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FDA Publishes Worldwide Import Alert for GMO Salmon



February 10, 2016 by David Lennarz

On January 29, 2016, the U.S. Food and Drug Administration (FDA) published a new import alert preventing all genetically modified (GMO) salmon from entering the United States.  The alert was prompted by the FY 2016 Omnibus Appropriations Act, which directs FDA not to allow food containing GMO salmon into interstate commerce until the agency publishes final labeling guidelines.  Currently only draft guidance on voluntary labeling is available.

Products on import alert are subject to detention without physical examination (DWPE) upon arrival to the United States.  In other words, all shipments of GMO salmon exported to the US will be detained by FDA. Usually facilities can petition FDA for exemption from an import alert by proving their shipments are continuously non-violative.  It’s likely, however, that FDA will not allow exemptions from this new alert because there is no regulation with which to prove compliance. While most import alerts offer instruction for requests for removal, the GMO salmon alert states “Under no conditions should the entry be released without concurrence from both DIO and CFSAN OC/DE for human food or DIO and CVM/OSC/DC/ for animal food.”

The Omnibus Appropriations Act encompasses GMO salmon manufactured in the US as well. Just two months ago, FDA approved AquAdvantage’s GMO salmon for distribution in the United States.  After scientific review, the agency determined the GMO salmon was equally as safe and nutritious as non-GMO salmon.  Despite the recent approval, the act will prevent the salmon from going to market.

It’s important to be aware of whether a product is on an FDA import alert before exporting or importing it into the United States. Products and facilities are added and removed from import alerts on a daily basis.  The Registrar Corp FDA Compliance Monitor allows users to monitor food facilities’ FDA compliance statuses, including whether they are subject to an FDA import alert.  For facilities that are subject to an import alert, Registrar Corp can help petition FDA for removal or exemption.

For more information about FDA import alerts, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

On February 4, 2016, the U.S. Food and Drug Administration (FDA) hosted a webinar regarding upcoming electronic filing requirements for Drug Master Files (DMFs).  FDA will require DMFs, as well as other pharmaceutical applications, to be filed in electronic common technical document (eCTD) format beginning May 5, 2017. Any paper submissions filed on or after this date will be subject to rejection. There will be no waivers or exemptions for submitting DMFs in eCTD.

FDA’s Electronic Submission Gateway

Any DMF submission 10gb or smaller must be submitted using FDA’s Electronic Submission Gateway (ESG).  During the webinar, FDA advised users to set up an ESG account now, as the process can take several weeks.  Each person in an organization that will use the ESG must obtain their own digital certificate.

Electronic submissions must be made in the version of eCTD currently supported by FDA, which is identified in FDA’s Data Standards Catalog.  Users resubmitting an existing paper DMF in eCTD format may keep their existing DMF number. Electronic DMF numbers must be six digits.  If a user’s DMF number contains less than six digits, zeroes should be added to the left.  For example, if the existing number is 1234, the number would be changed to 001234. Users submitting a new DMF must obtain a pre-assigned application number from CDER before making their first electronic submission.

DMFs Filed Before the Compliance Date

DMFs submitted in paper format before May 5, 2017 are not required to be resubmitted in eCTD format.  However, any amendments or updates to the paper DMF will still have to be submitted electronically. DMF holders may choose to convert their paper DMFs to eCTD in order to expedite FDA’s NDA/ANDA review process. If the DMF remains in paper format, FDA NDA/ANDA reviewers will request a paper copy of the DMF for any information needed that is not in electronic format, thus delaying the review. DMF holders that choose to convert their paper DMFs to eCTD format must first convert their DMF to CTD format.

Obtaining an ESG account and navigating FDA’s strict structural requirements for eCTD submissions can be a long and complicated process. Registrar Corp converts DMFs to eCTD and submits DMFs through FDA’s Electronic Submission Gateway at no cost for DMF Agent clients. We also act as the required point of contact for all technical issues associated with electronic DMF submissions. To learn more, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

Roos Foods, Inc., a cheese manufacturer based in Delaware, USA, pled guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) by introducing adulterated food into interstate commerce. The company has also entered into a consent decree of permanent injunction. Under the decree, Roos Foods and two of its co-owners cannot produce or distribute food in the United States until they receive confirmation from the U.S. Food and Drug Administration (FDA) that their operations comply with the FD&C Act and any applicable food safety regulations.

What sparked the criminal and civil actions against Roos Foods?

Investigations by FDA and the Centers for Disease Control and Prevention (CDC) in February 2014 identified Roos Foods’ soft cheeses as the likely source of a 2013 Listeria monocytogenes outbreak.  FDA inspected the facility and observed numerous serious violations, including:

  • Water leaking from the roof into various areas of the facility, including onto cheese processing equipment and storage tanks.
  • Leftover food residues after cleaning and sanitation operations had been performed.
  • The facility’s processing and storage equipment had uncleanable surfaces, creating a prime harborage area for Listeria.

These are only a few of the violations observed by FDA.  The agency suspended Roos Foods’ food facility registration in March 2014.  FDA has authority to suspend a registration when there is reasonable probability that a food will cause serious adverse health consequences or death to humans.

“The FDA will not tolerate food companies that fail to provide adequate safeguards and place the public health at risk by producing and shipping contaminated products,” said Howard Sklamberg, FDA Deputy Commissioner for Global Regulatory Operations and Policy.

Criminal and civil actions can be detrimental to both a food facility’s profits and reputation. Registrar Corp offers various food safety services to help facilities ensure they are abiding by FDA’s Current Good Manufacturing Practices (CGMPs).  Registrar Corp Food Safety Specialists can develop or review a facility’s HACCP or Food Safety plan as well as conduct a mock FDA inspection of a facility to identify any CGMP violations.

For more information about FDA food safety regulations or Registrar Corp’s services, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

         

FDA compliance monitorThe U.S. Food and Drug Administration (FDA) recently finalized two new rules that require food facilities and importers of food and beverages to monitor and document the compliance status of each supplier, “including FDA warning letters or import alerts relating to the safety of food and other FDA compliance actions.”  The two new rules, the Preventive Controls and the Foreign Supplier Verification Program (FSVP) rules, are part of FDA’s implementation of the Food Safety Modernization Act (FSMA).  Importers who wish to participate in FDA’s Voluntary Qualified Importer Program (VQIP) must also monitor their suppliers, as VQIP importers may not import any food subject to an FDA Import Alert or Class I Recall.

To assist the food industry to comply with this new requirement, FDA consulting firm Registrar Corp created the FDA Compliance Monitor.  Users simply submit the facility they would like to monitor and the FDA Compliance Monitor will reveal any FDA Import Alerts, Warning Letters, Import Refusals, or Inspection Classifications related to the facility. Printable reports allow users to document the compliance of their monitored facilities per FDA’s requirements.

Monitoring suppliers can be a time consuming process.  In order to monitor supplier compliance using FDA’s databases, a user would need to search each individual database for each supplier every time he wanted to purchase from them.  The FDA Compliance Monitor makes monitoring quick and easy by aggregating and organizing supplier data into one simple compliance dashboard.  Data within the monitor is consistently updated, and users are e-mailed anytime a change occurs in the compliance status of a company they are monitoring.

New users can sign up for a free 60-day trial today. Free trial users can monitor an unlimited number of companies for FDA compliance. No credit card information is required.  For those who wish to continue monitoring after the trial, it’s only $1.99 a month per monitored facility.

For questions about FDA’s new FSMA rules or the FDA Compliance Monitor, contact +1-757-224-0177, e-mail monitor@registrarcorp.com, or live help is available 24-hours a day at www.registrarcorp.com/livehelp.

         

Detained Stamp

Under the direction of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized nearly 90,000 bottles of RelaKzpro, a dietary supplement containing kratom, from a manufacturer in Illinois.  Kratom is a botanical substance that FDA has identified as a potential risk for public health and substance abuse.  The agency issued an Import Alert for the substance in February 2014. FDA administratively detained the RelaKzpro supplements early in 2016, and the products were seized shortly after.

“The FDA will continue to exercise our full authority under law to take action on these new dietary ingredients, especially if they ignore the notification requirements, as part of our commitment to protecting the health of the American people,” said Melinda Plaisier, FDA Associate Commissioner for Regulatory Affairs.

FDA was granted administrative detention authority in 2002 by a provision of the Bioterrorism Act.  The provision allowed FDA to detain any food, beverage, or supplements found during an inspection, examination, or investigation that was likely to pose a threat of serious adverse health consequences or death to humans or animals.  In 2011, the Food Safety Modernization Act (FSMA) expanded FDA’s administrative detention authority to allow FDA to detain any food, beverage, or supplement believed to be adulterated or misbranded.

Food products may not be moved while under an FDA detention order.  FDA may detain a product for up to 20 days (up to 30 if additional time is required to institute a seizure or injunction action) while the agency determines and executes regulatory action.

It’s prudent to ensure your products are FDA compliant before distributing them in the USA in order to avoid costly detentions.  Registrar Corp’s Regulatory Specialists can review food, beverage, and supplement labeling and ingredients for FDA compliance.  Clients receive a detailed report (typically 40 to 50 pages) explaining how FDA labeling and ingredient regulations apply to the particular product, along with a print ready graphic file that incorporates our suggested changes.

For questions about or assistance with FDA detentions or labeling regulations, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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