On Friday, January 4, 2013, the U.S. Food and Drug Administration (“FDA”) issued a Proposed Rule which proposed revisions to the current Good Manufacturing Practices (“cGMPs”) requirements for foods along with proposing the regulation for Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) under the Food Safety Modernization Act (“FSMA”).  This is noteworthy because FDA has not substantively revised the Food cGMP regulations since their establishment in 1986. The Proposed Rule makes several important proposed revisions to the regulatory requirements.

FDA Proposal: Food Sanitation “Shoulds” to Become … READ MORE

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After a full year’s delay the U.S. Food and Drug Administration has finally released some key proposed rules due under the 2011 Food Safety Modernization Act.  These proposed rules include (click on each to learn more):

1.  Hazard Analysis and Risk-Based Preventive Controls (HARPC)

2.  Produce Safety Standards

3.  Current Good Manufacturing Practice (CGMP) changes

Stay tuned to the FDAImports.com blog for more in-depth analysis of the proposed rules and what they’ll mean for industry, food safety and imports.

Read more on FSMA

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Generic drug manufacturers and certain others are subject to a new reporting requirement. It is perhaps buried in the Generic Drug User Fee Amendment (GDUFA), which was a part of the Food and Drug Administration Safety and Innovation Act (FDASIA) passed on July 9, 2012. Accordingly, FDA published a Federal Register announcement implementing this new requirement on October 2, 2012. This new requirement takes on a new urgency because the report is due 60 days after that announcement or by December 3, 2012. Failure to self-identify will … READ MORE

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The U.S. Food and Drug Administration recently released its Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for FY 2013.  Under FSMA FDA has the authority to assess and collect fees to cover reinspection-related costs and costs associated with non-compliance with a food recall order.  So just how much are we talking about?

• $221 per hour where domestic travel is required

• $289 per hour where foreign travel required.

That doesn’t sound too bad, right?  Think again. Though FDA explains each factor and details the … READ MORE

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FDA consulting firm, FDAImports.com, has won another substantial victory for a client on FDA Import Alert, this time for Import Alert 53-17, Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.  A Chinese company bringing in eye shadow to the United States found themselves on this import alert when their shipment was stopped at a U.S. port.  The charge stated that the product appeared to “contain a poisonous or deleterious substance which may render it injurious to health.”  The company … READ MORE

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FDAImports.com recently achieved another success, this time helping a client obtain removal from FDA Import Alert 53-17.  This particular Import Alert, “Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination,” affects over 50 International manufacturers and distributors of cosmetic products, especially products that come packaged in a kit or contain a variety of cosmetic products in one sellable unit.  In this case, a Chinese manufacturer was placed on the Import Alert Red List due to a labeling error that failed … READ MORE

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Santa Claus should be at the top of the U.S. Food And Drug Administration’s “naughty list” according to Benjamin England, a 17-year veteran of the FDA and Founder of FDAImports.com.  According to England Santa Claus has broken almost every rule in the book and violated numerous food, drug, facility registration and import laws, regulations and standards over the years as he has illegally imported millions of dollars worth of merchandise to children in the United States, albeit as gifts.  Since all imports coming into … READ MORE

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Are you a cosmetics manufacturer or importer bringing in product to the United States?  The FDA is serious about regulating cosmetics, especially when it comes to color additives (see chart).  Make sure you’re not making one of these common mistakes when it comes to importing your cosmetic products into the USA. The four most common mistakes are:

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1.  Using a color additive that is not FDA-Approved.  Many manufacturers use a color additive that is … READ MORE

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Companies that are directly affected by a major natural disaster or weather event, such as the Joplin, Missouri tornadoes or the earthquake and tsunami in Japan, should expect a heightened level of federal and state oversight in the future especially when it comes to facilities, documentation and equipment.

1. Facilities: Facility integrity will be a major factor in assessments including warehousing, manufacturing plants and other structures related to the import/export process.  Exporters must know precisely the extent of … READ MORE

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