Alkemist Labs offers guidance for finding a reliable analytical lab

Alkemist Labs has released a lab guidance document that will help supplement brands choose the right analytical partners to work with. Alkemist CEO Elan Sudberg said the free resource fills a gap in the market and should help motivated companies avoid obvious mistakes. 

The new document received specific input from attorney Rend Al-Mondhiry of Amin Wasserman Gurnani and Len Monheit, principal in the consulting firm Industry Transparency Center. 

Sudberg said it’s all too easy for brands to get this critical choice wrong. Failing to choose a high-quality lab could doom a startup from the start. 

“There is a good selection of labs that offer high-quality services, not only ours. Yet, for years I watched as brands struggled to evaluate labs and, in some cases, chose terrible labs with publicly documented quality deficiencies,” said Sudberg. “I couldn’t find an industry guidance anywhere, so we decided to develop one. We hope that this guidance will help the companies that want to do things right choose good labs.” 

The 10-page guidance, which is available as a free PDF download, lays out the key questions a brand must consider when looking for an analytical lab partner and when managing that relationship. 

Why it matters 

Al-Mondhiry chipped in with a discussion of the regulatory and liability reasons why ingredient testing is important. She used the questions surrounding the identity of elderberry (Sambucus nigra) products as a case study. Failure to properly identify this commonly adulterated botanical puts a brand in danger of action from the Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA), the lawyer said. That could include in egregious cases consent decrees that shut down a firm’s operations until it can demonstrate compliance and meet the conditions set out in the decree. 

In addition, brands run the risk of having competitors challenge their marketing language before the National Advertising Division (NAD) if they can’t demonstrate that products contain elderberry if the claim is they do contain the botanical (an actual case that came before NAD). 

Finally, but far from least, Al-Mondhiry said brands that fall short on testing can endanger the health of consumers and risk losing their trust. 

What to look for 

The meat of the guidance goes into the nitty gritty of how to select a lab that is both competent and is likely to be a good business partner. 

The first thing to look for is an ISO 17025 accreditation, one that is broad enough to include the expertise needed to test the kind of products the brand holder intends to bring to market.  

Another consideration is whether a lab participates in the National Institute of Standards and Technology (NIST) program aimed at improving lab proficiency. Under that anonymous program, labs receive a blinded sample for analysis and then can see how they performed relative to their peers. 

Among the many other things to look for, the guidance states, is whether the lab participates in industry trade associations, how well validated its test methods are and how transparent the test reports are. 

The document continues with a discussion of typical red flags seen when contacting substandard labs. Monheit concludes the guidance with a brief discussion of the inherent conflict of interests to be aware of when working with a contract manufacturer and relying on the manufacturer’s internal QA staff for testing recommendations. 

Stamping out “dry labbing” 

Petra Erlandson, Alkemist’s director of sales and marketing, said her company hopes the guidance will help weed out the persistent problem of “dry labbing,” in which intentionally fraudulent testing results are circulated through the industry.  

“Pure dry labbing, where a submitted sample never undergoes testing and receives an illegitimate report, appears to have been replaced with testing by input, which is not actually testing at all but rather just a review and calculation from batch records,” Erlandson said. 

She added that editing lab reports to change data or even substitute new species names in the case of botanical ingredient testing remains a common practice. 

“It’s our hope that this guidance will assist companies that value quality and valid testing to choosing high-quality labs,” Erlandson concluded. 

The free guidance can be downloaded here.