September 2019

New FTC Warning Letters Issued to Companies Selling CBD Products

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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By Jennifer Diaz|2022-07-07T13:46:03-04:00September 24, 2019|CBD, Export, FDA Issues, Import Alert, International Law, International Trade, U.S. Customs and Border Protection (CBP), U.S. Federal Trade Commission (FTC)|0 Comments

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

On 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 28^th, 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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By Jennifer Diaz|2022-07-07T13:45:15-04:00September 17, 2019|FDA Issues, International Law, International Trade, International Travel|0 Comments

FDA ISSUES ITS FIRST FSVP WARNING LETTER

The 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 their Tahini product.

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By Jennifer Diaz|2022-07-07T13:44:26-04:00September 4, 2019|Import, U.S. Food and Drug Administration (FDA)|1 Comment

New FTC Warning Letters Issued to Companies Selling CBD Products

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

FDA ISSUES ITS FIRST FSVP WARNING LETTER

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