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Transparency could be the 1st step towards greater consistency in testing methods & labs: Experts

By Stephen Daniells contact

- Last updated on GMT

Transparency could be the 1st step towards greater consistency in testing methods & labs: Experts

Related tags: Dietary supplement

Third-party labs that keep their testing information proprietary to gain a competitive advantage may actually be harming their business, say leading experts calling for more transparency in the analytical sector.

Calls for greater transparency have grown louder in recent times, particularly in light of the NY Attorney General’s probe into herbal supplements (and those calls have gone both ways as the industry seeks details from the AG on his testing and data).

Darryl Sullivan, director of scientific and regulatory affairs, nutritional chemistry and food safety at Covance Laboratories, told us he supports the important call for transparency in third-party laboratories.

“Testing laboratories need to be open about the methods they are using, and they need to be willing to share supporting information in the form of chromatograms and raw data,” ​said Sullivan. “There needs to be more consistency in testing methods and testing laboratories in the dietary supplement industry, and this may be the first step towards this.”

Frank Jaksch, CEO of Chromadex, told us that there has been chatter about transparency for analytical testing labs in the dietary supplement space for over 15 years. “Yes, I fully agree that analytical labs that are performing testing services for dietary supplement companies should be fully transparent; I think this goes without saying,” ​he said. “ChromaDex was one of the innovators in transparency when we started offering detailed reports with all of the customer sample and method details, a practice we started over 10 years ago.”​ 

‘The message is resonating’

Elan Sudberg, CEO of Alkemist Labs, spoke with us at Expo West about the need for transparency (video available HERE​), and there has been a lot of positive attention since then, he told us this week. “My comments in Anaheim continue to resonate as legal and media attention just keep getting more intense and we keep advocating,”​ said Sudberg.

“The concept of quality isn’t anything new; it’s as old as is cheating. What’s new is publicizing it alongside a company’s other important value propositions. While good players in the industry are still scratching their heads over the new sGMPs (Schneiderman’s new cGMPs) our trade associations have spoken on the matter. It is clear is that not only the FDA is ‘sort of watching’ but so are attorney generals and class action attorneys. If it wasn’t safe to cheat before, it’s just stupid now.”

Challenges of transparency?

Darryl Sullivan Covance
Darryl Sullivan, Covance

The transition to transparency would not be a huge challenge for Covance, said Sullivan. “We believe in transparency and openness in testing dietary supplements,”​ he said. “Other laboratories believe that they may gain a competitive advantage by keeping the majority of their testing information proprietary.  In fact, the opposite is probably true.”​ 

Alkemist’s Sudberg said his lab has been offering fully transparent lab results since they tested their first sample of Salvia officinalis​ leaf by microscopy. However, the transparency has come at a cost as business is lost to clients who are internalizing their testing utilizing Alkemist’s fully transparent lab results.

“We practice science and not proprietaries so that’s old news,” ​he added. “What has always been a huge challenge is getting the manufacturers of plant extracts, novel ingredients and finished products to be fully transparent so that little old testing labs like us can employ the correct testing methods when their clients become our clients.”

“This is not really all that complicated,” ​said Jaksch. “The transparency issue is not that difficult to fix:  Third party independent analytical labs are part of the process, and should be treated as such.  Companies that use analytical labs to outsource testing should have qualification procedures to evaluate the laboratories they are going to use. 

“They should also perform rigorous audits and inspections of the analytical labs they are evaluating.  Part of this qualification and inspection should include transparency testing.”

Gaia Herbs & UL

The entire dietary supplement industry can benefit from transparency around testing, said Sullivan, with programs like Gaia Herbs’ ‘Meetyour​herbs’​ a “great example for industry on openness and information sharing”​, he said.

Elan Sudberg, Alkemist Labs 1
Elan Sudberg, Alkemist Labs

“Gaia Herbs has a beautiful and simple process offering information to consumers because they think it’s valuable to them,” ​noted Sudberg. “I agree and appreciate that sentiment. The industry will decide whether we all have to emulate Gaia or jump on board UL’s ‘​Clear View‘.

“Of course just as our C of A’s are sometimes fraudulently Photoshopped by the unscrupulous, so can the quality offerings of bad players out there be faked. “Walking your talk” does require more effort and an ethical way of thinking, but it is far more sustainable long term than living in the grey space between illegal and unethical.”

All of the industry trade associations have also been trying to drive transparency in this area, said Sudberg. “What appears to have the strongest legs in this arena is NPA’s strategic partnership with UL’s ​Clear View. I can see this one taking the industry by storm and changing the final consumer’s subconscious to expect nothing less.”

Some industry stakeholders have said that greater transparency would solve many of the industry’s problems, but is transparency enough? For Covance’s Sullivan, more standardization and harmonization in third-party laboratories is needed. “When different labs use different methods – all sorts of questions can come up when the data differ,” ​he said.

“We need more standard methods from AOAC and USP and we need more method validation and harmonization.”

Jaksch: ‘Qualify, audit and inspect the laboratories’

Frank Jaksch Chromadex SSW NIU
Frank Jaksch, Chromadex

Chromadex’s Jaksch said that dietary supplement companies need to be more involved to ensure transparency. “Simply saying, ‘we need transparency’, does not offer any real solution, and what the industry needs are solutions,”​ he said.

“Many companies in the dietary supplement industry do not qualify, audit and inspect the laboratories they are using, which makes it very easy for unscrupulous laboratories to participate in this market,” ​he said. “Dry labbing is another good example of this problem.

“Unless companies in the dietary supplement market, that are using independent analytical laboratories, start scrutinizing, qualifying and inspecting the laboratories they are using, hopefully before they start using the lab, this problem with without a doubt persist for many years to come, and we will be having this same conversation about transparency 10 years from now.”

Jaksch’s 4 Basic Tips to Use While Selecting a Contract Laboratory

1.      Qualify the contract laboratories your company uses before sending samples and relying on the results they provide.  As a matter of fact it would probably be a good idea to have an SOP for “Qualifying Independent Contract Testing Laboratories”. The company would provide a checklist for performing due diligence on a laboratory before they are “qualified” for use, which could of course include transparency testing.

2.      Qualify more than one analytical laboratory.  Not only is it doubtful that you will be able to find one laboratory that can meet all of your needs, it is also better to use laboratories based upon their analytical expertise.

3.      Sign a contract or agreement with your 3rd party analytical laboratories which defines the relationship.  If your company uses a 3rd party analytical laboratory, you need to establish ground rules and expectations, which not only makes good business sense, but also is an important part of GMPs.  This agreement should include language about transparency, so the lab understands they it is part of a binding agreement.

4.      Visit, audit and inspect your contract laboratories.  Contract laboratories performing analytical testing services for dietary supplement manufacturers are in fact a part of the GMP process, which makes them fully accountable for being GMP.  Since contract laboratories are accountable for GMPs, the companies using the services of contract laboratories should visit, audit and inspect their labs to be sure they are compliant.

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