In response to a request from the State of Queensland, Australia, FDAImports.com partnered with Trade and Investment Queensland to present a webinar entitled “How to Successfully Export FDA and USDA Regulated Products to the United States.”  The webinar was a fantastic success, with more than 20 companies registered after only minimal marketing.

Ben England, Founder and CEO of FDAImports.com, and Rick Quinn, Principal of FDAImports.com, presented for an hour on the US Agencies, the import process, and the regulations and pitfalls involved.  Following the presentation, there was a productive Q&A session, … READ MORE

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FDAImports.com has opened a new expansion office in Manila, Philippines.  Manila is strategically located to allow FDAImports.com to handle client needs in the South Pacific – Malaysia, Indonesia, Thailand, Vietnam, and more.  The United States is one of the Philippines’ top trading partners, importing billions of dollars of machinery, apparel, and agricultural products.  “The Philippines export prime agricultural products to the United States,” said Ben England, Founder and CEO of FDAImports.com, “such as tropical oils, sugar cane, processed fruit and vegetables, tree nuts, and fruit and vegetable juices.”

“FDA’s regulatory interest in … READ MORE

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Ben England, Founder and CEO of Maryland-based international FDA consulting firm FDAImports.com, will be attending and presenting at IFEX Philippines 2013, a premier international sourcing hub for the finest ethnic Asian food, ingredients, and raw materials.  The show will be held at the SMX Convention Center, in Metro Manila, Philippines, from May 16 – 19.  Mr. England will be offering three presentations discussing the ins and outs of USDA, FDA, and US Customs compliance.

Two of Mr. England’s presentations are directed at exporters, manufacturers and other industry members: the first concerning food … READ MORE

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Rick Quinn, Principal at FDAImports.com, and Shelly Li, Regulatory Specialist of ExportToUsa.com.cn, traveled to China to visit companies listed on FDA Import Alert in March.

The team intended to increase Chinese companies’ awareness and understanding of FDA rules and regulations, as well as how to successfully export FDA-regulated products to the United States. During this trip, the team visited companies throughout  the provinces of Guangdong and Hainan. They visited industry members involved with food (mainly seafood), cosmetics, devices, etc.

Companies showed great interest in what FDAImports.com has to offer, especially in learning more about … READ MORE

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FDAImports.com announced recently that it would be presenting a webinar on April 15 for companies and trade professionals in the food, drug, cosmetic, homeopathic, dietary supplement, and medical and radiological device industries.  The webinar, which is called “How to Successfully Export FDA and USDA Regulated Products to the United States,” will broadly cover the regulations, requirements, issues, and pitfalls involved in importing goods to the US, before offering an open Question-and-Answer session.

Attendees will learn

• The US Agencies and what they regulate (FDA, USDA, etc.)
• FDA/USDA regulatory requirements for imported products
• The Food Safety Modernization Act: … READ MORE
  
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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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FDAImports.com Founder and CEO, Benjamin England, will present on FDA and Customs issues for importing and exporting consumer healthcare products at the Logistics Steering Committee Meeting of the Consumer Healthcare Products Association in Washington, DC.  The presentation will address the relevant import authorities for OTC and cosmetic products at the border, FDA Import Alerts, FDA’s import process and PREDICT system, exports from the United States and more.  The Consumer Healthcare Products Association (CHPA) is a member-based association representing the leading manufacturers … READ MORE

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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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FDAImports.com is pleased to announce 5 new labeling websites that we have developed in order to provide a fast, turn-key solution for preventing labeling errors before they happen.  Our new label review websites allow users in any FDA-regulated industry to quickly and easily upload their label and packaging graphic files and have them reviewed for FDA compliance by our team.  We’ve set up a streamlined process that will allow users to easily upload their label files for free, get a reasonable and flat-rate estimate, pay online and receive a … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, will present on FDA’s PREDICT system and issues affecting the distribution and importation of cosmetic, drug and combination products from an FDA regulatory perspective at this year’s 2012 Cosmetic Science Symposium in Newark, New Jersey.   The Cosmetic Science Symposium is a yearly event put on by the Personal Care Products Council, the leading national trade association for the cosmetic and personal care products industry.  The Science Symposium addresses topics such as microbiology, quality assurance, safety and ingredients from a wide array of industry leaders.  Mr. England’s presentation will … READ MORE

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If a labor dispute between U.S. seaport workers and port managers is not resolved before an impending September 30th deadline, then October 1 will represent more than the start of a new Federal Government Fiscal Year. It will also mark the start of a new import/export trade crisis that will make the last 12 months of U.S. economic problems pale in comparison, according to FDAImports.com. The looming shut down of many Eastern Seaboard and Gulf Coast ports will not only raise the costs of holiday merchandise but also gridlock … READ MORE

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