Drugs

FTC Updates Health Products Compliance Guide

The Federal Trade Commission (FTC) has released its new “FTC Health-Related Advertising Guide” that covers more stringent compliance factors than previously expected that industry should consider before publishing health product marketing (online or offline) advertisements. Attorney Phyllis Marcus (Hunton Andrews Kurth) writes in an online post that the FTC last published the guidance in 1998, styled at that time as a dietary supplement advertising guide. She says the 2022 version “covers a broad spectrum of products including foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests and health apps, and other health-related products.”

Since the earlier guide was issued, the agency says it had brought more than 200 cases challenging false or misleading advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. FTC’s new guide draws on those case experiences with 23 new examples. It also says the guide includes a “much more detailed discussion of the amount and type of evidence needed to substantiate health-related claims, with more emphasis on the fact that the FTC, as a general rule, expects high quality randomized, controlled human clinical trials.”

“One major revision is to extend the guidance covering dietary supplements to all health-related products,” an FTC release says. It also reflects updates to other FTC guidance documents, including the guidance on endorsements and testimonials and the enforcement policy statement on homeopathic drugs.

“As a general matter, marketers of health-related products, including dietary supplements, should be aware of FTC and FDA marketing requirements,” a client alert from law firm Klein Moynihan Turco says. “Specifically, advertising claims must be: 1) truthful; 2) not misleading; and 3) substantiated… Accordingly, marketing companies must now step up their efforts to secure the necessary studies and substantiating evidence prior to advertising a product to the public. Absent such measures, companies face the prospect of incurring the wrath of the FTC — resulting in bad press, liability, and hefty penalties.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome