This month marks the 1-year anniversary of President Obama signing into law the Food Safety Modernization Act (FSMA). One of the key implementation dates from the Act was January 4th, 2012, by when the following significant steps were to have been taken by FDA:

• Guidance for very small business exemptions from HARPC requirements

• Updated Good Agricultural Practices guidance for fresh produce

• Guidance related to intentional adulteration of food and mitigation strategies

• “National … READ MORE

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The FDA has recently made public and easily accessible several databases disclosing the results of FDA inspections for companies with compliance issues related to the Food, Drug and Cosmetic Act and results of criminal investigations and debarment actions along with an easy to use warning letter, untitled letter and cyber letter resource.  Although such information has always been available from FDA, it could only be obtained by a written request under the Freedom of Information Act … READ MORE

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In an executive order signed last week, President Obama ordered all government agencies to conduct a cost-benefit analysis before issuing a new regulation and to develop any future regulations in the least-burdensome manner possible and with specific performance goals. Obama also instructed federal agencies to seek and assess all available alternatives to direct regulation before issuing a new rule.

In an opinion piece published in The Wall Street Journal, Obama singled out the FDA as an example of an agency whose regulations have caused confusion.

Cost benefit analysis must benefit the government too, you know.  Obama is not saying “Be nice … READ MORE

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