Monthly Archives

September 2019

Best PracticesCBDCustoms ExpertFDA IssuesFTCImportImport AlertInternational LawInternational TradeTrade WarU.S.Customs

New FTC Warning Letters Issued to Companies Selling CBD Products

posted by Jennifer Diaz September 24, 2019 0 comments

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The United States Federal Trade Commission (FTC) issued a press release confirming is sent three warning letters to companies that sell oils, tinctures, capsules, “gummies,” and creams containing cannabidiol (CBD), a chemical compound derived from the cannabis plant. While the warning letters are not made publicly available, the FTC advised the warning letters were sent because the companies were advertising their CBD products could treat or cure serious diseases and health conditions, in violation of both the FTC Act (as well as U.S. Food and Drug Administration (FDA)) laws and regulations.

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Best PracticesCounterfeitsInternational LawInternational TradeIPR, Trademarks and Logos

How CBP Protects Your Intellectual Property Rights at the Border / ¿Derechos de propiedad intelectual en la frontera?

posted by Jennifer Diaz September 12, 2019 0 comments

IPR ---As an intellectual property right (IPR) owner, you have the right to work with CBP to prevent the unauthorized importation of infringing goods into the U.S. Registered trademarks, trade names, and copyrights can all be recorded with the with U.S. Customs and Border Protection (CBP). CBP helps trademark and copyright owners prevent the unauthorized importation of infringing products. CBP has the ability to detain, seize, and issue penalties to those who import goods which violate intellectual property rights.

This article will discuss:

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FDA IssuesInternational LawInternational TradeInternational Travel

Here are the Major Changes FDA is Proposing to Make to the Sunscreen Rule!

posted by Jennifer Diaz September 10, 2019 0 comments

dt_190222_sunscreen_800x450On February 26 2019, the United States Food and Drug Administration (FDA) proposed a rule that would alter the regulations associated with the manufacturing and selling of sunscreen, as well as other sun-care related products. Since the closing of the comment period on May 28th, 2019, FDA has received over one thousand comments from industry players voicing their concern over various aspects of the proposed measures.

The proposed rule was issued as part of the regulatory proceeding to put into effect a final monograph for nonprescription, OTC sunscreen drug products under the OTC Drug Review. An OTC monograph establishes conditions under which certain OTC drugs may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. The proposed rule classifies active ingredients and other conditions as:

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FDA ISSUES ITS FIRST FSVP WARNING LETTER

posted by Jennifer Diaz September 4, 2019 0 comments

FDA Warning LetterThe Food Safety Modernization Act (“FSMA”) is in full force and the U.S. Food and Drug Association (FDA) is now enforcing its Foreign Supplier Verification Program (FSVP) regulation. This blog discusses FDA’s first FSVP Warning Letter and illustrates what NOT to do when FDA starts asking questions about your products. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food imported into the United States has been produced in a manner that meets applicable U.S. food safety standards.

In the case of the U.S. importer who received the FSVP Warning Letter, their FDA issues started in the beginning of 2019 when a salmonella outbreak ravished multiple states and was traced back to the importer’s tahini product.

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CBPCustoms ExpertDepartment of Homeland SecurityEnforcementExportImportInternational BusinessInternational LawInternational TradeSupply ChainU.S.Customs

India removed from GSP, potential problems permeate

posted by Jennifer Diaz September 2, 2019 1 Comment

download-3After the Trump Administration officially revoked India’s participation in the Generalized System of Preference (GSP) on June 5, 2019, India announced that it intends to implement tariffs on roughly 30 HTS’s. The items, which include many agricultural goods, such as almonds and apples, would be subjected to 70% duties upon entry into India.

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