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Stepping Up

Will Obama’s FDA flexing its muscle squeeze Utah's supplement industry?



If there’s one thing a disinfectant should not do, it’s infect. Yet, that was exactly what the U.S. Food & Drug Administration worried that Utah’s Clarcon Biological Chemistry Laboratory “natural” hand-sanitizer products would do if not disposed of.

In a June press release, the FDA announced that an inspection found the Roy-based Clarcon’s hand-sanitizing products, lauded for having all natural ingredients and thus not containing harmful alcohol or silicon, also contained “high levels of disease-causing bacterias.” When the company failed to promptly destroy its unsanitary sanitizing products, U.S. Marshals on Aug. 1, acting on behalf of the FDA, seized the lab’s inventory and destroyed it. (Clarcon would not return a comment to City Weekly for this story.)

The Clarcon seizures have made some curious as to what the new surge in FDA enforcement will mean for Utah’s vibrant dietarysupplement makers. The actions of federal agents seizing Clarcon’s products speak louder than words about the new era of food-and-drug safety, but they were also actions backed up by the new FDA commissioner Margaret Hamburg, who announced in a press release: “Companies must have a realistic expectation that, if they are crossing the line, they will be caught, and that if they fail to act … we will.”

While Clarcon may fall under a similar industry umbrella of unregulated “natural” remedies often purveyed from Utah manufacturing bases, in legal terms, Clarcon’s sanitizer products, because they make an antibiotic claim, fall under the FDA’s definition of a “drug”—meaning the agency could regulate the products for safety and efficacy before they hit the market, explains FDA spokeswoman Siobhan Delancey.

“The 1994 Dietary Supplement and Health Education Act laid out the standard that dietary supplements could go on the market without prior FDA [approval]” Delancey says.

The question lingering now for supplement companies—many of which operate and distribute out of Utah—is whether or not there is a move afoot in the Obama administration to allow the FDA to regulate supplements as drugs, although federal legislation would be required to amend the Dietary Supplement and Health Education Act, a provision authored by Sen. Orrin Hatch, R-Utah. While no such legislation is currently in the works, the Obama administration has already expanded the scope of the FDA with the passage of the June 2009 Family Smoking Prevention and Tobacco Control Act, which gave the agency unprecedented powers in regulating tobacco products and how they’re marketed—like allowing the FDA to control the level of nicotine in cigarettes and prohibiting any kind of marketing that gives the impression of “light” or “low-tar” cigarettes.

The new commissioner also enacted rules to limit the number of warnings noncompliant companies would receive before facing enforcement action.

Forecasting new regulations for supplement makers, however, is premature. “But, we certainly have had a quite a few instances where we’ve taken action against dietarysupplement makers,” Delancey says.

Among those was a July 10 action the FDA took against a New Jersey supplement maker who failed to clean their equipment. Inspections at the company’s factories revealed "live and dead rodents and rodent urine, feces and gnaw holes on bags of product,” according to the FDA press release.

Loren Israelsen, the executive director of the United Natural Products Alliance, a supplement industry group centered in Utah, has spent the week meeting with FDA officials in Washington, D.C., to discuss pending enforcement and inspections to take place within the next month.

“We’ve been asking for this for years,” Israelsen says. “Now, it’s finally happening. All of the good companies welcome that, and our consumers will certainly benefit from a strong regulator that’s doing their job and going after companies that break the law.” The UNPA members in Utah comprise about 155 companies, contributing roughly $6 billion to the state’s economy annually. Being arguably among the top industries in the state, Israelsen sees the FDA’s increased regulation as lifting consumer confidence and helping dispel the myth that the supplement industry is unregulated.

Still, Israelsen is expecting that increased enforcement will come with increased interest by some in regulating supplements like drugs. He is not too worried about it, though, since he also expects that the FDA’s stepped-up inspection and enforcement will be solution enough.

“You can have laws on the books but, if there are no cops on the beat, it doesn’t matter,” Israelsen says.

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