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FDA Reauthorization Steers Clear Of Agency’s OTC Authority, DSHEA, AER Law

This article was originally published in The Tan Sheet

Executive Summary

The FDA reauthorization bill Congress has passed does not rock the boat on FDA's current authority over either over-the-counter switches or dietary supplements

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FDA publishes food registry guidance

The agency solicits public comment on a draft guidance regarding the reportable food registry, which is slated for implementation Sept. 8. Under RFR, responsible parties - including manufacturers, processors and packagers - will need to alert the agency through its main Web portal that an adulterated food product has the potential to "cause serious adverse health consequences or death to humans," FDA said June 11. The comment period ends June 26. The guidance includes information on when RFR reports must be filed and the information they must include. As specified in the FDA Amendments Act of 2007, RFR reporting requirements exclude infant formula and dietary supplements (1"The Tan Sheet" Sept. 24, 2007)

FDA publishes food registry guidance

The agency solicits public comment on a draft guidance regarding the reportable food registry, which is slated for implementation Sept. 8. Under RFR, responsible parties - including manufacturers, processors and packagers - will need to alert the agency through its main Web portal that an adulterated food product has the potential to "cause serious adverse health consequences or death to humans," FDA said June 11. The comment period ends June 26. The guidance includes information on when RFR reports must be filed and the information they must include. As specified in the FDA Amendments Act of 2007, RFR reporting requirements exclude infant formula and dietary supplements (1"The Tan Sheet" Sept. 24, 2007)

FDA publishes food registry guidance

The agency solicits public comment on a draft guidance regarding the reportable food registry, which is slated for implementation Sept. 8. Under RFR, responsible parties - including manufacturers, processors and packagers - will need to alert the agency through its main Web portal that an adulterated food product has the potential to "cause serious adverse health consequences or death to humans," FDA said June 11. The comment period ends June 26. The guidance includes information on when RFR reports must be filed and the information they must include. As specified in the FDA Amendments Act of 2007, RFR reporting requirements exclude infant formula and dietary supplements (1"The Tan Sheet" Sept. 24, 2007)

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