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Regulatory Musings and Compliance Cogitations with Russ Michelson

Compliance and Quality Compliance and Quality

Nutrition Industry Executive (NIE) Magazine had a virtual sit-down with Russ Michelson, Global Regulatory Director, VMS, Reckitt, Parsippany, NJ, www.reckitt.com

NIE: At a regulatory summit in the latter part of last year Steven Tave, director of the FDA’s Office of Strategic Planning and Operational Policy, stated that there was a “regulatory gap” in the dietary supplement industry—the gap between what the law requires, or compliance, and what can realistically be achieved through enforcement. Please comment on this.

Michelson: This term raised some eyebrows during the Summit, left some questions unanswered, and I’m really interested to see how the current ODSP team addresses this in 2021. To my knowledge, the term was introduced, but it has yet to produce any changes in policy, guidance, or empowerment of the industry.

You could argue that this “gap” is the space where self-regulation thrives, innovation flourishes, and where good players excel in doing the right thing within the guard rails provided not needing to rely on daily FDA (U.S. Food and Drug Administration) enforcement.

And yet, it’s also where the bad players take advantage, where many of the class-action lawsuits derive, and where the public can lose faith in the “lack of oversight.”

It does create a bit of uncertainty as an industry professional as to what aspects of compliance to truly focus on if FDA cannot realistically enforce it all, do you then regulate to your own priorities, regulate to avoid class-actions, regulate to meet retailer standards…or all of the above.

NIE: Some industry leaders have said that they believe that there are “two industries:” (1) the companies that have always worked very hard to comply, and (2) new players, almost exclusively online, who are in it to make a killing. What specific self-regulatory steps can the industry take to reduce the “two industries” problem, if there is a way?

Michelson: Well, I think the “two industries” thinking is an oversimplification. There are good and bad players, but also a lot of in between. The most established “good” companies can still get a 483 or a warning letter or a lawsuit on an off chance.

And not all new players are “bad,” meaning intentionally doing the wrong thing to make a buck. There will always be a subset of players who jump into the category quickly and with no cares to comply; they are unlikely to be moved off of their approach or willing to participate in trade associations or lean into best practices.

But many new entries are trying to do the right thing and just need opportunities to interact with the good players, find adequate resources to educate themselves, and build up that reputation as they build their brands.

Any new entry into any new category is going to stumble a bit, but if we build an environment where they have access to broader industry, trade associations, industry events, trainings, etc. you can raise that floor so that even the small online players are given the tools to be both successful and compliant.

NIE: Adulterated and illicit products were the subject of a paper published March 23 in the journal, Clinical Toxicology, whose authors found nine potentially dangerous stimulants in 17 supplement products sold in the U.S. Does this indicate a much larger problem than we realized, or something else; please explain.

Michelson: This isn’t particularly new. It’s been made significantly easier by the e-comm platforms where you don’t even need to get inside a retailer’s walls to start selling potentially dangerous products directly to consumers. But in the right context, this is actually good for the industry.

We, as responsible industry, don’t want unsafe and unproven ingredients on the market and harming consumers. And while regulations are in place to prevent this from happening, it’s not hard to break the rules and it’s nice to see some punishment on occasion when consumers and our industry PR are at risk.

The hardest part is separating that these are the exception to the industry, and just because the negative news gets the greatest reach doesn’t mean that this represents the majority of responsible industry that you find in respectable retail establishments.

NIE: Quality is also about the science. In what tangible what ways is having relevant science behind ingredients is so important? And how can this science be better communicated to the public at large?

Michelson: I could probably go on for an hour on this subject! Obviously one part is simply the quality of the clinical evidence of a given ingredient, and how that supports strong consumer-facing claims. The quality of the clinical development and protocols determines how appealing that ingredient will be to formulators as well as consumers, in the end.

But beyond that, the more an ingredient manufacturer invests in their clinical science they also have vested interest in the quality of the manufacturing process, the uniform farming, harvesting, production, etc. to regularly meet their established specifications. The last thing you’d want is to have a really novel, patented, clinically studied ingredient and not know batch to batch that it’s going to be of consistent quality. And along with investment in science and quality production is investment in compliance.

So while the stronger or more unique claims are often the consumer-facing message driven by strong ingredient science, you can also just as easily speak to your company’s efforts to ensure regulatory compliance (e.g. NDI [new dietary ingredient] compliance) or quality control efforts including production methods or testing protocols. I think being transparent with consumers about the amount of effort that goes into sourcing critical ingredients and how you formulate and test these ingredients can be just as meaningful as the structure/function claim that you place on the label and often can be seen as more honest.

NIE: Along these lines, a percentage of consumers and media outlets continue to believe that the supplement industry is an unregulated Wild West filled with crazy companies and dangerous products. What can be done to change this paradigm?

Michelson: Yeah, this is something I know everyone in the industry gets frustrated with. Have you ever listened to sports radio when a professional athlete gets dinged for using a WADA (World Anti-Doping Agency)-banned substance, for example? “It’s because they’re not regulated!” I think it stems from the belief that supplements are supposed to be more like drugs, and not more like foods. If people knew that supplements were part of the food category, do you think the messaging would be different? No one expects foods to go through pre-market registration, so how did that expectation come about for supplements? Clearly there is no easy fix, and we’re never going to stop the fringe players from breaking the rules, getting in trouble, and staining our industry from time to time.

I really do think it just comes down to the fact that consumers have this expectation, whether earned or not, that supplements are a light version of drugs, and get surprised when supplements are not overtly treated like drugs by FDA, when, in fact, many of the quality control procedures and GMP (good manufacturing practice) requirements are very drug-like and are in many ways in excess of what controls go into their food supply.

Focusing on transparency and sustainability instead of a flashy health claim could be one way to bring your brand out from underneath this stigma, but as an industry it will take a massive effort to bring consumer education up to the point where they understand the types of quality controls and research that truly goes in to producing a single dietary supplement product. If they knew the time and effort and science that the majority of industry puts forward to produce the product that they’re taking, do you think an average consumer would continue to call us the Wild Wild West?

NIE: Talk about clean labels, and what do they mean for your company? Expand.

Michelson: Clean label can mean so many things, both as a brand owner and as a consumer. And while we’ve overcome a little bit of the certification and “seal” overload, it can still be a bit confusing about how clean label claims are consistently defined and applied. As a regulatory professional, I know that only a handful of the “clean” claims that food and supplement manufacturers use have a clear FDA or USDA (U.S. Department of Agriculture) definition. The others fall into a self-certification or self-defined arena where it is crucial for a brand to have a clear and consistent message and point of view on what that term means. Vegan and vegetarian are good examples where you know there is no formal definition, but you pull together the correct global information to feel confident that the definition is consistently applied and robustly supported.

To me, clean label claims, whether certified as such or self-defined, can be meaningful differentiators and decision-making tools for the ever-savvy consumer. And now with more e-commerce opportunities you no longer have to rely on a little symbol on your pack to tell the story; you can speak to what “clean” means to you and your brand in a digital space that is not limited by the square inches of your label.

As a consumer, clean claims are a top priority when I am choosing my supplement regimen, and I am willing to spend a little more money on something free of certain artificial ingredients or attesting to certain practices that align with my beliefs.

And as a regulatory leader, I love bringing these stories to the forefront of a product concept and creating the opportunity to tell this story, in addition to our brand heritage story or the scientific story behind how our ingredients can help keep healthy people healthy in a unique way.