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FDA Flexes Warnings For Steroid Ingredients On Supplement Labels

 
• By Malcolm Spicer

Warning letters state that ingredients listed on labels for AndroPharm and Hardcore Formulations brand products "are synthetic steroids and do not constitute dietary ingredients" under FDA regulations.

Warning Rubber Stamp

Ingredients listed on labeling for AndroPharm and Hardcore Formulations brand sports nutrition supplements render them designer steroids, according to FDA warnings letters.

Warning letters submitted June 5 by FDA's Office of Pharmaceutical Quality Operations to AndroPharm LLC, in Boca Raton, Fla., and...

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More from Legal

FDA RIF Delays Response On NPA NMN Petition

 
• By Malcolm Spicer

Due to staff reductions at FDA ordered by DOGE, but accounting for return of some employees after their dismissals were rescinded, agency missed July 31 deadline it had set for responding to the NPA’s petition and expects to respond by Sept. 30.

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.

More from Policy & Regulation

FDA RIF Delays Response On NPA NMN Petition

 
• By Malcolm Spicer

Due to staff reductions at FDA ordered by DOGE, but accounting for return of some employees after their dismissals were rescinded, agency missed July 31 deadline it had set for responding to the NPA’s petition and expects to respond by Sept. 30.

US FDA’s Kratom Focus Pivots To ‘Concentrated Synthetic Byproduct That Is An Opioid’

 
• By Malcolm Spicer

Explaining he was a heroin addict for 14 years more than 40 years ago “because it was so available,” Secretary Kennedy says “our agencies have been asleep in the wheel” but “now we're going to wake up and we're going to start to stop this before it starts.”

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.