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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)...

Proposed Rule Making More OTC Switches Likely In US Makes More Tools Necessary For Sponsors

OTC drug development and marketing consultants spoke with HBW Insight about FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule. In first of two articles, they discuss proposed rule’s likely impacts on industry and remaining concerns around incorporating extra-label information in drug labeling.

US FDA Advisors' Push For BA.4/BA.5 COVID-19 Boosters Sets Up Regulatory, Manufacturing Crunch

If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.


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