Project Experience

Knowing An Agency's Reaction to Innovative Products Is Critical

Client Situation
While medical science seeks ways of treating life-threatening diseases, research is also being conducted into the prevention of these diseases through nutritional means. Innovative nutraceutical products face different regulations than dietary supplements. Nutraceuticals and functional foods are gaining momentum, and the market has become driven by clinical data to back up claims. A key issue revolves around whether these products are foods or drugs; although medicines are highly regulated, dietary supplements are not. Our client was interested in learning not only when two new nutraceuticals would be launched, but also more importantly, what FDA's reaction and stance to their claims would be.

Fuld Approach
Research efforts were concentrated on the competitors and at the FDA. While the agency cannot discuss individual product specifics, it is free to discuss classes of drugs or supplements. Fuld & Company spoke with advisory board members to better understand their issues and concerns about the regulation of nutraceuticals.

Benefits and Implications
Through Fuld & Company's research, we learned that FDA would challenge the first product submitted and force a delayed product launch, opening a window of opportunity for our client.
For more information about innovative products in the healthcare industry, contact either Anthony Nagle at tnagle@fuld.com or Cynthia Gerber Tomlinson at cgtomlinson@fuld.com.