There are a number of reasons why a company may want to begin a dialogue with FDA, but one key point should guide your approach: It is a science-based agency.
Go to them prepared with good research and good evidence, and you have a much better chance to get them to hear you and to take you seriously. They are prepared to talk science and to talk methods and specific approaches. They are constantly pulled in all different directions by a million things. But we found them ready to talk about enforcement of real issues we identified. The fact that the issues had industry-wide impact were also caught their attention.
About three years ago, Synutra Ingredients started to focus on the chondroitin market as our state-of-the-art production facility was ready to go online. We were set to become a vertically integrated supplier of chondroitin, the only one on the market. Our goal was to address the common adulteration in the chondroitin supply chain resulting from buyers putting downward pressure on prices and suppliers trying to beat their competitor’s prices, which often invited adulteration with substances that fooled common testing methods and were cheaper than actual chondroitin. We wanted to draw attention to economic adulteration and encourage the industry to adopt more effective testing methods.
Our advocating for more effective testing methods is an important point. Why would we want suppliers we may compete with to improve their quality? It’s simple. Because of our scale, if companies are actually purchasing chondroitin and not an adulterant masquerading as chondroitin, we can easily compete on price. But there is an even more compelling reason that involves protecting consumer demand: ultimately, if consumers are not experiencing the benefits of chondroitin they are going to think, “Maybe there is no chondroitin in my chondroitin, I’d better try something else.” They are going to stop buying chondroitin. Consumers deserve the benefits they expect to receive when they purchase a product.
We started our approach to FDA with the guidance of my friend, regulatory attorney Scott Bass of Sidley & Austin. We developed a comprehensive memo and made a formal presentation with a lot of data we had collected on the chondroitin supply chain, including a sample survey of finished products purchased from different vendors. We provided analysis that supported our contention that the chondroitin supply chain was seriously adulterated, and the accepted testing methods were inadequate for identifying common adulterants. The comprehensive approach got their attention. And they were not only keenly interested in following our progress as we took our testing results to a broader group of scientists and engaged their participation in expanded testing methods refinement, they helped inform the industry of the issue by using chondroitin as an example of economic adulteration.
The science-based information we were producing not only engaged the interest of FDA, but also USP and AOAC, which then became partners in our in-depth investigation over the last year to identify a new adulterant that turned up on the market.