Affiliations: Functional Food Ingredients Division, Healthcare
Products Business Unit, Kaneka Corporation, Osaka, Japan
Note: [] Address for correspondence: K. Hosoe, Functional Food
Ingredients Division, Healthcare Products Business Unit, Kaneka Corporation,
3-2-4 Nakanoshima, Kita-ku Osaka 530-8288, Japan. Tel.: +81 6 6226 5402; Fax:
+81 6 6226 5059; E-mail: kazunori.hosoe@kn.kaneka.co.jp
Abstract: Coenzyme Q_{10} (CoQ_{10}) is
a naturally occurring component present in living cells. Its physiological
function is to act as an essential cofactor for ATP production, and to perform
important antioxidant activities in the body. In most countries,
CoQ_{10} has been widely used as a dietary supplement for
more than 20 years. Recently, the use of CoQ_{10} as a
dietary supplement has grown with a corresponding increase in daily dosage. The present review describes the safety profile of CoQ_{10} on
the basis of animal and human data. The published reports concerning safety
studies indicate that CoQ_{10} has low toxicity and does not
induce serious adverse effects in humans. The acceptable daily intake (ADI) is
12mg/kg/day, calculated from the no-observed-adverse-effect level (NOAEL) of
1200 mg/kg/day derived from a 52-week chronic toxicity study in rats, i.e., 720
mg/day for a person weighing 60 kg. Risk assessment for
CoQ_{10} based on various clinical trial data indicates that
the observed safety level (OSL) for CoQ_{10} is
1200 mg/day/person. Evidence from pharmacokinetic studies suggest that
exogenous CoQ_{10} does not influence the biosynthesis of
endogenous CoQ_{9}/CoQ_{10} nor does it
accumulate into plasma or tissues after cessation of supplementation. Overall,
these data from preclinical and clinical studies indicate that
CoQ_{10} is highly safe for use as a dietary supplement.
Additionally, analysis of CoQ_{10} bioavailability or its
pharmacokinetics provides the pertinent safety evaluation for
CoQ_{10}.
