U.S. Food and Drug Administration (FDA) Archives - Page 29 of 42

Jennifer Diaz Teaches Two Medical Device Seminars at FIME

I’m pleased to be back for my fourth year teaching at FIME! For those of you that don’t know, FIME was rated the #1 medical show in the USA by Successful Meetings Magazine. FIME runs from August 6-8, 2014 at the Miami Beach Convention Center. You still have limited time to register to attend the conference and my seminars! This year, I’ll be presenting two seminars, both on August 6, 2014. The two topics are:

10:00 a.m. – “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”
12:00 p.m. – “Streamlining the Process – How to Expedite Clearance of Your Medical Devices with U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP)”

After attending this seminar, you will know how to effectively operate your business with a new understanding of how to effectively resolve the “worst case scenarios” and importantly, you will learn what compliance is necessary so you can expedite the clearance of your goods. We will discuss how we handle everyday examples of difficult issues with both the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP). FDA issues include what to do if you receive a “Notice of FDA Action” stating that a medical device is adulterated or misbranded and will be refused admission into the United States, or a “Warning Letter” that could potential state you must stop producing certain medical devices because they are […]

By Jennifer Diaz|2022-07-08T16:52:19-04:00August 1, 2014|U.S. Food and Drug Administration (FDA)|0 Comments

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

White House’s OMB Intervenes to Weaken FDA’s Proposed Regulation of E-Cigs

On April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA “deemed” tobacco products, and as such, subject to the FD&C Act. OMB intervened to weaken FDA’s original proposal.

If the proposed rule became final – e-cigarettes (and the other products “deemed” tobacco products) would have been subject to:

(1) Enforcement action against products determined to be adulterated and misbranded;
(2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products;
(3) required registration and product listing for all tobacco products;
(4) prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use;
(5) prohibition on the distribution of free samples;
(6) premarket review requirements;
(7) Requirement for a minimum age of purchase; (what this will do to online sales was yet to be determined)
(8) health warnings for product packages and advertisements; and
(9) prohibition of vending machine sales, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.

After analyzing the proposed rule and its potential economic effects, the White House’s Office of Management and […]

By Jennifer Diaz|2022-07-08T16:50:18-04:00July 1, 2014|E-Cigarette, U.S. Food and Drug Administration (FDA)|2 Comments

Do You Want to be a “Trusted Trader”? C-TPAT is No Longer Enough

U.S. Customs and Border Protection (CBP) recently published the long awaited Federal Register Notice, dated June 16, 2014, discussing the “Announcement of Trusted Trader Program Test.” This new “Trusted Trader” program is big news for U.S. and non-resident Canadian importers, and if implemented will combine the Customs-Trade Partnership Against Terrorism (CTPAT) and Importer Self Assessment (ISA) programs, making ISA extinct. CBP is currently recruiting test companies that have to be willing to go through an 18 month program test.
What is the Trusted Trader Program?

CBP will unify CTPAT and ISA programs into a new “Trusted Trader” program. Companies will still have the option to apply for CTPAT and opt out of the Trusted Trader Program, but, the ISA program will be replaced by the Trusted Trader program. CBP aims to align the Trusted Trade program with Authorized Economic Operator (AEO) programs, which focus on a combined trade and security compliance model.
CBP is collaborating with the U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA), to develop the new “Trusted Trader” program aims to “streamline the process through which importers can establish to CBP that they strive to secure their supply chains and strengthen their internal controls for compliance with the existing laws and regulations administered or enforced by CBP.” The 3 government agencies will collaborate, share information, streamline the application and validation process; and increase the efficiencies in the existing trade programs.
CBP plans to utilize the Centers of Excellence and Expertise […]

By Jennifer Diaz|2022-07-08T16:31:08-04:00June 26, 2014|CTPAT, U.S. Consumer Product Safety Commission (CPSC), U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|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

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