How much would you be willing to pay an attorney or paralegal to take care of all your FDA facility registration and product listing woes?  $500?  $750?  What about to have a reputable company serve as your US Agent, facilitating communications with FDA and making sure that your registrations and listings are up-to-date and compliant?   $1000?  Many companies are charging prices like these or higher for these services.  There seems to be a mindset in the industry that these services are hugely complex and take many hours, so they’re worth hundreds or … READ MORE

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By now food manufacturers should be more than aware of the new Biennial Food Facility Registration requirement set forth under the Food Safety Modernization Act (If not, read this NOW).  Though registration is a relatively painless process, it can be time-consuming and frustrating, especially for those who registered several years ago and now must find or obtain their login credentials.

FDA has taken note of the food industry’s scramble to obtain their login credentials and complete their registrations.  FDA recently released a statement to the effect that officials may “exercise … READ MORE

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On November 26th, 2012 the U.S. Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a New Mexico producer of peanut butter and peanut products due to a “reasonable belief” that their products had sickened some consumers with a strain of Salmonella.  This marks the first time that FDA has leveraged this new enforcement authority given to it under the 2011 Food Safety Modernization Act (FSMA).  Under the FSMA, FDA can suspend the … READ MORE

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ExportToUsa.com.cn, the Chinese branch of FDAImports.com, was recently featured in China Seafood Magazine answering questions regarding imports, registrations, facilities, import alerts and the Food Safety Modernization Act.  The 3 page Q/A was developed by the team at FDAImports.com and ExportToUsa.com.cn to provide simple explanations of FDA regulations for Chinese seafood manufacturers and exporters.  Some of the questions answered in the article were:

Q: What is a U.S. Agent for? 

Q: What do I do … 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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On September 11th 2011, Cargill recalled an additional 185,000 pounds of ground turkey citing a potential contamination risk of Salmonella Heidelberg.  This recall follows the previous massive recall of 36 million pounds of ground turkey products on August 3rd.  In our blog post discussing the first turkey recall we predicted that Cargill would meticulously invest in research and backtracking to understand how the contamination occurred.  As predicted, Cargill has assembled an outside panel of experts to do this very thing.  After discussing their already implemented food safety procedures Cargill states that, “we believe a panel of independent experts will … READ MORE

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According to research done by www.FDAImports.com, The U.S. Food and Drug Administration (“FDA”) aggressively stepped-up the number of food-facility inspections in China last year according to the FDA Inspection Classification Database. Between fiscal year 2009 and 2010, FDA had a thirteen-fold increase in food-facility inspections in China. Last year’s dramatic increase foreshadows FDA’s greater international profile through inspecting foreign food-facility, which Congress mandated in the recently passed FDA Food Safety Modernization Act (“FSMA”).

China has played an increasingly important role in supplying food to the United States. Between 1999 and 2008, China went from the eleventh-largest supplier of … 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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FDAImports.com, LLC, consultants and affiliated attorneys have been thinking about and praying for all of our friends, colleagues and clients affected by the massive earthquake and tsunami which struck Japan on March 11th. We wanted to provide an update on the affect of these events upon those importing FDA-regulated products to the United States from Japan. Certainly the earthquake in Japan will exact personal, social, and economic consequences that will be with us for many years. More particularly, this will have long-term … READ MORE

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FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public … READ MORE

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On January 4, 2011, the Food Safety Modernization Act (FSMA) was signed into law and the U.S. Food and Drug Administration (FDA) gained significant new authorities. Among other things, the FSMA made a number of changes to FDA Food Facility Registration authority. These provisions are effective on July 4, 2011 or sooner, if FDA issues a regulation implementing the provision.  Read to the end of this blog because there are two other provisions that will intersect with the registration provisions in dramatic ways, particularly for foreign food facilities and … READ MORE

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