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FDA

CosmeticsE-CigaretteFoodFSMAGluten FreeImportImport AlertInternational TradeMedical DevicesPre-complianceReasonable CareTobaccoU.S. Food and Drug Administration (FDA)

Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

posted by Jennifer Diaz May 27, 2021 0 comments

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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Best PracticesFoodImportInternational BusinessInternational TradeLabelingPre-complianceSupply ChainU.S. Food and Drug Administration (FDA)

FDA OPENS NEW FSVP PORTAL FOR IMPORTERS

posted by Jennifer Diaz May 27, 2021 0 comments

The Foreign Supplier Verification Programs for Food Importers (FSVP), establishes guidelines for importers to vet their foreign manufacturers, ensuring that food products destined for the U.S. are safe for consumption. The FSVP was created under the Food Safety Modernization Act (FSMA). These standards of the FSVP are in line with the goals articulated in the U.S. Food and Drug Administration (FDA)  Strategy for the Safety of Imported Food. The FDA seeks to ensure that foreign-manufactured food products are safe for consumption. Further, as discussed in Diaz Trade Law’s previously published blog, the FDA issued its first FSVP warning letter in September 2019, and since then has issued at least 60 more!

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FoodFSMAImportImport AlertInternational TradePre-complianceReasonable CareSupply ChainU.S. Food and Drug Administration (FDA)

FDA Further Extends UFI Flexibility For Food Facility Registrations

posted by Jennifer Diaz April 22, 2021 0 comments

Background on Food Facility Registration

The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the  FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

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Best PracticesCustoms ExpertEnforcementExportInternational BusinessInternational LawInternational TradePre-complianceU.S. Food and Drug Administration (FDA)

OTC Drug Manufacturers are Required to Pay FDA Facility User Fees by May 10, 2021

posted by Jennifer Diaz April 8, 2021 0 comments

Co-Authored by Denise Calle.

On March 26, 2021, Food and Drug Administration (FDA) published the Federal Register Notice, “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing the OTC Monograph Drug user fee program fee rates for FY 2021. This is the first year FDA has expanded user fees to OTC Drug Manufacturers and submitters of OTC monograph order requests.

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Best PracticesCustoms ExpertEnforcementEventsInternational LawInternational TradeLabelingU.S. Food and Drug Administration (FDA)

Cleaning for COVID-19 – Importing Cleaning Products: Who Regulates You?

posted by Jennifer Diaz March 15, 2021 0 comments

Co-Authored by Denise Calle

A year into the COVID-19 pandemic, the U.S. Environmental Protection Agency (EPA) and The Food and Drug Administration (FDA) are in full enforcement mode carefully monitoring novel products claiming to treat, mitigate, or “kill” COVID-19. Compliance advisories issued at the beginning of the pandemic are now being replaced with enforcement advisories. Manufacturers, importers, distributors, and others engaged in the production or sale of products claiming to mitigate or “kill” COVID-19 should be more cautious than ever when developing product claims for both product labels and marketing material or alternatively, confirm products comply with the numerous regulations governing COVID-19 cleaning products.

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Best PracticesCustoms ExpertEnforcementEventsExportImportInternational BusinessInternational LawInternational TradeSupply ChainU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

FDA Webinar on Human Drug Importations

posted by Jennifer Diaz March 2, 2021 0 comments

On January 14, 2021, the United States Food and Drug Administration (FDA)  kicked off the year with a set of Webinars for the trade community. Specifically, the Center for Drug Evaluation and Research (CDER) held its first annual Small Business and Industry Assistance (SIBA) Compliance Conference.  The topics covered various areas dedicated to compliance including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.

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Best PracticesCOVID-19Customs ExpertEnforcementExportImportImport AlertInternational BusinessInternational LawInternational TradeMexicoSeizuresSupply ChainU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

FDA Import Alert on Mexican Hand Sanitizer

posted by Jennifer Diaz February 4, 2021 0 comments

For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.

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Customs ExpertEnforcementExportFoodImportSupply ChainU.S. Food and Drug Administration (FDA)

Comment on FDA’s Proposed Rule – French Dressing

posted by Jennifer Diaz January 14, 2021 0 comments

On December 21, 2020, the Food and Drug Administration (FDA) proposed a rule to revoke the Standard Of Identity (SOI) for French dressing. FDA found that French dressings’ current standard of identity “no longer promotes honesty and fair dealing in the interest of consumers”.  Effectively the amending of the SOI may allow producers more flexibility, keeping the market competitive with nonstandardized foods.

According to the Federal Register Notice, the proposed rule would not require anything new from salad dressing manufacturers. Rather, by providing the flexibility for innovation, the amendment to French Dressing’s SOI presents an opportunity for social benefits at no cost to the industry or consumer.

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Caribbean Basin InitiativeCustoms ExpertExportFoodImportInternational BusinessInternational TradeU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

OPPORTUNITIES IN AGRICULTURE – WHY CHOOSE THE CARIBBEAN?

posted by Jennifer Diaz September 28, 2020 1 Comment

Because of its production limitations, the Caribbean has become a growing market for U.S. suppliers. As one of the most diverse regions in the world, the islands of the Caribbean attract a lot of visitors. With the development of tourism comes an increased demand for imported products from the U.S.—due in part to their perceived higher quality.

 

 

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Best PracticesCOVID-19CTPATCustoms ExpertEnforcementExportImportInternational BusinessInternational LawInternational TradeU.S. Customs and Border Protection (CBP)U.S. Food and Drug Administration (FDA)

DTL Tuned-In to the 2020 World Trade Center Miami’s International Trade Week – Check out our Recap:

posted by Jennifer Diaz May 27, 2020 0 comments

111During the weeklong series of 10 informative webinars on trade regulations, we heard TOP TIPs from numerous federal agencies, including U.S. Customs & Border Protection (CBP), U.S. Food and Drug Administration (FDA)’s Division of Southeast Imports, Miami’s CBP Fines, Penalties & Forfeitures (FP&F) Office, Miami CTPAT Field Office and more! Each webinar was produced to assist importers and exporters understand compliance and hot issues. Below are summaries of two webinars – FDA Import Operations Associated with COVID-19 Efforts and CTPAT – State of the Program / Minimum Security Criteria Updates:
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