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FDA Seeks Public Comment on Post-Market Chemical Review Prioritization Method

Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released its draft post-market chemical review prioritization method for public comment. Public comments are due July 18, 2025....more

MAHA Assessment: What Food and Chemical Stakeholders Need to Know

When the Make America Healthy Again (MAHA) Commission unveiled its Make Our Children Healthy Again Assessment on May 22 (reissued May 28), it framed the document as a clarion call: U.S. regulators must combat childhood...more

FDA to Overhaul Post-Market Chemical Review Program for Food Chemicals

Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) announced plans to update its food safety post-market chemical review program over the next few months to increase transparency and accelerate its...more

FDA Food Chemical Regulation: Understanding Pesticide Action Levels

The U.S. Food and Drug Administration’s (FDA) March 2025 publication of its new “Chemical Contaminants Transparency Tool” spotlighted a lesser-known aspect of FDA’s regulation of pesticide residues on food: action levels....more

FDA Food Chemical Regulation After the MAHA Executive Order

Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This was the latest example of...more

GRAS Self-Affirmation for Food Ingredients – To Be or Not to Be?

Key Takeaways - What Happened: HHS Secretary Kennedy directed FDA to consider removing the current self-affirmation pathway for determining that a food ingredient is Generally Recognized as Safe (GRAS)....more

FDA Proposes New Rule on Testing Talc-Containing Cosmetic Products

Mandatory testing of talc-containing cosmetic products is coming. At the end of December, the Food and Drug Administration (FDA) proposed a cosmetics rule and test method for asbestos in talc that was required under Section...more

MoCRA Guidance Update for Registration and Listing of Cosmetic Product Facilities and Products

Key Takeaways - What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of cosmetic product facilities and products....more

MoCRA Update for Starting the Year Off Right

Key Takeaways - What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December....more

MoCRA Enforcement Pushed Six Months

Key Takeaways - What Happened: FDA announced delayed enforcement for MoCRA facility registration and product listing information....more

Cosmetic Product Registration and Listing Under MoCRA Comes Closer

Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, providing more information on the newly...more

More Chemicals Banned from Cosmetics

With the passage of Washington’s Toxic-Free Cosmetics Act of 2023, several states are gearing up to pass similar laws. The new Washington law bans the manufacture, sale, and distribution of cosmetic products that contain any...more

Cosmetics – Moving From Voluntary Compliance to Mandatory Regulation

Compared to drugs and even food, cosmetics have been the regulatory stepchild in the Federal Food, Drug, and Cosmetic Act (FFDCA) since its adoption in 1938 – until now. At the end of 2022, Congress enacted legislation to...more

FDA Updates Policies to Increase Supply of Ethanol Available for Use in Hand Sanitizers

Key Takeaways: • What Happened: FDA updated its temporary hand sanitizer production policies to permit use of fuel- or technical-grade ethanol that contains certain impurities up to given limits. • Who’s Impacted:...more

FDA Policy Provides Enforcement Relief Regarding Certain Medical Devices Due to Pandemic

Key Takeaways: • What Happened: FDA announced temporary relief from certain premarket regulatory requirements pertaining to certain new or modified medical devices intended for use against the novel coronavirus....more

FDA and FTC Warn Dietary Supplement Manufacturers Against Making Fraudulent Anti-Coronavirus Claims

Beware of fraudulent claims that products will kill the coronavirus (officially, the Novel Coronavirus SARS-CoV-2) or cure the disease caused by that virus (Novel Coronavirus Disease 2019, abbreviated as COVID-19). The Food...more

Competing Cosmetic Safety Bills Would Each Expand FDA Regulatory Authority

On October 25, 2017, Senator Orin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act.” The proposed legislation would amend the Federal Food, Drug and Cosmetic Act of 1938 (“FFDCA”) and allow the...more

Cosmetic Safety Legislation Introduced, Again

In what is the latest in a line of Congressional proposals to beef up the federal government’s authority to regulate cosmetics, Senator Dianne Feinstein (D-CA), has proposed a bill aimed at dramatically increasing Food and...more

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