“What underpins our entire motivation and our company philosophy is that we pride ourselves on the fact that we have science to back up what our claims are. We agree that most of the stuff out there (in the weight management category) is a lot of hype, a lot of snake oil but not scientific substation as to what these things purport to do,” NutriForward chief medical officer Dr Jay Yepuri told Nutraingredients-USA.
The company’s dietary supplement Riduzone is based on a single active ingredient, oleoylethanolamide (OEA). OEA is a natural metabolite of oleic acid made in the small intestine that has been shown to regulate hunger. OEA arises from the metabolism of olive oil and other oleic acid rich foods. But while this could have potentially given rise to a claim that the ingredient was present in the food supply, and indeed many ingredients are on the market without NDIs resting on similarly flimsy reeds, Shashi Marulappa, CEO of NutriForward, said that the company’s advisers said OEA’s status as a metabolite and the fact that the company intended to present it at higher concentrations meant that an NDI filing was necessary.
“We consulted with a law firm, a consulting company and a toxicologist and they all came up with the same answer. The consensus was that because OEA was never marketed legally as an item of food we needed an NDI,” Marulappa said.
NDI filing process
Some observers have said that the NDI filing process has become unnecessarily burdensome and has yielded a very high rate of failures. Marulappa said his team found the process to be fairly seamless.
“We did not have much problem with FDA. We followed the guidelines very carefully. All we had to do was one small modification in the serving size,” Marulappa said.
“We did not face as many problems as a number of other new ingredients have. Mostly this is because this is a metabolite and we had very strong science behind this. We also were in constant contact with FDA. We had a pre NDI notification conference call with them and we worked with them to address any problems before we filed. We took six or seven months to prepare the filing and we got our no objection letter back within 60 days. FDA doesn’t ‘approve’ new ingredients, but they did agree that OEA was reasonably expected to be safe,” he said.
Years’ worth of studies
In addition to the wealth of safety data, Yepuri, who is trained as a gastroenterologist, said OEA has a strong suite of science backing its potential effects.
“OEA is a naturally produced molecule in the human small intestine that affects satiety. It is about 10 or 12 years ago that the mechanism for distilling OEA out of olive oil was elaborated and established. From that time there has been a slew of studies looking at OEA’s effects in a number of mammals toward affected satiety and limiting caloric intake,” Yepuri said.
“Even more interesting to us are its potential effects on serum cholesterol and fatty liver,” he said.
The supplement will be launched in October and for the foreseeable future will be for sale solely on the company’s web portal. In crafting the message for the new supplement, Marulappa said the company was mindful of the category’s reputation for over-the-top claims as it develops the final label language for the product.
“Right now we are looking at a claim along the lines of “Supports healthy appetite, body weight and body fat composition,” he said.