Nutraceutical folk confront 'land mines'

LEHI — The Internet. The First Amendment. Overseas manufacturing facilities. Sports associations. Even California's Safe Drinking Water and Toxic Enforcement Act of 1986.

Those are among the legal and regulatory land mines that the nutraceutical industry confronts. Nearly 100 people gathered Friday at Thanksgiving Point to learn more about them at a Nutraceutical Law Symposium, believed to be the first of its type in Utah.

"In the course of talking to clients and many in the community, they felt like there was a need, that there wasn't anything else like this out there," said Michael Mangelson, chairman of the technology and intellectual property group in Salt Lake City for law firm Stoel Rives, the event's lead sponsor. "So much focus has been placed in Utah on IT and other industry groups that cater to those companies, but several people who share the same interest believed we needed to do something for these nutraceutical groups."

Much of Friday's discussion focused on understanding federal agencies — primarily the U.S. Food and Drug Administration and the Federal Trade Commission — and what they expect from the relatively new but burgeoning nutraceutical industry.

"Perhaps at first the FDA wasn't so aware of what was going on because it wasn't as popular or as profitable," Mangelson said. "But last year in Utah, there were over $5 billion in revenues just from Utah nutraceutical companies, so it's becoming much more of a player, and when you start getting that success, people take notice.

"You're dealing with new industries, and the rules that apply to traditional industries have not been applied in that context before, and I think that is also part of both parties kind of feeling each other out and trying to come to some common ground."

That can be difficult. Jonathan W. Emord, a partner with law firm Emord & Associates PC, spoke about how the FDA exceeds constitutional and statutory limits on its power by interpreting and redefining elements of regulations.

"If you can't count on the government to abide by the law and the regulatory agencies to abide by the law, then you really have nothing to protect yourself even if you do abide by the law," Emord said.

Ann Grimaldi, a partner with law firm McKenna Long & Aldridge LLP, told of industry troubles complying with the 1986 California act. That measure, prompted by an initiative, requires toxins and carcinogens to be listed on labels, among other provisions. The dietary supplement industry, from manufacturers to retailers, is being targeted, she said.