Alkemist Labs rings alarm on doctored C of A certificates

By Danielle Masterson

- Last updated on GMT

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Related tags c of a Alkemist labs lab testing Fda Adulteration dry labbing dry reporting elderberry

Alkemist Labs' CEO Elan Sudberg says he's seen evidence that some ingredient suppliers and marketing companies have been altering valid lab reports and using those falsified reports to promote their products.

Alkemist Labs reports these alterations have emerged in multiple forms, from changing or removing the client name to replacing the lot number. In some cases the practice has extended to changing the results of the analysis. 

Not a new problem

Back in 2012, Dateline NBC did an undercover investigation that revealed some unscrupulous companies in the industry were issuing a Certificate of Analysis (C of A) with any test results the client requested and not actually testing the product at all. The practice was dubbed ‘dry labbing.’ 

The most recent incident was on May 6th, when several industry contacts said they had received an email offering elderberry botanical extracts for sale and linked lab reports purporting to show elderberry (Sambucus nigra​). The linked report had been significantly altered from the original version. The company also clipped the images from the report and pasted those images in their marketing materials without any attribution.

“We’re calling this new problem ‘dry reporting’ and it has the potential to create as many terrible headlines for the industry as the dry labbing scandal did. The industry needs to be on high alert,”​ warned Elan Sudberg, Alkemist Labs CEO. 

Industry-wide problem 

The practice has not been limited to reports produced by Alkemist Labs.

“We have had this issue for years. It comes and goes,”​ said James Neal-Kababick, director, Flora Research Laboratories. “We even had a company that was so bold that they sent us one sample to test and sent that data to FDA showing their product was clean but it was not their product.  The FDA contacted us and asked for confirmation of the sample type and appearance, which was not what they had in their lab. We have also had companies advertise that they test all products with our lab when they were not testing anything at our lab and had to involve our legal counsel to resolve it.”

In one recent incident, a doctored Alkemist Labs report on elderberry was e-blasted along with a falsified report from DNA4 Technologies, a lab that provides DNA testing for natural product identity and purity.

“We’ve demanded that the offending company send a letter to all the original e-blast recipients that correctly identifies that DNA4 did not test the extract powder described in the advertisement, as well as to modify the ad that is posted on their website and include a notation that a previous version of the ad incorrectly linked our report testing raw materials, to the advertisement for a powdered extract,”​ said David Erickson, PhD, CEO and co-founder of DNA4.

Sudberg told NutraIngredients-USA​ that they have received a variety of colorful responses from the offenders. 

“We have had several replies ranging from ‘we certainly did no such thing, but if we find out that one of our employees did THEY WILL BE PUNISHED’ to ‘but the company we bought this from said we could’." 

Sudberg said they are actively evaluating various ways to offer the industry a verification step for their C of As. “There are options, from QR codes to Blockchain, and we’re looking at everything. For now, we’re inviting people to email us any C of A’s with our name on them and we will verify authenticity.”

Don’t blame it on FDA

“This has been going on for as long as I can remember and I do not think the FDA’s suspended actions are changing that. Even if FDA did inspect the facility, they would not necessarily know the test results were altered,”​ explained Neal-Kababick. 

Sudberg agrees. “I don’t think FDA suspending inspections is helping the quality of this industry. Cheaters have always been cheating and always will. The mad rush on immune supportive botanicals due to the coronavirus has challenged the supply chain, and cheaters are taking advantage of vulnerabilities.”

Guiding principles 

In 2016 Alkemist Labs issued a policy and guidance to the industry when it was discovered that companies were mimicking Alkemist Labs distinctive report format. Those guidelines continue to enforce that: 

  • All Certificates of Analysis issued by Alkemist Labs will contain the following: “Copyright © Alkemists Pharmaceuticals 2020. All rights reserved.”
  • Clients may request to use lab reports issued by Alkemist Labs in their marketing materials, and we encourage them to do so, but must obtain written permission from the company to help weed out misused reports.
  • No changes or redactions of any kind are permitted, nor may the Alkemist Lab name and/or logo be removed or blurred.

“If you get a C of A that says it’s from us, email it to us and if it is authentic, we will verify that. We hope other testing labs in our industry will follow suit.”

Sudberg added that the Alkemist Labs C of A is valuable because of the reputation they have built and they intend to protect that integrity.

“We appreciate that our reputation engenders trust and worked hard for it, so now we will work even harder against these cheaters to make sure our name stays credible.”

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