Supplement rules may be issued next month

WASHINGTON — After more than a decade of waiting, dietary supplement manufacturers could see final rules from the Food and Drug Administration on how to make their products as early as June, based on a decision made Wednesday.

Dietary supplements are a $4.6 billion industry in Utah, and these final regulations will affect how companies have to test ingredients that go into their products and other rules, whether they make one pill or hundreds of different ones.

The Office of Management and Budget gave its approval Wednesday to good manufacturing practices regulations originally called for in a 1994 law. The regulations go back to the FDA, which may publish them in as little as five weeks.

Supplement manufacturers welcomed the news that the process was almost complete, but because no one has seen the final rules yet — they are protected by presidential privilege until they are published in the Federal Register — it is too early to tell what changes have been made.

The proposed rules called for testing requirements that were more stringent than for some pharmaceuticals, said Dr. Daniel Fabricant, vice president of scientific and regulatory affairs at the Natural Products Association. This was the main concern, not only because the tests would cost a lot of money to run, but also because they did not make a difference in product quality, Fabricant said.

He said the focus should be on what ingredients go into the supplement, which will influence what type of product comes out.

"We want a fair regulation but a strong regulation," Fabricant said.

Many companies already have their own standards in place to make sure products are safe, which they took upon themselves to complete while they were waiting for these regulations, Fabricant said.

About 180 million people take dietary supplements, and the regulations are designed to add to the assurance that what they are taking is safe.

"It helps reinforce consumer confidence," Fabricant said.

Loren Israelsen, executive director of the United Natural Product Alliance, an international group based in Salt Lake City, said he is hopeful the final rules will "reflect reality" and that the government took the alliance's concerns about the proposed regulations into account.

"We don't want standards to do things that are pointless," Israelsen said.