Industry Roundup: SEC Fines MJN, Criminal Charge For Herbals Seller, Decree Closes Aspen Supplement Marketer
This article was originally published in The Tan Sheet
Executive Summary
FCPA violations cost Mead Johnson $12M; decree closes Aspen supplement marketer; equity funding for SmartyPants; homeopathic online retailer warned; ForeverGreen launches strong; and more news in brief.
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QHC study
FDA plans to conduct a study to "further explore" the use of report card grading schemes in qualified health claims (QHCs), according to a notice published in the Federal Register May 22. The study builds off previous research that found report card schemes were effective in conveying the "intended ordering of scientific certainty," but led consumers to be more certain of "B" and "C" claims than claims of higher scientific certainty, which did not receive a grade (1"The Tan Sheet" Oct. 10, 2005, p. 7). The proposed study will attempt to correct for "misperceptions" observed in the previous study and will position unqualified claims as "A" grade claims. Additionally, the study will use actual health claims and variants of these claims rather than hypothetical claims. Green tea and cancer, coronary heart disease and consumption of monounsaturated fatty acids from olive oil as well as omega-3 fatty acids and CHD claims will be used. An earlier version of the study was proposed in March 2005 (2"The Tan Sheet" April 4, 2005, In Brief)...
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.