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Product Labels Final Rules Food and Drug Administration (FDA)

Womble Bond Dickinson

New FDA Criteria for Labeling Food as "Healthy"

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All of us have probably had the experience of browsing the aisles at the grocery store looking for healthy foods to take home for our families. A few foods we find may include the word “healthy” on the packaging. Did you know...more

Clark Hill PLC

The Learned Concierge - February 2025, Vol. 16

Clark Hill PLC on

The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

BakerHostetler

The FDA’s New Definition of ‘Healthy’: A Step Forward, or a Step Too Far?

BakerHostetler on

The Food and Drug Administration (FDA) recently issued a final rule updating the definition of the term “healthy” for use on food labels. This change aims to align with modern nutrition science and the latest Dietary...more

K&L Gates LLP

FDA Proposes Front-of-Package Labeling Requirements

K&L Gates LLP on

On 14 January 2024, the US Food and Drug Administration (FDA) issued a proposed rule to be published on 16 January, which, if finalized, will require a front-of-package (FOP) nutrition label on most packaged foods. This FOP...more

Holland & Knight LLP

FDA's New Year, New Rules: Labeling for Healthier Choices

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is taking a stronger approach toward supporting health goals in 2025 and beyond by setting the tone and releasing a number of regulatory actions aimed at enhancing consumer health...more

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Quarles & Brady LLP

Brace Yourself: DEA’s Final Rule on Quotas Squeezes Inventory Levels and Signals Further Supply Restrictions

Quarles & Brady LLP on

On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more

Arnall Golden Gregory LLP

In Through the Out Door: FDA Issues Guidance on Its Importation of Prescription Drugs Final Rule

Channeling Led Zeppelin’s “In Through The Out Door,” in May 2022, the Food and Drug Administration issued a guidance for industry entitled, “Importation of Prescription Drugs Final Rule Questions and Answers (Small Entity...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Foley Hoag LLP

New Intended Use Rule Finalized

Foley Hoag LLP on

On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Hogan Lovells

After a long and winding road, FDA finalizes much-debated “intended use” rule

Hogan Lovells on

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more

Knobbe Martens

FDA Issues Final Rule on Use of Symbols in Labeling

Knobbe Martens on

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Cozen O'Connor

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

Cozen O'Connor on

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

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