TSI Group’s HMB ingredient, branded as MyHMB, recently received authorization for its leucine metabolite from ANVISA (Brazilian Agencia Nacional de Vigilancia Sanitaria), the regulatory agency which regulates dietary supplement ingredients. This marks a significant milestone for MyHMB’s growth in a global marketplace, TSI said, and is part of greater ambitions to open consumer access to the ingredient in all global markets.
 
Supplementation with HMB, which is a metabolite of the amino acid leucine, has been clinically associated with improvements to lean body mass, muscle strength, and physical function, with research pointing to an optimal dosage of 3 grams daily. MyHMB has two mechanisms of action by which it can increase muscle protein synthesis while also reducing the breakdown of muscle, TSI Group reports, even in individuals where protein quality is suboptimal.
 
“Consumers reach for supplements because of achy joints, when in fact the root cause may be lost muscle mass that does not provide sufficient stability for joints,” Larry Kolb, TSI Group president, said. “Maintaining the muscle you built earlier in life is important because once you’ve lost muscle mass, it is much more difficult to gain it back, especially as you age.”
 
“To receive the ANVISA positive listing was a very comprehensive task,” John C. Fuller, Jr., PhD, TSI Group’s director of Regulatory, said. “Brazil is highly regulated, which fits with our extensive research dossier well. I am gratified to have successfully completed this application because MyHMB will end up helping a lot of people in Brazil.”
 
Significance of the Brazilian Market
Brazil is the most affluent country in South America, and is considered to be one of the most important markets to achieve international growth by TSI Group. To begin, the company reports that consumers in this marketplace tend to have a proactive relationship with their physicians and pharmacists.
 
“In Brazil, pharmacists and physicians play a strong and well-established role in educating and prescribing proven health products to patients across the country,” Kolb said. “When an ingredient has been shown to be highly efficacious in a clinical setting, pharmaceutical companies will aggressively market the product through their vast sales forces directly to physicians. Our ANVISA authorization has enabled us to move forward with a strategic and robust MyHMB launch with two of the largest Brazilian pharmaceutical companies. Their sales forces, consisting of several thousand trained sales professionals, represent MyHMB and its tremendous muscle health benefits in conversations with physicians and pharmacists every day.”
 
Additionally, Brazil’s consumer marketplace is experiencing a significant demand for a muscle health ingredient of MyHMB’s caliber, Kolb said.
 
“Collagen, as well as approved biologics glucosamine/chondroitin, are already enjoying overwhelming popularity in Brazil for joint health. There is also widespread acceptance of vitamin D for bone health, which can be combined with MyHMB – the combination is backed by a recently published human clinical study showing that vitamin D plus MyHMB improves muscle mass, strength, and function in older adults, even without exercise. Our brand partners like the synergistic consumer benefits with the addition of MyHMB to their bone and joint products. One customer’s sales are rapidly increasing, which validates a strong consumer need for total musculoskeletal health. When we educate consumers effectively through our brand partners’ physician sales force, they get it. It makes sense to them, and they feel motivated to take MyHMB with their joint and bone products.
 
Kolb said that, especially in international markets, the role that muscle health can play in joint pain is relatively understated and not completely understood by consumers. “People ages 45 and above, especially those older than 70, are typically unaware of the issues associated with the accumulation of muscle loss, and how it could impact their mobility and negatively impact their quality of life,” he said. “Too many people are unaware that the problem may be that their body’s muscle-producing machinery has degraded. Pain in the joints is likely a secondary symptom but is often thought of as the root cause. We want to educate and encourage people to manage their muscle health before it’s too late, and they’ve lost too much muscle due to their age.”
 
MyHMB has received regulatory approval in China, Canada, the U.S., the E.U., Brazil, Argentina, Chile, Uruguay, India, Japan, Vietnam, Malaysia, Taiwan, Indonesia, the Phillipines, Singapore, New Zealand, and Australia to date.