As the Aesthetics Industry continues to grow at a staggering rate, oversight will be stricter – and players flashing shiny things to captilize on this growth will continue to emerge.
Ensuring that the products you use in your medspa or aesthetic practice are FDA-approved for their intended purposes is crucial for client safety, compliance, and protecting your business from legal risks.
It is your responsibility to know what is and what isn’t “allowed.” Do not go on the word of your friend, peer, vendor, etc.
Bookmark this page, use it, and stay compliant.
What Does FDA Approval Mean?
FDA approval confirms that a product has been evaluated for safety and efficacy for a specific use. Using unapproved products, or those approved for different purposes, can result in severe consequences, including fines, liability issues, or harm to clients.
Step-by-Step Guide to Checking FDA Approval
1. Search the FDA’s Databases
The FDA provides several tools for verifying approval or clearance:
- Drugs@FDA:
- Use this database for prescription and over-the-counter drugs. Enter the product name or active ingredient and review its approved uses.
- FDA Medical Device Database:
- Check if a device (e.g., lasers, injectables, or microneedling tools) is cleared or approved for the specific treatment you offer.
- OTC Monograph Compliance:
- Many over-the-counter products fall under FDA monographs, which outline permitted ingredients and claims. If the product’s claims exceed the monograph’s scope, it requires specific approval.
2. Review Product Labeling
Carefully examine the product’s label and any inserts. Look for:
- Specific phrases like “FDA-approved for [use].”
- Warning signs such as vague terms like “FDA registered,” which does not mean FDA-approved.
3. Check the Manufacturer’s Website
Reputable manufacturers typically provide FDA approval or clearance documentation on their website. Look for:
- Premarket Approval (PMA) numbers for devices.
- New Drug Applications (NDAs) for drugs.
If this information isn’t clear, it’s a red flag.
4. Contact the Manufacturer Directly
Reach out to the manufacturer and request proof of FDA approval or clearance for the specific claim or use case. Legitimate companies will readily provide documentation.
5. Use the FDA Warning Letters Database
The FDA issues warning letters for products or manufacturers making unapproved claims. Search the database to ensure the product hasn’t been flagged:
6. When in Doubt, Consult a Regulatory Expert
If you’re still unsure, reach out to a regulatory consultant or legal expert familiar with FDA compliance to avoid potential risks.
Red Flags to Watch For:
- Vague Claims: Phrases like “FDA registered” or “meets FDA standards” do not equal approval.
- Broad Promises: Claims such as “cures aging” or “treats all skin conditions” are often signs of unapproved products.
- No Clear Documentation: If the manufacturer cannot provide proof of FDA approval or clearance, proceed with caution.
Why This Matters for Medspas
Using unapproved products can lead to:
- Legal Consequences: Fines, product seizures, or legal action from the FDA.
- Safety Risks: Harm to clients due to untested or unsafe ingredients.
- Reputation Damage: Losing client trust over compliance issues.
By taking the time to verify FDA approval, you’re protecting your clients, your staff, and your business.
