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Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their U.S. Food and Drug Administration (FDA) registrations every even-numbered year between October 1 and December 31.  Facilities have just one month left to renew their registrations for 2017.

FDA recently published a draft guidance to help food facilities better understand FDA’s registration and renewal requirements.  Entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry,” the guidance aims to provide answers to frequently asked questions received from stakeholders regarding FDA registration regulations and the final rule titled “Amendments to Registration of Food Facilities” that was issued in July 2016.

The seventh edition builds upon former versions of FDA’s food facility registration guidance.  Several new questions were added regarding FDA’s renewal period since the sixth edition.  Some examples include:

Q: “Do new food facilities need to wait until October 1 of a biennial renewal year to register?”

A: No. A facility can register with FDA initially any time throughout the year.  The operator, owner or agent must register the facility before beginning to manufacture, process, pack or store food for consumption in the U.S.  If the initial registration occurs prior to October 1 of a biennial renewal period, the facility must renew their registration.  This is true even if the registration is only months, or even days, old.

Q: “Will a food facility be issued a new registration number during the registration renewal process?”

A: No, a facility will keep its original registration number as long as its registration is renewed by the deadline. In the event that a facility misses the renewal period it would be required to re-register, resulting in a new registration number.

Q: “How will FDA conduct the verification process for U.S. agents?”

A: FDA will send an email to the individual listed as a facility’s U.S. Agent.  The individual must confirm that they accept responsibility as the U.S. agent for the specified facility. The identified individual has 30 days to respond to FDA verification request. A registration is not valid until FDA receives confirmation from the U.S. Agent.  If the individual denies responsibility or if FDA receives no response within the 30 days, the agency will remove the registration from its database. FDA’s new verification step makes it more important than ever to designate a reliable U.S. Agent.  Learn about the benefits of designating Registrar Corp as your U.S. Agent here.

Q: “Is a foreign facility required to provide assurance that FDA will be permitted to inspect the facility?”

A: Yes, foreign food facilities are required to assure that FDA will be permitted to inspect their facility in ways outlined by the Food, Drug, & Cosmetic Act (FD&C Act.) Registrar Corp can provide a mock inspection service to ensure that foreign food facilities meet all FDA inspection requirements.

Q: “If a foreign facility has not renewed its registration by December 31 of a biennial renewal period, will the facility still be able to import food into the United States?”

A: If a food facility does not renew its registration by December 31, its registration will be deemed expired and FDA will cancel the registration. Food exported to the US by a foreign facility with a canceled registration is subject to being held at the port of entry. 

Q: “If I am the owner, operator, or agent in charge of a facility, may I authorize another individual to update the facility’s registration?”

A: Yes, the owner, operator, or agent may authorize another individual to update a facility’s registration. This person may or may not be the facility’s U.S. agent. As a facility’s U.S. Agent, Registrar Corp will update and renew a facility’s registration at no additional cost.

FDA also added many questions regarding the Unique Facility Identifiers (UFIs) finalized in the July 2016 rule.  Examples of some new UFI questions include:

Q: “When will I be required to submit a UFI in my registration submission?”

A: A UFI will be required in registration submissions beginning on October 1, 2020.

Q: “Which UFI or UFIs are recognized as acceptable to FDA for food facility registration purposes?”

A:  FDA recognizes Data Universal Numbering System (DUNS) numbers as acceptable UFIs.  Though FDA’s UFI requirement does not come into effect until 2020, it is prudent to apply for a DUNS number for your facility in advance, as it may take some time to obtain. Registrar Corp can assist a facility in obtaining a DUNS number free of charge.

FDA has opened up the draft guidance for public comment. You may submit your comments for here.  Submit by February 6, 2017 to ensure your comments are considered before FDA begins working on its final draft.

Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including registration, registration renewal, and new requirements under the Food Safety Modernization Act (FSMA).  Registrar Corp’s Regulatory Specialists register and renew thousands of food facilities each year and act as the U.S. Agent for over 13,000 facilities around the world.  Contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp for assistance.

         

The USDA Food Safety Inspection Service (FSIS) recently announced that it will allow voluntary use of the U.S. Food and Drug Administration (FDA) new Nutrition Facts format for food labels on meat and poultry labels. This announcement comes as FSIS works to finalize its own nutrition labeling and serving size regulations. FSIS’s goal is to produce nutrition labeling regulations for meat and poultry products that will parallel FDA’s regulations in efforts to help prevent consumer confusion and nonuniformity in the marketplace.

FDA’s new food labeling regulations came into effect on July 26, 2016.  Changes are reflected in the appearance and content of calories, serving sizes of food, nutrient daily values, added sugars, and more. The compliance date is July 26, 2018 for all food facilities, except those with less than 10 million dollars in annual food sales, who will have an additional year (July 26, 2019) to comply.

To help ensure compliance with FDA’s new regulations, meat and poultry companies that would like to use the FDA Nutrition Facts format for their products must first submit their labels to FSIS for review.  FSIS will review only one sketch label submitted per company or corporation. Any additional similar labels from the same company or corporation that use the new FDA format can be generically approved after the approval of the sketch label. Meat and poultry companies may use Registrar Corp’s blog on updated FDA food labeling regulations as guide on how to format their sketch labels.

The new FSIS nutrition labeling regulations will likely be similar to FDA’s, but there is no guarantee that the label requirements will be identical. Therefore, FSIS is advising companies that decide to use the new FDA format that they may need to revise the format again when FSIS issues its final regulations. FSIS is open to all comments regarding the new meat and poultry labeling and nutrition requirements. Comments may be submitted here through December 16, 2016.

Registrar Corp’s Labeling and Ingredient Review Specialists can help update meat and poultry labels to comply with FDA’s new rules. For more information, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

 

 

 

         

The U.S. Food and Drug Administration (FDA) recently sent a reminder to medical device establishments that had not yet registered for 2017.  FDA requires establishments involved in the production or distribution of medical devices intended for use in the United States to register their establishments annually between October 1 and December 31.  The registration fee for the fiscal year (FY) 2017 is $3,382, which is a decrease from the fee for FY 2016 of $3,845.

fda-med-dev-reminder-email

A majority of the establishments that must register with FDA must also list their devices and the activities performed on those devices. A list of who is required to register, list, and pay fees can be found here.  It is a prohibited act to manufacture or distribute devices in the United States without a valid FDA registration.  Therefore, it is prudent for any device establishments that plan to continue business in the U.S. in 2017 to renew their registration as soon as possible.

FDA has deemed certain establishments and devices are exempt from registering due to low risk to patients and the role they play in advancing digital health. The product codes of devices that meet the exemption requirements are:

  • LMB – Device, Digital Image Storage, Radiological
  • LMD – System, Digital Image Communications, Radiological
  • NFF – Device, Storage, Images, Ophthalmic
  • NFG – Device, Communications, Images, Ophthalmic
  • OUG – Medical Device Data System
  • NXQ – Daily Assist Devices

Establishments dealing with the devices listed above should not list these devices with FDA during their 2017 registration.

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations. Registrar Corp can help device establishments determine their applicable FDA registration requirements as well as register establishments and list devices with FDA. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.

         

On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would require device manufacturers to submit labels and package inserts to FDA electronically when listing Class II and Class III home-use devices. The rule would allow manufacturers to submit labels and package inserts for Class I or other excluded home-use devices voluntarily.

FDA defines a home-use device as “a medical device intended for users in any environment outside of a professional healthcare facility.” These devices are intended for use in homes and healthcare facilities where:

  • A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
  • A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

Some examples of class II home-use devices include powered wheelchairs as well as certain pregnancy test kits. Examples of class III home-use devices include implantable pacemakers and replaceable heart valves.

According to FDA, the proposed rule would “better allow manufacturers to provide such facilities with information that is more robust, up-to-date, and user-friendly.” Once finalized, FDA has plans to make the device labeling information public through an FDA-managed or partner website.  If finalized, manufacturers of class II and class III home-use devices would have to begin submitting labeling information 90 days after the publication of the final rule.

FDA opened this proposed rule for comments on October 17, 2016 for a 90-day period.  Interested parties may submit electronic comments at www.regulations.gov. Enter docket number FDA-2016-N-2491 in the search box.  FDA will review all comments before the release of the final rule, expected January 17, 2017.

Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations for medical devices, including labeling requirements. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.

         

FDA Requests Public Comment on “Healthy”



October 3, 2016 by David Lennarz

On September 28, 2016, the U.S. Food and Drug Administration (FDA) opened the term “healthy” to public comment through a “request for information.”  The agency’s goal is to promote the development of healthier foods and to assist consumers in making food choices that are consistent with current public health recommendations.  Food manufactures may continue using the term “healthy” as long as they meet the current regulatory guidelines during the comment period.

Examples of questions FDA hopes to have answered during the comment period include “What should healthy mean from a nutrition perspective?” and “How do consumers view the word healthy?” Interested parties can find information for submitting written and electronic comments here.  In addition to allowing industry to submit written comments, FDA plans to host public forums to receive further feedback.

FDA’s request for information on the term was sparked in part by a citizen petition filed by KIND LLC in December 2015 after receiving a warning letter for using the term “healthy” on some of its product labels. In its petition, KIND urged FDA to update its definition of “healthy” to be consistent with evolving information on overall nutrition quality rather than specific nutrient levels.  For example, foods like almonds, avocados, and salmon are too high in fat to meet FDA’s current regulations for “healthy,” but are recognized as having a valuable place in a healthy diet.

Until FDA lands on a final definition for “healthy,” the agency is using enforcement discretion to allow certain foods that don’t meet the agency’s current requirements to bear the content claim “healthy.” According to a guidance document recently published by FDA, it has no intention to “enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.”  The criteria outlined in the guidance document apply to foods that:

  • Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Registrar Corp stays up-to-date on U.S. FDA food labeling regulations and will continue to update industry as FDA’s decision on redefining “healthy” unfolds.  Please feel free to contact us with any questions regarding U.S. FDA requirements for using certain claims or other FDA labeling regulations, including the recently finalized changes to the Nutrition Facts Chart.  You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online 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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