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FTC’s Health Products Guidance: Attorneys Discuss Insistence On RCTs, Implications For Businesses

 
• By Eileen Francis

The updated and expanded guidance embodies the US Federal Trade Commission’s enforcement approach for more than a decade, identifying randomized clinical trials as the competent and reliable scientific evidence needed to back health-related claims. Attorneys from Kelley Drye & Warren, Lathrop GMP and Amin Talati Wasserman weigh in.

FTC Legal Gavel Concept 3D Illustration

The US Federal Trade Commission’s Health Products Compliance Guidance is a “sweeping overhaul” of its predecessor and a continuation of the agency’s decade-long march toward a drug-like substantiation standard for non-drug product claims, says John Villafranco, a partner at Kelley Drye & Warren, LLP.

“This updated guidance synthesizes the agency’s approach and seeks to put broad swaths of the health and personal care industries on notice that FTC staff is attempting to raise the...

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More from Legal

NAD Asks FTC To Pull Bandage Off Firm’s Plan To Exhaust Inventory Using ‘2X Faster Healing’ Claim

 
• By Malcolm Spicer

After National Advertising Division attorneys, in a review prompted by a challenge by Band-Aid line marketer Kenvue, recommended ASO LLV cease use of its “up to 2x faster healing” claim, they determined the firm had not fully complied.

Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

 
• By Malcolm Spicer

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.

Loper Bright Could Trip FDA On Self-Affirmed GRAS

 
• By Malcolm Spicer

Instead of arguing FDA’s not authorized to offer option under authority from 1958 Food Additives Amendments, potential litigation could contend the law requires agency to continue making self-GRAS without notification available.

EU Probiotics Deadlock: Ombudsman Finds ‘No Maladministration’ By The Commission

 
• By David Ridley

In response to an IPA Europe complaint, European Ombudsman Emily O’Reilly finds that the Commission’s interpretation of EU food legislation in relation to probiotics is “reasonable and in line with the main goal of this legislation, which is to ensure a high level of consumer protection.”

More from Policy & Regulation

NAD Asks FTC To Pull Bandage Off Firm’s Plan To Exhaust Inventory Using ‘2X Faster Healing’ Claim

 
• By Malcolm Spicer

After National Advertising Division attorneys, in a review prompted by a challenge by Band-Aid line marketer Kenvue, recommended ASO LLV cease use of its “up to 2x faster healing” claim, they determined the firm had not fully complied.

Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

 
• By Malcolm Spicer

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

 
• By Malcolm Spicer

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.