final rule Archives | Customs & International Trade Law Blog

UPDATE: Non-Commercial Airplanes and Cruise Ships on Temporary Sojourn are Now Prohibited To Travel To Cuba.

cuba - prohibt Following President Obama’s historical break in precedent, easing restrictions on Cuba in 2016, President Trump now seeks to deprive the Communist regime of revenue from American citizens.

President Trump, not wanting the US to be complicit in the oppression and subjugation of Cubans, has decided to roll back the newly established relationship and directed the Bureau of Industry and Security (BIS) to draft a final rule limiting the types of aircraft that are authorized to fly to Cuba and the types of vessels that are authorized to sail to Cuba on temporary sojourn. This change is likely to be a result of the exponential growth of the island’s economy, coupled with the lack of improvement in overall quality of life for its citizens.

[…]

By Jennifer Diaz|2021-11-09T09:31:34-05:00June 4, 2019|Cuba, Customs Expert, Enforcement, Export, International Business, International Law, International Trade, International Travel, U.S. Bureau of Industry and Security (BIS), U.S. Department of Commerce (DOC)|1 Comment

Using a Middleman? Learn How to Lower Your Customs Value Using First Sale!

Pursuant to the Customs Modernization Act, the importer of record (IOR) must use “reasonable care” when providing the value of the goods to Customs and Border Protection (CBP). All merchandise imported into the United States is subject to valuation or appraisement. The Trade Agreements Act of 1979, codified at 19 U.S.C. § 1401a, sets forth a hierarchy of methods for the appraisement of imported merchandise. Under the Trade Agreements Act of 1979, the transaction value of imported merchandise is the primary or preferred method for determining the value of imported merchandise. Generally, transaction value is the price actually paid or payable for merchandise when sold for exportation to the United States, plus certain statutorily enumerated additions.

[…]

By Jennifer Diaz|2021-10-29T14:59:42-04:00March 26, 2019|China, China Trade War, Customs Expert, Import, Import Alert, International Business, International Law, International Trade, Supply Chain, U.S. Customs and Border Protection (CBP)|3 Comments

Trump Administration Tightens Cuba’s Sanctions Program

Since June 2017, we have been anxiously awaiting changes to the Cuba sanctions program since President Trump signed an executive order and emphatically stated that his administration would tighten loose regulations established under the Obama Administration.

On November 8, 2017, the U.S. Department of the Treasury stated,

“We have strengthened our Cuba policies to channel economic activity away from the Cuban military and to encourage the government to move toward greater political and economic freedom for the Cuban people”

[…]

By Jennifer Diaz|2021-11-05T14:55:38-04:00November 9, 2017|Best Practices, Cuba, International Business, International Trade, International Travel, U.S. Bureau of Industry and Security (BIS), U.S. Department of Commerce (DOC), U.S. Department of State (DOS), U.S. Office of Foreign Assets Control (OFAC)|3 Comments

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.

[…]

By Jennifer Diaz|2021-11-09T13:40:46-05:00October 6, 2017|Best Practices, Customs Broker, Food, Import, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|1 Comment

FDA Extends Compliance Dates for the New Nutrition Facts Label Rule

Take 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.

[…]

By Jennifer Diaz|2022-07-06T15:51:31-04:00August 11, 2017|Best Practices, Customs Broker, Food, Import, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

FDA Launches New Webpage to Promote Use of Symbols in Medical Device Labeling

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later.

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.

[…]

By Jennifer Diaz|2022-07-06T15:45:03-04:00April 28, 2017|Best Practices, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|3 Comments

19 Antibacterial Soap Ingredients to be Banned by the FDA!

Co-authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law.

Do you assume that when shopping for soaps or body washes, consumers will often times reach for products labeled “antibacterial” in hopes that those products will keep them and their families safer? If so, you would be right. The popularity of antibacterial products has grown tremendously since they first appeared on the market. According to a 1998 Gallop Study of Consumer Awareness and Perception of Antibacterial Products, 33% of those surveyed expressed the need for special antibacterial products to protect their homes from bacterial and viral pathogens. A similar study conducted by Gallop in 2010 revealed that an overwhelming 75% of those surveyed said they preferred to purchase products with antimicrobial protection. […]

By Jennifer Diaz|2021-11-09T14:14:21-05:00November 17, 2016|Import, U.S. Food and Drug Administration (FDA)|Comments Off