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On February 14, Registrar Corp, a U.S. Food and Drug Administration (FDA) consulting firm, launched two free tools to assist food facilities in complying with FDA requirements for Low-Acid Canned and Acidified Foods.

Most facilities that manufacture, process, pack, or store food intended for consumption in the United States are required to register with U.S. FDA as food facilities. Food facilities that produce certain shelf-stable, hermetically-sealed low-acid canned or acidified foods must also obtain a Food Canning Establishment (FCE) registration.  FDA requires FCE manufacturers to file documentation for each process used in the production of Low-Acid Canned and Acidified Foods and assigns unique “Submission Identifiers” (SIDs) to each of these “Process Filings.” Common examples of foods subject to FDA’s FCE and SID requirements include canned tuna, canned roasted red peppers, and coconut water.

Registrar Corp’s FCE Wizard allows users to identify whether their products are subject to these FDA FCE and SID regulations. Users simply answer a few questions, and the FCE Wizard generates a free report indicating possible requirements for each of the facility’s products based on factors such as pH, water activity, and ingredients.

For individuals aware that their products are subject to FCE-SID requirements but uncertain if a particular SID remains valid, Registrar Corp has developed the SID Verifier.  Registrar Corp’s SID Verifier allows users to verify whether SIDs are currently on file in FDA’s database.  Manufacturers, importers, and customs brokers filing entries of Low-Acid Canned and Acidified Foods will find this tool especially helpful, as valid SIDs must be submitted as “Affirmation of Compliance Codes” (AofC) when importing these products into the United States.  Verifying SIDs before filing can help avoid time-consuming detentions and entry errors that may lead to low filer evaluations.

Registrar Corp’s team of FCE specialists provides assistance with the FCE registration process and offers guidance as to required elements, formats, and particularities of SID submissions.  For further assistance with FDA FCE and SID requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

To use Registrar Corp’s FCE Wizard, click here.
To use Registrar Corp’s SID Verifier, click here.

This blog was originally published as a press release.

         

On February 7, the U.S. Food and Drug Administration (FDA) e-mailed medical device establishments that did not complete their annual registration for 2017.  According to the e-mail, establishments that do not register and pay the associated fees by February 23, 2017 will have their registrations removed from FDA’s database of active registrations. Medical devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States.

FDA Email Unregistered Device Establishments

The registration fee for fiscal year (FY) 2017 is $3,382.  Registrar Corp can help medical device establishments verify that their registrations were completed for 2017 as well as register device establishments with FDA and facilitate payment of the associated fees.  For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

         

On February 1, 2017, the U.S. Food and Drug Administration (FDA) removed all food facility registrations that were not properly renewed for 2017 from its registration database.  Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their FDA registrations between October 1 and December 31 of each even-numbered year.  FDA considers any registrations not renewed by the deadline to be expired and removes these registrations from its database. Once removed, registration numbers typically cannot be reinstated.  Facilities with expired registrations will need to re-register with FDA and obtain a new registration number before they manufacture, process, pack, or store food, beverages, or dietary supplements to be consumed in the United States.

14% of food facilities registered with FDA were removed from FDA’s database after the 2014 renewal period.   Registrar Corp Vice President David Lennarz predicts that the drop in registrations may be even greater this year due to new verification requirements implemented during the 2016 renewal period.  Food facilities located outside of the United States are required to designate a U.S. Agent for FDA Communications in their registration renewal.  Unlike in previous years, individuals or entities listed as U.S. Agents in 2016 were required confirm with FDA acceptance of their designation and corresponding responsibility.

Prior to this new verification step, a U.S. Agent could be designated in a foreign facility’s renewal without the U.S. Agent’s affirmative written agreement.  Many persons previously designated as U.S. Agents would have preferred to decline because a foreign facility’s U.S. Agent is liable for financial obligations, including payment of any FDA re-inspection fees related to the facility. The re-inspection fee rate for foreign facilities for Fiscal Year 2017 is $285 per hour (81 FR 50525).  FDA may bill for every aspect of a re-inspection, including time spent preparing and traveling, so the fees can quickly add up to thousands of dollars.  FDA also contacts U.S. Agents regarding shipments, inspection scheduling, and other regulatory matters.  These matters often require an immediate response.

In 2016, FDA addressed the issue by implementing the new verification procedures.  The agency does not consider a facility’s 2016 renewal confirmed unless the designated U.S. Agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its U.S. Agent did not affirmatively agree, its registration will have been removed from FDA’s food facility registration database.

To avoid costly detentions or regulatory action, it’s prudent for all food facilities to verify that their FDA registrations were properly renewed for 2017 before continuing with business as usual.  This is especially true for food facilities located outside the U.S.  Registrar Corp will verify that your FDA food facility registration was properly renewed for 2017 at no cost.  Facilities that need a U.S. Agent may retain Registrar Corp.  Simply contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

This blog was originally published as a press release.

         

The U.S. Food and Drug Administration (FDA) recently issued guidance for industry to assist with the submission of warning plans for cigars. On May 10, 2016, FDA published a final rule that granted the agency authority to regulate all tobacco products, including cigars, e-cigarettes, hookah tobacco, and pipe tobacco.

What is a warning plan?

A warning plan details how a company plans to achieve random distribution of the required warning statements on cigar packages and advertisements. For each brand of a cigar product, FDA requires that all statements be displayed on packaging an equal number of times within a 12-month period.  All statements must be randomly distributed in all areas that the product is marketed in the US. For advertising, all warning statements must rotate quarterly in an alternating sequence. There are six required warning statements:

  1. WARNING: This product contains nicotine. Nicotine is an addictive chemical.
  2. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
  3. WARNING: Cigar smoking can cause lung cancer and heart disease.
  4. WARNING: Cigars are not a safe alternative to cigarettes.
  5. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
  6. There are two options for the reproductive health warning: 1) WARNING: Cigar use while pregnant can harm you and your baby, or 2) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

Who submits the cigar warning plans?

A cigar product manufacturer, distributor, importer, or retailer should submit the warning plan. In most circumstances, FDA believes that manufacturers are most capable of creating a sufficient warning plan for packaging.

What is the compliance deadline?

Warning plans for cigars should be submitted to FDA by May 10, 2017 or 12 months before advertising and marketing begin, whichever date is later. FDA expects that a large volume of plans will be submitted near this deadline and thus suggests they be submitted as soon as possible to ensure they are reviewed in time to comply with the warning requirements that take effect on May 10, 2018.   FDA has deemed it unlawful for cigar products to be produced, manufactured, or distributed in the United States without the packaging containing one of the required statements once the warning requirements take effect.

FDA encourages cigar product manufacturers, distributors, importers, and retailers to submit warning plans electronically, with all content in Portable Document Format (PDF) format.  Electronic submissions must be submitted through FDA’s Electronic Submissions Gateway.

Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations.  Registrar Corp can help tobacco product manufacturers determine how FDA’s guidance apply to their particular products.  Additionally, Registrar Corp can also review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations. For more information, contact Registrar Corp at
+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 issued a guidance that extends the compliance dates for tobacco ingredient submissions for newly deemed tobacco products introduced into interstate commerce on or before August 8, 2016. FDA plans to enforce the ingredient list submission requirement on August 8, 2017 for businesses that are not small-scale manufacturers, and on February 8, 2018 for small-scale manufacturers. The original date for compliance was February 8, 2017.

The compliance deadlines have been extended  to allow manufacturers and importers additional time to prepare quality submissions.  The extension also allows some manufacturers to submit multiple lists for multiple tobacco products.

Ingredient submissions should include the following information:

  • Manufacturer/Importer Identification
  • Product Identification
  • Ingredient Identification
  • Ingredient Quality

Registrar Corp assists tobacco manufacturers with FDA compliance, including registration, listing, and labeling requirements.  For more information on FDA regulations for tobacco manufacturers, including the recently finalized refuse to accept tobacco rule, contact Registrar Corp at +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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