Rick Quinn, Principal at Maryland based FDA consulting firm, FDAImports.com, will be serving as a panelist at the Natural Products Expo West Town Hall meeting for retailers, “Defining Natural Together” on Sunday, March 10th, 2013 at 9am Pacific Time.  The session, part of the Natural Products Expo West event in Anaheim, CA, is intended to provide an opportunity for attendees to work together to create a meaningful industry definition of “natural” in the absence of a functional definition from the U.S. Food and Drug Administration (FDA).  Rick Quinn will … READ MORE

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Apparently, the smaller something is, the longer it takes to talk about.  This is the axiom currently employed by FDA, illustrated by the agency’s recently published guidance on nanomaterials in cosmetics and foods (5 years in the making).   While the European Union already requires companies to prove a product containing any nanotech materials is safe before the product can be sold to consumers, FDA has sat on the sidelines, forcing many industries to wait for some kind of guidance from FDA on how to proceed.

Slow to Speak

Back in 2007, … READ MORE

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The demand for organic products is on the rise, despite higher prices, according to a recent report from the TABS Group, Inc. The Annual Organic Product Study for 2011 showed an estimated 15-20% growth in sales for organics products, for both foods and cosmetics. The research showed that consumers 40 and under purchase more organic products than older consumers, even though the younger demographic has less disposable income to absorb the higher price points commanded by organic products. This trend indicates sales in organic goods are … READ MORE

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If you remember only one thing about FDA-related legal matters involving imported products it should be this:  Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse itself.

For instance, in late 2011 FDA detained multiple shipments of children’s medicine being imported by a multi-national drug company.  FDA alleged that the drugs appeared to be misbranded and unapproved. Eventually FDA refused all of the shipments. FDAImports.com reviewed … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, was featured in this month’s FDLI Update for his presentation during Food Week 2012 entitled, “How to Use Existing Quality Systems to Comply with FSMA Requirements.”  Mr. England co-presented at the Food and Drug Law Institute’s (FDLI) annual Food Week Conference along with David Calvin, Associate Director of Quality Programs and Government Affairs at H.J. Heinz.  The presentation focused on documentation and system compatibility in light of emerging FSMA implementation policies.
England explained how to use existing systems in order to … READ MORE

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Below are some of our favorite quotes and exchanges from last week’s Energy and Commerce Subcommittee on Health hearing, “Examining the Current State of Cosmetics.”  If you haven’t read our first blog about it please read that here.  What follows below are some of the more interesting quotes and exchanges from Michael Landa’s testimony portion of the hearing (our thoughts in italics):

 “FDA’s current authority is principally post-market…the pre-market authority is limited to color additives… we have the authority to ban ingredients … READ MORE

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Last week the U. S. House of Representatives, Energy and Commerce Subcommittee on Health, held a hearing entitled, “Examining the Current State of Cosmetics,” the first of its kind in decades, featuring panel testimonies and inquiry related to the overall safety of cosmetics in the USA.  A few assumptions emerged as the hearing got underway:

Cosmetics are under-regulated compared to other products

The FDA has shockingly little resources assigned to cosmetics

The FDA has little authority to regulate, recall, etc…

There … READ MORE

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Question:  What’s worse than driving a stolen car around town?

Answer: Not knowing that you’re driving a stolen car!

If you know something horrible is about to happen, you can prepare for it.  But it’s a whole different story when something bad is about to happen to you and you have no clue that it’s coming!  That’s exactly the conversation we’re having with dietary supplement importers about the coming FDA imported food fees beginning October 1st, 2011.  Much … READ MORE

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In a previous FDAImports.com article on the Japan Earthquake it was stated that FDA-regulated products from Japan will likely face many new hurdles in order to enter the United States. FDA will likely subject them to greater regulatory review by inspecting incoming food, drugs and medical devices and possibly subjecting them to laboratory testing.

On June 1, 2011, the Center for Device and Radiological Health (“CDRH”) and the Center for Biologic Evaluation and Research (“CBER”) issued a … READ MORE

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The FDA has recently made public and easily accessible several databases disclosing the results of FDA inspections for companies with compliance issues related to the Food, Drug and Cosmetic Act and results of criminal investigations and debarment actions along with an easy to use warning letter, untitled letter and cyber letter resource.  Although such information has always been available from FDA, it could only be obtained by a written request under the Freedom of Information Act … 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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