LinkedInFacebookInstagramXYouTube
305-456-3830|info@diaztradelaw.com

U.S. Food and Drug Administration (FDA)

Call 305-456-3830 or email info@diaztradelaw.com.

FDA Finalizes Guidance on Mandatory Cosmetics Recalls: What Importers and Manufacturers Need to Know

On October 23, 2026, the U.S. Food and Drug Administration (FDA) published a notice announcing the availability of its final guidance, Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry. The guidance explains how FDA intends to exercise its mandatory recall authority under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The guidance addresses when FDA may order a mandatory recall, the procedures the agency must follow, and what companies can expect if a recall is ordered. It finalizes a December 2025 draft without substantive changes.

For cosmetics importers, manufacturers, distributors, and brand owners, the guidance reinforces the importance of having procedures in place to identify potentially unsafe products, respond to FDA communications, and manage recalls when necessary.

Key Takeaways

  • FDA Clarifies Mandatory Recall Authority: The final guidance explains how FDA may require the recall of certain adulterated or misbranded cosmetic products that present a serious health risk.
  • Voluntary Recalls Remain the First Step: FDA generally must provide the responsible person an opportunity to voluntarily recall the affected product before ordering a mandatory recall.
  • Importers and Manufacturers Should Review Recall Procedures: Businesses should evaluate product traceability, supplier communications, distribution records, and recall response plans.
  • No New Recall Authority Created: The authority comes from MoCRA, enacted in 2022. The final guidance […]
By |2026-11-12T17:20:46-05:00November 12, 2026|Best Practices, Cosmetics, Import, U.S. Food and Drug Administration (FDA)|0 Comments
Read More

Reminder: FDA VQIP Applications for FY2027 Close September 1

Short summary: The FDA has announced that the application window for Fiscal Year 2027 Voluntary Qualified Importer Program (VQIP) benefits closes on September 1, 2026. For companies importing FDA-regulated food products, the approaching deadline is a reminder to confirm eligibility, supplier certifications, and application readiness before time runs out.

Deadline and Program Overview

Food importers seeking faster FDA entry processing should take note: the application period for the FDA’s Voluntary Qualified Importer Program (VQIP) for Fiscal Year 2027 closes on September 1, 2026.

VQIP is a fee-based program established under the Food Safety Modernization Act (FSMA) that rewards importers with strong supply chain controls and demonstrated food safety compliance. Approved participants may benefit from expedited review and importation of eligible human and animal food products entering the United States.

Applications approved for FY2027 will provide benefits beginning October 1, 2026, provided the FDA receives both an approved application and the required user fee payment.

Eligibility Requirements 

Importers should not assume they qualify automatically. One of the most common barriers to participation is the requirement that all foreign suppliers associated with VQIP-covered products maintain a valid facility certification issued by an FDA-accredited certification body under the FDA’s Accredited Third-Party Certification Program.

Importers considering VQIP participation should verify:

  • Foreign suppliers hold current certifications from FDA-accredited certification bodies.
  • Required regulatory audits have been completed.
  • Supply chain documentation and food safety controls meet FDA expectations.
  • Internal records are current and ready for submission through the VQIP portal.

Why Importers Should Consider VQIP

For qualifying importers, VQIP can provide meaningful operational advantages, including:

  • Expedited […]
By |2026-08-06T10:10:21-04:00August 6, 2026|U.S. Food and Drug Administration (FDA)|0 Comments
Read More

FDA Proposes New Rule Requiring Foreign Tobacco Manufacturers to Register with the Agency 

Short summary: The FDA has proposed a new rule that would require foreign tobacco product manufacturers to register their establishments and submit product listings to the agency, aligning them with requirements already applicable to domestic manufacturers. While the rule is not yet final, it signals increased oversight of imported tobacco products and enhanced coordination between the FDA and U.S. Customs and Border Protection (CBP).  

On June 26, 2026, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would significantly expand its oversight of imported tobacco products. If finalized, the rule would require foreign tobacco product manufacturers to register their establishments with the FDA and submit product listings. These requirements have long applied to domestic manufacturers but not foreign producers. 

The proposal is intended to close a regulatory gap, strengthen FDA enforcement, and improve the agency’s ability to identify and stop unauthorized tobacco products from entering the United States, particularly e-cigarettes and other youth-appealing products. It also represents another step toward increased scrutiny of imported tobacco products and the companies that manufacture them. 

What Would Change? 

Under the proposed rule, foreign establishments that manufacture, prepare, compound, or process tobacco products for sale in the United States would be required to: 

  • Register their manufacturing establishments with the FDA; 
  • Submit product listings identifying the tobacco products manufactured […]
By |2026-07-07T10:27:17-04:00July 7, 2026|Import, Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments
Read More

FDA Just Added the First New Sunscreen Active Ingredient in Nearly 30 Years

Topline summary: The FDA has approved bemotrizinol as the first new active sunscreen ingredient in nearly 30 years, creating both an opportunity and a compliance obligation for OTC drug and cosmetic importers. Being permitted to use the ingredient is not the same as being compliant. Manufacturers and importers still need to confirm their reformulated product meets every condition of the updated monograph, including SPF testing, Drug Facts labeling, and valid FDA drug establishment registration and drug listing before goods ship. 

On June 9, 2026, the FDA issued a final order adding bemotrizinol to the OTC sunscreen monograph (M020)—the first new sunscreen active ingredient permitted in the United States in nearly three decades. The ingredient, submitted by DSM Nutritional Products at concentrations up to 6 percent and long marketed in Europe, is now recognized by FDA as generally recognized as safe and effective (GRASE) for adults and children six months and older.

For manufacturers and importers of sunscreens and other OTC drug and cosmetic products, this is a real opportunity—and a regulated change that touches your formulation, your labeling, your drug establishment registration, and your treatment at the U.S. border. A new permitted active ingredient is not a green light to ship. It is a trigger to confirm your pre-compliance posture before the first entry.

The Challenge: “Permitted” Is Not the Same as “Compliant”

A GRASE listing means bemotrizinol may be used in OTC sunscreens. It does not mean your reformulated product automatically conforms to monograph M020. Sunscreen is regulated by FDA as an […]

By |2026-06-10T10:25:49-04:00June 10, 2026|U.S. Food and Drug Administration (FDA)|0 Comments
Read More

FDA Announces One-Day Inspection Pilot

The U.S. Food and Drug Administration (FDA) announced that it is piloting one-day inspectional assessments. These assessments will be shorter, more focused, and will complement existing standard FDA inspections.  

Shorter Inspections, More Coverage 

Launched in April 2026, the pilot is part of a broader initiative to make the agency’s inspectional resources more targeted and efficient. The new assessments will allow for broader coverage, enabling the agency to assess more facilities without compromising regulatory rigor. 

The pilot is being conducted across multiple FDA inspectorates, including human and animal foods, biologics, medical products, and clinical research programs. Facilities are selected using risk-based criteria such as:  

  • Product type 
  • Prior inspection outcomes 
  • Operational characteristics  

As of late April 2026, the FDA has completed approximately 46 one-day assessments.  

The agency made clear that one-day inspectional assessments are not intended to replace standard FDA inspections. Instead, they are meant to provide an additional tool to the agency’s enforcement approach. The ‘one-day’ framework is also flexible – investigators retain authority to expand the scope or duration of an assessment if warranted.  

The pilot will continue through fiscal year 2026. The FDA is currently developing evaluation metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making. 

What Facility Owners and Operators Should Do 

Facility owners and operators should remain ready […]

By |2026-05-26T12:37:26-04:00May 26, 2026|Best Practices, Cosmetics, Enforcement, Food, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|0 Comments
Read More
This website uses cookies and third party services. By continuing to use our website, you agree to the Privacy Policy. OK
Skip to content
Go to Top