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Signed into law in 2011, the Food Safety Modernization Act (FSMA) expanded the preexisting U.S. Food and Drug Administration (FDA) registration requirements to include biennial registration renewals.  Food facilities must now renew their FDA registration between October 1 and December 31 of each even numbered year.  Registrar Corp put together the need-to-know facts about registration renewal.

Who is required to renew?

Domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.  This does not include farms, restaurants, or retail food establishments.

What are the consequences for not renewing?

Failing to register, renew registration, or update required elements of a registration is a prohibited act.  The federal government can bring a civil or criminal action in Federal court to prosecute a person who commits a prohibited act.

For foreign facilities in particular, any food shipped to the U.S. by a facility with expired registration will be held at its port of entry by FDA or sent to a secure facility by FDA or the Customs and Border Protection Service.  FDA will restrict the food from being delivered to the importer, owner, or consignee until the responsible facility is properly registered.

Registering with FDA gives the agency permission to inspect a facility.

FSMA requires FDA to double the number of inspections it conducts every year through 2016.  During an inspection, FDA will verify the facility’s registration status, check for labeling compliance and good manufacturing practices, and more.  Registrar Corp offers a Mock Inspection Service for food facilities.  The firm will dispatch a food safety expert trained in FDA inspections to help the facility prepare.

For foreign facilities, FDA will contact both the facility and its U.S. Agent about inspections.   It’s good to be aware that since FDA updated its food facility registration system in August 2014, food facilities are no longer able to list the same e-mail address for both the facility and its U.S. Agent.   Any facility that currently lists the same e-mail for both will be required to change this before it submits its renewal.   Registrar Corp offers a U.S. Agent service that includes registration renewal.  Also, facilities that choose to designate Registrar Corp as their U.S. Agent receive the mock inspection service mentioned above for no additional cost, other than travel and lodging expenses, if FDA sets an inspection date.

How do I renew my FDA registration?

You can renew your registration with FDA by mail, fax, or online, but a number of mistakes are commonly made when facilities attempt the renewal process on their own.  Registrar Corp helps food facilities comply with FDA regulations and has successfully registered thousands of food facilities with FDA.  As an added benefit of registering through Registrar Corp, you will receive a Certificate of Registration to display at your facility and assure clients of your FDA registration.

For any questions about FDA food facility regulations, or to learn more about Registrar Corp’s registration and U.S. Agent services, contact +1-757-224-0177 or get help 24 hours a day through the Live Help chat service: http://www.registrarcorp.com/livehelp.

         

Join Registrar Corp at Natural Products Expo East 2014



September 16, 2014 by David Lennarz

Registrar Corp is heading to Baltimore, Maryland this week for Natural Products Expo East, the leading trade show on the East Coast for the natural, organic, and healthy products industry.  From September 18 to 20, thousands of industry professionals will gather at the Baltimore Convention Center to discover the latest and greatest natural products on the market.  No matter how healthy, food products sold in the United States have to adhere to certain U.S. Food and Drug Administration (FDA) requirements before they can find their way onto store shelves and into the hands of consumers.  Registrar Corp will be available to help food companies navigate FDA regulations.

One good thing for Natural Products Expo exhibitors to know is that FDA requires food facilities to renew their FDA registrations between October 1 and December 31 of every even numbered year. Registrar Corp can ensure your facility registration is properly renewed, as well as review and modify your product labeling for compliance with FDA requirements.

For questions about FDA food regulations or to set up a meeting with Registrar Corp at the show, contact us at 1-757-224-0177 or get help 24 hours a day through the Live Help chat service: http://www.registrarcorp.com/livehelp.

         

Did you know: FDA Considers Online Promotion as Labeling?



September 15, 2014 by David Lennarz

On June 27, 2014, the U.S. Food and Drug Administration (FDA) issued a warning letter to Zarbee’s Inc. regarding claims the company made on its website and social media.  According to FDA, the health claims made about some of the products that Zarbee’s sells online “cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act.” FDA warned that, because Zarbee’s had not completed the proper requirements for distributing drugs in the U.S., the products could not be legally introduced into U.S. commerce.

FDA also wrote that Zarbee’s website offered products as a treatment for conditions that are not self-diagnosable or self-treatable, making it impossible to include adequate directions for safe and effective use for those intended uses. Because of this, FDA deemed those products to be misbranded.

Many companies don’t consider their online presence when working to comply with FDA regulations. What many don’t know is that FDA considers websites and social media to be an extension of product labeling, meaning that claims and information that a company puts online regarding its FDA-regulated product are subject to FDA review and requirements. This is true for all domains because consumers in the U.S. can still access out-of-country domains. For example, a Canadian company cannot refrain from making an FDA-restricted claim on its “.com” domain while still making the claim on its “.ca” domain, even if that claim is allowed in Canada.

In some cases, FDA may even consider third-party promotion to be part of a company’s labeling if FDA believes the company had any influence over the promotion. For example, in the warning letter to Zarbee’s, FDA criticized the company for “liking” certain testimonials about its products’ health benefits on Facebook.  It appears that, though the testimonials were written by consumers, Zarbee’s “likes” were considered to be endorsements of the consumer statements.

Registrar Corp offers a label review service for drug, food and beverage, medical device, and cosmetic companies. Our Regulatory Specialists will assess all aspects of your labeling, including your website, and suggest modifications where necessary.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. If you have questions about FDA labeling regulations or any other FDA regulations, contact us at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

         

FDA Publishes IDE Decision Guidance



September 12, 2014 by David Lennarz

On August 18, 2014, the U.S. Food and Drug Administration (FDA) published  “FDA Decisions for Investigational Device Exemption Clinical Investigations”, a draft guidance that details FDA decision making when it comes to approving or disapproving investigational device exemption (IDE) applications and provides information about steps sponsors may take after FDA makes a certain decision.

In most cases, a medical device must comply with certain requirements, such as performance standards and premarket approval, before FDA will allow the device to enter and/or be distributed in the United States.  With IDE approval, a device may bypass some of the regulatory requirements for medical devices and still be legally shipped into the U.S. for the purpose of conducting investigations on the device.  All clinical studies of investigational devices require IDE approval by an institutional review board (IRB), but high risk devices also require FDA approval.

FDA can approve, approve with conditions, or disapprove an IDE application. Once FDA receives an application, the agency has 30 days to inform the sponsor its decision. If FDA fails to do so, the IDE application is automatically approved. FDA looks at IDE applications to determine whether there are sufficient data to support the initiation of human clinical studies and to ensure the safety of study participants and address any other concerns. If approved (with or without conditions), FDA will specify a maximum number of U.S. subjects and investigational sites in its decision letter. Studies must be conducted in accordance with these limits. FDA may also suggest modifications to the study design, but sponsors are not required to implement them.

FDA Approval

FDA will approve an IDE application if the sponsor has provided sufficient data and the agency has no outstanding issues that need to be addressed to support the proposed investigational plan. The sponsor may begin subject enrollment immediately upon receiving IRB approval.

FDA Approval with Conditions

If FDA determines there are issues that need to be addressed in a timely manner, but there are no subject safety concerns, the IDE will be approved with conditions.  Just like FDA approval without conditions, the sponsor may immediately begin enrollment once the sponsor receives IRB approval. The difference is that the sponsor will have 45 days from the date of the FDA’s decision letter to submit information addressing the issues identified in the letter. Sponsors can request an extension to respond to FDA, but if the sponsor does not respond in the given amount of days, FDA may place a hold on the study or take other regulatory action.

FDA Disapproval

If FDA identifies outstanding issues that need to be resolved before subject enrollment begins, the IDE will be disapproved. The sponsor will be unable to initiate enrollment, but will be able to amend the application and respond to the issues identified in FDA’s decision letter. If the outstanding issues are resolved, FDA may grant an approval or approval with conditions.

As an alternative to disapproving an IDE application, FDA may decide to grant “staged approval” or “staged approval with conditions.” This means that FDA grants approval for only a portion of the intended study while certain questions and issues are resolved, after which the study may gain approval or approval with conditions.  This occurs if FDA finds that beginning a portion of the study would be significantly beneficial compared to the risks.

IDE applications must include the informed consent document that is intended to be given to potential study participants. Informed consent documents inform potential subjects of important information about the study, including the risks and benefits of participation. 21 CFR Part 50 lists specific requirements for the format of informed consent documents. Failing to comply with the format requirements can be cause for approval with conditions or even disapproval.

Registrar Corp is an FDA consulting firm that helps medical device establishments comply with FDA regulations. We can properly register an establishment with FDA, review device labeling for FDA compliance, and properly format a 510(k). For questions about IDE applications or other FDA medical device regulations, contact Registrar Corp at 1-757-224-0177 or tweet us @RegistrarCorp. We are also available 24/7 through our Live Help chat service.

         

The Generic Drug User Fee Amendments (GDUFA) of 2012 give the U.S. Food and Drug Administration (FDA) authority to collect annual user fees from active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities.  The fees are due on October 1 of each year. FDA must receive the full payment within 20 days of the due date.

The FY 2015 facility fees are:

  • Domestic FDF facility: $247,717
  • Foreign FDF facility: $262,717
  • Domestic API facility: $41,926
  • Foreign API facility: $56,926

What happens if FDA does not receive the payment on time?

The facility will be placed on a publicly available arrears list and no new drug submission referencing the facility will be received until the fee is paid.  Along with this, all FDFs and/or APIs manufactured in the facility will be deemed misbranded, making it illegal to ship the products into interstate commerce or import them into the U.S.

Can FDA require a company to pay multiple facility fees?

Yes.  If a facility manufactures both FDFs and APIs, both fees must be paid for that facility.  A company will also have to pay separate fees if it owns multiple facilities in different geographic locations.  A company may be able to pay only one facility fee if it owns two facilities that are considered to be in the same geographic location.  For facilities to qualify as being in the same geographic location:

  • The activities in the separate buildings must be closely related to the same business enterprise
  • The two facilities must be under the supervision of the same local management
  • FDA must be able to cover both facilities in a single inspection

FDA requires facilities to submit a GDUFA cover sheet along with user fees.

The cover sheet allows FDA to track the payment and ensure the correct fee was paid by a facility.  Cover sheets are submitted to the User Fee System, which is now open for FY 2015 submissions.  Facility fee cover sheets must include:

  • The facility’s name and address
  • The facility’s FDA establishment identification (FEI) number and data universal numbering system (DUNS) number
  • Confirmation of whether the facility manufactures human drugs that are not human generic drugs

Registrar Corp offers a variety of services for drug facilities, including proper FDA registration renewal, product listing, label reviews for FDA compliance, detention assistance, and more.

If you have any questions about generic drug facility fees or any other FDA drug regulations, contact us at +1-757-224-0177 or receive online Live Help from Regulatory Specialists: 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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