MSM (methylsulfonylmethane) is a naturally occurring nutrient found in the normal diets of humans and almost all other animals. It has long been recognised for its ability to support overall joint health and a normal range of motion. Many companies are leveraging opportunities to fortify and enhance products with MSM, and at the forefront of that initiative is Bergstrom Nutrition, the manufacturer of OptiMSM®.
When asked about Bergstrom Nutrition’s decision to expand beyond dietary supplements, Tim Hammond, Vice President of Sales & Marketing, commented: “We’ve been the world leader in the production of MSM for more than 25 years; we’re the only US and North American manufacturer and we’re also the only MSM producer that continues to invest in research. We are always exploring new categories, applications and consumer friendly ways to use OptiMSM.
“Whether, food, beverage, dietary supplement or topical application, the addition of OptiMSM can deliver multiple benefits. Our customers have been successfully and safely formulating with OptiMSM for more than 20 years, primarily in the joint health category. Hair, skin and nail products have also benefited from OptiMSM’s ability to support the structural integrity of the skin, and MSM has long been a valued ingredient in dermatology.
Strenuous activity is often associated with inflammation, wear and tear on joints, muscles and other connective tissue
“Strenuous activity is often associated with inflammation, wear and tear on joints, muscles and other connective tissue: adding OptiMSM to sports nutrition products may support faster exercise recovery. We are planning at looking at several other applications in the near future, including MSM’s possible ability to enhance the bioavailability of other ingredients.”
He added: “One of the drivers that prompted us to look at additional applications is what is happening in Europe regarding the European Food Safety Association (EFSA), and the lack of any approved joint health claims, and identifying what we needed to do to comply with EFSA’s requirements — coupled with how each country views the selling and marketing of supplements. A great example is how EU companies are changing their product label if they do not have an approved health claim. We looked at a potential joint health claim and, because of the research that’s required in that area, most of those studies have been done with diseased populations or disease states. We tried to identify pathways we could explore to execute studies on a healthy population and base claims on those investigations.”
NBR: What sort of progress have you made regarding a health claim that EFSA might consider?
Jane Duvauchelle: First of all, we have to consider whether the cost justifies the outcome; and we’ve already invested in the European marketplace to try to drive claims; Bergstrom Nutrition submitted an Article 13 claim during the first wave to support our distributor and their customers that was denied. Since those initial submissions and the massive amount of denials, EFSA has developed guidance documents on specific claims that have been helpful for us to evaluate a path forward. The guidance helps to provide a roadmap for us regarding what markers EFSA will accept. Knowing this, we can shape our studies accordingly.
Preliminary results have shown that we have a really good chance of seeing some statistically valid results
So there’s currently a study under way, and another starting in a few months, that will look specifically at the markers that EFSA has stipulated. What we don't know is whether our investment will move the dial enough to satisfy EFSA review. The human body is a complex organism and we’re dealing with a healthy population. Achieving a significant result, one that will be meaningful to EFSA, could prove to be challenging for us because we’re working with a nutraceutical that’s supporting your body’s efforts to support the benefit you hope to see. It’ll be interesting to see the results and see how they compare with the existing literature.
Rodney Benjamin: Of course, the smaller the change, the larger the population has to be, and with a larger sample size, the more specialised the studies are going to be, so it ends up being quite an investment. But preliminary results have shown that we have a really good chance of seeing some statistically valid results and, hopefully, it will provide enough evidence to sway EFSA and obtain a health claim. It won’t be specific to joint health, but it’ll be a joint health ingredient that will support a health claim in the EU.
NBR: Did you identify sports nutrition because of its current popularity or had research already been done that identified a specific application in this area?
Tim Hammond: Athletes were a natural progression from trying to help an ageing population with joint health issues and it allows us to target a younger demographic that can also benefit from MSM. In our view, sports nutrition or active nutrition is a broader category and more about the demands of an active lifestyle.
We looked at the course of exercise recovery and how we could do research on a healthy population that had measurable outcomes, and how that information could benefit a wide range of end-users, such as those desiring to remain active as they grow older to competitive athletes wanting to improve and maintain their fitness levels. We also believe there are real benefits to consumers whose jobs demand strenuous activity; supplementing daily with OptiMSM could reduce their muscle soreness and help relieve joint stress, in turn making their life just a bit easier.
Athletes were a natural progression from trying to help an ageing population with joint health issues
Benjamin: Based on joint health studies in arthritic populations, we knew that MSM played a role in reducing oxidative damage and stress. It also appeared to help with pain reduction and range of motion, etc., and we were aware of its function in delayed onset muscle soreness (DOMS), which meant that people were less prone to post-exercise aches and pain, more active, recovered sooner and were more likely to continue with an exercise regime … all of which led us to look at exercise recovery.
Hammond: It also played into what is currently going on in Japan and the so-called Locomotive Syndrome; the country has an ageing population and what they’re trying to do there is keep their elderly healthy and mobile, which provided a point of entry and an opportunity to develop a product solution for our Japanese customers. It’s all related to healthy ageing in the end; you have to use the word ‘exercise’ because of the claim language requirements, but we’re really looking at any type of recovery from a strenuous activity, be it gardening, moving furniture around the house, etc.
Another aspect of MSM and sports nutrition is that it’s not nutrient-timing specific. During the last year, we’ve been able to collaborate with a very large protein manufacturer to develop a post-workout protein drink containing an efficacious dose of OptiMSM. Another company formulated a ready-to-mix pre-workout drink containing OptiMSM, ribose, coconut water and arginine. So we can fit in to a number of different categories offering multiple benefits, from reducing oxidative stress to improving mobility and how MSM might benefit people who are involved in high-intensity fitness training.
NBR: Education, both for finished product manufacturers and consumers is a growing trend in the functional food market; is there more that Bergstrom can do?
Duvauchelle: Companies can always do more; but educating consumers in the current EU and its 28 member states’ regulatory environment presents many obstacles for finished product brands to overcome. The Nutrition and Health Claims Regulation (NHCR) requires premarket approval on all commercial communications; that’s advertising, labelling and would include how you educate your potential customer about your product. We are seeing less innovation as companies settle to use repetitive approved claim language or no claim at all. OptiMSM is a branded ingredient and, although we are used to marketing in the US, having an international perspective helps us better prepare our customers for success. And that is why we are hoping to have the evidence to submit an approved health claim for our ingredient. It ultimately helps our customers market to theirs.
Educating consumers in the current EU and its 28 member states’ regulatory environment presents many obstacles
Hammond: Regarding education, we’ve worked very closely for the last 3 years with the International Society of Sports Nutrition. We’ve participated in their events; many of the people on their board and their members have been participants in our studies and we try to engage them for consultancy about the best ways to position the ingredient in the sports nutrition market.
And, of course, we’re not just talking about sportspeople, we have to consider the industrial athletes as well, such as labourers, factory workers and farmers; as they age, it gets harder and harder for them to do their jobs. These aren’t necessarily the people who would seek out information about MSM or read academic journals; reaching and educating them can be a challenge. To echo Jane’s comments, it is an expensive proposition for an ingredient manufacturer to educate consumers; but, having strongly branded finished product partners certainly helps to spread the message.
Duvauchelle: What I think is interesting is the concept of adding OptiMSM to other products. Through the various research we’ve done and consumer use, we know OptiMSM is an ingredient that is experiential. As long as the consumer feels a benefit, they don’t necessarily care exactly what’s in the formulation … as long as it keeps being effective. We believe that OptiMSM is one of those components that will genuinely drive positive consumer experiences and benefits.
Our studies show that OptiMSM is absorbed quickly and reaches peak levels within 90 minutes (with a half life of about 8 hours), so it’s not something the body has to get used to or take time to acclimate to, which allows us to look at many different categories. For example, there are people who are very knowledgeable about protein and branched chain amino acids; MSM may complement how these products work in the body in a very different way. As the sports nutrition sector continues to evolve, particularly in Europe, it presents a real opportunity to formulate MSM into a range of unique combinations and a variety of applications.
NBR: Would you consider celebrity endorsement?
Hammond: It’s difficult to do that effectively. At one time there were celebrities involved in MSM and we remain open to that concept; but, as we build our research base and look into what may be the best benefit, we’ve based our marketing, our reputation and our integrity on the quality of our ingredient, on-time delivery, our customer service and also, basically, coming down to providing multiple animal and human clinical studies that allow our customers to strongly substantiate claims that support their marketing.
One thing that’s challenging in a position like ours, as an ingredient supplier, is that we’re not consumer-facing
Duvauchelle: One thing that’s challenging in a position like ours, as an ingredient supplier, is that we’re not consumer-facing. We’re not the final brand. The end-user will recognise the finished product, so things such as celebrity endorsement actually fit better with the end product as opposed to a specific ingredient. Our obligation is to provide the evidence, to build the reputation of the ingredient so that it makes it into the finished product brand. We supply the tools, in the form of a consistent product that they can rely on, to position their own finished product.
Hammond: What I see happening in the EU is that bone and joint health get lumped into a single category – and that shouldn’t really be the case. There’s a lot of great bone health ingredients out there, and MSM has some applications in that area, but when bone and joint are combined, EFSA tends to look at bone-related aspects and not joint. So what we can do is create the best research possible and provide that information to the formulators, R&D professionals, the press etc., and let people know that about the multiple benefits of OptiMSM in multiple areas of application.
Duvauchelle: Not only do we have the flexibility regarding the multiple benefits of how OptiMSM works, we also have the benefit of flexibility and versatility in terms of platforms: MSM is water-soluble, so it can be used in drinks, in creams and in lotions. The ingredient itself has applications that haven’t been fully explored yet and those markets are ripe for development, including healthy ageing and sports nutrition, and as individuals continue to better understand what MSM can do, that also provides further opportunities for brand and finished product manufacturers.
Benjamin: Another interesting thing about MSM is that, beyond its own efficacy, studies have been done that show that MSM is synergistic with other actives, such as glucosamine, and increases their efficacy too. I’m very keen to strengthen that dataset and demonstrate that combining MSM with other ingredients improves the benefits — efficacy and bioavailability — of both actives within a single formulation, both topical and oral.
The Bergstrom Nutrition plant
Hammond: The MSM market is still growing. I believe that the growing database of MSM research and exploring its future applications is very exciting. I think the best is yet to come. We’ve been very successful in joint health, but the work we’re doing now, expanding into some smaller categories, could lead to a number of different uses that could open doors to more core growth. In addition, we’re always looking at new ingredients and synergies with other ingredients.
Our challenge is to identify ingredients that we can get involved with that behold themselves to the same level and standards as MSM; we work closely with glucosamine and chondroitin producers, because we’re part of that trifecta of joint health; but, in reality, we don’t have a lot of resources to dedicate to that area, but we try to educate ourselves, stay current in the market and stay on top of the issues and opportunities, and constantly strive to improve the health and well-being of both our customers and our end-users.
The pharmaceutical spectre
NBR: Do you feel any pressure from the pharmaceutical industry to comply with current good manufacturing practices or live up to US FDA standards?
Benjamin: The pressure is out there, no doubt. From a manufacturing perspective, we’ll be ready for it and we’ll come up to the required standards if they get implemented. But, the whole notion of comparing a nutritional ingredient with a drug component doesn’t make sense. We’re not talking about the same magnitudes of efficacy, side-effects or even purpose. You can’t market a nutraceutical like a drug or expect to see the same levels of efficacy in a naturally derived or occurring nutrient.
The whole notion of comparing a nutritional ingredient with a drug component doesn’t make sense
Duvauchelle: However, if we were able to market a nutraceutical like a pharmaceutical, get the margins that a drug delivers and get a patent like a pharmaceutical, that would be a different story and a different investment proposition. It’s just not possible to ask someone to comply with pharmaceutical regulations when you’re working with the margins, marketing and communications associated with nutraceuticals and still get a product out to the consumer.
Hammond: We feel as a raw ingredient manufacturer, being GRAS, GMP-compliant, ISO and FSSC 22000 certified, along with our continuous investment in research to support claim language, that we’ve pretty much raised the bar as far as manufacturing practices are concerned.
