Where did this idea come from?

In full transparency, which is kind of my thing, the idea was birthed as a gorilla marketing campaign to combat a particular lab doing harm to our industry. It was a subversive way to call them out without getting sued into oblivion. Instead of saying, ‘don’t use that lab’, I was saying, ‘here is how to pick a good lab’ which would steer companies away from them.  As the idea evolved into a bigger and bigger initiative, we knew it had to be far more than a LinkedIn post. We’ve actually been working on this as time allowed for two years.

What’s the purpose?

The purpose is to help guide the industry on how to choose a lab. While this sounds trivial, it is in fact quite complicated, with myriad considerations.  While the cGMPs are prescriptive, the FDA does not specify the exact analytical techniques, test methods to use, or full parameters to be measured. So as the botanical and fungal categories began to explode, uninformed companies in our industry simply started sending their botanical and fungus to the goliath generalist labs who test pharmaceuticals, tilapia, aerospace textiles, and also botanicals. Even worse, some chose a lab that was well known for cheating, and absolutely deserved the warning letters they received. I felt like there needed to be better guidance on all the considerations that  go into choosing the best lab for your particular needs. We hope that this guidance will help the companies that want to do things right choose good labs.

The content piece guides people in selecting a good lab.  Can you share an example or two that you have seen happen when a company uses a bad lab?

Labs act as the gatekeepers of quality. While they should always be physically audited, there is a subject matter expert level of trust that comes with the lab relationship. It is common for companies to simply lean on the lab and trust that they are doing the right thing. To ‘Trust the Science’ as ‘they’ say. I always challenge the science, which is built into how we review our testing data and results. There should always be room for deliberation. A good lab will welcome an investigator inquiry about a pass or fail. When you work with a bad lab you open the gate of quality to many terminal paths. The least worst thing is that an ingredient is dilute and doesn’t work and will not earn return sales. The middle worst are costly legal challenges and reputation-destroying and shameful FDA 483s and warning letters. The worst worst thing is that a consumer is harmed. All these options are entirely possible if a generalist lab or cheating lab is deployed. Educated qualification of a lab removes these risks.

This guidance assumes the reader does indeed care about working with good labs and doing things right. Could someone reverse engineer the guidance to find a dry lab?

Ha! I never thought of that… Yes. I suppose if one’s desire is to defraud the people, they could use what we have assembled as a check list to avoid, get the results they seek and show up to the marketplace with a ‘lab tested’ product masquerading as high quality, safe and effective when in fact it may not be what’s on the label at all. This is where programs like Alkemist Assured come in, with a third-party quality confirmation. I continuously urge and challenge this industry to take quality out of the closet and share their quality story at the consumer level INCLUDING the lab hired to be their gatekeeper and even results that may not be easily understood by the consumer.

What are you hoping to achieve with this?

My initial goal was to put a particular lab out of business by adjusting the ‘Overton window’ of acceptance criteria for labs. Let’s help people ask the questions that would remove that lab from the playing field. In the time it took us to put this together, that lab was acquired, re-organized and, hopefully ,is now managed better. Unfortunately, the original owners pivoted and now run a dietary supplements contract manufacturer providing services for packaging, formulation, and label design. 

How would you feel about other good labs recommending people use this guidance?

I hope they do! I love this industry. I love what we make. I love why we make it. I love most of the people who run it. I want this industry to thrive and move away from the false narrative that we are unregulated, untested, and unsafe. Whatever it takes to get there, I will drive forward.

Will the bad labs be mad at you?

Early in my career, Alkemist Labs was responsible for crushing the adulterated Hoodia market with a single light microscopy. I received two separate death threats from upset vendors whose powder they claimed as Hoodia I proudly failed. I took those threats seriously and have been bragging about them ever since. It felt good to have an impact and help save unsuspecting brands from unnecessary hardship. I hate cheaters of any sort and consider it my mission to combat them, so I truly hope this upsets a handful of active labs.