CRN Scientists Offer ULs for CoQ10, Creatine, Lutein, Lycopene

WASHINGTON--Two scientists with the Council for Responsible Nutrition (CRN) contributed three risk assessments that are scheduled for publication in Regulatory Toxicology and Pharmacology. The papers address coenzyme Q10 (CoQ10), creatine monohydrate, and the carotenoids lycopene and lutein.

According to CRN, the scientists undertook the assessment to help regulators determine safe upper levels (ULs) for these non-essential nutrients in dietary supplements. "[They] are becoming more popular and more prevalent in dietary supplements and a safe upper level has not yet been established by governing bodies for these nutrients," said Andrew Shao, Ph.D., CRN's vice president of scientific and regulatory affairs and co-author of the papers. Shao and John Hathcock, Ph.D., CRN's vice president of scientific and international affairs, reviewed randomized clinical trials in humans to develop ULs using basic elements of the Food and Nutrition Board's methods and the World Health Organization's highest observed safe limit (OSL). Uncontrolled trials and animal data were used for supportive information only.

• CoQ10: A number of trials have been conducted using a range of doses, and reports of adverse gastrointestinal effects are likely not related to CoQ10 intake, given there is no dose-response relationship. The OSL risk assessment suggests safe intake up to 1,200 mg/d.

• Creatine: Research does suggest creatine has a consistent ergogenic effect; however, evaluation of research data does not provide a basis for risk assessment without using the OSL method. This method suggests safe intake up to 5 g/d for chronic supplementation.

• Lutein/Lycopene: Oral forms of these carotenoids may provide benefits for eye, prostate, skin and cardiovascular health, according to a large body of human and animal research. OSL risk assessment suggests evidence of safety up to 20 mg/d for lutein and 75 mg/d for lycopene.

"Risk assessments allow us to put forth science-based guidelines for safety levels," Hathcock said. "Since there are no observed adverse effects for these nutrients, governing bodies haven't set upper limits, leaving the door open for regulatory mischief. ... These risk assessments are necessary to ensure that science, not rhetoric, leads the way when it comes to safety."

Hathcock and Shao have conducted additional risk assessments on carnitine, and glucosamine and chondroitin sulfate, which have been accepted for upcoming publication in the same journal.