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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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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FDA OPENS NEW FSVP PORTAL FOR IMPORTERS

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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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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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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OPPORTUNITIES IN AGRICULTURE – WHY CHOOSE THE CARIBBEAN?

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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COVID FLEXIBILITY – FDA Announces Temporary Policy Regarding Certain Labeling Requirements for Foods

The U.S. Food and Drug Administration is issuing a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators. The goal is to provide regulatory flexibility, where appropriate, to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic.

Entitled “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” this guidance is one of several the FDA has issued to provide temporary flexibility to the food industry to help support the food supply chain and meet consumer demand during the pandemic.

 

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CBP ISSUES WITHHOLD RELEASE ORDER TARGETING TUNA HARVESTED WITH FORCED LABOR

Effective February 4, 20Tuna19, Customs and Border Protection (CBP) has ordered the detention at all U.S. ports of entry of tuna and any such merchandise manufactured wholly or in part by the Tunago No. 61, which is a fishing vessel owned by Tunago Fishery Co., LTD a company located in Vanuatu. According to the CBP press release of February 6, 2019, importers of detained shipments are provided an opportunity to export their goods or demonstrate that they were not produced with forced labor. The Tariff Act of 1930 (19 U.S.C. § 1307) bans imports of merchandise or food produced in whole or at least in part by forced labor, including convict labor, forced child labor, and indentured labor.

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Bioengineered Food Labeling

In our July 27, 2018 blog , we explained what bioengineered (BE) food is and informed you about the United States Department of Agriculture’s (USDA) Agricultural Marketing Service’s (AMS) new proposed rule for BE foods. The new rule is a result of the 2016 amendment to the Agricultural Marketing Act of 1946, which would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content. The amended Act directs the Secretary to establish the National Bioengineered Food Disclosure Standard (NBFDS) for disclosing any BE food and any food that may be bioengineered. This proposed rule is intended to provide a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. The standardized disclosure of information will facilitate food purchasing for consumers by eliminating the current uncertainty when purchasing food; effectively improving overall consumer confidence, without harming food manufacturing; and providing farms and production companies a logical, consistent standard for future labeling and packaging. […]

FDA Issues Guidance Documents on Food Facility Registration

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 FDA

Constituent Update

August 17, 2018, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act).

One of the documents being published today is the seventh edition of a guidance to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements. Previous iterations of this guidance were released following the adoption in 2002 of amendments to the FD&C Act that required food facility registration. […]

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