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Insights

FDA & FTC compliance insights for healthcare marketing

Plain-English breakdowns of the warning letters, settlements, and regulatory shifts that determine whether your marketing can survive contact with a regulator.

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Tactical playbook

How to Respond to an FDA Warning Letter: The Step-by-Step Playbook for the First 15 Business Days

The first 15 business days after a warning letter determine how enforcement proceeds. Here's the exact sequence of actions - from calling an attorney in the first hour to submitting the formal response - that protects your practice and maximizes the chance of favorable resolution.

12 min
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Tactical playbook

How to Audit Your Healthcare Practice's Social Media for FDA/FTC Compliance: A Step-by-Step Framework

Your social media is the highest-velocity compliance surface in your practice - and the one that typically has the least review before publish. Here's the audit framework to catch compliance issues before a regulator does.

11 min
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Specialty playbook

Exosome Marketing Compliance: The Current FTC Enforcement Priority - and How to Stay Off the Target List

Exosome marketing sits at the top of the FTC's 2024-2026 healthcare enforcement priority list. The claim patterns they target are consistent - and fixable. Here's the full playbook.

9 min
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Specialty playbook

PRP Injection Marketing Compliance: What Orthopedics, Sports Medicine, and Hair Restoration Practices Keep Getting Wrong

PRP marketing looks simpler than stem cell marketing but carries a distinct compliance pattern. Here's what orthopedic, sports medicine, hair restoration, and aesthetic practices need to know about marketing PRP compliantly.

9 min
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Specialty playbook

Body Contouring Marketing Compliance: CoolSculpting, EmSculpt, Morpheus8 and the Device-Specific Rules Practices Miss

Body contouring devices have specific FDA-cleared indications. Marketing them for unapproved body areas, with guaranteed results, or with transformation-style before/afters triggers multiple enforcement patterns. Here's how to market compliantly.

10 min
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Specialty playbook

Hormone Replacement Therapy Marketing Compliance: HRT, TRT, and Bioidentical Advertising Rules

HRT, TRT, and bioidentical hormone marketing sits in an unusually complex regulatory position - prescription drugs plus compounded drugs plus anti-aging claim rules. Here's how to market these services compliantly.

10 min
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Specialty playbook

Ketamine Clinic Marketing Compliance: Off-Label Psychiatric Advertising, FDA Warnings, and What Still Runs

The FDA has specifically warned against ketamine therapy marketing patterns. Here's what's actually being enforced, which claims produce action, and how ketamine clinics can market compliantly in 2026.

10 min
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Specialty playbook

Peptide Therapy Marketing Compliance: BPC-157, Ipamorelin, and the FDA Schedule Changes That Shifted Everything

The FDA scheduled several commonly-marketed peptides as prohibited for compounding in recent years. Peptide clinic marketing that hasn't updated is operating in a different regulatory world than it started in. Here's the current framework.

10 min
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Specialty playbook

Hair Restoration Marketing Compliance: FUE, FUT, PRP, Exosomes, and the Guarantee Language Getting Clinics Sued

Hair restoration is one of the most litigated healthcare marketing categories - FTC actions, state AG consumer protection cases, and private class actions. Here's the full compliance playbook for surgical and non-surgical offerings.

10 min
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Stay ahead of enforcement

Scan your marketing before regulators do.

RegenCompliance checks every word of your clinic's marketing against live FDA and FTC enforcement data - and rewrites violations automatically.