U.S. Food and Drug Administration (FDA) Archives - Customs & International Trade Law Firm

FDA Proposes New Rule Requiring Foreign Tobacco Manufacturers to Register with the Agency
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FDA Proposes New Rule Requiring Foreign Tobacco Manufacturers to Register with the Agency
Import, Tobacco, U.S. Food and Drug Administration (FDA)

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 Jennifer Diaz|2026-07-07T10:27:17-04:00July 7, 2026|Import, Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Just Added the First New Sunscreen Active Ingredient in Nearly 30 Years
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FDA Just Added the First New Sunscreen Active Ingredient in Nearly 30 Years
U.S. Food and Drug Administration (FDA)

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

FDA Update: Increased Cosmetics Oversight Under MoCRA
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FDA Update: Increased Cosmetics Oversight Under MoCRA
Cosmetics, Enforcement, International Trade, U.S. Food and Drug Administration (FDA)

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 Jennifer Diaz|2026-05-08T14:51:49-04:00May 8, 2026|Cosmetics, Enforcement, International Trade, U.S. Food and Drug Administration (FDA)|0 Comments