Nature’s Way was one of four companies that were caught up in the second round of Schneiderman’s probe into the dietary supplements industry. In late February he sent letters to the companies (the others were NBTY, Pharmavite and Nutraceutical Corp ) demanding detailed manufacturing and quality control documentation.
Involving the whole supply chain
The key element of Nature’s Way’s new identification scheme is a policy that every botanical material the company receives will have to be accompanied with proof of origin that can be traced back to the plant in the ground. This will include verification of time and place of harvest, photos of the plant, proof that a scientifically valid procedure was followed to compare the plant to a botanical reference, and a pressed sample of the plant itself.
The company invited Roy Upton, founder of the American Herbal Pharmacopoeia (AHP), to speak to the gathering of vendors at Nature’s Way’s headquarters in Green Bay, WI. Travis Borchardt, vice president of regulatory affairs and QA/QC at Nature’s Way, said the original idea was for Upton to brief the company’s quality control staff on ways the company could institute it’s more rigorous identification scheme. Then the idea broadened, he said.
“We thought, why don’t we also use this an opportunity to pull the supply chain together and make it consistent across the board to use a botanical ID approach and start with the plant when it’s in the ground,” Borchardt told NutraIngredients-USA. The workshop included a number of Nature’s Way’s raw material suppliers, including some who supply wild-crafted materials, and a couple of contract manufacturers.
“Historically we have received mostly powders. We have used a variety of methods, typically chemistry, to identify the materials that arrive on our doorstep,” Borchardt said.
Quality back to the plant in the ground
While the company already had a vendor qualification scheme in place, it wanted to build another level of security into the system, he said.
“Quality can’t start when the powder shows up on the doorstep. If that’s your expectation, it’s not going to happen. A lot of our vendors were already doing that (verifying the in-the-ground source). It was a matter of standardizing an approach.
“Our expectation here at Nature’s Way is that we will receive documents with each shipment that the ID of the plant was done in a scientifically valid manner. We want proof an authoritative reference was consulted and a person with the appropriate experience and training was there to say that this is the correct plant. And we will require proof that another ID was done at the receipt of the plant at the powdering or processing facility. We expect to get those documents with every batch of powder, and then we will pair that with the chemistry results.
“It’s sort of an orthogonal approach to identity. We want to really have solid proof in our files as a dietary supplement manufacturer that we know exactly where the powder that ends up in our tablets or capsules came from,” Borchardt said.
Smart phone as quality tool
Upton said the first part of the workshop gave an overview of all the different methods that can be used to identify botanical materials, from organoleptic, macroscopic approaches through microscopy down to the various chemical procedures.
“I talked about the toolbox of methods that are used and that no there is no one method that is better than any other. You need to use the most appropriate set of methods depending on what you are testing, and what kind of matrix it’s in and what you’re looking for. Is it a raw material, an extract, an isolate? Are you looking just for identity, or quality, or the concentration of active compounds? Are you looking at purity?” Upton said.
“The second part of the workshop was how do we get back to the plant and how do we document the organoleptic, macroscopic characteristics of the plant material in the field. One of the participants had made a comment that this will increase costs and time. I told them, your people are already out in the field. Everyone has a smart phone with GPS on it, and even my dumb phone will take pictures. And they can fit a field press in the pickup truck. It’s a change in orientation, but not a great increase in cost or time.”
The new program, which will be fully implemented over the remainder of the year, will bolster Nature’s Way’s internal confidence in its supply chain. The question then becomes, could it become a differentiator in the marketplace, too? Many companies in the dietary supplement business have given lip service to the idea of transparency, but then become circumspect about the specifics, treating supply arrangements as proprietary information.
“It’s a new day. The industry historically has been a little bit paranoid and what they believe is intellectual property is not really trade secret information. It pertains to practices that ensure identity, quality and safety. It makes sense to me to allow full transparency into those processes so that customers can have full confidence in what we are doing. It’s an opportunity for us here at Nature’s Way and we need to get better at communicating our approach,” Borchardt said.
“If you think about it, if a company is selling something or a company is buying something and they can’t answer the basic question of how do you know you’ve got the right stuff, should they really be in the business of selling products to manufactures or consumers and why would anyone ever want to buy from them?” Upton asked.
“Even though Schneiderman’s approach is not as scientifically valid as it could or should be, it did wake up the industry overall that you have got to get tougher on the supplier which up to now has been exempt from dietary supplement GMPs,” he said.