News & Analysis as of

Over The Counter Drugs (OTC) Marketing

Venable LLP

Marketing FDA-Regulated Products: An Excerpt from the Advertising Law Tool Kit

Venable LLP on

The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more

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On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more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

Foley & Lardner LLP on

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

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...

Foley Hoag LLP on

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

MoFo Life Sciences

FTC Issues Notice Of Penalty Offenses On Substantiation Of Product Claims

MoFo Life Sciences on

On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional...more

McGlinchey Stafford

FTC Issues New Health Products Compliance Guidance

McGlinchey Stafford on

The Federal Trade Commission (FTC) has issued a new Health Products Compliance Guidance document to provide guidance to businesses on how to ensure that claims about the benefits and safety of health-related products are...more

Rivkin Radler LLP

FTC Issues New Business Guidance for Marketers and Sellers of Health Products

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On December 20, the Federal Trade Commission’s Bureau of Consumer Protection announced the issuance of Health Products Compliance Guidance. The revised Guidance updates the FTC’s 1998 guide, Dietary Supplements: An...more

Mintz - Health Care Viewpoints

CBD Regulatory Enforcement Continues with Over-the-Counter CBD Pain Relief Products

Enforcement by the Food and Drug Administration (FDA) against cannabidiol (CBD)-containing products continues through the issuance of two new warning letters. On March 22, 2021, FDA published a press release cautioning...more

Husch Blackwell LLP

FDA Issues Warning Letters On Marketing And Sale Of OTC CBD Products

Husch Blackwell LLP on

The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - February 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Dechert LLP

Election 2020: How a Biden-Harris Administration May Impact OTC and Supplement Companies

Dechert LLP on

As we look ahead to a Biden-Harris administration and its potential impact on the over-the-counter (“OTC”) and dietary supplements industries, we see both opportunities and risks. While democratic control is typically...more

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