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FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements

Wheat Stalk 100% Gluten Free Label Vector Illustration

According to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.

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By Jennifer Diaz|2021-03-26T14:09:13-04:00July 8, 2014|Best Practices, FDA Issues, Food, FSMA, Gluten Free|0 Comments

FDA Issues Final Compliance Policy Guide for Food Facility Registration

The U.S. Food and Drug Administration (FDA) has issued the “Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food” (the CPG). The CPG provides guidance for FDA staff pertaining to the enforcement of the food facility registration provisions of section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were amended by the FDA Food Safety Modernization Act (FSMA). Under these provisions, any food facilities which manufacture, process, pack or hold food for human or animal consumption in the United States must be registered with the FDA. Additionally, each registered facility is required to biennially renew their registrations with the FDA. The CPG further describes the FDA’s authority to suspend a food facility’s registration.

In April 2013, the FDA published a draft of the CPG and of the two comments received, no significant changes were recommended to the draft CPG. Therefore, no substantive changes were made from the draft to the final version of the CPG.

Please note that this CPG replaces the previously issued “Compliance Policy Guide Sec. 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”

If you wish to obtain additional information on which food facilities must be registered with the FDA, or if you would like assistance in registering your food facility, please feel free to call me at (305) 260-1053, or email me at JDiaz@bplegal.com.

By Jennifer Diaz|2022-07-07T10:18:37-04:00June 2, 2014|FDA Issues, Food, FSMA|1 Comment

FDA Released Draft Guidance on Prior Notice of Imported Foods

For those of you keeping up with the FDA Food Safety Modernization Act (FSMA), big changes are coming for those in the food industry. We have been keeping you up to date with blogs on updates to FSMA. We have even created an updated website on FDA to help you understand the vast requirements under the FSMA, as well as complying with FDA generally. If you are a foreign manufacturer, processor, packer, storer or holder of food products, you need a U.S. agent, and must register with the FDA – for more information, review www.FDA-USA.com.

The latest news is that the FDA has released the third Edition of the U.S. Food & Drug Administration (FDA) draft guidance titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers”. Prior notice is just what it sounds like, “notification to the FDA that an article of food, including food for animals, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border.”

FDA is seeking comments on the draft guidance and addresses questions received since the publication of the second edition of the guidance in May 2004. The guidance also includes information related to the FSMA, which requires additional information to be provided in a prior notice of imported food submitted to the FDA. The FSMA included a new Prior Notice element, now the FDA requires a person submitting prior notice of […]

By Jennifer Diaz|2022-07-07T10:11:17-04:00April 7, 2014|Customs Broker, FDA Issues, Food, FSMA, Import|0 Comments

Join FDA in Miami to Discuss Major FSMA Proposed Rules

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies.

The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically. The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers. I believe we can expect to see enforcement and penalties from FDA – if you have not met your manufacturer yet, now is the time!

The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.

The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond […]

By Jennifer Diaz|2022-07-07T10:03:21-04:00September 26, 2013|FDA Issues, Food, FSMA, Import|0 Comments

FDA Finally Issues Definition of “GLUTEN FREE”!

HOT OFF THE PRESS!!! FDA issued the update below today DEFINING the term “Gluten Free”. As a Celiac, this is extremely exciting news! The reason this is a HUGE deal? Us Celiac’s need to know we can trust food products that are labeled “gluten free”. If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers…

My sincere hope is FDA will now test imported products that make “GLUTEN FREE” claims, and assure these companies are legitimately using the gluten free claim. Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim! The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA’s own laboratories to check the parts per million of gluten in the product. If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product – meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA’s Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.

The “Compliance Date” for this final rule is August 5, […]

By Jennifer Diaz|2022-07-07T10:01:48-04:00August 2, 2013|Best Practices, FDA Issues, Food, FSMA, Import|0 Comments

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