Natural Products Insider – Regulatory Updates: Adverse Event Reports Up Dramatically in Past Decade – April 21, 2011

April 21, 2011 By

April 7, 2011

Adverse drug reactions (ADRs) reported to the US Food and Drug Administration (FDA) have increased dramatically over the past decade, according to new research from the University of Maryland School of Pharmacy. The report examines FDA’s adverse events data since 1969 and found that 55% of all ADRs had been reported between 2000 and 2010. Lead researcher Sheila Weiss Smith cautioned that the reports do not accurately reflect the actual number of reactions as many go unreported, and also emphasized what she feels is the findings’ most important takeaway: the need for better quality reporting. Researchers found many reports lacked needed information, including one-third that failed to document the patient’s age, a critical piece of data. “Without ages, you have to throw out those reports,” said Weiss Smith.

April 11, 2011

Associations Advocate EFSA Claims Revision

PARMA, Italy—In a joint commentary, three European industry associations highlighted weaknesses of the recently published claims opinions from European Food Safety Authority (EFSA). European Federation of Associations of Health Product Manufacturers (EHPM), European Responsible Nutrition Alliance (ERNA) and European Botanical Forum (EBF) said the EFSA’s continued reliance in the assessment process on criteria which are unfeasible and inappropriate for the majority of claims, and this is contributing to the high number of negative EFSA opinions.

The associations said the European Commission should undertake a discussion of the specificities and limitations of nutritional research and reappraise the claims evaluation process before rejecting claims based on EFSA opinions.

The fourth batch of claims opinions, published by EFSA were published last week, have remained consistent in EFSA’s assessment criteria as compared to the third batch published last year, despite weaknesses in the approach, the commentary noted.

EHPM, ERNA and EBF also highlighted these flaws last month in a letter to Basil Mathioudakis, head of the European Commission’s food law unit. These weaknesses include the discrepancy between the way in which the information has been compiled and presented and the way in which EFSA is carrying out its assessments; EFSA’s almost exclusive reliance on randomized controlled trials demonstrating measurable and meaningful improvements of health (also called the pharmaceutical approach); and the way in which the claims legislation is being interpreted, which the groups believe is unduly restrictive making it impossible to acknowledge and assess a number of health effects.

April 13, 2011

Rise in Supplement Use by U.S. Adults

HYATTSVILLE, M.D.—Researchers from the Centers for Disease Control and Prevention (CDC) and the National Institute’s of Health (NIH) have found dietary supplement use has grown since the National Health and Nutrition Examination Survey III (NHANES III, 1988-1994), including specific growth in use of calcium, vitamin D, folic acid and multivitamin supplements. In this latest report, the researchers noted dietary supplement use in adults aged 20 and over is widespread, and the percentage of the U.S. population that has used at least one multivitamin/mineral product rose from 43 percent in NHANES III to 53 percent in the current analysis period of 2003-2006. The researchers, a combination of CDC National Center on Health Statistics (NCHS), NIH Office of Dietary Supplements (ODS) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD) scientists, concluded the increased supplement usage should fact or into any surveys or analyses of nutrient intake in the U.S. population, especially relative to intakes above recommended levels.