Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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By Jennifer Diaz|2021-07-22T11:27:59-04:00May 27, 2021|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Trade, Medical Devices, Pre-compliance, Reasonable Care, Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments

Drug Paraphernalia, Priority Trade Initiatives, & Forced Labor

You don’t want to miss this one!

What: Drug Paraphernalia, Priority Trade Initiatives, & Forced Labor – An Update on CBP Enforcement

When: November 27th, 2018, 12:00PM-1:00PM EST

RSVP TODAY!

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By Jennifer Diaz|2018-11-13T13:42:28-05:00November 13, 2018|Best Practices, Customs Broker, Events, Import, Import Alert, International Law, International Trade, Penalty, Seizures, Tobacco, U.S. Customs and Border Protection (CBP)|0 Comments

FDA Issues Guidance Documents on Food Facility Registration

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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. […]

By Jennifer Diaz|2019-10-21T08:50:23-04:00September 18, 2018|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Law, International Trade, Medical Devices, Tobacco, U.S. Food and Drug Administration (FDA)|2 Comments

HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now? / ¡AYUDA! CBP INCAUTO MIS PRODUCTOS DE TABACO COMO PARAFERNALIA DE DROGAS, ¿AHORA QUÉ HAGO?

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Our office has increasingly received requests for guidance on importation of marijuana paraphernalia products to the U.S. where twenty-six (26) states have legalized the use of marijuana for medical purposes and/or personal consumption such as California, Massachusetts, Maine and Nevada. The purpose of this article is to dispel the confusion as to why paraphernalia products (grinders, storage containers, rolling paper, pipes, vape pens, etc.) are continuously being seized by U.S. Customs and Border Protection (CBP), even when such products may be used by tobacco smokers. It is important to address the realities between federal and state laws regulating drug paraphernalia products so importers can avoid CBP’s enforcement of U.S. Laws.

Why Does CBP Stop Drug Paraphernalia?

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By Jennifer Diaz|2019-07-03T13:10:41-04:00May 30, 2017|Best Practices, Customs Broker, E-Cigarette, Import, Import Alert, International Travel, Seizures, Tobacco, U.S. Customs and Border Protection (CBP), U.S. Department of Homeland Security (DHS), U.S. Food and Drug Administration (FDA)|0 Comments

The End of Vape Shops, Hookah Shops, & E-Cigs? FDA’s New “Deeming” Laws

On April 24, 2014, the U.S. Food and Drug Administration(FDA) announced that it was officially “deeming” e-cigs, e-hookah, vape pens, and other tobacco products subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article covered the proposed regulation at the time. On May 10, 2016 the FDA published the final rule on the new deeming law.

What Are Tobacco Products and What’s Being Regulated?

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By Jennifer Diaz|2019-10-21T08:46:47-04:00May 26, 2016|Best Practices, E-Cigarette, Import, Seizures, Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments

World Trade Month – Business Opportunities with Cuba – May 14, 2015 – #OWITonCuba

Are you in South Florida and thinking of doing business with Cuba? Do you want to hear from those already successfully doing business with Cuba? Do you want to fully understand what is legal now?

May 14, 2015, I have JUST the event for you! This is your LAST CHANCE to register!

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By Jennifer Diaz|2019-10-21T08:45:46-04:00May 11, 2015|Best Practices, Cuba, Events, Export, Import, OWIT, Speaking, Tobacco, U.S. Office of Foreign Assets Control (OFAC)|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.

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By Jennifer Diaz|2014-07-01T18:27:17-04:00July 1, 2014|E-Cigarette, Import, Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments

E-Cigs “Deemed” Tobacco Under New FDA Proposed Rule

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On April 24, 2014, the U.S. Food and Drug Administration (FDA) announced what some call a “long- awaited” proposed regulation that will impact the future of the currently booming e-cigarette industry. Currently, e-cigarettes are not a part of FDA’s purview and have no FDA oversight – FDA’s proposed rule intends to change this in a big way.

How is Tobacco Defined Currently?

Section 201(rr) of the Federal Food, Drug and Cosmetic Act (FD&C Act), (21 U.S.C. 321(rr)),as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), currently defines the term “tobacco product,” as ” any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product… “.

The Tobacco Control Act permitted FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco automatically as “tobacco product” under the FD&C Act.

Section 901 of the FD&C Act gives the FDA leeway to include “any other tobacco products that the Secretary by regulation deems to be subject to this chapter” and therefore subject to FDA regulation under the FD&C Act.

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By Jennifer Diaz|2014-04-25T01:15:25-04:00April 25, 2014|Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments