U.S. Food and Drug Administration (FDA) Archives - Page 19 of 42

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

India removed from GSP, potential problems permeate

After 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-listed items. The items-which include many agricultural goods, such as almonds and apples- would be subjected to 70% duties upon entry.

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Ignorance is No Defense! Learn What CBP Considers Prohibited/Restricted

United States Customs and Border Protection (CBP), one of the principal agencies under the leadership of DHS, has released an updated list detailing items prohibited from entry into the US. These goods fall under a variety of classifications, including “dangerous toys, cars that don’t protect their occupants in a crash, bush meat, or illegal substances like absinthe and Rohypnol”.

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By Jennifer Diaz|2022-07-07T13:35:11-04:00July 3, 2019|CTPAT, Customs Expert, Enforcement, Expert, Export, FDA Issues, Import, International Business, International Law, International Trade, International Travel, Pre-compliance, TSA, U.S Department of Homeland Security (DHS), U.S. Customs and Border Protection (CBP), U.S. Department of State (DOS)|0 Comments

Government Agencies Seek out Blockchain solutions to Strengthen Current Systems

In an effort to improve the security and tranquility of Americans, Department of Homeland Security (DHS) along with U.S. Customs and Border Protection (CBP) U.S. Citizen and Immigration Services (USCIS) and Transportation Security Administration (TSA) are looking for tech-startups and scientific talent to be integrated into DHS’ Silicon Valley Innovation Program (SVIP). DHS and its subsidiary groups seek to find commercially viable companies to invest in, many of which reside in the same territory of SVIP–Silicon Valley. The goal is to bridge the gap between American technological innovation and the security and effectiveness of government agencies, tasked with the protection of the country.

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By Jennifer Diaz|2022-07-07T13:33:17-04:00June 19, 2019|China, China Trade War, Enforcement, Expert, Export, International Business, International Law, International Trade, Supply Chain, Technology, U.S Department of Homeland Security (DHS), U.S. Customs and Border Protection (CBP), U.S. Department of State (DOS), U.S. Food and Drug Administration (FDA)|0 Comments

Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun’s ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

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By Jennifer Diaz|2022-07-07T13:31:00-04:00May 30, 2019|Customs Expert, Enforcement, Expert, FDA Issues, Import, International Trade, IPR, Trademarks and Logos, Labeling, Medical Devices|0 Comments

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