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]”
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.