The United States Food and Drug Administration (FDA) has released import detention and refusal statistics pertaining to fiscal year 2011 (October 1, 2010-September 30, 2011). These statistics may be enlightening for importers and exporters of FDA-regulated products.
This data shows that Drugs, Biologics and Tobacco Products have the highest number of exams per line entry when entering the United States. It is not surprising, therefore, that Drugs and Biologics are also the most likely to be detained by FDA. What is surprising, however, is that Tobacco Products are disproportionately more likely to be released after examination.
Additionally, although Medical Devices have the second lowest examination rate among all FDA categories, Medical Devices have the second highest detention rate. Products within the Medical Device category are also the most likely to be refused entrance into the United States. This past fiscal year alone, FDA refused admission to 62,498 medical device line entries (more than 80% of all FDA refusals).
Important conclusions may be drawn from the recently released data:
The data could be interpreted as a stark warning for the medical device industry. Products regulated as medical devices are at a greater risk for refusal of entry with nearly half of medical devices detained for further examination being ultimately refused entry. The message is clear and the lesson is in the details: before shipping to the U.S. exporters and importers of medical devices must be certain that they have met all FDA requirements and their products are 100% compliant, including registration, listing and labeling!
Exporters and importers of other FDA-regulated products, also, should note important warnings from the data. Drugs, biologics and tobacco products are likeliest to be examined on entry, and drugs and biologics also are most likely to be detained by FDA for further examination. Exporters of these products should be aware of the heightened risks of their products being examined.
The food industry should not breathe easy either, despite the statistics. The Food Safety Modernization Act mandates increased inspections of imported foods and provides FDA with additional resources for such inspections. In the case of food and dietary supplements, the past may not be prologue.
FDA does not examine every product imported to the United States; the agency simply does not have the resources to physically review all imported foods, dietary supplements, drugs, medical devices, cosmetics, biologics, electronics, and tobacco products. Instead, FDA examines a portion of those products, some at random, and some based on the level of perceived risk.
For companies faced with a detention, it is critical to act quickly:
1) Get a copy of the Notice of Action (NOA) as soon as possible. These are written notices provided by FDA that indicate the exact nature and quantity of the detention, time frame requirements and FDA contact information. Notices of Action are provided by FDA to the importer’s customs broker and to the importer of record only, so you may need to inquire if the importer has received the Notice of Action.
2) Contact Registrar Corp for immediate assistance. Simply phone: +1-757-224-0177 or contact via Live Help: http://www.registrarcorp.com/livehelp
A compromise bill was recently passed giving U.S. FDA an additional $50 million in funding for 2012. While FDA sought significantly more funding, the results were better than expected in the current budgetary environment. With the growing responsibilities mandated by the Food Safety Modernization Act (“FSMA”), signed in to law January 4, 2011, the additional funds will go far in helping the FDA increase the frequency of inspections and support other FSMA-related activities.
Registrar Corp will continue to keep you updated on the implementation of FSMA. For more information on how the Food Safety Modernization Act may affect you, Registrar Corp is available by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive regulatory updates, visit: http://www.registrarcorp.com/fda-updates
Recently the FDA has issued warning letters to companies, stating that their products are considered unapproved new drugs. The FDA came to this decision based on the testimonials found on the companies’ Facebook and Twitter accounts. The statements found on these pages referred to claims that are not suitable to use for dietary supplements.
Most companies have been given fifteen days to correct their violations or face further regulatory action. View one of the FDA warning letters here. For questions regarding dietary supplement claims, Registrar Corp is available for discussion by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates
Last month, the FDA issued their first ever import alert based on a foreign firms refusal to permit an FDA inspection. This comes as a result of the Inspection, Compliance, and Response component of the new Food Safety Modernization Act, which increases the number of foreign inspections to be performed by the agency.
Enhanced partnerships with local governments, international capacity building, close food-borne illness surveillance, among other factors will allow FDA to better target industries and companies for their foreign inspection program.
For questions regarding this import alert or FDA inspections, Registrar Corp is available for discussion by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates
The U.S. Customs and Border Protection (CBP) has recently proposed to increase the informal entry limit from $2,000 to $2,500. According to CBP, the limit increase will reduce administrative burden for importers and others by expanding the informal entry procedures. In addition, this measure is expected to save the trade industry approximately $11 million in processing fees annually for merchandise.
However, please note that all food and beverage products entering the United States not only have to conform with CBP requirements, but U.S. Food and Drug Administration requirements as well. If you would like assistance with FDA compliance, Registrar Corp is available for discussion by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates
On October 7, 2011, the FDA opened docket FDA-2011-D-0721 for the Guidance for Industry on Implementation of Fee Provisions of the FDA Food Safety Modernization Act. This means that comments related to facility reinspection and recall order fees that began October 1, 2011 can be submitted to the FDA either electronically or via the mail.
Despite the comment period, the FDA has still noted that any facility reinspection where the first inspection occurred on or after October 1, 2011 can expect to receive an invoice for the inspection fees. Similarly, a recall order issued on or after October 1, 2011 can expect to receive an invoice as well. During an initial inspection, the FDA has noted that they will provide an information sheet outlining the fees for reinspection and describing instances where a facility reinspection fee can be collected. The facility being inspected will be informed during the initial inspection that they could pay a fee for reinspection if their violations are “materially related to a food safety requirement of the FD&C Act.” The FDA is not expected to send out invoices until after January 1, 2012.
For now, the FDA has postponed the Importer Reinspection User Fee. The FDA has noted that they will evaluate these fees and notify the public prior to assessing them. Registrar Corp will continue to post new developments as they are issued. If you have further questions regarding an upcoming inspection, Registrar Corp is available for discussion by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates
The Food Safety Modernization Act (FSMA), signed into law January 4, 2011, created sweeping reforms for the FDA. One of the major reforms involves the user fees to help cover FDA costs. According to the new law, the FDA is authorized to collect user fees to cover 100 percent of their costs for reinspections of domestic and foreign facilities; and food and feed recall activities beginning fiscal year (FY) 2012 and for each year afterwards. The FDA has released an assessment of these fees on September 30, 2011 and are outlined below.
Beginning FY 2012, the FDA will begin to charge reinspection fees. Reinspection, according to the FDA, is defined as one or more inspections conducted by FDA where non-compliance related to food safety has been found where they will determine if the compliance issue has been resolved. If a primary inspection resulted in compliance issues, the FDA will issue an Official Action Indicated (OAI) and will be verified upon reinspection that the issues from the OAI are resolved. The fees for reinspection are $224 per hour for US facilities and $325 per hour on foreign facilities. The fees will be based on direct hours spent on reinspection such as physical surveillance, compliance reinspection, preparation and arrangement for reinspection, travel to and from the facility, preparation of reports, analyzing samples, inspection of labels, and any other action required as specified by OAI the document.
The FDA has also noted that they will assess a fee for non-compliance with a recall order. Non-compliance can include not initiating a recall as ordered by the FDA, not conducting a recall in a manner specified by the FDA, or not providing the requested information regarding the recall to the FDA. The fee will be paid by the party responsible of the domestic facility or the importer that does not comply with a recall order. In all, the party that receives the FDA recall order will be responsible for paying the fees. The fees will be based on the number of direct hours spent taking action. This may include conducting audit checks, reviewing periodic status reports, analyzing those reports and audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition. The fee rate will be the same as reinspection fees, $224 per hour for domestic facilities and $325 per hour for foreign facilities.
Registrar Corp will continue to post new developments as they are issued. If you have further questions regarding an upcoming inspection, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates
On September 19, 2011 the FDA issued a revised guidance on marketing unapproved drugs. Previously under CPG 440.100, unapproved new drugs that were on the market illegally for any number of reasons were removed from the market in an orderly approach.
The revised CPG 440.100 now clarifies that any unapproved drugs entering the market after September 19, 2011 will be “subject to immediate enforcement action, without prior notice and without regard to the enforcement priorities set out in CPG 440.100.” Drugs that are on the market as of September 19, 2011 will continue to have the regulation of the 2006 CPG 440.100 applied which will give a higher priority to high-risk categories.
FDA Revised Guidance If you have further questions about listing your drug product, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates
On September 6, 2011 the Food and Drug Administration issued a letter with recommendations to help expedite the entry review process for medical and non-medical radiation-emitting electronic products. In this letter the FDA has noted that Affirmation of Compliance (AofC) codes should be provided at the time of entry to the U.S. and that appropriately submitted AofC codes will not only expedite the admissibility process but will also increase the likelihood that your shipment is not held for further entry review by FDA personnel.
In this letter the FDA has asserted that importers of these products work very closely with their brokers, filers, and other import personnel to verify that the information submitted is accurate and that the correct product codes are entered. The FDA has warned that “inaccurate or inconsistent data may lead to delays”. Furthermore, the AofC codes should be submitted with the relevant qualifier to the FDA and U.S. Customs and Border Protection.
Additionally, CBP regulations compel importers to note whether or not their products comply with federal performance standards. The FDA works with CBP by providing Form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, which must be filled out by the importer. Moreover, radiation-emitting devices are also subject to regulation by the Center for Devices and Radiological Health (CDRH) and are subject to federal performance standards. However, there are medical radiation-emitting electronic products that have reporting requirements under 21 CFR 1002 but are not subject to federal performance standards, in which case, Form FDA-2877 is not required.
On the whole, importers, brokers, filers, and other import personnel should take extra care to ensure correct AofC codes that are applicable to medical devices and radiation-emitting electronic products. If you have further questions about importing your medical and non-medical radiation-emitting electronic product, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates
The Food Safety Modernization Act (FSMA) was signed in to law January 4, 2011 and scheduled to be implemented over the next few years. In this law the FDA was mandated to create at least two pilot projects involving produce and processed foods. The FDA was also tasked with establishing record-keeping requirements to aid in the tracing of high-risk foods. On September 7, 2011, the FDA issued a press release stating it’s intent to implement the mandated pilot projects and their purposes.
The FDA will work with the Institute of Food Technologists (IFT), a non-profit scientific society, to establish these pilot programs under an existing contract with the FDA. The programs are expected to evaluate different methods and technologies for the most rapid and effect tracing of foods. It will also evaluate what types of data are most important, ways to connect various points in the supply chain and methods to ensure that the data is made more readily available to the FDA.
Throughout the pilot programs, key stakeholders will be able to provide input and the FDA has acknowledged that it will make efforts to also include those representing the food supply chain, such as farms, restaurants and grocery stores. Michael R. Taylor, FDA Deputy Commissioner for foods, stated that they will also consider what is most practical for various sized facilities.
In all, the pilot projects aim to enhance the FDA and industry’s ability to trace foods responsible for foodborne illnesses. After the projects are complete, more data will be gathered and the FDA will issue, as mandated, proposed regulations on record-keeping. They are also slated to define high-risk foods by considering known and potential risks of contamination and illness. Registrar Corp will continue to post new developments and is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: http://www.registrarcorp.com/fda-updates