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FDA Stands Firm: Clinical Trials Exploring Structure/Function Effects Need IND

 
• By Ryan Nelson

Despite industry's assertion that FDA is unlawfully reinterpreting statutory definitions under the Federal Food, Drug and Cosmetic Act, the agency's republished final guidance maintains that cosmetics evaluated for structure/function effects in clinical trials require Investigational New Drug go-ahead before being transported from one state to another. Anti-aging skin- and hair-care research could be impacted most.

Personal-care firms examining products' potential structure/function benefits via clinical trials need an Investigational New Drug exemption to ship product across state lines to study sites, according to reissued final guidance from FDA that reinterprets the definitional divide between cosmetics and drugs.

The agency's position, while not legally binding, stands to have a significant impact on the cosmetics sector, and likely the

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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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Global Alliance Urges UN General Assembly To Put Self-Care At Centre Of NCD Strategy

 
• By David Ridley

Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.

Danes Get OTC Access To ED Treatment

 
• By Tom Gallen

Navamedic has launched Eroxon in Danish pharmacies giving men in the country OTC access to an ED treatment for the first time.

Perrigo Sees Growth Opportunities In Tariff Storm

 
• By Malcolm Spicer

As largest provider of private label/store brand OTCs with “100 plus molecules across 100% price point coverage,” CEO Patrick Lockwood-Taylor says Perrigo’s in position to capitalize as consumers become “more cautious” and look for lower-priced products.