News Release: November 29, 2024
The FDA has issued a critical warning letter to Centura Pharmaceuticals Inc. regarding their product, BLT 1-2-3 Cream. If your medspa uses this topical analgesic cream, it’s time to evaluate your inventory and take proactive steps to ensure compliance and client safety.
Here’s what you need to know about the FDA’s findings, the potential risks, and actions you can take to protect your business.
The FDA Warning Letter: What Happened?
On November 15, 2024, the U.S. Food and Drug Administration (FDA) flagged the “BLT 1-2-3 Cream” for the following violations:
- Unapproved New Drug:
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- The product was classified as an unapproved drug under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- The cream was marketed for temporary relief of pain and itching during cosmetic procedures such as laser hair removal and tattoo removal, making it subject to FDA drug regulations.
- Misbranding:
- The product’s labeling failed to meet the requirements for over-the-counter drugs, making it non-compliant under section 502(ee) of the FD&C Act.
- Safety Concerns:
- The FDA raised alarms about the potential for excessive application of the cream, particularly before cosmetic procedures, increasing the risk of severe side effects from systemic absorption.
The FDA has requested Centura Pharmaceuticals to address these violations within 15 working days.
Why This Matters to Your Medspa
Using or promoting unapproved products like the “BLT 1-2-3 Cream” can expose your medspa to significant risks:
- Compliance Issues: Selling or using unapproved drugs can lead to FDA enforcement actions, including fines or product recalls.
- Client Safety Risks: Overuse of topical analgesics can result in adverse reactions, especially without professional supervision.
- Reputation Damage: Association with non-compliant products can harm your brand’s credibility.
Recommended Actions for Medspa Owners
Review Your Inventory:
If you currently stock or use “BLT 1-2-3 Cream,” consider halting its use until further clarification is provided.
Educate Your Team:
Inform staff about the FDA warning and the potential risks associated with this product.
Switch to Approved Products:
Ensure your medspa only uses FDA-approved products to maintain compliance and safeguard clients.
Stay Informed:
Subscribe to industry news sources (like Medspa Mastery) to stay updated on compliance and regulatory changes.
Resources for Medspa Owners
Staying on top of FDA regulations is critical to running a safe and compliant medspa. The warning about “BLT 1-2-3 Cream” serves as a reminder of the importance of using approved products and maintaining high standards for client safety. To avoid potential risks and liabilities, review your products today and stay connected with Medspa Mastery for ongoing updates and insights.
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