News & Analysis as of

Marketing Food and Drug Administration (FDA) Labeling

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Foley & Lardner LLP

DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information

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In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation and Regulatory Update - July 2023 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Update on Sesame Allergen Labeling - The U.S. Food and Drug Administration (FDA) has released an FDA Voices “Catching Up with Califf” update that addresses the...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and...

On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for...more

Foley Hoag LLP

OPDP Issues Final Guidance on Best Practices for Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer...

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On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues First Untitled Letter of the Year to Xeris Pharmaceuticals

The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more

American Conference Institute (ACI)

[Webinar] 40th FDA Boot Camp - March 22nd - 23rd, 8:15 am - 1:30 pm EST

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more

Wilson Sonsini Goodrich & Rosati

FTC Releases Health Products Compliance Guidance

Businesses making health claims about their products (e.g., foods and dietary supplements) or services (e.g., apps) should take note of new guidance that the Federal Trade Commission (FTC) released at the end of December...more

Alston & Bird

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

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Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...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

Steptoe & Johnson PLLC

Senators Introduce Law Providing Legal Pathway for CBD Products

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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 (the “Act”), which generally provides a legal pathway for certain hemp-derived...more

Alston & Bird

Food & Beverage Digest - April 2021

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Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...more

Fox Rothschild LLP

Labeling Considerations For Cannabis Pet Products

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With the passing of the 2018 Farm Bill, the market for cannabis pet products has rapidly grown. As a result, broad-reaching marketing campaigns highlighting the available products and the claimed benefits have become much...more

Fox Rothschild LLP

The Regulation Of Hemp, Hemp Derivatives And CBD In Animal Products

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If you are trying to navigate the space where hemp products intersects with animal products, it can be unclear as to which authority to turn to for guidance. In the United States, FDA, FTC, DEA and USDA share governance over...more

Rivkin Radler LLP

CBD Health Claims Raise FTC’s Hackles (And Prompt Class Action Suits)

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Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more

Husch Blackwell LLP

CBD Companies Now Facing Monetary Penalties For Deceptive Marketing, Will Civil Liability Follow?

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The Federal Trade Commission (“FTC”) has joined the U.S. Food and Drug Administration (“the “FDA”) in enforcing laws related to marketing CBD products. The FDA has historically issued warning letters and pursued companies...more

American Conference Institute (ACI)

[Virtual Event] Dietary Supplements - June 23rd - 24th, 8:30 am - 3:45 pm EDT

Join key industry stakeholders to discuss the latest developments affecting the dietary supplement industry. Now in a Virtual Format. American Conference Institute (ACI) together with the Council for Responsible Nutrition...more

American Conference Institute (ACI)

[Webinar] What New Dietary Ingredient Master Files Mean for Innovation & Compliance - May 27th, 1:00 pm - 2:00 pm EST

FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more

Shook, Hardy & Bacon L.L.P.

COVID-19 Client Primer | Consumer Protection Enforcement Challenges in the Age of COVID-19

The Federal Trade Commission (FTC), in its mission to protect consumers from deceptive and unfair commercial practices, has been particularly vigilant during the COVID-19 pandemic because of an expected increase in outright...more

Akin Gump Strauss Hauer & Feld LLP

FDA Submits Progress Report on Policy Development Related to CBD Products

Thursday, March 5th, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on FDA action to develop an enforcement discretion policy and evaluate potential regulatory pathways for consumer...more

BCLP

FDA Labeling Guidance: Making Structure/Function Claims for Dietary Supplements

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Dietary supplement manufacturers seeking to explain and market their products must carefully craft statements on supplement labels to ensure compliance with the Food and Drug Administration’s (“FDA’s”) regulations regarding...more

Bradley Arant Boult Cummings LLP

The Beginning of the End or the End of the Beginning? The FDA Issues 15 New Warning Letters to CBD Companies - Cannabis Industry...

The U.S. Food and Drug Administration (FDA) sent a shot across the bow of the cannabidiol (CBD) industry on November 25. The FDA disclosed that it issued warning letters to 15 companies “for illegally selling products...more

American Conference Institute (ACI)

[Event] Rx Drug Advertising and Promotion Executive Think Tank – Embrace this New Era of Advertising with Creative and...

ACI is delighted to present our inaugural Think Tank on Rx Drug Advertising and Promotion. Attend this intimate and in-depth symposium where the “who’s who” of pharmaceutical advertising and promotion will gather to discuss...more

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