Blog
Did the FDA Ban Red Number 3?
FDA has taken action to prohibit FD&C Red Number 3 in foods and drugs. Red Number 3 is also known as erythrosine. On January 16, 2025, FDA published a notice in the Federal Register revoking the authorized use in food and ingestible drugs of FD&C Red Number 3. The prohibition on using Red Number 3…
De Minimis Rule Entry Process Ends
On August 29, 2025, U.S. Customs and Border Protection (CBP) began rejecting all De Minimis Rule (aka Type 86) entries. The De Minimis Rule had previously allowed shipments valued at $800 or less to be filed as Type 86 entries with limited data elements provided to CBP. This action implements the executive order issued on…
FDA De Minimis Exemption for Food Shipments Revoked
On July 9, U.S. Customs and Border Protection (CBP) announced that all shipments presented for entry of FDA-regulated commodities, including food, must be submitted to FDA for review regardless of value. Previously FDA had exempted food from having to be reviewed at entry by the agency if the shipment was valued at less than $800…
Supreme Court Declines to Expedite Review of Tariff Litigation
Tariff litigation update: On June 20, 2025, the U.S. Supreme Court denied a motion by Learning Resources, Inc. to expedite consideration of a petition for writ of certiorari before judgement in their challenge to the authority of Trump Administration to impose broad tariffs under the International Emergency Economic Powers Act (IEEPA). Therefore, the tariffs will…
What is PCQI?
PCQI means Preventive Controls Qualified Individual and is an important part of the Preventive Controls for Human Food Rule (21 CFR Part 117) and Preventive Controls for Animal Rule (21 CFR Part 507). The term is defined in 21 CFR 117.3 and 21 CFR 507.3: A qualified individual who has successfully completed training in the…
Additional 25% Tariffs on Canada and Mexico Suspended March 6
On March 6, 2025, President Trump announced a suspension of most of the additional 25% tariffs imposed on March 4, 2025, on Mexico and Canada. Under the new tariff structure the additional 25% tariffs will apply only to goods that do not qualify as originating goods under the U.S. Mexico Canada Agreement (USMCA). The duties…
CBP: Canada and Mexico Tariffs of 25% Start March 4
U.S. Customs and Border Protection tonight published Cargo Systems Message Service notices #64297449 and #64297292 regarding Canada and Mexico tariffs. The notices instruct customs brokers and the importing community that effective 12:01 am eastern standard time, all products of Canada and Mexico, including food, are subject to an additional 25% ad valorem tariff. CSMS #64297449 states that all products…
What is FSVP?
FSVP stands for Foreign Supplier Verification Program. FSVP is a regulation that requires importers of most foods to verify the food safety practices of their foreign suppliers. When did FSVP go into effect? The Foreign Supplier Verification Program regulation went into effect for most importers on May 30, 2017. Why did the United States require…
Food Industry Regulatory Update January 28, 2025
In This Week’s Edition: FDA Revokes Use of Red No. 3 The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is amending its color additive regulations to no longer allow…
Is Coconut an Allergen? FDA Allergen Labeling Requirements
The Food Allergen and Consumer Protection Act of 2004 (P.L. 108-282) requires major food allergens to be labeled on all packaged foods that are under the jurisdiction of the U.S. Food and Drug Administration (FDA), including dietary supplements. Tree nuts are one of the major food allergens defined in the law. Is coconut an allergen?…