Latest Developments New User Fees- Registration Suspension Administrative Detentions Updated Prior Notice Filings Anti-Smuggling New Dietary Supplements guidance Processed foods and produce pilots to explore how to quickly trace foods back to source of contamination-
Registration RenewalEach food facility must renew its U.S. FDA registration every two years (4th quarter of every even-numbered year). Starting October 2012Low acid and acidified food manufacturers typically must have two separate FDA registrations for each location, • (1) a Food Facility Registration (“FFR”), which all food facilities must file, regardless of whether they handle low acid and acidified foods, and • (2) a Food Canning Establishment (“FCE”) registration.Note: An Update to electronic system on 8/1/12, for new companies entering data into systemThe data in these two registrations must match precisely.
United States Agent Foreign Establishments must notify FDA of the name, business name, address, phone number, and email address of their United States agent. The US Agent must reside or maintain a place of business in the US.
United States AgentU.S. Agents have been designated since 2003, and foreign companies have not had to update that information since the initial designationSince 2003, many customs brokers and importers have allowed foreign companies to designate them as the required “U.S. Agent”
New FDA User FeesNew FDA User Fees Effective October 1, 2011FDA Hourly Rate For Reinspections and Reconditioning: $221 per hour, domestic $289 per hour for foreign travelRevision Announced August 1, 2012, effective October 1, 2012
FSMA Reinspection FeesInvoiced to the foreign facility’s designated “U.S. Agent”That could be an importer who agreed to act as the U.S. AgentThat could be YOU ----- if you have been designated as the “U.S. Agent” by a foreign food facility’s FDA registration
Reinspection“Reinspection” is one or more inspections subsequent to such an inspection which identified non-compliance materially related to a food safety requirement.
New FDA User FeesReinspection Fees Fee is based on the number of direct hours, including: time spent conducting the physical surveillance at the facility, whatever components of such an inspection are deemed necessary making preparations and arrangements for the reinspection
New FDA User FeesReinspection Fees traveling to and from the facility preparing any reports, analyzing any samples examining any labels if required performing other activities until the facility is in compliance.
New FDA User Fees“Reconditioning Fees” on Imported Food Fees must be paid by owner of food or importer, depending on circumstances Fees must be paid at the hourly rate for all expenses in connection with arranging, conducting, and evaluating the results of examinations and additional examinations of product
New FDA User Fees“Reconditioning Fees” on Imported Food. Will be charged where reconditioning is required to bring food into compliance Will be charged if product is destroyed
Fees Related to Import Alerts (DWPE) Will be charged where food is detained by an Import Alert No charge if food is detained, not subject to an Import Alert, and Shipper or Importer submits satisfactory proof that food is not adulterated.
Fees Related to Import Alerts (DWPE)Exporters applying for removal from DWPE must pay FDAs hourly charges for evaluating the application, including the cost of inspecting the foreign facility if necessary.
New FDA User FeesNot Complying with a Recall Order (1) Not initiating a recall as ordered by FDA (2) Not conducting the recall in the manner specified by FDA (3) not providing FDA with information regarding the recall as ordered by FDA. An importer who does not comply with a recall order is responsible for paying the fee The party paying the fee would be the party that received the recall order.
Other Recent Changes By FSMA Affecting CustomsBrokers, Freight Forwarders and Importers
Prior Notice Filers need to indicate whether a food product has been refused entry to another country
Registration SuspensionFDA’s power to suspend the registration of food facilities effectively closes any facility that created, caused, or is responsible for food having a reasonable probability of adverse health consequences to humans or animals.FDA may also suspend registration of facilities suspected to have prior knowledge or involvement in introducing such food into commerce in the United States.
Registration SuspensionRegistration may be held in suspension until U.S. FDA determines the cause to be rectified and that no further health consequences exist.FDA also announced its right to require “corrective action plans” from suspended facilities as proof that no further health consequences exist.
Administrative DetentionAllows FDA to proactively halt food suspected of adulteration or misbranding at the border instead of being required to wait for a proven health concern.If FDA suspects food to have been produced or processed in unsanitary conditions, the agency may administratively detain food products for up to 30 days.
Import SafetyVoluntary Qualified Importer Program(VQIP) Implementation was due June 2012 FDA must establish a user-fee funded VQIP to expedite entry into the United States of imported food from eligible, qualified importers. To be eligible to participate, an importer must offer food for importation from a facility that has a certification by an accredited third party. FDA will qualify eligible importers to participate in VQIP based on risk considerations. The new law directs FDA to issue guidance on participation in and compliance with VQIP.
Import SafetyForeign Supplier Verification Program (FSVP) Regulation was due January 2012 FSVP requires all importers to conduct risk-based foreign supplier verification activities to verify that imported food is not adulterated and that it was produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable.
Shipment Detained?Shipment arrives, FDA has options: 1. Release 2. Detain –Review – Release 3. Detain – Review – Test – Release 4. Detain – Review – Test – Refuse entryPhone call in the nightIf importer advises you of detention, ask for a copy of the “Notice of FDA Action.”
Compliance IssuesMisbranding: FDA has jurisdiction to ensure that food labeling is truthful, non-misleading, and adequate to ensure that foods are safe and effective for their intended uses.Adulteration: FDA has jurisdiction to ensure that foods are properly processed, meet their specifications and are not contaminated.
Common Reasons for DetentionFailure to label product correctly – Most of these detentions could have been avoided by pre-shipment label review.Failure to make required electronic filings – Registrations, Process Filings, Prior Notices…
Food Labeling & IngredientsA top reason product is detained: Incorrect labeling, unapproved ingredients, prohibited health claimsEasy problems to avoidCommon errors in trying to avoid problems: Copy other wrong labels Only follow part of the regulations
FDA Automatic DetentionProducts from certain countries, foreign manufacturer, a specific product, or shipper may be placed on “Automatic Detention,” also called DWPE.Reasons may include: article has been manufactured, processed, or packed under insanitary conditions article is adulterated, misbranded
Removal from FDA Automatic Detention/DWPENot easy: FDA must believe the issue(s) causing the listing have been resolved (i.e. what have you changed?);A minimum of five consecutive non-violative commercial shipments before the FDA will consider removal;Shipments should represent routine commercial entries and include certain documentation;A written petition with documentation must be submitted to FDA for their review/action
Proactive versus Reactive Numerous regulations already exist U.S. offers enormous market potential and products will only need to comply with specific regulations, not all. Best advice: stay informed. Many changes are coming over the next 4 years. Investing in compliance is much cheaper than reacting to a failed inspection or detention in the U.S. Detentions mean demurrage, laboratory testing fees, warehousing fees, cost to “recondition” product, return freight, possible FDA fees, and loss of a customer.
Compliance to U.S. FDA Regulations BEFORE first shipment to the U.S is much cheaper than a single detention. Think about the various costs of a detention: 1. Demurrage: $$$ per day 2. Laboratory testing fees: $$$ per sampling/test 3. Warehousing fees: $,$$$ ? 4. Freight cost to return the product: $,$$$ ? 5. Cost to “recondition” the product (re-label, for example): $,$$$ ? 6. Cost of loosing a client: $$$,$$$ ? 7. FDA Fees $$$?
About Registrar CorpExpertise in Food & Beverages, Medical Devices, Cosmetics, Radiation Emitting Devices, and DrugsFounded in 2003, based in Hampton, Virginia, USA with over 100 employeesAll services are fixed fee, no hourly rates25,000 total clients served from more than 150 countries“Live Help” on web site19 overseas offices.
Food & Beverage ServicesFDA Food Facility RegistrationsRegistration Renewals in 2012U.S. Agent ServiceFood Labeling ReviewsLow-Acid & Acidified Canned Food RegistrationsPrior Notice FilingsDetention AssistanceAudit Service starting October 2012
Pre-Inspection Audit ServiceCOMING SOON • As part of our U.S. Agent service, Registrar Corp will dispatch a food safety expert trained in FDA inspections to facilities to help prepare if a notice of FDA inspection after October 1, 2012 is received. • This assistance is included at no additional charge other than travel and lodging expenses.
Need Additional Assistance?US Agent and Detention Services Drug Products Establishment Registration Product Listing Label & Ingredient Reviews Drug Master Files (DMF) Medical Devices Establishment Registration Device Listings 510(k) Administrative Review Medical Device Master Files (MAF)
About Registrar Corp Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA 23666 P: +757-224-0177 F: +757-224-0179 E: firstname.lastname@example.org