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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The FDAImports.com team achieved another Import Alert success, this time obtaining a green ticket for a Chinese firm for FDA Import Alert 99-29, “Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs.” Import Alert 99-29 is a daunting countrywide Import Alert for China- an Import Alert that didn’t see any exemptions until 2012 when FDAImports.com obtained the first exemption ever for a Chinese company. “What we’re … 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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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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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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Americans consume an incredible amount of imported foods. For shrimp, over 90% of what we consume is imported, for produce, 35%, and some estimates claim that 20% of the total U.S. food supply is imported.1  Whether it’s caviar or truffles or bananas or cookies, we love our food choices, in season and out, and would be devastated if our imported food supplies suddenly dried up.  Yet whenever there is a food safety scare (E. coli, Listeria, Salmonella, antibiotics), some Americans are quick to turn on “foreign foods” … READ MORE

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FDAImports.com recently helped a Chinese company obtain the first Green Ticket from FDA Import Alert #99-29, a sweeping and unshakeable Import Alert for Chinese protein products due to the presence of Melamine and/or Melamine Analogs.  This Import Alert traces back to 2007 when thousands of pets in the United States died due to the presence of Melamine in certain pet foods containing contaminated vegetable proteins.  Since FDA could not identify the specific manufacturers of the contaminated vegetable proteins, it created this countrywide Import Alert, leading to the automatic detention of every imported food shipment of these … READ MORE

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FDAImports.com recently achieved another Import Alert success for one of its clients, this time for FDA Import Alert #36-04, “Detention Without Physical Examination of Honey and Blended Syrup Due to Presence of Fluoroquinolones.”  FDA implemented this Import Alert many years ago upon discovery of certain antibiotics, specifically, ciprofloxacin and enrofloxacin in honey products and blended syrups.  The antibiotics, while permitted for use in cattle, are not permitted for honeybees as the residues can transfer into the honey and its products.

In this case, the U.S. importer contacted … READ MORE

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FDAImports.com’s success rate continues to increase, as it successfully petitions FDA to remove yet another client from Import Alert—this time, Import Alert #45-02, “Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.”

FDA placed a Mexican manufacturer of flavoring concentrates and extracts for use in beverages on Import Alert #45-02 in 2002, because one of its concentrates was found to contain Brilliant Blue FCF (certifiable as FD&C Blue No.1), which the company failed to … READ MORE

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