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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

EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in...more

Florida bans “cultivated” meat- first in a potential series of similar bans

Key Takeaways - What Happened: Florida passed a ban on the manufacture and sale of cultivated meat. Who’s Impacted: Cultivated meat manufacturers and distributors....more

EPA Renews Biotechnology Innovation Efforts under New Executive Order

On September 12, 2022, President Biden issued an Executive Order (EO) calling on his Administration to renew efforts to improve the clarity and efficiency of regulatory processes for biotechnology products. Launching a new...more

USDA Opens Comment Period for Labeling Requirements for Cell-Cultured Meat and Poultry Products (Updated)

Update - In response to stakeholder requests, USDA-FSIS has extended the comment period for its proposed rule to December 3, 2021. On September 3, 2021, the U.S. Department of Agriculture, Food Safety and Inspection...more

USDA Opens Comment Period for Labeling Requirements for Cell-Cultured Meat and Poultry Products

On September 3, 2021, the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS) opened a comment period in advance of a proposed rule on labeling requirements for meat and poultry products comprised...more

Bipartisan Legislation Proposed to Authorize CBD Dietary Supplements and Food Additives

On May 19, 2021, Senators Rand Paul (R-KY), Ron Wyden (D-OR), and Jeff Merkley (D-OR) introduced the Hemp Access and Consumer Safety Act of 2021 (SB 1698), which would address long-standing regulatory uncertainty facing...more

USDA Announces Intent to Transfer Regulatory Authority Over Animal Biotechnology from FDA to USDA

Key Takeaways What Happened: USDA is seeking comment on its intent to transfer portions of the regulatory framework governing agricultural animals modified or produced by genetic engineering from USDA to FDA....more

FDA Requests Comments on Labeling Cell-Cultured Seafood Products

On October 7, the U.S. Food and Drug Administration (FDA) published a request for comment on proposed labeling for cell-cultured seafood products. 85 FR 63277 (Oct. 7, 2020). Stakeholders now have an opportunity to comment on...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

U.S. Government Accountability Office Issues Recommendations to Clarify Joint Framework for Regulating Cell-Cultured Meat Products

The U.S. Government Accountability Office (GAO) is recommending that the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA) strengthen existing efforts to prepare for oversight of...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

FDA Reopens Public Docket Seeking Data on the Safety and Potential Benefits of CBD

On March 5, 2020, the U.S. Food and Drug Administration (FDA) announced an expansion of its effort to comprehensively evaluate cannabidiol (CBD) products, including an opportunity for stakeholders and other members of the...more

Senate Introduces Bill to Formalize Joint Framework for Regulating Cell-Cultured Meat Products

Producers of cell-cultured meat – synthetic meat products derived from animal cell cultures that are intended to simulate the taste, appearance, and texture of traditional animal products – may soon receive regulatory...more

Following Hearing, FDA Will Accept Comments on Cannabis Until July 2

On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a full-day public hearing to obtain scientific information about issues associated with food and other products that contain cannabis and cannabis-derived...more

USDA Issues Legal Opinion on Hemp

On May 28, 2019, the U.S. Department of Agriculture (USDA) released a legal opinion resolving significant ambiguities about the legality of hemp following the passage of the Agricultural Improvement Act of 2018 (more commonly...more

2018 Farm Bill Legalizes Industrial Hemp

Passage of the Agricultural Improvement Act of 2018 (commonly known as the “Farm Bill") into law on Thursday, December 20, 2018 is anticipated to encourage rapid growth in the burgeoning U.S. hemp industry. The $867 billion...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

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more

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