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Consumer Health Product News Roundup

This article was originally published in The Tan Sheet

Executive Summary

Sigma-Tau launches colic-reliever; Arbonne gets essentially green; CocoProtein drink available Oct. 1; Comparative claim webinar; BioTrim offers ‘Premier’ benefits; Youtheory hires Nick Bitz.

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Research & Development In Brief

Vitamin D influences gene expression: Vitamin D significantly influences how 229 genes are expressed, including those associated with autoimmune disease and cancer, according to researchers who mapped where the vitamin binds in the human genome. They note in a study published online Aug. 24 in Genome Research that the vitamin attaches in especially high concentrations near genes associated with multiple sclerosis, Crohn's disease and type 1 diabetes. The discovery of where vitamin D binds to genes "provides a powerful approach to further understanding the molecular bases of complex disease," in part because how vitamin D influenced disorders was poorly understood, according to the study. The research "may help point researchers in other directions for studying the clinical benefits of vitamin D," said Andrew Shao, senior VP of scientific and regulatory affairs at the Council for Responsible Nutrition. However, he added, the research "reveals nothing about how much vitamin D people should consume," as that was not the focus of the analysis. The current recommended daily intake for vitamin D is 200 IU for people up to 50 years old, 400 IU for 51- to 70-year-olds, and 600 IU for older people, but experts including American Academy of Dermatology members advocate to increase the RDI, stating that some people may need to use a supplement for good health and others may need higher doses (1"The Tan Sheet" July 26, 2010)

Rejection Rate Soars In Q4 For EU Fast-Track Requests

October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.

Biden Regulatory Freeze May Pause SUNSET Rule

Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.

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