Registrar Corp | U.S. FDA News Updates



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In early 2014, the U.S. Food and Drug Administration (FDA) and the Center for Food Safety (CFS) came to an agreement regarding finalization deadlines for FDA’s proposed rules under the Food Safety Modernization Act (FSMA).  The deadline for two of those rules is coming up in just six months.  FDA is required to publish final versions of its proposed rules for “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” by August 30, 2015.

The proposed rules for human and animal food establish new requirements for facilities that manufacture, process, pack, or store food for human or animal consumption.  For example, food facilities will be required to write and follow a Food Safety Plan.  The facility will need to analyze potential hazards for each type of food at the facility and establish controls to prevent or significantly minimize the potential for occurrence of those hazards.

FDA’s proposed rules for human food were published in January 2013, while the proposed rules for animal food were published in October 2013.  FDA published revisions to both proposed rules in September 2014.  Once the final rules are published, food facilities will have 1 to 3 years to comply, depending on the size of the business.  Compliance dates are as follows:

  • Very small business: 3 years from publication date
  • Small business: 2 years from publication date
  • Other businesses: 1 year from publication date

Registrar Corp can help food facilities navigate and comply with FDA’s upcoming rules for human and animal food.  Registrar Corp can assist in the development or review of a Food Safety Plan, as well as review product labels for FDA compliance and more.   To learn more about FDA’s upcoming final rules under FSMA or how Registrar Corp can assist your facility, contact +1-757-224-0177.  Help is available 24 hours a day through Registrar Corp’s Live Help.

         

Outsourcing facilities must register annually with the U.S. Food and Drug Administration (FDA) and pay an annual establishment fee. FDA offers a reduced annual fee for small businesses, which the agency defines as facilities “with gross annual sales totaling $1,000,000 or less in the 12 months ending on April 1 of the FY immediately preceding the FY in which the annual establishment fee is assessed.”

An outsourcing facility that qualifies as a small business must complete and submit a Small Business Establishment Fee Reduction Request form (Form 3908) to FDA by April 30, 2015 in order to be eligible for the reduced small business fee for fiscal year (FY) 2016. The request must be submitted annually, so small businesses that requested the reduced fee in April 2014 will need to submit a request again this year.  FDA will publish its fee rates for FY 2016 no later than 60 days before the start of the FY.

FDA’s FY 2015 fee rates for outsourcing facility establishments are as follows:

  • Outsourcing facility – $16,442
  • Small business – $5,103
  • Reinspection fee – $15,308

Existing outsourcing facilities were required to complete their annual registration between October 1 and December 31, 2014, but a facility can newly register as an outsourcing facility at any time throughout the year.  Even if a facility registers outside the annual registration period, the facility must pay the full fee.  Once a facility registers, FDA will send an invoice for the annual fee and the facility will have 15 days to pay in full.

To learn more about registration, fees, and drug product reporting for outsourcing facilities, read about FDA’s three outsourcing facility guidances published in November 2014.

Registrar Corp can register a facility as an outsourcing facility and assist in submitting a request for a reduced small business fee.  For questions regarding FDA’s regulations for drug and outsourcing facilities, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day through the Live Help service: http://www.registrarcorp.com/livehelp.

         

Gluten-Free Food Market Sales Increase 63%



February 25, 2015 by David Lennarz

According to Mintel, gluten-free food market sales increased 63% from 2012 to 2014 due to increasing awareness of celiac disease and perceived benefits of gluten-free dieting.  Mintel Food Analyst Amanda Topper believes the market will continue to grow.  Gluten-free snack foods showed an increase of 163% over the two years, the largest growth percentage of all the food categories.

It may seem like a great idea to join in on this booming market, but before you label your products as “gluten-free”, make sure the product meets U.S. Food and Drug Administration (FDA) standards for gluten-free labeling.   In August 2013, FDA released a final rule that legally defined the term gluten-free and similar terms for the first time in history.  The rule became effective in August 2014. Products that claim to be gluten-free but do not meet FDA’s standards will be deemed misbranded.

Registrar Corp assists food facilities with U.S. FDA regulations.  Registrar Corp’s Regulatory Specialists can help a food facility determine whether or not its product may be labeled as gluten-free, as well as review its product labels for FDA compliance.  For questions regarding FDA regulations for food facilities, contact Registrar Corp at 1-757-224-0177 or receive Live Help from a Regulatory Advisor 24-hours a day at http://www.registrarcorp.com/LiveHelp.

         

Number of FDA Registered Food Facilities Drops 14%



February 23, 2015 by Maria Utecht

There were 195,518 food facilities registered with the U.S. Food and Drug Administration (FDA) as of January 22, 2014.  As of January 12, 2015, the number of registered facilities had dropped to 166,753.   This reflects a 14% decrease from the number of FDA registered food facilities in January 2014.

The ten countries with the most FDA registered food facilities remain the same as in 2014, but France and Italy moved above China in 2015.  A complete breakdown of the number of registered facilities by country can be found on Registrar Corp’s site.

FDA Food Facility Registration Statistics

Registrar Corp Vice President David Lennarz believes that the significant drop was due to facilities failing to renew their registrations by the deadline.  “Under the Food Safety Modernization Act (FSMA), food facilities were required to renew their registrations between October 1 and December 31, 2014,” Lennarz said. “We know that in early January 2015, FDA purged its registration system of non-renewed registrations.  It’s probable that the drop was actually greater than 14%. Our previous data was from February 2014, but by December 2014 the number or facilities could have increased due to new registrations.”

It is not possible to reactivate a cancelled registration.  Any food facility that was removed from FDA’s registration database will need to re-register and obtain a new registration number. Registrar Corp advises any facility that was removed to refrain from sending any shipments to the US until it obtains a new registration number, as distributing food in the United States without a valid FDA registration is a prohibited act.  Prior Notice submissions will not be accepted without a valid registration number and shipments sent to the US without Prior Notice and a valid registration are subject to detention.

Registrar Corp can quickly and properly re-register a facility to help get its shipments back on track.  When a foreign facility re-registers with FDA, it will need to designate a U.S. Agent for FDA communications.  As a facility’s U.S. Agent, Registrar Corp will re-register the facility with FDA, file three complimentary Prior Notices on the facility’s behalf, and assist the facility in the instance of an inspection or detention.  To learn more about Registrar Corp’s registration and U.S. Agent services, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/LiveHelp.

         

On Monday, February 16, 2015, the U.S. Food and Drug Administration (FDA) purged approximately 2,628 medical device establishments that did not complete their annual registrations by the deadline from its registration database.  Owners and operators of companies that produce and distribute medical devices for use in the United States are required to register with FDA and review their listing information between October 1 and December 31 each year.  On December 30, 2014, before the fiscal year 2015 registration deadline, there were approximately 24,123 device establishments in FDA’s database.  On February 18, 2015, the number had been reduced to approximately 21,495.

FDA, medical devices

Failure to register a device establishment with FDA is a prohibited act under the Food, Drug, and Cosmetic Act (FD&C Act).  Devices shipped to the U.S. by an unregistered establishment may be denied entry.  FDA may hold the devices at the port of entry until the establishment is properly registered.

Medical device establishments that did not register with FDA between October 1 and December 31, 2014, should refrain from distributing devices in the U.S. until the establishment is registered with FDA and its devices are listed.  Registrar Corp, a U.S. FDA compliance firm, can properly register an establishment and list its devices.  For assistance with registration or other FDA requirements for medical devices, contact Registrar Corp at +1-757-224-0177, or receive help from a Regulatory Advisor 24-hours a day at http://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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