CRN Members Explain: The importance of coming together as an industry

Q&A with David Keller, DPM, MBA, of the Keller Consulting Group

David Keller, DPM, MBA, of the Keller Consulting Group, is an associate member of CRN. Since 2018, Keller Consulting has focused on foods and dietary supplements (ingredients and finished products) and cosmetics. The company helps plan and execute all IP, regulatory, due diligence and clinical study projects. Previously, Dr. Keller was the Vice President of Scientific Operations and began with Ganeden Biotech as a consultant in 2003 and remained with the company for more than fourteen years. Dr. Keller oversaw all science-related aspects of the company. This included all clinical trials (which resulted in more than 25 published papers), regulatory (4 FDA GRAS notifications as well as multiple international approvals), quality control, along with the company's IP portfolio. 

Q: Walk us through what you do within the industry? 

David: So, I work primarily with ingredient companies but work with finished product companies as well. Usually, a company will come to me and say, “We have an interesting ingredient or idea for a product. We now need to develop a regulatory and science path, the right way, to get us to commercialization.” And “the right way” usually means being fiscally responsible. With all the rising costs, it's a real challenge today putting a plan together within a budget that a company will be able to sustain, while, at the same time, checking off the regulatory and science boxes needed to take things to the next step. 

Q: Given the fact that you have been in and around this industry for a while, where do you think things are headed? 

David: Particularly driven by COVID, people are now understanding they must be more proactive, rather than just reactive, about their health. And I think our health care system needs to do the same. People are realizing many of the supplements or functional foods in the market have real health benefits when taken proactively. Now, there’s two sides to that coin. You have some companies that work with good ingredients and put out high quality products. And then you have some companies — that would not be members of CRN — who are putting less-than-quality products into the market. So, the challenge right now, particularly for consumers, is differentiating between good products versus those that are questionable. 

Q: What are your client companies surprised to learn when they come to you with their plan to launch a product? 

David: So, it depends on their level of knowledge. I think a lot of companies are surprised about what claims they can and can't make and what the FDA today considers part of your claim set. I find people at some companies think that because it's not on the package, they don’t have to consider what language they’re using on their website or in their social media posts.   

Q: You mentioned COVID and its lingering impacts. Are there any other things you’ve noticed in terms of consumer behavior that factors into the advice you give your clients? 

David: I think functional foods are becoming increasingly popular. People have a certain level of pill fatigue. When most people buy a 30-day supply of a supplement, the bottle isn’t empty on Day 30. But, when you have foods that people are eating every day, it's easier and many times cheaper to incorporate it into a routine that they already have. So, more and more companies are looking to invest in the functional foods sector. Related to supplements, as consumers are more cost weary, supplements that are not just single ingredients, but rather combinations, in efficacious amounts, are interesting to consumers. And at the same time, as was the case with probiotics, consumers are doing their research, they’re learning about these products, figuring out those that they consider quality, and those they don’t. Because they ultimately want more control over their health.  

Q: Why is it important in your mind to be part of an association like CRN? 

David: I chaired the working group on probiotic labeling. And it highlighted for me that the more we come together as an industry, in terms of standards and best practices, the stronger we become collectively. Ultimately it creates a new bar that quality companies should have no issue following and sets them apart from those that aren’t delivering the same level of quality and consistency. So being involved in an association is important because a lot of times we win or lose as an industry.  

Q: You have an MBA and could work in any sector. Why do you stay in this industry? 

David: That's a great question. There's a lot of industries that are very interesting, but there are few like this one where you really can make significant changes in people's lives across a very large part of the population. Time and again you hear people say supplements are unregulated and they're the “Wild, Wild West,” but the reality is there is good science to what we do, and lots of great ingredients that have tremendous health benefits. And whether it's for your family, your friends, or just the world in general, it's an industry that's really helping people.