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On October 23, 2014, the U.S. Food and Drug Administration (FDA) published a Consumer Update regarding undeclared food allergens (food allergens that are not listed on labels).  Labelers of FDA-regulated foods are required to list major food allergens on product labels under federal law.  When a consumer is allergic to a food ingredient, they look to labels to inform them of whether or not a food is safe for them to eat.  Therefore, when food contains an allergen but does not list the allergen on its label, it’s a serious health risk. According to the Consumer Update, undeclared allergens are the leading cause of food recalls requested by FDA.  The three allergens most commonly involved in food recalls are milk, wheat, and soy.  Other major allergens include peanuts, fish, crustacean shellfish, eggs, and tree nuts.

Recall data show that labels with undeclared allergens are often a mistake.  When a company sells similar products with slightly different ingredients, a product may end up with the wrong label.  Many mistakes are also due to computerization and labels being printed directly onto packaging.  Mistake or no, however, the public health consequences of undeclared allergens are still severe.  About 1/3 of foods reported to FDA as serious health risks from September 2009 to September 2012 involved undeclared allergens.

FDA is currently exploring new methods of allergen testing.  While the commonly used allergen detection program ELISA is fairly low-cost and easy to use, the program sometimes produces incorrect results.  So, FDA is working to develop more in-depth detection methods based on mass spectrometry and DNA.

If FDA finds a label with undeclared allergens, the product will be deemed misbranded, and FDA may demand a recall or even detain the product.  Recalls demand substantial time and money, as firms must halt distribution and resolve the issue at hand.  For example, in the case of undeclared allergens, a firm would have to produce and apply a new label onto its products.  It’s always best to review product labels before distributing products in the United States.  Registrar Corp Regulatory Specialists are well versed on FDA label requirements and offer a label review service for food and beverage companies.  We will cross-reference a firm’s product label against thousands of pages within the Code of Federal Regulations and modify the label for FDA compliance.

For more information on FDA label requirements, or to request a label review, contact Registrar Corp by phone: +1-757-224-0177 or via 24/7 Live Help: http://www.registrarcorp.com/LiveHelp.

         

On October 30, 2014, the College of William & Mary in Williamsburg, Virginia is hosting Science Careers Outside the Lab, a panel to educate students on ways to use their science degrees.  Anna Benevente, Registrar Corp’s Director of Product, Label & Ingredient Reviews, will act as a panelist.

Registrar Corp, a U.S. FDA compliance firm in Hampton, Virginia, frequently hires college graduates with biology, chemistry, and other science majors to work in our Product, Label & Ingredient Reviews Department as Regulatory Specialists.  The position involves assisting businesses that have products that are regulated by FDA, namely Foods, Drugs, Medical Devices, and Cosmetics.  The research is focused on the federal regulations that govern a product and any guidance that has been issued by FDA regarding it.  Our typical client is a foreign manufacturer or distributor who would like to export to the U.S. and needs to make sure that his product and the labeling that accompanies it are compliant with FDA regulations.  At the end of our research, we produce a report that explains the regulations that govern the product and any compliance issues that it might face.

If you are interested in working for Registrar Corp, talk to Anna after the show or e-mail your résumé to Registrar Corp Vice President David Lennarz at dlennarz@registrarcorp.com.

         

U.S. and Mexico Enter Mutual Recognition Arrangement



October 30, 2014 by David Lennarz

On October 17, 2014, the U.S. Customs and Border Protection (CBP) and Mexico’s Tax Administration Service (SAT) signed a mutual recognition arrangement aimed at linking CBP’s Customs-Trade Partnership Against Terrorism (C-TPAT) and SAT’s New Certified Companies Scheme (NEEC).  The arrangement is intended to help secure and facilitate global cargo trade.

Benefits for program members will include:

  • Fewer exams when shipping cargo
  • A faster validation process
  • Common standards
  • Efficiency for Customs and business
  • Transparency between Customs administrations
  • Business resumption
  • Front-of-the-line processing
  • Marketability

Earlier this year, the U.S. and Mexico entered another partnership aimed at promoting the safety of fresh agricultural products.  The two countries are forming multiple partnerships related to trade since Mexico is one of the United States’ largest trading partners.  In 2013, Mexico was the 3rd largest supplier of imports to the US and was the 2nd largest market for US exports.

Though partnerships are making trade between the two countries safer and easier, the U.S. Food and Drug Administration (FDA) still has plentiful requirements for foreign companies distributing food and beverages, drugs, medical devices, or cosmetics in the United States.  FDA and CBP work together at U.S. ports of entry to ensure compliance.  Mexican companies must register with FDA, follow strict labeling requirements, and maintain a U.S. Agent for FDA communications.

Registrar Corp, an FDA compliance firm, can assist Mexican companies with all of these requirements and more.  Visit our site to see all of the services we offer.  If you have any questions about FDA regulations for companies located outside the U.S., contact Registrar Corp at 1-757-224-0177 or speak to a Regulatory Specialists 24 hours a day at: http://www.registrarcorp.com/livehelp.

         

Prior to October 2012, there were over 450,000 food facilities registered with the U.S. Food and Drug Administration (FDA).  As of February 19, 2014, there were less than 200,000.  How could the number of registered food facilities drop to less than half of what it was in less than two years?  According to FDA’s Registration Statistics webpage, the significant decrease was due to food facilities failing to renew their FDA registrations in 2012.

In 2011, the Food Safety Modernization Act (FSMA) established a new regulation that requires food facilities to renew their FDA registrations between October 1 and December 31 of each even-numbered year.  With 2012 marking the first ever renewal period, it took a number of companies by surprise, leaving many with expired registrations when they didn’t renew by the deadline.  Once an FDA facility registration expires, it becomes a prohibited act for that facility to distribute products within the United States.  Unfortunately, some facilities don’t realize their registration has expired until their products are detained at the port of entry or they fail a facility inspection.

We are now in the midst of the 2014 FDA registration renewal period.  As Registrar Corp travels to tradeshows around the world, we are surprised to find that many companies we talk to are still unaware of the renewal requirement.  Once the renewal period ends, FDA will remove non-renewed registrations from its system.  Don’t let your FDA registration expire.  Make sure to renew your registration by December 31, 2014.  When you renew your FDA registration through Registrar Corp, you can be assured your renewal will be completed properly, and you will even receive a certificate of registration to include with your shipments.

Registrar Corp is an FDA consulting firm that helps food and beverage facilities comply with FDA regulations.  For questions about FDA registration renewal or any other FDA regulations for food and beverage facilities, contact Registrar Corp at 1-757-224-0177. Receive online Live Help from Regulatory Specialists 24 hours a day at: http://www.registrarcorp.com/livehelp.

         

All facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with the U.S. Food and Drug Administration (FDA), but food facilities that work with Acidified or Low Acid canned foods are considered to be Food Canning Establishments (FCE) and need an additional registration.  If an FCE does not follow FDA registration and process filing requirements, FDA may detain the facility’s Low Acid or Acidified foods at the point of entry until the products are brought into compliance, destroyed, or re-exported.

How do I know if my product is considered an acidified or low acid food?

Though there are a few exceptions, a food is usually considered to be an Acidified or Low Acid food if it is packaged in a hermetically sealed container, has a water activity of 0.85 or above, and is not stored, distributed, and retailed under refrigerated conditions.  If the food has a final equilibrium pH less than or equal to 4.6, the food is Acidified. If the food has a final equilibrium pH greater than 4.6, the food is Low Acid.

How do I register as a food canning establishment?

You can register online or on paper by completing Form FDA 2541. Registration should occur within the first ten days after engaging in the manufacturing, processing, or packing of an Acidified or Low Acid canned food.  Each separate processing plant needs its own FCE registration.  Keep in mind that the address listed in the FCE registration must match the address listed on the establishment’s bioterrorism registration (the registration required for all food facilities).  All information submitted to FDA must be in English or FDA will return the form without consideration.

Are there any other requirements for food canning establishments?

Yes.  Along with the additional registration, FCEs must file scheduled process information (Form FDA 2541a) for every container type and size of each Acidified and Low Acid food product.  Every process filing will have its own submission identifier (SID) to be used in conjunction with the facility’s FCE number.  The SID consists of the year, month, and day that the process filing form is submitted and a unique number decided by the filer to identify each process filed on the same day.  Process filings do not expire if there are no changes to the process, but any change in concentration, ingredients, processing parameters, pH, or packaging will require a new SID submission.

The scheduled processes used and filed by a food canning establishment must be established by a Process Authority, an individual or company with training and experience in thermal processing.  While Registrar Corp is not a process authority, Registrar Corp FCE specialists can help you determine whether or not your product is considered an Acidified or Low Acid food and can assist with FCE registration and filing scheduled processes.  Registrar Corp can also assist with the FCE process by translating the FDA 2541 forms into certain languages and converting container sizes into inches and 16ths, the appropriate units required by FDA.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. For assistance with FCE regulations, contact Registrar Corp at +1-757-224-0177 or receive online Live Help from Regulatory Specialists any time 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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