FDA Seeks Public Comments on Proposed Final Order for OTC Sunscreen Safety

FDA is proposing to amend the Over-the-Counter (OTC) Monograph which covers sunscreen drug products for OTC human use. The public has until November 12, 2021 to submit comments on the impact the proposed changes may have on consumers and industry. This blog provides background on why FDA is considering such changes and discusses FDA’s newly deemed final order for OTC sunscreens as well as the changes included in the proposed order for sunscreens. Industry is encouraged to contact Diaz Trade Law to assess the implications of the proposed changes on its products and to assist in drafting and submitting comments to FDA.

Why is FDA Taking New Steps to Enhance Sunscreen Safety?

The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act reformed and modernized the way FDA regulates certain OTC monograph drugs, including sunscreen.

The CARES Act replaced the rulemaking process for OTC monograph drugs with an administrative order process for issuing, revising, and amending the OTC monographs.  The administrative order process gives FDA new tools to help revise the OTC monographs as science changes, innovation progresses, new data becomes available, or emerging safety signals arise.

For sunscreens specifically, in addition to establishing a deemed final order, the CARES Act requires FDA to issue a proposed order to amend and revise the deemed final order for sunscreens. The FDA believes that most sunscreens on the market will be in compliance with the deemed final order because the provisions are nearly identical to the pre-CARES Act marketing conditions for sunscreens.

As background, an OTC […]

Comment Now – CBP Proposed Rule on Country of Origin Determination for Imports under USMCA

Background on CBP Country of Origin Determination and USMCA

All merchandise of foreign origin imported into the United States (U.S.) must generally be marked with its country of origin, and it is subject to a country of origin (COO) determination by CBP. The country of origin of imported goods may be used as a factor to determine eligibility for preferential trade treatment under a free trade agreement.

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By |2021-10-07T14:33:42-04:00September 21, 2021|AD/CVD, Canada, Customs Broker, Import, International Law, International Trade, Mexico, NAFTA, Pre-compliance, Reasonable Care, U.S. Customs and Border Protection (CBP), USMCA|Comments Off on Comment Now – CBP Proposed Rule on Country of Origin Determination for Imports under USMCA

Keysight Technologies Pays $6.6M to State Department for Export Violations

The U.S. Department of State and the California-based company Keysight Technologies Inc. have reached a settlement of $6.6 million for violations of the Arms Export Control Act (AECA), 22 U.S.C. § 2751 et seq., and the International Traffic in Arms Regulations (ITAR), 22 C.F.R. Parts 120-130.  This settlement comes after a compliance review by the Office of Defense Trade Controls Compliance (DDTC) in the Department’s Bureau of Political-Military Affairs for exporting unauthorized software used for testing radar equipment (on fixed or mobile platforms) to countries including Russia and China.

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By |2021-10-07T14:34:25-04:00September 17, 2021|Customs Expert, Enforcement, Export, International Trade, ITAR|Comments Off on Keysight Technologies Pays $6.6M to State Department for Export Violations

$432k Penalty From BIS Stresses Importance of Export Compliance

Building and maintaining a strong export compliance program is essential if you don’t want your company to become a headline. The Bureau of Industry and Security (BIS) announced an administrative settlement with a penalty amount of $432,570, for Alfa Laval US of Richmond, VA and Alfa Laval Middle East Ltd. of the United Emirates for alleged violations of the Export Administration Regulations. 

Do you know if your company is meeting export regulations and obligations? Obtaining counsel who is an expert in export compliance is the first step. Are your employees/staff trained in all exporting issues? Our one-hour webinar is a must attend to help provide you with a foundation of tools and key elements that must be included in your export compliance program. Register today to hear from the following experts: 

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Food Importers: How to Import Food Compliantly & Survive a FSVP Audit

The U.S. Food and Drug Administration (FDA) is now  auditing Foreign Supplier Verification Program (FSVP) Importers to ensure they comply with the FSVP program. To date, over 92 warning letters have been issued against companies for FSVP violations. If your business is importing food into the U.S., or wants to start, our one-hour, NEI accredited, webinar on “Importing Food in Compliance with U.S. FDA & Surviving A FSVP Audit” will provide best practices and TOP tips to comply with FDA regulations and avoid, navigate, and mitigate any potential  FDA compliance action.

Register today to to hear directly from Senior Trade Advisor, Domenic Veneziano, DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally import food and best practices for surviving a FSVP audit.

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By |2021-09-07T15:53:46-04:00September 6, 2021|Best Practices, Food, Import, International Trade, Labeling, Pre-compliance, U.S. Food and Drug Administration (FDA)|Comments Off on Food Importers: How to Import Food Compliantly & Survive a FSVP Audit

Jen Diaz to Moderate FCBF Webinar on IPR featuring CBP Branch Chief and UL

Diaz Trade Law is excited to announce that President Jennifer Diaz will be moderating the upcoming FCBF webinar titled “IPR with CBP and UL” with the Chief of the Intellectual Property Rights Branch of U.S. Customs and Border Protection, Alaina van Horn, and UL Brand Protection Manager, Lisa Deere.

The Florida Customs Brokers & Forwarders Association (FCBF) encourages all custom brokers, patent, trademark and all international trade professional to join its Intellectual Property Rights (IPR) with U.S. Customs and Border Protection (CBP) and UL. This one-hour webinar will give custom brokers, importers, and all other international trade professionals the ability to learn and understand CBP’s IPR customs and enforcement. 

This webinar will be Friday, September 3, 2021 at 11:30 AM EST.  

Register Now! 

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By |2021-09-02T16:43:47-04:00September 2, 2021|Best Practices, Counterfeits, Customs Broker, Import, International Trade, IPR, Trademarks and Logos, Seizures, Speaking, U.S. Customs and Border Protection (CBP)|Comments Off on Jen Diaz to Moderate FCBF Webinar on IPR featuring CBP Branch Chief and UL
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