AG/FDA Blog

CPSC: The Price of Hubris

Late last week, the CPSC community received one of its rarest gifts: A judicial opinion in a litigated civil penalty case. Judge William Conley of the U.S. District Court for the Western District of Wisconsin calculated the penalty Spectrum Brands ow… Read More
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Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act.   See generally Foo… Read More
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CPSC: Let’s Play Penalty Roulette

Commissioner Mohorovic has just issued a thoughtful statement discussing the black hole that the Consumer Product Safety Commission calls its civil penalty policy.  This statement follows another he filed this week discussing the $4.5 million pena… Read More
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FDA FSMA Final Rule – Mitigation Strategies to Protect Food Against Intentional Adulteration

The Food and Drug Administration (FDA) has published in the Federal Register a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration, 81 Fed. Reg. 34,165 (May 27, 2016), 21 C.F.R. Part 121 (Final Rule).  The proposed r… Read More
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FDA Final Rule: CGMPs and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

On September 17, 2015, the federal Food and Drug Administration (“FDA”) released a major final rule to implement the Food Safety Modernization Act (“FSMA”): Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Contr… Read More
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Killer Coffee Mugs?! Really?!

By former CPSC Commissioner Nancy Nord Did anyone else notice CPSC’s recent recall of ceramic mugs?  The agency is concerned about 4400 mugs with hairline cracks.  The hazard is not that they could break and cut the user, or that there could be… Read More
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Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are ta… Read More
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Food Stamp Vendors Face Increased Eligibility Requirements and Oversight Following Implementation of Farm Bill’s SNAP Provisions

The 2014 Farm Bill contains several important provisions which will impact retail stores that participate in the USDA Food and Nutrition Service’s (FNS) Supplemental Nutrition Assistance Program (SNAP).  The key changes for food stamp vendors incl… Read More
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