The ingredient development firm announced the new approval recently. The official imprimatur through Agencia Nacional de Vigilancia Sanitaria (ANVISA) not only opens up the Brazilian market, but gets a foot in the door for the use of myHMB in healthy aging products in other markets in Latin America as well, according to Larry Kolb, co founder and president of TSI.
TSI Group brought the original ingredient developer, Metabolic Technologies Inc., fully within house more than a year ago.
Metabolic Technologies, based in Ames, IA, is a spinoff technology company from Iowa State University. The company was built around the discovery of the ingredient. The strategic acquisition integrates TSI’s HMB production and global sales and business development capabilities with MTI’s intellectual property portfolio and clinical research and development strengths.
Research history backs ingredient
HMB was first discovered by MTI in the early 1990s. It has long been popular among sport nutrition brands for its strength, recovery and improved body composition benefits for highly trained and competitive athletes. But lately TSI has been spreading the word about an expanding and body of evidence that shows HMB provides muscle health benefits to a much larger base of consumers beyond traditional sports nutrition.
HMB, or β-hydroxy β-methylbutyrate, is naturally produced in the body during the metabolism of the essential amino acid leucine, which is found in virtually all protein sources. TSI co founder and president Larry Kolb said research done on myHMB, the company’s branded, nature identical form of the substance, has shown that HMB supplementation can lead to beneficial results. In a study done on judo competitors and wrestlers the researchers concluded that, “The results indicate that supplying HMB promotes advantageous changes in body composition and stimulates an increase in aerobic capacity.”
The ingredient basically mimics the ingestion of much higher amounts of leucine, leading to greater muscle protein synthesis. That amount of leucine would be impractical to ingest by consuming whole protein, Kolb said.
Solid dossier helps navigate ANVISA’s choppy waters
Kolb said the powerful science behind myHMB was helpful both in navigating the potentially problematic ANVISA approval process as well as lining up retail and formulation partners in the country.
“It became a three year process for us because halfway through our first submission they changed their regulations and we had to restart the clock,” Kolb told NutraIngredients-USA.
Even so, Kolb said his company was confident the submission would eventually succeed.
“We have such an extensive dossier on toxicity and clinical safety trials, similar to a GRAS affirmation in the US or a master file in Canada. We did hire a consulting agency because everything is done in Portuguese, and they are right there in that time zone if any questions needed to be answered,” Kolb said.
Strong science attracts strong partners
The strong science suite has also helped the company line up some powerful market partners, Kolb said. Unlike in the United States, in Brazil many supplement products are produced by and sold by pharmaceutical companies that use their captive sales staffs to market the products alongside their drug offerings to pharmacies and health care practitioners.
TSI has managed to attract Hypera Pharma (formerly known as Hypermarcas), Brazil’s largest pharmaceutical company by market capitalization, to use myHMB in a supplement formulation aimed at health aging. Also on board is another pharmaceutical firm known as Europharma Laboratories (not to be confused with the US-based supplement brand Europharma).
“In both cases these companies have upwards of 2,000 sales reps that call on doctors,” Kolb said.
“In Brazil, pharmacists and physicians play a strong and well-established role in educating and prescribing proven health products to patients across the country,” he added.
“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,” Kolb said.
MyHMB is already being sold in Argentina as well as Brazil, Kolb said. But the ANVISA approval will go a long way toward opening up other attractive markets like Colombia.
“Other Latin American countries have their own regulatory approval processes, but they do recognize ANVISA, so it makes it easier,” Kolb said.