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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

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

EU Industry Wants EFSA Changes To Support Innovation

 
• By Tom Gallen

Prominent trade groups call on the European Commission to improve risk assessment of innovative food products by making changes to processes at the European Food Safety Authority.

US FDA Clarifies Success For An NDI Notification Fits Only The Notifier’s Ingredient

Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.

Price To Resolve US Hemp Dilemma Too High In House Appropriators’ FY 2026 FDA Spending Bill

 
• By Malcolm Spicer

Provisions in bill approved by Agriculture, Rural Development, FDA and Related Agencies Subcommittee aren’t likely to pass largely because they set a price too high for delta-8 THC and other ingredients to meet the definition of hemp as a de-scheduled substance.