2015 - Page 3 of 6 - Customs & International Trade Law Firm

IS YOUR COSMETIC PRODUCT REALLY A DRUG?

In Junealone, the U.S. Food and Drug Administration (FDA) refused the importation of over 200 different shipments of Cosmetics from 22 different countries.

The two main reasons the FDA cited in refusing entry of cosmetic products were:

The products were “misbranded” (lack of adequate directions for use, nutrient content and/or health claims, anti-ageing labeling claims rendering the product a drug; or
The products were “adulterated” (unsafe addition of a color additive).

Definition of a Cosmetic vs. Drug

Misbranding may come down to whether the FDA believes the product is a drug (which is often based on the products intended use, and labeling claims). It is therefore important to know the difference in the way FDA defines cosmetics and drug products, to ensure you label your products correctly.

A product designed for “cleansing beautifying, promoting attractiveness, or altering the appearance,” is generally defined as a cosmeticby the FDA.

A drugon the other hand, is as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.”

Why Cosmetic Products will be Refused by the FDA

One prevalent reason the FDA refuses cosmetic products is because of the claims cosmetic products makes rendering the product a “drug”. A health claim is one example of a type of claim, specifically it is a claim that the product affects the structure and or function of the human body. If your product makes a […]

By Jennifer Diaz|2022-07-07T10:50:38-04:00July 21, 2015|FDA Notice of Detention, Notice of Refusal, U.S. Food and Drug Administration (FDA)|0 Comments

Embassies and Island Wide Wi-Fi by July in Cuba

President Barack Obama announcedWednesday that the U.S. and Cuba will now reestablish diplomatic ties and reopen embassies in their respective capitals. The announcement comes just one month after the Secretary of State removed Cuba from the State Sponsor of Terrorism list. Although it would take an act of Congress to lift the trade embargo, reopening embassies is another brick in the foundation of normalizing trade relations. With the new embassies opening in July, there will be greater contact between the US and the Cuban people which will ultimately lead to a change in the US’s attitude towards the trade embargo.

A new US embassy is not the only thing coming to Cuba in July. Cuba’s state-run telecommunications company is planning on opening a network of Wi-Fihotspots that spans the entire island. They also plan on cutting the price of hourly access in half to $2. However, even though costs are less and there will be more Wi-Fi hotspots, the internet […]

By Jennifer Diaz|2022-07-07T10:49:21-04:00July 1, 2015|Cuba, Export, Technology, U.S. Bureau of Industry and Security (BIS), U.S. Office of Foreign Assets Control (OFAC)|2 Comments

“Fast Track” Bill Signed Into Law: Next Up Trans-Pacific Partnership

On Monday, President Obama signed Trade Promotion Authority (TPA) into law. TPA, also known as the “fast track” bill, was seen as a crucial component in solidifying the Trans-Pacific Partnership (TPP). Although the re-authorization of TPA grants the President greater authority in his ability to negotiate and secure a trade deal–thus speeding up the TPP negotiation process–the TPP still has some tough negotiations ahead. However, the new authority Congress granted the President will now give him the power needed to ultimately conclude negotiations on the TPP.

The TPP covers almost 40 percent of the goods and services produced in the world. The United States ships more than $1.9 billion in goods to TPP countries every day. One of the main objectives of the TPP–according to USTR and the Obama administration–is to cut the “red-tape of trade,” by reducing costs and making CBP more efficient. Specifically, the TPP looks to create commitments that would ensure the quick release of goods through customs.

The TPP is not the only trade deal the Obama administration has in their sights. The U.S. Trade Representative, Michael Froman, looks to tie up the Transatlantic Trade and Investment Partnership Agreement (TTIP), the World Trade Organization’s Information Technology Agreement, the Environmental Goods Agreement, and the 24-party Trade in International Services Agreement.

In 2014, there were over 23,000 intellectual property rights seizures by U.S. Customs and Border Protection (CBP), with the property seized having an estimated MSRP value of $1.2 billion. According […]

By Jennifer Diaz|2022-07-07T10:45:32-04:00June 30, 2015|Customs Expert, Export, Free Trade Agreement, Import|0 Comments

Doing Business in Cuba: What’s Next? Live Webinar – June 23

On Tuesday, June 23, 2015 at 12:00 noon EST, join OWIT International for an insightful conversation about rapidly evolving business opportunities in Cuba.

The Webinar will highlight particular areas of interest, including:

Learning what is legal for U.S. businesses as it relates to Cuba.
Learning what travel to Cuba is authorized.
Learning about IDT Telecom’s direct interconnect with Cuban Telecom (ETECSA), and future opportunities for growth in telecom and financial services

I have the pleasure of presenting with Julie Manevitz the Director of Operations for Global Top Up at IDT Telecom.

OWIT Members benefit from a reduced registration fee of $25, while the fee for future members is $40. REGISTER TODAY!

By Jennifer Diaz|2022-07-07T10:42:42-04:00June 19, 2015|Cuba, Export, Import, OWIT-South Florida|1 Comment

Food Importers – FDA Issues New Guidance Aimed at Expediting Your Importations

The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years and was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. FSMA requires FDA to establish a voluntary, fee-based program, named the “Voluntary Qualified Importer Program” (VQIP) which promises expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.

On June 4^th, 2015 the FDA published a draft version of “Guidance for Industry: FDA’s Voluntary Qualified Importer Program (VQIP)”. According to FDA’s website, VQIP will also benefit consumers by enabling the FDA to focus its resources on high risk foods, further protecting consumers from the potential health hazards associated with those foods. In order for a food importer to be eligible for the VQIP program, the importer should:

Have at least a 3 year history of importing foods
Have a Data Universal Numbering System (DUNS) number
Use a paperless filer/broker who received a passing rating during their last FDA evaluation
Import food that is not subject to an import alert or Class 1 recall
Not be, nor any non-applicant entity associated with the VQIP food be, subject to an FDA administrative or judicial action, have a history of significant non-compliance with food safety, or have one or more […]

By Jennifer Diaz|2022-07-07T10:39:22-04:00June 11, 2015|Best Practices, Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|2 Comments

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