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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The FDA regulatory consultants and affiliated attorneys at FDAImports.com recently achieved another success for one of their clients, obtaining removal from an FDA Import Alert for cosmetics.  The client, a Chinese cosmetic firm, was placed on FDA Import Alert 53-06, “Detention Without Physical Examination Of Cosmetics Containing Illegal Colors,” because a previous entry of product tested positive for an illegal color additive.   

The complicating factor in this case was that the product in question was a limited run so sending five additional clean shipments to … READ MORE

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Imagine a government official approaching you outside your business one afternoon.  The official demands that you empty your pockets. You refuse and ask why. “Because you appear to have contraband in your pockets.”  When you ask what evidence he has he answers, “I’m not sure . . . yet.” What would you do in this case?

This example seems outrageous to Americans and their love relationship with rights to privacy and against unlawful search and seizure. But it is similar to FDA’s every day “regulatory” actions against … READ MORE

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1. Does my product comply with federal law?
The USDA administers the National Organic Program (“NOP”). NOP regulations set out the requirements for the handling, certification, processing, composition, and labeling of organic products.  Products labeled as “organic” or “100% Organic” have one set of labeling and certifying requirements. Products labeled as “Made with Organic” (i.e., ≥70% organic ingredients) have another set of requirements. Finally, products declaring the presence of organic ingredients in the ingredient list are exempt from certification, but have other restrictions.

2. Does my product … READ MORE

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FDAImports.com recently assisted a Chinese company with removal from FDA Import Alert 53-17, “Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.”  This case is of particular interest, because it is a reminder that FDA makes mistakes too. In this case, FDA wrongly added the company to Import Alert even though the cosmetic presented no actual safety risk or violation.

FDA Import Alert 53-17 is a very common Import Alert for cosmetic products with China, Mexico, and Canada having the most companies listed.  Typically, an Import Alert listing comes … READ MORE

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