Richard Starr at Venable LLP

Red Dye No. 3 Ban at FDA and What's Next

On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more

1/22/2025 / Chemicals , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Manufacturers , Public Health , Regulatory Oversight

AI On the Prize: Decoding FDA's Latest Guidance

Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

1/16/2025 / Artificial Intelligence , Bias , Biologics , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Premarket Approval Applications , Product Development Protocols , Regulatory Requirements , Risk Management , Software , Transparency

FDA Issues Final Rule Updating the Criteria for Use of the "Healthy" Nutrient Content Claim

On December 19, 2024, the Food and Drug Administration (FDA) announced a final rule updating the definition of the term "healthy" as used in food labeling. Under the rule, manufacturers may use the term "healthy" and similar...more

12/24/2024 / Final Rules , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels

New York Court Denies Dietary Supplement Trade Association's Motion for a Preliminary Injunction - The New State Law Is in Effect

As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law went into effect on...more

4/30/2024 / Dietary Supplements , Manufacturers , Minors , New Legislation , Trade Associations

Council for Responsible Nutrition Seeks to Enjoin Enforcement of New York Law Restricting the Sale of Dietary Supplements for...

As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law is to go into effect on...more

4/11/2024 / Dietary Supplements , New Legislation , New York , Preliminary Injunctions , TRO , Weight-Loss Products

FDA Issues a New Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

As promised last month, we are happy to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the...more

4/8/2024 / Comment Period , Dietary Supplements , Draft Guidance , Food and Drug Administration (FDA)

NAD Issues Decision Addressing “Clean,” “Ethically and Sustainably Sourced,” and Efficacy Claims for Amyris Clean Beauty, Inc....

Earlier this month, the National Advertising Division of BBB National Programs (NAD) recommended that Amyris Clean Beauty, Inc.’s (Amyris) Biossance skincare products modify or discontinue several claims regarding their...more

3/18/2024 / Advertising , Certifications , Ethical Standards , Marketing , NAD , Personal Care Products , Product Labels , Sustainability

In “Made in America” Case NAD Finds That Advertisers Should Not Rely on Disclosures to Cure a False or Misleading Claim

The National Advertising Division of BBB National Programs (NAD) recommended last month that Stihl Incorporated USA (Stihl), a manufacturer of equipment and tools, discontinue or modify its unqualified “Made in America”...more

3/14/2024 / Advertising , Disclosure , False Advertising , Made in the USA , Misleading Statements , NAD

FDA Finalizes Section V of the 2016 Revised Draft NDI Guidance

On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more

3/11/2024 / Dietary Supplements , Filing Requirements , Final Guidance , Food and Drug Administration (FDA) , Manufacturers

Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more

10/9/2023 / Clinical Evaluations , Comment Period , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , New Guidance , Premarket Approval Applications

Prepare Now for the New FDA Requirements for Cosmetics Companies

Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more

7/21/2023 / Adverse Events , Best Practices , Cosmetics , Disclosure Requirements , Federal Food Drug and Cosmetic Act (FFDCA) , Filing Deadlines , Food and Drug Administration (FDA) , Interstate Commerce , Manufacturers , Manufacturing Facilities , New Legislation , Personal Care Products , Product Labels , Recordkeeping Requirements , Registration Requirement

DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more

4/24/2023 / Department of Defense (DOD) , Emergency Use Authorization (EUA) , Expedited FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Military End Use , Pharmaceutical Industry

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

3/28/2023 / Clinical Laboratories , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Public Health Emergency

FDA Infant Formula Updates: New Labeling Guidance, Call for Enhanced Safety Measures, and Draft Protein Efficiency Ratio Testing

Infant formula manufacturers should be aware of several recent actions taken by the Food and Drug Administration (FDA). In total, these actions reflect FDA's dedication of resources to the infant formula industry....more

3/24/2023 / Baby Products , Draft Guidance , Food and Drug Administration (FDA) , Labeling , New Guidance

Richard Starr

Venable LLP

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