Robert Ullman Steps Into Senior Counsel Role, Offers Industry Advice

Robert Ullman has assumed the role of senior counsel of Ullman, Shapiro & Ullman, after more than 45 years of serving as partner for the New York law firm he founded, the firm announced Jan. 16.

In an interview with "The Tan Sheet," Ullman outlined some of the top issues the industry will face in the coming years, including supplement good manufacturing practices, the new adverse event reporting law and emerging nanotechnology.

He cited nanotechnology as an emerging issue that could lead to litigation in the industry, particularly about whether the inclusion of the technology would render a substance a new dietary ingredient.

"Nanotechnology is one of those areas that we could almost argue that it doesn't create anything new - it's simply a change in the technique of manufacturing existing products," Ullman explained.

"But it raises all kinds of issues in terms of introducing nanoparticles into the air and into the environment and I think this is something that is still in the developmental stage, although we do see nanotech products out there in our industry," he said.

"We could make an argument that that makes any product, at the very best, a new dietary supplement when it's manufactured at the nanotech level. On the other hand, you can say, 'Hey, this is CoQ10. This is just how we make it. That doesn't mean it's a new dietary ingredient,'" Ullman said.

"You can argue both ways, and I think we may find FDA taking a position that there will be some new dietary ingredients coming out of that technology," he said.

"I believe it will open itself up for a viable legal argument that it's not a new dietary ingredient so this is an argument that depending on how it's thought through - how it's presented - could really go either way."

"Now my biggest fear in that particular ballpark is FDA decides, 'Hey, this is much too tricky. This requires a lot more work before a product can come on the market. This is a new dietary ingredient at the least, or maybe we should treat it as a food additive, depending on the application of the definition of a food additive,'" Ullman said.

"Bad facts lead to making bad law," he said.

"What we do not see is any particular FDA-type regulatory activity and what the implications are when you manufacture at that level is something that we don't really know," Ullman said.

The supplement GMPs are "probably going to occur much sooner. It's inevitable," Ullman said.

"But until that crystallizes into regulatory activity, that will take a little while" before industry will have to deal with them. "FDA will start going after the most egregious stuff," Ullman said.

He advises industry stakeholders: "Don't cut corners."

Additionally, "it's going to take some time before" regulations mandated by the supplement adverse event reporting law "materialize with enforcement."

Provisions of the AER law went into effect in December, but the agency said it will practice enforcement discretion until December 2008 to give industry a year to come into compliance with the law.

"This does not mean industry should take that year to forget about it, particularly when you talk about AERs. This is an area where compliance by industry shouldn't wait," Ullman advised.

Throughout his career, Ullman argued many pivotal cases "on behalf of the natural products industry including groundbreaking litigation against the FDA, which paved the way for the passage of DSHEA," according to a Jan. 16 release announcing Ullman's step down to senior counsel for Ullman, Shapiro & Ullman.

Those groundbreaking cases include Ullman's work on the FoodScience case in 1985 and the Traco Labs litigation several years later, in which FDA argued the companies' products were food additives subject to premarket approval.

As senior counsel he will continue to assist clients with whom he has an established relationship as well as new clients desiring his expertise, although he is leaving his customary 60-hour workweeks behind," according to Ullman's firm.

- Jessica Lake ([email protected])