FDA Issues Guidance Documents on Food Facility Registration

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 FDA

Constituent Update

August 17, 2018, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act).

One of the documents being published today is the seventh edition of a guidance to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements. Previous iterations of this guidance were released following the adoption in 2002 of amendments to the FD&C Act that required food facility registration. […]

USDA Proposed Rule to Inform Consumers of GMO’s (Costing Industry 1.7 BILLION)

Do you want to know if your food contains any GMOs? Do you know what the difference is between a GMO and Bioengineered Food? For the last 2 years, the USDA has been writing new rules for labeling and packaging food with GMOs – learn the latest below!

What is Bioengineered Food? […]

By |2021-11-03T15:18:55-04:00July 19, 2018|Best Practices, Customs Broker, Food, Import, U.S. Food and Drug Administration (FDA)|Comments Off on USDA Proposed Rule to Inform Consumers of GMO’s (Costing Industry 1.7 BILLION)

FDA Issues New Guidance to Help Food Facilities Meet Registration Requirements

fda .On May 25, 2018, the U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States to register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act. In 2016, FDA issued a final rule to reflect these changes, which include the following:

  • Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
  • Facilities are required to renew their registration every other year.
  • FDA now has the authority to suspend a facility’s registration.

Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. To further assist small facilities, the SECG includes an “At-a-Glance” that summarizes all of the […]

Exporting 201 – Advanced Exporting Webinar 5/22 – RSVP Today!

Whether you are a new or experienced exporter, the next webinar is essential!

  • When do you get to hear from a Board Certified Expert on actual horror stories and when it’s in your best interest to file a Disclosure?

RSVP now to join our Exporting 201 webinar. And don’t forget to check out all of our upcoming webinars!

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FDA Takes New Steps in Oversight of Imported Foods

FDA announced that it has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by the FDA Food Safety Modernization Act (FSMA). The organization being recognized is ANSI-ASQ National Accreditation Board (ANAB), an organization jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ) based in Milwaukee, Wisconsin. This organization is being recognized because it met the applicable FDA requirements, validated through application review and on-site assessment.  FDA is recognizing ANAB for a five year term of recognition. (For more information on FDA’s standards for recognition, see: Key Facts about the Accredited Third-Party Certification Program) […]

Food Importers – Want to Expedite Your Importations with FDA?

 On January 2, 2018, FDA announced that it expects to begin accepting applications in early 2018 for its Voluntary Qualified Importer Program (VQIP), which we first advised you of back in 2015. VQIP is a voluntary, fee-based program for importers that will allow expedited review and importation of human and animal foods into the United States for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. Below are the most important VQIP questions and answers from the FDA. […]

UPDATE: FDA Delays Compliance Dates for the New Nutrition Facts Label Rule

 

In an earlier article, we detailed some of the new changes that would be implemented with the new Nutrition Facts Label rule. That article also provided the compliance dates for the rule. On September 29,2017, however, the FDA proposed yet another deadline extension for food companies to bring their products’ labeling into compliance with the new Nutrition Facts Label rule. Amid concerns of requiring more time to implement the final rules, raised by trade groups and companies, the FDA decided to further delay the compliance dates. The proposed extension dates are January 1, 2020, for companies with food sales of $10 million or more a year and January 1, 2021, for companies with less than $10 million a year in food sales.

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FDA Extends Compliance Dates for the New Nutrition Facts Label Rule

 

Nutrition FactsTake a look at any food label. Check out the back panel entitled, “Nutrition Facts”. It should look similar to the image on the left. Take a look at the total carbohydrate. In this sample, the total carbs is 37g, with 4g of dietary fiber, and 1g of sugar. That leaves 32g of carbohydrates unaccounted for! What are those carbs you might wonder? Well, a majority of them are added sugars.

On May 20, 2016 the FDA finalized the new Nutrition Facts label final rule for packaged foods. It was the first major update, and regulation, to the nutrition facts label in 20 years. The FDA’s regulation targeted sugars, in particular “added sugars”, and provided a major update to the amount of nutrients people customarily consume. Additionally, the nutrition facts label received a face lift.

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By |2021-03-26T12:30:01-04:00August 11, 2017|Best Practices, Customs Broker, Food, Import, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off on FDA Extends Compliance Dates for the New Nutrition Facts Label Rule

Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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By |2017-05-19T10:38:15-04:00May 19, 2017|Best Practices, Customs Broker, Events, Food, FSMA, Import, Import Alert, Seizures, Speaking, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off on Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP
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