News & Analysis as of

Labeling Enforcement Food and Drug Administration (FDA)

Mintz - Health Care Viewpoints

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

Wiley Rein LLP

FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations

Wiley Rein LLP on

The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): •Standardized test methods to detect...more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

King & Spalding

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

King & Spalding on

On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

King & Spalding on

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

Greenberg Glusker LLP

Modernization of Cosmetics Regulation Act - What Companies Need to Know

Greenberg Glusker LLP on

Beginning on December 29, 2023, the Modernization of Cosmetics Regulation Act (MOCRA) became effective. Signed into law on December 29, 2022, MoCRA significantly expands the U.S. Food and Drug Administration’s (FDA) authority...more

Mintz - Health Care Viewpoints

FDA Warns “Natural” Birth Control Company: Three Takeaways from the NOV Letter

A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this...more

ArentFox Schiff

Modernization of Cosmetics Regulation Act of 2022

ArentFox Schiff on

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023. Among the Act’s many provisions is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which significantly expands the U.S....more

Foley Hoag LLP

New Regulatory Pathway for Cannabidiol Products May be Forthcoming

Foley Hoag LLP on

The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more

Goodwin

California Finally Breaks From FDA On CBD: Governor Newsom Signs AB-45

Goodwin on

On October 6, 2021, California Governor Gavin Newsom signed AB-45, creating an explicit framework for the manufacture and sale of hemp-derivative products in the state of California. While hemp was legalized at the federal...more

Ervin Cohen & Jessup LLP

Will The FDA Enforce Its New Nutrition Labeling Rule? 

On September 18, 2020, the U.S. Food and Drug Administration announced additional flexibility for manufacturers to comply with the agency’s updated Nutrition and Supplement Facts labeling requirements. Those requirements go...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

Seyfarth Shaw LLP on

The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

Mintz - Consumer Product Safety Viewpoints

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

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