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FDA Issues

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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
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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
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FDA Update: Increased Cosmetics Oversight Under MoCRA 

The U.S. Food and Drug Administration (FDA) recently published a Voices blog, highlighting the progress the agency has made in implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA Background

MoCRA instituted a sweeping overhaul of federal cosmetics regulation that significantly expanded the FDA’s authority over the cosmetics and personal care industry. The FDA views MoCRA as the most substantial expansion of FDA cosmetics oversight since the Federal Food, Drug, and Cosmetic Act was enacted in 1938.

MoCRA was signed into law in December 2022 and introduced a broad range of new regulatory requirements aimed at improving consumer safety, increasing transparency, and strengthening FDA enforcement capabilities. The law applies to a wide array of cosmetic products, including makeup, skincare, fragrances, shampoos, and other personal care items used daily by consumers.

Implementation Update

In its recent update, the FDA highlighted several ways the legislation is already reshaping the cosmetics industry. One of the most significant developments is the agency’s increased visibility into cosmetic manufacturing and ingredient use through mandatory facility registration and product listing requirements. The FDA reported:

  • 15,000 unique, active cosmetic product facility registrations
  • Over 1 million unique, active cosmetic product listings.
  • adverse events reported by industry increased by more than threefold

Before MoCRA, the FDA received just 5,176 cosmetic establishment registrations and 35,102 cosmetic product listings through the Voluntary Cosmetic Registration Program. This […]

By |2026-05-08T14:51:49-04:00May 8, 2026|Cosmetics, Enforcement, International Trade, U.S. Food and Drug Administration (FDA)|0 Comments
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FDA Finalizes New National Drug Code Format

On March 5, 2026, the Food and Drug Administration (FDA) published a Final Rule adopting a new format for the National Drug Code (NDC). The rule takes effect on March 7, 2033. On the effective date, the FDA will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs to the uniform 12-digit NDC format.

What is the NDC?

The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by the FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

  • 4-4-2
  • 5-3-2
  • 5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once the FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- […]

By |2026-03-05T10:07:14-05:00March 5, 2026|Enforcement, Food, Import, Medical Devices, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|0 Comments
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FDA Takes Action to Improve Gluten Ingredient Disclosure in Foods

On January 22, 2026, the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food.

Background

The FDA received a citizen petition requesting that the FDA act to protect consumers with celiac disease by better enabling them to identify, through labeling, whether a food includes gluten-containing grains (GCGs), and to address cross-contact with GCGs. FDA subsequently reviewed available data and reports, which indicated that serious data gaps are limiting the agency’s ability to fully evaluate the public health importance of these ingredients, including data on adverse reactions.

Request for Information

The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.

The agency is inviting comments concerning adverse reactions due to “ingredients of interest” ( i.e., non-wheat GCGs and oats) in the United States. The RFI also aims to collect data on labeling issues or concerns with identifying ingredients of interest on packaged food products in the United States.

The FDA is particularly interested in:

  • Data and information on IgE-mediated and non-IgE-mediated food allergies and adverse reactions to non-wheat GCGs (including prevalence, severity, and potency).
  • Data and information on gluten in oats (including frequency and amounts of gluten in oats), and the prevalence, severity, and potency of IgE-mediated and non-IgE-mediated allergy and adverse reactions to oats.
  • Data and information on undisclosed ingredients of interest (including their prevalence and usage amounts […]
By |2026-01-23T07:58:08-05:00January 23, 2026|FDA Issues, Food, Gluten Free, news, U.S. Food and Drug Administration (FDA)|0 Comments
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