The National Association for the Specialty Food Trade (NASFT) will host its 37th annual Winter Fancy Food Show this weekend (January 15th-17th). NASFT is an international organization composed of domestic and foreign manufacturers, importers, distributors, brokers, retailers, restaurateurs, caterers and others in the specialty foods business. Their annual Winter Fancy Food Show attracts more than 17,000 attendees. Each year, there are over 80,000 products featured. Specialty food products range from confections, cheese, coffee, snacks, spices, ethnic, natural, organic foods and beverages and more. Exhibitors come from just over 35 countries around the world. Many of these products are newly developed, and frequently these companies will have questions about U.S. FDA Labeling or Regulations. Registrar Corp attends trade shows, like the Winter Fancy Food Show, to meet companies in need of U.S. FDA Regulation answers. We are always happy to help. If you would like more information about FDA’s requirements food manufacturers, Registrar Corp’s team of regulatory advisors is available 24/7 via Live Help or call Registrar Corp’s U.S. Office at: +1-757-224-0177.
Learn more information about the Winter Fancy Food Show or about NASFT by clicking these links.
In December 2011, a new bill was introduced in the U.S. Senate that would require medical device manufacturers to monitor the performance of implant products, even after the medical devices are cleared for marketing by the FDA.
This new bill addresses the complaints from many patient advocate groups of the FDA’s 510(k) process, which they feel is the cause of thousands of failing all-metal hips. The 510(k) process used by the U.S. FDA allows a manufacturer to sell a new medical device by only showing that it is “substantially similar” to a product already on the market. This process is commonly used for the sale of certain implants, like artificial joints.
Though this new bill will not require any additional mandated FDA premarket testing, it would give FDA additional authority to force device makers to track and report the performance of such implants. The proposed bill would also tighten federal scrutiny of product recalls.
The goal of the bill is to better patient safety – – without slowing the process for device approval. The three senators that introduced the bill feel it is necessary for consumers of these medical devices. They are: Herb Kohl (D) of Wisconsin, Richard Blumenthal (D) of Connecticut, and Charles E. Grassley (R) of Iowa. They also sent letters to five major manufacturers of medical devices asking how they keep track of product safety and recall devices.
For more information on the proposed FDA bill, click here. As the bill goes through the legislative process, Registrar Corp’s team of experts will keep you up-to-date. If you have any U.S. FDA questions, feel free to contact us at +1-757-224-0177 or for immediate assistance go to www.registrarcorp.com/livehelp.
The FDA and the EMA have announced a plan to work together on GMP inspections and information-sharing projects. EMA is responsible for requesting European Economic Area (EEA) inspections in the U.S. and will take the lead on the European Union (EU) side. With the globalization of the manufacture of drugs, authorities from FDA and EMA have experienced an increasing demand for their limited resources. This is because many FDA inspections occur in the EEA, and many EEA authority inspections occur in the U.S. In addition, there is a new trend for drugs manufacturing to be located outside of the U.S and E.U. Both the FDA and the EMA feel that the sharing of resources is extremely important and useful.
This news is good for manufacturers as well. It means that their resources will also be spared from having to go through both FDA and EEA GMP inspections.
The FDA and the EMA plan to execute this new proposed initiative in January of this year. The strategy will take into account a number of considerations before deferring or waiving a GMP inspection on each other’s regions. Specifically, it will affect GMP inspections concerning manufacturing sites in the U.S. and the E.U. involving drugs for both human and veterinary use. The strategy targets sites that have in the past been known to the FDA and the EEA authorities to be GMP compliant. Though pre-approval inspections will stay mostly the same, post-authorization/surveillance inspections will be impacted by this new plan. Both the FDA and the EMA plan to review the strategy after a 3 year period.
For more information on the relationship between the FDA and the EMA and its effect on GMP inspections, click here.
The U.S. FDA will submit a proposal to the White House to research consumer attitudes toward proposed changes to the nutrition facts label. This is part of an effort to increase readership and usability of the label and will amend the requirements currently prescribed to the food industry.
Such changes may include removal of the statements “Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.”; removal of the table in the footer which lists the Daily Values for total fat, saturated fat, cholesterol, sodium, total carbohydrate and dietary fiber; and changes to the amount of information provided and the format in which it will be displayed.
As the Winter Fancy Food Show is fast approaching (January 15-17, 2012), many foreign exhibitors are preparing to ship via DHL, UPS, or FedEx for their last minute smaller samples that don’t warrant a space on a cargo ship. So the question is, Will all go well for those Biscotti cookies from Italy? Or that great tasting Pino Noir from France? The answer could be yes and should be yes; as long as the exporters remember to follow a few compliance guidelines that, although are very simple, are often overlooked.
Exporters should remember even though they are exhibitors and may not have any other business in the U.S., they are still obligated to have a FDA Food Facility Registration as required under the Bioterrorism Preparedness and Response Act of 2002. Additionally, their FDA Food Facility Registration also requires that they list a designated U.S. Agent for FDA communications. It is a common error that even if a shipper does remember to obtain a Food Facility Registration, he often fails to put the proper address; using the forwarder or shipper’s address instead of the correct Foreign Food Facility address. For a quick way to register a food facility and have a designated U.S. Agent for FDA communications, visit www.registrarcorp.com
Exporters are also obligated to file a Prior Notice before shipping their food or beverages. Advance notice of these shipments allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect that nation’s food supply against terrorist acts and other public health emergencies. For more information on how to file a Prior Notice go to www.priornotice.com
The Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) require food product labels on almost all packaged foods to include information like nutritional values, ingredients, and calorie counts in readable type. Labeling violations result in more than 22% of all food detentions in the United States. For more information on how to file a Prior Notice go to www.registrarcorp.com
Exporters frequently use express carriers (DHL, UPS, FedEx, etc), thinking they can avoid complying with many of the FDA food safety regulations. But, in the year 2011, the U.S. Food and Drug Administration began its detailed implementation work for the Food Safety Modernization Act (“FSMA”). Food safety advocates in Congress are now going after the additional funding FDA needs to fulfill the various FSMA mandates.
Another FDA regulation that exhibitors at tradeshows often overlook is the low-acid canned food requirements. The Food and Drug Administration requires a registration for the manufacturing site and submission of process filings (submission identifiers, or an “SID” for each product, each size) for low-acid and acidified canned foods. For more information on how to file an FCE/ SID go to www.fce-sid.com
Follow the above-mentioned compliance tips when you are shipping your food and beverages to the 2012 Winter Fancy Food Show this year and your products should arrive without delay.
For U.S. FDA Regulatory Assistance, contact Registrar Corp at www.registrarcorp.com/livehelp or phone us at +1-757-224-0177.
The U.S. Food and Drug Administration (FDA), along with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH), has developed the Food Safety Preventive Controls Agency (FSPCA). The FSPCA will create training courses and materials on preventing contamination for both human and animal food during production. This is in response to the propose rules (set to be issued by the U.S. FDA in early 2012) that will require facilities that make or handle food for people and animals in the United States to put measures in place to help prevent food-borne illnesses. To learn more about the FSPCA, read the full article from the U.S. FDA website.
An import “detention” occurs when FDA (or U.S. Customs and Border Patrol, acting for the FDA), in examining an FDA-regulated product offered for import, halts the entry for further examination. Further examination often requires laboratory analysis or scientific and technical data concerning the product. Import detentions are costly even where the product ultimately is released by FDA and allowed entry to the United States. The process delays shipments, complicates logistics and often adds storage costs. In addition, the Food Safety Modernization Act (FSMA), passed in 2011, authorizes FDA to charge importers and exporters for FDA’s costs in connection with some detentions.
Import “detentions” end in one of two ways. Either the product is released and allowed entry to the United States, or it is refused entry. An import “refusal” occurs when FDA determines that the product will not be allowed entry to the United States. At that point, the product must be shipped elsewhere or destroyed.
Obviously, importers and exporters should endeavor to avoid detentions, if possible. However, many detentions are unavoidable. If an imported product is detained, importers and exporters should take appropriate action so that FDA does not refuse entry.
For companies faced with a detention, it is critical to act properly. We recommend the following immediate actions:
1) First, gather the facts about the detention. Do not argue with FDA or the inspector who detained your product. Do not respond to the detention charges until you have gathered all of the facts about the detention and are aware of the FDA’s concerns. Be aware that it may be impossible for you to objectively view the situation from the position of the FDA inspector who detained your product and that you may not know all the nuances of a particular FDA regulatory requirement. Failure to appreciate the nuances of FDA detentions could cause you to inadvertently make matters worse. If the shipment has more than nominal value, it is worthwhile to retain a professional consultant familiar with the FDA and its procedures (like Registrar Corp) to assist with your detention, rather than attempt to resolve the issue without such assistance. Note to non-U.S. exporters: If you have retained Registrar Corp as your facility’s U.S. Agent for FDA communications, assistance with detentions may be provided at no additional cost (depending on the reason for the detention); simply contact your Registrar Corp Regulatory Adviser as soon as you learn the shipment is detained. Please contact Registrar Corp before you speak with FDA about the detention.
2) Upon detaining a shipment, FDA will issue a written document called the “Notice of Action” to the importer of record and to the customs broker who filed the entry. The Notice of Action will present the formal reasons why the products have been detained and will identify which section of the law FDA charges may have been violated. These are the detention charges to which you must respond — with documentary proof, not bombast. As shown by the statistics released by FDA (see December 8th blog), FDA may release detained products upon receipt of sufficient proof rebutting the charge stated by the Notice of Action. The Notice of Action will set a deadline for your response, called the “Respond By” date. That deadline should be taken seriously. If it passes without extension, it will be too late to avoid refusal even for admissible goods!
3) Contact Registrar Corp for immediate assistance, even if Registrar Corp is not designated as U.S. Agent for your facility. Simply phone: +1-757-224-0177 or contact via Live Help: http://www.registrarcorp.com/livehelp
There is a growing concern in the Dietary Supplement industry that the new re-inspection fees mandated under the Food Safety Modernization Act (“FSMA”) could be a hardship on an already aggressively regulated industry. In 2007, the FDA issued current Good Manufacturing Practices (cGMPs) for dietary supplements, a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. The FDA enforces these requirements by performing cGMP inspections at facility sites. Since their inception, the number of cGMP inspections have increased each year. So far, 2011 has nearly 20 times more inspections than what was performed in 2008, according to FDA data and an article on Nutra Ingredients-USA.com.
If FDA conducts a cGMP inspection and records its observations on Form 483 as “Official Action Indicated”, or “OAI”, it could begin assessing the FSMA re-inspection fees almost immediately when it returns to determine whether its observations have been properly addressed. These fees would more than likely drive costs up for the manufacturer, and in turn for the consumer of dietary supplements as well.
The warning letters continue as the FDA vows to maintain cGMP vigilance with inspections (see article from Nutra Ingredients-USA.com). It is clear that the dietary supplement industry will need to have stricter procedures in place to ensure they have thoroughly covered everything under FDA’s cGMP requirements. Otherwise, re-inspection fees, as well as other penalties, could arise from non-compliance.
For U.S. FDA Regulatory Assistance, contact Registrar Corp at www.registrarcorp.com/livehelp or phone us at +1-757-224-0177.
Earlier this year, the United States Food and Drug Administration (FDA) announced new fees for failure to comply with a recall order, importer re-inspections and some facility re-inspections. The U.S. FDA Food Safety Modernization Act (FSMA) amends the Federal Food, Drug and Cosmetic Act (FD&C Act) and mandates that the U.S. FDA contemplate the burden of these fees on small businesses. The fees are imposed as a means to capture the costs incurred by the U.S. FDA performing these activities each year. Effective October 1, 2011, these fees could result in large costs for companies exporting to the United States. These fees are especially concerning to small companies which might not have the means to pay.
What can be done to reduce the burden on businesses facing economic hardship?
Realizing the potential effect on businesses, the U.S. FDA requested permission to use emergency clearance procedures to obtain Office of Management and Budget (OMB) approval of the information collection related to the Economic Hardship Fee Reduction Guidance. If the U.S. FDA were to use the normal clearance procedures instead of emergency clearance procedures, the approval of the information collection would not be finalized in time to issue invoices for fees, as FDA intends, in January 2012. With its emergency request, the FDA is attempting to speed up the processing of the economic hardship fee reduction guidance.
When will the Guidance document be published for the Economic Hardship Fee Reduction?
The U.S. FDA is requesting OMB approval of this emergency processing by January 6, 2012. The Economic Hardship Fee Reduction Guidance will provide information to firms who may wish to apply for a reduction in fees that have been invoiced in FY 2012.
Is the Economic Hardship Fee Reduction Guidance the same as the Small Business Guidelines?
No. During fiscal year 2012, U.S. FDA will consider waiving some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors. Independently, FSMA provides that U.S. FDA shall develop a proposed set of guidelines in consideration of the burden of fee amounts on small businesses. Currently, the Agency is reviewing the public comments received in response to the August 1, 2011, Federal Register notice seeking information to be used in developing these proposed guidelines, which U.S. FDA intends to publish for comment in fiscal year 2012.
For questions related to U.S. FDA fees or any U.S. FDA regulation, you can contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.
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