As part of a series on how dietary supplement companies can best work with their contractors, NutraIngredients-USA contacted executives from four analytical labs, Alkemist Labs, Covance Laboratories, ChromaDex and Flora Research Laboratories. These experts were unanimous in saying the most important part of that process is not the expertise of the lab itself. While important, those expensive chemical analysis machines are only as good as what they’re used for. And deciding that is based on a clear understanding of what kind of business the dietary supplement client is operating and what kind of problems they are trying to solve.
Full information lays groundwork for fruitful relationship
“We always let our clients know how important it is for them to give us as much information about the samples being tested as possible, e.g. Certificates of Analysis (C o A’s), any special conditions used to create the material so that we can reproduce those conditions as closely as possible,” said Sidney Sudberg LAc, DC, president and CSO of Alkemist Labs.
“When I begin working with a new client the most important first step is open communication. I need to know as much about their products as possible, including the manufacturing process, the ingredients, the fortification levels of nutrients, the label claims, and the markets they plan to be in,” said Darryl Sullivan, director of industry and regulatory affairs at Covance.
“I often find that clients are not willing to share all of the above mentioned information. This makes it difficult to plan a scientifically valid testing program,” he said.
James Neal-Kababick, director of Flora Research Laboratories, said he was among the pioneers to apply forensic chemical techniques to the analysis of samples from the dietary supplement industry, whether it’s trying to identify a mystery adulterant in an incoming raw material or trying to figure out how apparently anomalous materials ended up in a finished product. But all too often, he said, he has found it necessary to apply that same forensic mindset to a client’s sample simply because he didn’t have enough information to start with.
“Often, company stakeholders come to us with requests to do some testing related to a bigger issue not disclosed. For instance, they may ask if we can test a finished product for label claim substantiation or for adulteration with clandestine drugs. However, they fail to explain that they are responding to an FDA action or perhaps a complaint letter from an attorney. This is a huge mistake. By doing this, they fail to allow us to bring our decades of expertise to fully bear on the problem,” Neal-Kababick said. “My number one request to new clients is ‘Don’t leave anything out. Don’t give me part of the story.’ ”
Be honest with yourself about goals
In addition to being forthright with the contracting lab, Tony Nguyen, ChromaDex’s director of sales in the analytical services and reference standards division said that a company needs to be honest with itself. What does it really want from a testing program?
“Before seeking out an analytical service provider, I would strongly recommend that any business sit down with their key internal stakeholders and have an honest discussion about the role that analytical testing plays in their business... Does analytical testing look more like a box to check in a process flow chart in your company or are safety and quality non-negotiable pillars upon which your brand is built?” Nguyen said.
“Once you have established your priorities, actively communicating those needs to potential service providers and ensuring your service contract reflects those priorities will help lead to a relationship with high levels of satisfaction,” he said.
Neal-Kababick noted that fully understanding the problem to be solved can help save headaches, money and potentially business-threatening problems down the road. In the case of testing done to respond to regulatory enforcement actions or to defend against law suits, knowing the full scope of the issue can inform what program is put in place.
“Often, once this is disclosed, we offer very specific guidance which may include not doing any testing at all but rather seeking counsel or the guidance of a compliance expert. It all depends,” he said.
Knowing when to say you don’t know something
The low barriers to entry in the dietary supplement business means that many new clients might have a lot of what former Secretary of Defense Donald Rumsfeld famously called the “unknown unknowns.” The experts contacted by NutraIngredients-USA said it’s necessary for new clients to not only be completely forthright about what they want but also about who they are. Pretending to know more than you do will only lead to costly misunderstandings, they said.
“In turn I will share with them exactly what test methods I will be using, and how I will handle their samples from the beginning to the end of the testing process,” Covance’s Sullivan said.
“The expertise and experience client’s bring to the table varies widely. Some are very experienced and know exactly what they need and how to interpret technical data while others are not sure of what they need. We try to hold the hands of new clients each step of the way and make submission an easy process for them. However, it is critical that the client provides our laboratory with the required information to do the necessary testing,” Neal-Kababick said. “When clients fail to provide this information or argue that it is not necessary, they can end up paying for testing that is not fit for purpose.”
Will Black, vice president of sales and marketing for ChromaDex, said the level of industry knowledge seems to be rising, even if there are still too many players who don’t fully understand their responsibilities under DSHEA.
“There is an unevenness in the understanding and the level of importance of testing and compliance within the industry.In today's’ environment, safety and compliance are not discretionary – they are mandatory. The good news is we have seen an increase in the level of attendees when we sponsor GMP related training which indicates that awareness of and interest in this critical topic is growing, and more businesses are prioritizing their commitment to building it into their operational culture,” he said.
"One trend we are seeing in these interactions is a desire from our customers to form strong collaborative relationships, essentially using the independent testing laboratory as a trusted partner in quality with a broad approach to a company’s testing needs," Sudberg said.
This report is part of a series on how companies can get the best value from their service vendors. The article on working with public relations professionals can be found here. Another installment looked at working with outside legal counsel. Part 2 of this report on analytical labs will look at how the function has changed with new problems that arise from the marketplace and new demands from regulators and clients.