“It has been an immense privilege to have Duffy’s service and leadership over the past decade, and we are grateful for all of his contributions to CRN and to our industry,” said Steve Mister, president & CEO, CRN. “We wish Duffy all the best as he leaves CRN for this exciting opportunity, and we look forward to seeing his continued success.”
Shao is taking on a job he had previously done in an earlier stint with CRN from 2005 to 2011, when he left the trade organization for a position at network marketing giant Herbalife, where he was vice president, global nutrition policy and vice president, worldwide scientific affairs. Most recently, he served as regulatory & policy science director for Amway/Nutrilite.
Crucial time in industry’s history
Shao comes back to the organization at a crucial time in the history of regulation in the dietary supplement industry. The regulatory structure of the industry is nearing its 25th anniversary, and there is a growing consensus that changes are needed.
Earlier this month, FDA Commissioner Dr Scott Gottlieb, MD, announced an intent to form a new regulatory framework for the industry. Gottlieb said he was forming a working group on dietary supplements within FDA. The plan will include looking into modifications to the New Dietary Ingredient notification process as well as the formation of a group looking into the safety of botanical materials. His announcement was met with cautious optimism on the part of industry stakeholders.
This new atmosphere, where industry power brokers are open to a frank discussion about where regulations need to be beefed up or modified, is a sign of how far the dietary supplement realm has come since Shao’s last stint at CRN.
“I think the industry has matured a lot, and globally it has come a long way, too,” Shao told NutraIngredients-USA.
“If you think back 10 or 15 years ago—and think of the policy reform discussions we are having now—back then those would have been met with immediate opposition and the suspicion that FDA was somehow trying to undermine the industry,” he said.
The industry’s defining regulation, the Dietary Supplement Health and Education Act (DSHEA), was pushed through in 1994 partly in response to a perception that FDA was considering regulations that could have turned some of what are now called dietary supplements into OTC drugs. A key tenet of the law was to maintain free access to these products for consumers. “Don’t let FDA take our vitamins away!” was the rallying cry.
New spirit of collaboration
In the interim 25 years, much has changed in the industry. Shao said with the maturation of the market has come a self confidence that allows companies and trade organizations to consider working hand in glove with FDA to find ways to make existing laws work better and to improve the regulatory structure instead of manning the ramparts against an agency that was seen as essentially hostile toward dietary supplements.
“We are now coming around to confronting some of those issues. I see a higher level of collaboration between the agency and the industry than ever before. I think that’s a result of great leadership from the associations and great leadership at the agency,” Shao said.
“I think it’s great that the commissioner has come out with these proactive comments,” he said. “And I think it’s great that there was an acknowledgement that there is a need to find ways of providing the industry and companies with an incentive to continue to innovate.”
“The devil will be in the details, and I now I have to sit down with the rest of CRN’s leadership to see exactly how we’ll go about that,” Shao said.
Shao said he will continue to reside in Southern California while he helps CRN through this transition. The organization said it will evaluate its leadership needs to fulfill its strategic plan and will make an announcement on a permanent head of science and regulatory affairs later this year.