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FDA's Final IND Guidance Has Industry On Edge: What Happens Next?

 
• By Ryan Nelson

It remains to be seen how industry responds to FDA's newly reissued final guidance advising firms to file Investigational New Drug applications for studies exploring would-be cosmetics' structure/function benefits, and how rigorously the agency enforces its position. Attorney Paul Hyman speculates that FDA could rely on INDs to reinforce its authority in the context of warning letters issued to cosmetics firms for unapproved drug claims.

Questions abound following FDA's republication of final guidance that casts would-be cosmetics as drugs requiring Investigational New Drug applications if they're studied in clinical trials for structure/function effects, regardless of whether sponsors intend to market them along purely cosmetic lines.

"It obviously doesn't leave us in a comfortable position," said Paul Hyman, a partner at food and drug law firm Hyman, Phelps & McNamara, in a Nov. 4 interview. "Frankly...

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FTC Consumer Privacy Policy Driven By ‘Straw Man’ Arguments – Commissioner Holyoak

 
• By Eileen Francis

The US FTC’s contention that ‘notice and choice’ has failed as the cornerstone of consumer privacy regulation and must be abandoned in favor of data minimization and other more stringent measures does not adequately account for the complexity of business practices and consumer behavior, FTC commissioner Melissa Holyoak asserted at the NAD’s 2024 Annual Conference.

FTC’s New Commissioner ‘Dismayed’ By Agency Overreach

 
• By Eileen Francis

FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements. 

Beauty Brands Not On TikTok Shop ‘Really Missing Out’ – KO-Pack

 
• By Eileen Francis

At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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FDA Draft Guidance Waves Green Flag On Changing Color Additives For Drugs In US

 
• By Malcolm Spicer

In a nod to drug manufacturers’ potential interest in moving to natural alternatives for petroleum-based synthetic dyes the agency intends to remove from use, document explains process for asking for approval for “any dye, pigment, or other substance that can impart color to a food, drug, cosmetic,

Urgo Makes Moves In Poland And Belgium

 
• By Tom Gallen

French consumer health player Urgo has added to its dietary supplements offering with separate deals in Poland and Belgium.

Cosmetics Industry: Push Congress To Apply Pressure On MoCRA – Attorney

 
• By Eileen Francis

The US cosmetics industry, particularly small- and medium-sized businesses, should reach out to their representatives in Congress to encourage pressure on the US Food and Drug Administration to implement cosmetics reform, despite agency staff cuts.