Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be possible. Specifically, actions related to product imports, ingredients, long-standing Standards of Identity, and recall communications are changing the FDA regulatory landscape.
Elimination of the de Minimis Import Exemption
Until recently, small shipments of FDA-regulated goods—valued under $800—could enter the U.S. under a de minimis exemption. This meant they did not undergo significant regulatory scrutiny by the Agency, as a matter of efficient use of resources. As of July 9, 2025, U.S. Customs and Border Patrol announced this exemption no longer applies to FDA-regulated products. All imported food, dietary supplements, and cosmetics, regardless of value, must now be declared and properly documented for FDA review.
The result will be increased scrutiny of all products at port. Now, even low-value packages are subject to the same FDA scrutiny as high-value shipments, with respect to safety and counterfeit and adulterated products. Furthermore, all importers must file full FDA documentation for each shipment, including Prior Notice and the proper use of product codes. Finally, the Agency will be able to scrutinize low-value shipments that were purchased online if they are offered for import. Importantly, this means the Agency is more likely to discover repeat offenders because of its electronic review system.
Ingredient-Level Oversight: FDA Approval of Natural Dyes
On July 14, 2025, FDA announced it approved a color additive petition for gardenia blue, a naturally derived dye made from the gardenia fruit and soy protein. Gardenia blue is set to replace synthetic blue dyes in products like sports drinks and candies. FDA is still in the process of reviewing whether soy must be listed as an allergen, as petitioners claim it is not present in the final ingredient. Gardenia blue is the fourth natural dye FDA approved this year, along with galdieria extract blue, butterfly pea flower extract, and calcium phosphate. This reflects FDA’s initiative to replace synthetic dyes with natural ones, including by urging companies to phase out Red Dye No. 3 (FD&C Red 3) ahead of the 2027 deadline.
In addition to FDA’s ban of Red Dye No. 3 earlier this year, the Agency intends to revoke authorization for Citrus Red No. 2 and Orange B, and work with companies to phase out other synthetic dyes (e.g., FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2).
Deregulatory Action: 52 Food Standards of Identity to Be Revoked
On July 16, 2025, FDA published one final and two proposed rules centered on revoking Standards of Identity (SOIs) for a total of 52 products. First, the Final Rule revokes the standards for 11 canned fruits and vegetables, which includes 7 standards for canned fruits artificially sweetened with saccharin or sodium saccharin. Second, one Proposed Rule would revoke the SOIs for 18 dairy products (e.g., certain milk and cream products, cheeses and related cheese products, and frozen desserts). This is a particularly notable proposal, as it could significantly impact the dairy industry. Finally, the other Proposed Rule would revoke the SOIs for 23 food products (e.g., bakery products, canned fruit juices, macaroni and noodle products, fish and shellfish, and food dressings and flavorings).
These actions are part of the FDA’s goal of identifying and eliminating “outdated or unnecessary regulations.” The Agency states that the 52 SOIs are either unnecessary or outdated because of advances in consumer protections like ingredient safety requirements, labeling, and safe production practices. FDA initially established SOIs to provide consistency in the marketplace by ensuring that foods have certain ingredients and characteristics and are produced or formulated in a specific manner. The final rule will take effect September 22, 2025, unless it receives significant adverse comments by August 18, 2025. For the proposed rules, the public has until September 15, 2025, to provide comments.
The removal of SOIs for certain dairy products is especially notable for several reasons that go beyond the routine rollback of outdated regulations. Be on the lookout for our deep dive into how this proposal could affect consumers and industry.
Operation Stork Speed: FDA Urges the Infant and Children's Food Industry to Improve Recall Communications
Recently, FDA issued a letter asking companies involved in the manufacture and distribution of infant formula, baby food, and foods intended for children to improve the speed, clarity, and transparency of their product recall communications. In the letter, released July 9, 2025, the Agency emphasized the public health responsibility these companies bear in protecting vulnerable consumers. FDA reminded the industry of its legal obligation to promptly notify the Agency when a decision to initiate a recall is made and encouraged broader efforts to proactively inform the public in clear and accessible ways. To support this industry call to action, FDA is launching several short-term initiatives, including a centralized web page for recalls, enhanced filtering on the FDA Enforcement Report system, and leveraging stakeholder feedback to improve recall communications. Longer-term plans involve designing a digital platform for more efficient recall documentation and exploring AI-based tools for data analysis.
What to Do as a Brand
- Prepare for increased product scrutiny at the border—even for small shipments
- Review your supply chain partners to ensure robust FSVP documentation
- Verify that all facility and importer registrations are current and complete
- Monitor regulatory developments for both product ingredients
- Consider providing comment on FDA’s proposed revocations of the SOIs
- Streamline your recall procedures to meet FDA's standard for swift, transparent, and effective recalls
