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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FDAImports.com recently unveiled its new logo as part of an overall re-branding to better reflect diversification of services, global reach and market expansion with new projects and initiatives.  This includes a strong synthesis with its Chinese branch located in Qingdao,ExportToUsa.com.cn, whose new logo is also shown below.

“We’ve doubled our team in 6 months with real live attorneys and in-house consultants and see growing opportunities in the FDA-, USDA- and Customs-regulated import, export, and manufacturing sectors in terms of compliance and transaction assistance,” said Benjamin England, Founder and CEO of … READ MORE

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China Seafood Show Qingdao China

“One of the most crucial success factors for breaking into a new market in a new country will be the relationships you establish there,” says Benjamin England, Founder and CEO of American consulting firm, FDAImports.com and Chinese counterpart, ExportToUsa.com.cn.  Mr. England’s firm has been establishing connections and partnerships with Chinese companies, manufacturers and trade organizations and hopes that the Qingdao Seafood Expo will further cement those relationships … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, recently led a webinar in conjunction with seafoodsource.com entitled, “Ensuring the Safety of Japanese Seafood.”  This webinar addressed the state of food safety and seafood coming from Japan as industry resumes and picks up again following the tsunami and earthquake in the spring.  Mr. England addressed the issue, identifying key factors such as FDA’s import alerts, HARPC, FDA examinations and private testing of exports.  Additional discussion centered on the coming FDA … READ MORE

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For years Benjamin England of FDAImports.com LLC has argued that FDA improperly treats import alerts as automatic detentions and wildly throws around its authority when the agency finds what it calls the “appearance” of a violation of FDA law from evidence other than the examination of samples. FDA has attempted to avoid this allegation by changing the name of its import alerts from “automatic detention” to “detention without physical examination.” It matters because FDA lost several lawsuits alleging that because its “automatic detentions” are actually … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, will be presenting at a RAPS webinar on July 20th, 2011 titled, “Imports and the FDA:  Insight Into Evolving Regulations.”  This webinar will cover the changing landscape of FDA import regulation and requirements and the various implications new regulations will have on regulatory affairs professionals, sourcing and supply managers, consultants, executive management, manufacturing directors, risk management specialists and others.  Mr. … READ MORE

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The Food and Drug Law Institute (FDLI) recently launched its first Chinese conference, US- China Food And Drug Law: Ensuring Quality, Improving Safety, Expanding Access. FDAImports.com, was represented at the conference by its CEO, Benjamin England, Mr. Rick Quinn, Senior Associate Attorney, Mr. John Wu, FDAImports.com, LLC’s Country (China) Director, and Ms. Shelly (Xiaoxia) Li, ExportToUSA.com.cn, Qingdao, China Office Manager.  Mr. England also presented during a panel discussion explaining to Chinese companies how the U.S. Food and Drug Administration enforces federal laws relating to imported products and how the Food Safety Modernization Act … READ MORE

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FDA’s Center for Drug Evaluation and Research (“CDER”) is establishing a new office, which in part will focus on drug importations. This move highlights CDER’s increased involvement in determining the compliance of individual drug-shipments imported into the United States. Also, this new office may likely centralize admissibility decisions, leaving the FDA field offices (and importers) waiting for decisions on drug entries. These affects will cause drug-importers greater delays in importing their products … 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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The www.FDAImports.com, LLC expert team of FDA consultants and FDA attorneys obtained removal of another client processor from another FDA Import Alert, this time, Import Alert #72-03, “Detention without Physical Examination and Intensified Coverage of Pig Ears and other Pet Treats Due to the Presence of Salmonella.”

A 2004 FDA examination and sampling found Salmonella in untreated rawhide scraps. FDA placed the Mexican processor on the Import Alert Red List. That shipment was a one-time event, as the Mexican supplier was in the business of processing and shipping finished rawhide pet chews and treats – not unfinished rawhide scraps.   However, in … READ MORE

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Rick D. Quinn (FDAImports.com, LLC) (Columbia, MD)

President Barack Obama signed into law the FDA Food Safety Modernization Act (“FSMA”) on January 4, 2011. FSMA is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food Drug and Cosmetic Act.

FSMA enlarges FDA’s power to regulate the safety procedures domestically and internationally for the producing, manufacturing, packing, storing and transporting of food. Also FSMA provides FDA with new powers to regulate food imports by increasing FDA’s ability to inspect foreign and domestic facilities, increasing FDA’s enforcement powers (including broadening FDA’s administrative detention powers and FDA’s … READ MORE

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