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Supplement Firms Making Sunscreen Claims Warned In FDA Crackdown

 
• By Malcolm Spicer

Claims that rendered the firms' products unapproved new drugs and were listed in FDA warning letters include "It’s basically an oral sunscreen … This would be especially useful for people who have had skin cancer, are at risk for skin cancer.” The firms FDA warned are Isocell North America Inc., Sunergized LLC, Pharmacy Direct Inc. and Napa Valley Bioscience LLC.

Four dietary supplement firms that recently received FDA warning letters not only marketed their products with claims intended for sunscreen drug ingredients, they also made claims that would get sunscreen products in a regulatory jam.

Claims that rendered the firms' products unapproved new drugs and were listed in warning letters FDA published May 22 include...

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Advocate For 7-OH Sees No ‘Public Health Emergency’ Or ‘Sort Of Signal’ For Scheduling

 
• By Malcolm Spicer

Holistic Alternative Recovery Trust says FDA should review data and other information available about the safety of all kratom extracts before it moves ahead on its proposal to recommend Schedule I controlled substance for 7-OH.

Kratom Industry Argues FDA Scheduling Plan Shows 7-OH At Root Of Botanical’s Regulatory Rot

 
• By Malcolm Spicer

Supporters of planned FDA action to recommend DEA schedule 7-OH include Global Kratom Coalition and Regulatory Service International consultancy firm. AHPA also supports FDA decision but says marketers of kratom extract mitragynine likely aren’t out of the weeds as far as questions about safety.

Germany Leading Enforcement Against Unsafe Supplements Sold In EU

 
• By Tom Gallen

Germany was more active than any other EU member in the second quarter in submitting notifications to the Commission regarding problematic food supplements.

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

More from Policy & Regulation

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

US Tax Code Already Spells Using HSA/FSAs For Dietary Supplement Purchases, NPA Tells IRS

 
• By Malcolm Spicer

Internal Revenue Code should include within its definition of “medical care” spending the consumers' purchases of supplement products based on labeling of FDA-approved health and structure/function claims, NPA CEO Daniel Fabricant says.

EFSA: ‘A Dose Of Estragole Without A Harmful Effect Cannot Be Established’

 
• By David Ridley

Dietary supplements containing estragole may have to be removed from the European Union market due to carcinogenic risk, according to a draft scientific opinion from EFSA that is currently out for consultation.