HEALTH

CRN to publish risk assessment of amino acids

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition on Thursday announced that its risk assessments on the safe upper-intake levels for the amino acids taurine, glutamine and arginine used in dietary supplements will be published in the April issue of the peer-reviewed journal Regulatory Toxicology and Pharmacology. “Over the last decade the prevalence of amino acids within sports nutrition supplements and ‘energy-boosting’ functional foods and beverages has significantly increased,” stated Andrew Shao, CRN vice president of scientific and regulatory affairs and co-author of the paper. “We chose to assess the safety of taurine, glutamine and arginine because they are among the most widely used and studied of the supplemental amino acids.”

CRN concluded that the absence of adverse effects is strong for taurine at up to a dose of 3 g per day; for glutamine, at up to 14 g per day; and for aginine, at up to 20 g per day.

“CRN is dedicated to helping ingredient manufactures deliver the safest products possible to consumers, and risk assessments are the best indicators we have to establish upper limits,” stated John Hathcock, senior vice president of scientific and international affairs and also co-author. “These risk assessments … represent the first time upper-intake levels have been identified for amino acids.  …  It is important that we don’t allow for a non-scientific approach, such as the use of a random multiple of the recommended daily allowance.”

The upper levels do not suggest that supplements taken above the level identified are unsafe, nor do they constitute a recommended intake, the authors cautioned. They merely identify the highest quantitative level at which there is no known toxicity, ensuring that science is the deciding factor when it comes to setting and enforcing regulatory guidelines for ingredients used in dietary supplements. 

This is the eighth in a series of risk assessments completed by CRN scientists.  Previous risk assessments on vitamins C and E were published in 2005 and on vitamin D in 2007 in the American Journal of Clinical Nutrition.  Risk assessments on nonessential nutrients including coenzyme Q10, lutein and lycopene, creatine, carnitine, glucosamine and chondroitin sulfate were published in 2006 and 2007 in the journal Regulatory Toxicology and Pharmacology.

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J&J posts record sales for Q1

BY Drew Buono

NEW BRUNSWICK, N.J. Johnson & Johnson released its first quarter 2008 sales results and it showed that the company had record sales for the quarter of $16.2 billion. This was a 7.7 percent increase as compared to the first quarter of 2007. Net earnings for the quarter were $3.6 billion.

Sales growth reflects the strong performance of Remicade, a biologic approved for the treatment of a number of immune mediated inflammatory diseases, which increased by 12.7 percent; and Concerta, a treatment for attention deficit hyperactivity disorder, which increased by 12 percent.

Sales though were also negatively affected by the proton pump inhibitor Aciphex, which saw sales decline by 27 percent, the pain patch Duragesic which fell by 35.3 percent, and the anemia drug Procrit, which fell by 37 percent.

Also during the quarter, the company announced that it received an approvable letter from the Food and Drug Administration regarding its application for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections, as well as submitting an application to the FDA for tapentadol hydrochloride immediate release tablets, an investigational oral analgesic for the relief of moderate to severe acute pain.

“We achieved solid earnings in the first quarter which reflects our continued focus on profitable growth for Johnson & Johnson,” said William Weldon, chairman and chief executive officer. “Our strategy of being broadly based remains one of the keys to our consistent long-term performance.”

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Perrigo gets FDA approval for generic OTC Zyrtec

BY Michael Johnsen

ALLEGAN, Mich. Perrigo earlier this week received final approval from the Food and Drug Administration to manufacture and market over-the-counter store-brand equivalents to McNeil Consumer’s Children’s Zyrtec oral solution, indicated for indoor and outdoor allergy and hives relief.

According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the last 12 months ending December 2007 were approximately $80 million.

Perrigo expects to begin shipping the product immediately.

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