncommon in matters of public health and safety. “Except in public health emergencies, government action by press release is a way of the past," he said. “It is rarely used and almost never without the science behind it being disclosed. The action by the New York Attorney General’s office is a major backward step in transparency in government."
Campaigning for Transparency
The natural products industry quickly spearheaded a campaign to encourage the Attorney General’s office to produce the data. On Twitter, CRN and NPA have been tweeting to the Attorney General Eric Schneiderman (@AGSchneiderman) and his press secretary Matt Mittenthal (@MattMittenthal) with the hashtags #ReleaseTheReport and #Transparency.
But it’s not just twitter; both organizations have sent emails and made phone calls, totaling in the hundreds, according to Fabricant. He added NPA has not talked to anyone in the Attorney General’s office yet, but he expects that to happen this week.
“Even if people are critics of the industry, why wouldn’t we want transparency?" Fabricant asked. “If it happened to this industry, it could happen to anyone. It’s just bad policy."
Mister also noted CRN’s phone calls to the Attorney General’s office haven’t been returned. However, he said he is encouraged by the support the campaign has received. “There is a groundswell pushing back on the Attorney General, and that makes me optimistic."