We’d like to take a moment to introduce one of our partners here at FDAImports.com, the Global Food Safety Forum (GFSF), a 501(c)(3) focused on establishing dialogue, training, and private-public collaboration in all areas of food safety, imports and the food supply chain.  Founded and managed by GIC Group President/CEO and Chairman of GFSF, Rick Gilmore, GFSF creates key opportunities between the U.S. and China such as training events, workshops, delegation visits, consulting services, and research projects. We … READ MORE

FDAImports.com Founder and CEO, Benjamin England, recently spoke at the Food and Drug Law Institute’s Annual Conference on the Food Safety Modernization Act and imports.  During the presentation, “How FSMA Changed the Game on Imports,” Mr. England discussed, along with leading FDA lawyers and industry and FDA officials, elements related to FSMA affecting imported foods and international trade, including the Foreign Supplier Verification Program (FSVP), the Voluntary Qualified Importer Program (VQIP), various challenges to the international supply … READ MORE

What happened when observers pointed out that the Congressional Budget Office estimated it would cost $1.4 billion over 5 years to implement FSMA even though Congress only gave FDA a $50 million boost for this year? Silence.  What happened when industry and consumers complained that FDA had failed to propose new rules before the one-year anniversary of FSMA, thus violating the law?  Silence.  And what do we hear now, nearly five months after a draft of proposed rules were sent to the Office of Management and Budget (OMB) … READ MORE

The FDA has “a total of about 50 full time equivalents to regulate a very large and growing industry,” said Michael Landa, Director of the Center for Food Safety and Applied Nutrition at the FDA in a statement made during a Senate hearing on the safety of cosmetics a few weeks ago. Landa went on to state that although the cosmetics industry is moving product in the billions of dollars, FDA has little more than a dozen employees that actually work in the trenches of … READ MORE

As the FDA launches its pilot program related to tracking high-risk foods, we are once again reminded of the ongoing difficulties FDA experiences when it comes to choosing between acting quickly and acting thoughtfully.  Think back to 2011’s food safety crises involving salmonella and E. coli. On numerous occasions, FDA was last to comment, often because they didn’t want to speak out of turn and provide inaccurate information.  At other times, however, they were simply scooped by the world’s mass media who, with … READ MORE

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

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

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

Christmas.  Easter.  Halloween.  If it’s a holiday then Americans are spending.

A recent Journal of Commerce article, Imports Set to Surge, delivers growing import statistics and projects increased growth for coming months with the implication that retailers are building up stock for increased spending.  “Imports from Asia in January rose 2.9 percent year-over-year, and Moreno forecasts traffic growth will level out at 2.5 percent in 2012,” the article states.  Yet it seems that every time a gift-giving holiday comes around, importers are always behind in … READ MORE

Technology is central to the success (or even existence) of FDA’s food tracking and tracing pilot currently underway as part of FSMA’s new authority grant to the Agency.  If you have not read our first blog about the pilot conducted by FDA and IFT please read that here now.  What the statute accurately communicates but vastly underestimates is the difficulty and scale of the role of technology in the successful development of the program.   Sec. 204 2(B) of FSMA states that FDA … READ MORE

The U.S. Food and Drug Administration recently unveiled a new pilot program studying tracking and tracing technologies for high-risk foods. The pilot is contemplated in Sec. 204 of the Food Safety Modernization Act (FSMA), a legislative initiative aiming at reducing foodborne outbreaks and increasing the FDA’s ability to quickly identify and report outbreaks to the American public. In a post on the FDA’s Transparency Blog, Sherri McGarry, Senior Adviser, Coordinated Outbreak Response and Evaluation Network Office of Foods at FDA, communicated her view of the importance of this pilot; “When a foodborne outbreak occurs, it is up to … READ MORE

In a recently updated Q/A section on the FDA’s FSMA web page, FDA attempts to clarify the impact of FSMA upon “High-Risk” food facilities.  Essentially, FDA plans to utilize a database to identify the world’s High Risk Facilities and inspect them all every 3 years. Also FDA plans to inspect the world’s Non High-Risk facilities every 5 years.  According to FDA, there are currently 22,325 domestic facilities classified as HR. That designation was arrived at by application of the following criteria:

… READ MORE

Benjamin England, Founder and CEO of FDAImports.com recently presented at the 2012 Journal of Commerce Cool Cargoes Event entitled “Planning an FDA-Proof International Container Cold Chain.”  The Cool Cargoes track is part of the JOC’s annual TPM conference (Trans-Pacific Maritime). Mr. England’s presentation answered the following core questions:

   • How will FSMA impact cold chains?

   • What is the legal impact of FSMA?

   • What new fees should I be concerned about under FSMA?

   • What is VQIP and FSVP and how will they … READ MORE

Recent statements from the CDC regarding food safety trends and statistics have been wildly reductionist and inconclusive. But they do provide us with hints about the future direction of federal government thinking with respect to managing food safety risks: Food tracking and supply chain tracing.

Enter the Digital Database Savior

“We need better – and more – information about what foods are causing outbreaks and where those foods are coming from,” said Hannah Gould, CDC epidemiologist, in a recent presentation. “Knowing more … READ MORE

Partygoers will be having much less fun this St. Patrick’s Day as the supply of green beer is drastically reduced thanks to the FDA’s crackdown on the illegal colorants used to make the beer green.  Hundreds of leprechauns were busted Monday in the largest multi-agency food-related bust in the last 30 years. The FDA and special agents from OCI, FBI and another unnamed federal agency partnered together to mount a full-scale offensive on the secretive underground … READ MORE

On February 23rd 2012 the FDA issued an Interim Final Rule (IFR) implementing enhanced food facility record inspection authority granted to the Agency by Congress in the Food Safety Modernization Act.[1]  Under the old regulations, FDA could only demand that you immediately produce distribution records (one up-one back in the distribution chain) when it had a “reasonable belief” that a specific article of food was adulterated and presented a serious risk to human or animal health. [2], … READ MORE

The Food Safety Modernization Act (FSMA) enacted January 4, 2011 set forth a variety of benchmark reporting requirements for FDA, one of which is a summary of the FDA’s foreign offices and their progress and direction for the future.  The FDA has recently submitted this report and it gives us a glimpse into the international intentions of FDA.  Being in the FDA Import Regulatory Consultant business, we think that’s kind of useful. FDA’s report discusses the agency’s vision for its field offices, a distinction between “posts” and “offices,” the tasks and activities of foreign posts, the past progress and … READ MORE

Benjamin England, Founder and CEO of FDAImports.com and ExportToUsa.com.cn, presented on Food and Drug Regulation and Importing Requirements along with Rick Quinn, Principal at the firm, to a delegation of Chinese Food and Drug officials from the Hubei Province this week at a special training event in Chantilly, VA.  The training event addressed the legal requirements for regulating and importing food and drugs into the United States with special attention given to Chinese products and the FDA Food Safety … READ MORE

The Food Safety Modernization Act
View more presentations from FDAimports.com
The recently enacted Food Safety Modernization Act is the greatest expansion of FDA’s food regulatory authority since the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act. This presentation discuses the scope, impact and implementation of the Act. Presented by FDAImports.com Founder and CEO, Benjamin England.  Make sure you visit our online home base … READ MORE

This month marks the 1-year anniversary of President Obama signing into law the Food Safety Modernization Act (FSMA). One of the key implementation dates from the Act was January 4th, 2012, by when the following significant steps were to have been taken by FDA:

• Guidance for very small business exemptions from HARPC requirements

• Updated Good Agricultural Practices guidance for fresh produce

• Guidance related to intentional adulteration of food and mitigation strategies

• “National … READ MORE

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

36 million pounds of ground turkey. 

That’s a ton of meat, 18,000 tons of meat to be precise. That’s the weight of 120 million brand-new iphones (without the box).  So if almost everyone in Japan bought an iphone-4 today and then put them all on a scale, that’s how much the recalled turkey meat would weigh.

Confused yet? Good.

An importer or manufacturer goes through this same kind of mental trauma every second of every day during a recall or … READ MORE

Can you spell “ex-am-in-ation”?

Even if you can spell it, can you define it?  If you can’t then you won’t have any surprises this fall while you’re importing food to the USA.  If you can correctly define what an “examination” is then you’d better sit down before you continue reading this.

The U.S. Food and Drug Administration (FDA) examines only 2% of the shipments entering the U.S. market under its jurisdiction, including imported foods. Starting October 1, 2011, under the Food Safety Modernization Act, FDA will beginning charging food importers a fee (based upon an hourly rate) … READ MORE

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

According to research done by www.FDAImports.com, The U.S. Food and Drug Administration (“FDA”) aggressively stepped-up the number of food-facility inspections in China last year according to the FDA Inspection Classification Database. Between fiscal year 2009 and 2010, FDA had a thirteen-fold increase in food-facility inspections in China. Last year’s dramatic increase foreshadows FDA’s greater international profile through inspecting foreign food-facility, which Congress mandated in the recently passed FDA Food Safety Modernization Act (“FSMA”).

China has played an increasingly important role in supplying food to the United States. Between 1999 and 2008, China went from the eleventh-largest supplier of … READ MORE