CRN to Explore Adding Medical Food to Mission

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Washington, D.C. – The Council for Responsible Nutrition (CRN) has voted to explore adding the medical food industry to its mission.

“CRN’s Board of Directors believes there is enormous growth potential for the medical food industry over the next several decades as healthcare practitioners, the academic community, and policy makers continue to look at the ways that nutrition contributes to better health,” said CRN Board Chair Jim Hyde, vice president and general manager, Balchem Human Nutrition and Pharma, in a statement.

The CRN Board of Directors voted unanimously at their June board meeting to consider adding this sector. CRN is the leading trade association for the dietary supplement and functional food industry.

“We’ve already begun talking with some of the significant providers of these products to the market, and we understand some of their concerns focus on the lack of clarity provided by FDA’s oversight of the industry, leading to some controversy and uncertainty about these products,” said Steve Mister, CRN president and CEO, in the same press release.

CRN is the leading trade association for the dietary supplement and functional food industry. The CRN Board of Directors voted unanimously to consider this sector at its June board meeting.

“Several years ago, we opened our doors to functional food companies with the reasoning that we were already representing the ingredient suppliers manufacturing the ingredients that went into the food. We envision the same synergistic approach with medical food,” Mister added.

The term “medical food” is defined by Congress under Section 5(b)(3) of the Orphan Drug Act as “a food which is formulated to be consumed [orally] or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

CRN has previously expressed concerns that a more narrow interpretation of that definition offered by FDA that limits the range of available products may undermine Congressional intent for this category, thereby stifling the market’s ability to reach its potential. On the other hand, CRN fears that some companies may try to take advantage of the lack of clarity with illegitimate products, leaving the industry open to the risk that rogue players will define the industry.

“In many ways, there are similarities between where medical foods are today and the dietary supplement industry immediately following the passage of the Dietary Supplement Heath and Education Act,” said Mr. Mister. “CRN wants to work with responsible companies who want to play by the rules. We want to ensure those rules protect consumers, but also allow for industry to innovate and grow. Twenty years from now, we don’t want medical food companies to be in the position of looking back and wishing they had established themselves as a unified industry sooner. Consumers will benefit from a vibrant medical food industry that develops and delivers helpful, innovative products under reasonable regulation that assures fly-by-night companies don’t grab and destroy the reputation of those companies investing in science and following the law.”

As part of its exploratory process, CRN intends to convene the major players in the industry, some of whom are already CRN members, as part of a listening tour to determine where voids in representation exist, if CRN can fill those needs, and what the regulatory and policy priorities of the medical food industry should be.

Published on WholeFoods Magazine Online, 7/11/17

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