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

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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By |2021-07-22T11:27:59-04:00May 27, 2021|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Trade, Medical Devices, Pre-compliance, Reasonable Care, Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

FDA Further Extends UFI Flexibility For Food Facility Registrations

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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By |2021-10-07T15:02:48-04:00April 22, 2021|Food, FSMA, Import, Import Alert, International Trade, Pre-compliance, Reasonable Care, Supply Chain, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Further Extends UFI Flexibility For Food Facility Registrations

FDA Webinar on Human Drug Importations

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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Comment on FDA’s Proposed Rule – French Dressing

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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By |2021-10-12T15:05:30-04:00January 14, 2021|Customs Expert, Enforcement, Export, Food, Import, Supply Chain, U.S. Food and Drug Administration (FDA)|Comments Off on Comment on FDA’s Proposed Rule – French Dressing

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 the importer’s tahini product.

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By |2021-10-28T15:35:34-04:00September 4, 2019|U.S. Food and Drug Administration (FDA)|1 Comment

Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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By |2022-07-06T15:47:05-04:00May 19, 2017|Best Practices, Customs Broker, Events, Food, FSMA, Import, Import Alert, Seizures, Speaking, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off on Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

I am Not Worried That My Food Is “Safe”, Are You?

The United States Congress is considering legislation to make the food we eat, especially imported food, "safe and secure". In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy. The U.S. Food and Drug Administration already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human consumption. The current FDA system is working very well, and the only achievement of the proposed legislation will be to increase the price of food.

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