Is the tide changing on FDA's scrutiny of contract labs?

By Stephen Daniells contact

- Last updated on GMT

© Getty Images / gorodenkoff
© Getty Images / gorodenkoff
Is the FDA starting to take a closer look at the third-party contract laboratory space? A recent warning letter suggests maybe it is...

The third-party lab category is similar to the contract manufacturer space – there are a bunch of them out there, some of them like to walk in the sunlight but some prefer the shadows. We don’t know who they are, what quality measures are in place, what type of clients they interact with, and on and on.

I’m not suggesting that by staying in the shadows anyone is doing anything wrong. Some people are happy to go about doing a good job with the minimum of fuss. They may think that business is good, so they don’t need to engage with trade associations, exhibit at trade shows, or talk to people like me. 

But it would be good to have increased transparency around the whole testing category, as Alkemist Labs' Elan Sudberg has been calling for over the years.

A spotlight briefly shined on the topic of dietary supplements testing in 2012 when Dateline NBC ran an exposé on “dry labbing”. This is a practice whereby research or analysis is claimed to be done, but in reality, the conclusions are guessed at or copied from other sources without actually doing any analysis. Some stakeholders pushed back on claims that dry labbing was “widespread”​, while one expert told us, “Most of us know which labs are dry labs, or at least horrifically incompetent”​.

Warning letter

But a flash of mainstream media interest is nothing compared to increased FDA scrutiny, and a recent warning letter sent to a third-party lab for a raft of GMP violations for finished pharmaceutical testing (21 CFR 210 & 211) perhaps hints at things to come for the wider category. It should be stressed that none​ of the violations cited by FDA in the June 4, 2019 warning letter​ relate to the testing of dietary supplements (under 21 CFR 111), and the lab in question stated to the Agency that it "primarily test[s] botanical and nutritional products", ​suggesting that the testing of pharmaceuticals was/is only a small part of the business. 

The warning letter could be a wake-up call to the wider category. Brandon Griffin, CEO/Co-Founder at REJIMUS​, made some great points on LinkedIn this week in response to the warning letter (reproduced with his permission): “For clients and industry friends, we've been actively warning you all about what's coming next in terms of Agency focus and efforts to ensure compliance at all levels of the supply chain, including the requirement for auditing the third-party labs (should any testing be outsourced) just as you would a contract manufacturer itself.

“[Contract manufacturers] also need to read the fine print when sending out the testing to understand what is to be reported as GMP vs. non-GMP. Audit for the qualification of those methods, and expect access to all your data and documentation, not just a piece of paper,”​ he added.

Griffin added: “While contract labs in the food/supplement space have been largely absent from the Agency focus to date (in my professional opinion), the tide is changing.”

Choosing a lab

Choosing a contract lab must be a daunting exercise, even for industry veterans. There are some resources out there, such a AHPA’s Choosing an Analytical Lab​ guidance​, which was authored by Steven Dentali, PhD, in 2003. Dr Dentali also co-authored an article with BCIT’s Dr Paula Brown for the January/February 2009 edition of Nutraceuticals World​.

The three main points that come out of reading those documents are that a company should understand:  

  1. The method of analysis (how good is it - USP, AOAC, etc.)
  2. The implementation of methods (how good the lab is at running them)
  3. The reference standard (what is to be measured)

But even armed with these basic questions, how does someone (especially someone new to the industry) navigate that space? We continue to hear stories of people shopping for labs based purely on price. They may also shop for results (and we’re back to dry labbing again).

Concern

Every week we see new companies launching dietary supplement brands, with the internet aiding the proliferation of these products. FDA data continues to show that companies are not meeting the standards set by current good manufacturing practices.

And let’s be honest, we have no idea how many products are out there. Estimates range from 50,000 to 80,000 – that’s a difference of 30,000: That’s a big hole in the data set.  

Who are these brands? How and where are they being made? How are they being tested? Who is testing them?

And I cannot go through a whole editorial without saying, “And what about CBD?” How much do these new brands know about dietary supplement GMPs? Who is testing these products? What are they testing for? What methods are they using? Are those methods validated? Who validated them? Are they testing for synthetic adulterants?

We need answers to these questions. Many people are now advocating for mandatory product registration. This publication agrees with those calls. Alkemist's Sudberg and some other stakeholders have called for transparency around the testing labs. Again, yes please!

I didn’t intend this editorial to be doom and gloom: The industry needs to be ready if third party labs do increasingly come under FDA’s gaze because consumers and the mainstream media may latch on to what they find. But there are also opportunities here. There are many companies doing things the right way, working with high quality labs and testing above and beyond what's needed from cGMPs and FSMA. The industry should also be ready to embrace those opportunities.

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