Protein enhanced with plasma gas gets third-party affirmation for regulatory standing

05-Mar-2018 - Last updated on 05-Mar-2018 at 18:31 GMT

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Technology by New York startup Plasma Nutrition treats whey protein with gas in a plasma state to improve its bioavailability and efficacy. Does the resulting product need an NDI? GRAS affirmation? Based on a legal review with a big FDA-specialist law firm, it needs neither, the company says.

The company consulted with Hyman, Phelps & McNamara, a D.C-based FDA dedicated law firm. The process included going over the science, theory and technology of the company.

“We don’t get a certificate or anything—it’s a legal opinion that our technology does not alter that GRAS status,” Steve Motosko, co-founder or Plasma Nutrition, told NutraIngredients-USA.

“If you’re using [protein from] Glanbia or Milk Specialties, that existing regulatory framework still applies once being processed by our technology,” he added.

Plasma Nutrition’s founders, which include Motosko and Chris Flynn-Rozanski, have been working on the technology for five years.

“We have done legal work during the development of this technology before, but as we get set for a really exciting 2018, we wanted to make sure that we can reaffirm that,” Rozanski said.

“We’re a technology company that makes food technology,” he added. “When it comes to food and nutritional supplements, we take much care and pride in the regulatory pieces as we do in the science and the clinical research that we do. For us, it’s just part of our corporate ethos in being thorough, and everything we do is with extreme care and consciousness.”

The company’s model is to own and license the intellectual property and to partner with existing manufacturers to install a machine to perform the transformation step. The machine itself is compact, so it can be relatively easily retrofitted into existing powder-handling facilities, Motosko said.

You can read our past coverage of Plasma Nutrition HERE.