“We commit to the lifecycle of all of our products,” Frankos told NutraIngredients-USA during a recent tour of the company’s facilities in Southern California.
Post market surveillance
After his hire in 2010, Frankos, who now has the title of senior vice president of global product science, safety and compliance, took on the task of improving the company’s tracking of products post market, which includes its adverse event reporting system. Frankos, who before Herbalife was at FDA as the head of the Office of Dietary Supplements, has seen what that looks like from the other side of the fence, and the view isn’t always pretty.
“The only way to know how your products perform is to monitor post market," he said.
“I’ve heard companies say, ‘we don’t’ get any complaints. We don’t have any adverse events.’ That just means that you don’t have a system in place to collect adverse events,” he said.
Of the estimated 1,500 or so dietary supplement companies making an estimated 55,000 to 85,000 products, only 257 have reported adverse events to FDA in the last five years, Frankos said.
“There is less than 5% compliance with the adverse event reporting law. It’s always the same companies submitting every year. We have submitted regularly,” Frankos said.
IT infrastructure
The situation at Herbalife is especially complex. The company sells its supplements, foods and meal replacement products through a global network of millions of independent distributors. Frankos' mission is made easier by the big investment that Herbalife has made in improving its worldwide IT infrastructure. Company officials said more than $100 million has been spent on this effort in recent years.
The sophistication of Herbalife’s integrated IT systems means that the company can collect AERs in real time from its operations in 89 countries. The product information can be quickly matched with the manufacturing history, Frankos said.
“Every day there are at least 1.5 million people taking our products so we have to be able to collect that data in real time." Frankos said.
“The collection of AERs is becoming a worldwide requirement. Whenever we have an adverse event, we send a report to the QA team to test that product. And we can follow reports if someone says the product smelled funny or tasted bad and follow that product (including where and when it was made and where the ingredients came from) to find out what happened," he said.
“We also have systems in place to monitor social media, so that we can hear what people are saying about the products,” Frankos said. A quality concern might show up in that channel that might not rise the level of an adverse event or where the customer might not have known how to submit an AER.
The AER software and hardware system that Herbalife uses is similar ot those used by the drug industry, he said. This includes the use of MedDRA codes (Medical Directory for Regulatory Activities), unified codes of symptoms that can, for example, reduce all the words a consumer might use to report an upset stomach to a set of standardized data points. In this way events can more easily be grouped by type and manipulated for statistical analysis.
Ironing out supply problems
That’s the back end. At the front end during the product development cycle, there’s work to be done, too. The vast and complex word of botanical ingredients is full pitfalls and promise, and it has been Shao’s job since 2011 to avoid the first and identify the latter.
“We take a rigorous approach to ingredient qualification,” said Shao, who is vice president of global product science, safety and compliance.
“Today, there are all kinds of deficiencies among suppliers,” Shao said. Too often, he said, suppliers come to the table with “half-baked” ingredients that are insufficiently characterized, lack validated test methods or have paper-thin science dossiers that might rely on tangential science information on the ingredient.
“So many academics do studies (on given ingredients) but without industry-relevant end points in mind,” Shao said. Trying to rely on studies like these to back your ingredient won't fly with Herbalife, he said.
“Our hope is, if (the suppliers) are educated, these deficiencies will be less.”
“We have had global quality summits with our suppliers,” Frankos said, in which as many of 200 suppliers will gather to hear Herbalife’s requirements and gain insight into how they might meet those.
Being a unified idea on quality and safety
Shao and Frankos both said Herbalife, with its 6,000 or so employees had become, as many larger companies do, a series of silos. Getting groups to talk to one another around the issue of quality and safety has been part of their mission. And as the company becomes increasingly de-siloed, other departments become educated, Shao said. Now, when product development teams are researching new concepts and thinking about potential new suppliers, “they already know what type of questions I’m going to ask,” Shao said.
“Most importantly, we make sure all stakeholder departments in the company are aligned” around the mission of turning out products with the highest levels of safety and quality.