FDAImports.com achieved a major victory this month, making life easier for importers of pacifiers. The Automated Broker Interface utilized for making entry with U.S. Customs and Border Protection was originally set-up to force importers to notify and submit information to FDA every time they brought in pacifiers. Only one problem: FDA has jurisdiction over pacifiers–which become a medical device–only when they are intended for teething.

This ABI setup, which forced an FDA submission, often caused FDA to hold the pacifiers under the mistaken belief the pacifiers … READ MORE

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

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

FDAImports.com and ExportToUsa.com.cn Founder and CEO, Benjamin England, was recently invited to join the China International Aquatic Products Network as an official expert resource for FDA regulation and imports to the United States.  In this capacity he will assist CIAPN and its members with FDA compliance issues, specifically, seafood and aquaculture compliance. CIAPN is sponsored by the China Aquatic Processing and Marketing Association, which serves Chinese seafood manufacturers and producers.

CIAPN has also published research and articles from FDAImports.com and ExportToUsa.com.cn on a variety of FDA compliance and … 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

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

Cue the soundtrack from Jaws.

Earlier this month, the California Department of Toxic Substances Control (DTSC) issued a press release alleging that several nail polish manufacturers failed to declare the presence of potentially dangerous cosmetic ingredients, Toluene, Dibutyl Phthalate (DBP) and Formaldehyde. DTSC based its allegations on initial testing of 25 different cosmetic brands, chosen at random. The investigation also revealed that many of the brands failed to declare these ingredients even though their labeling explicitly stated they were free of these chemicals.

California authorities … READ MORE

In February 2012, news of fake Avastin in the United States hit the news wires.  Cancer patients were being administered water while under the impression that it was the actual cancer treatment drug, Avastin.  People were outraged.  Weeks later, another shipment of the counterfeit drug was discovered in the United States.  “What’s being done about this?” was the outcry from the press.  Shortly thereafter, the Senate passed the Counterfeit Drug Penalty Enhancement Act of 2011,1 a bill that had been sitting in committee … 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

FDAImports.com and Benjamin L. England & Associates have officially moved and are now in our new office space.  Please note our change of address and new phone number below. Our email, website and fax information will remain unchanged.

810 Landmark Drive
Suite 126
Glen Burnie, MD 21061

(410) 220-2800 (phone)
(443) 583-1464 (fax)

www.fdaimports.com
info@fdaimports.com

FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a single device, currently costs approximately $3,500 in (up front) user fees, and may take up to 60 days to process.  So what does one get for all that time and money?  In responding to … 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

Beijing has announced plans to ban people convicted of food safety crimes from investing in and operating related businesses for the rest of their lives.

According to the new draft amendment to Beijing Food Safety regulations, companies whose lack of food safety controls results in a crisis will be ordered to cease operation and pay fines ranging from RMB 5,000 to 100,000 ($800 – $16,000 appx). Companies who cause a severe food safety issue will also have their permits and business licenses revoked.

Multiple levels … 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

FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap between budget and its ever-increasing responsibilities. As the agency attempts to launch new procedures and regulations in coming years, a primary source of funding will be from user fees, according to the justification set forth.  It’s not that FDA is unfamiliar with user fees … READ MORE

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

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

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

The U.S. Food and Drug Administration announced last week that it will not ban BPA, the on-again off-again controversial chemical used in a variety of food packaging applications.  This announcement from FDA is the most recent in a long string of protests, promises, and petitions.  This time, FDA issued a slightly anti-climactic, “it appears safe but we still don’t know.”  When BPA issues were first raised by consumers, FDA initially claimed that they could not regulate it and essentially absolved themselves from ongoing participation in the … 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

FDAImports.com is located a mere 15 minutes from the Port of Baltimore, 30 minutes from FDA headquarters and 5 minutes from Route 95, the East Coast’s major interstate.  With this proximity it seemed only fitting that we take a moment to highlight some of the advantages of the Port of Baltimore (or “Ball’mer” as we call it here).

• In 2011 Baltimore ranked 11th in the nation for dollar value of cargo and 12th for total cargo tonnage out of 44 U.S. port districts.
• In 2011 … 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