Can I say it?
Can I say “FDA cleared” in a med spa ad?
It depends. 3 rules fired across 3 sample sentences, and the checker's own text explains why.
The short answer
It depends. The checker warns on this wording but does not block it. The first rule it hits is CG-REG-001. Its reason: Dietary supplements and most services cannot be FDA approved. For a drug or device the claim must be true, specific to the product and use, and sourced.
Source the rule cites: FDCA 505 (drug approval) and 510(k)/PMA (devices); FDA promotional labeling and advertising rules; FTC Act section 5
Checked as an ad promoting a drug or device. Context changes the result. The same samples hit these blocking rules: 0 in a drug or device ad, 1 in a supplement ad, 0 in a clinical service ad.
A clear result is not an all-clear. The checker flags wording for review and does not know your evidence, your state or your platform's review. Read the limitations.
Sample wording, run through the checker
These are sentences written to contain the phrase, not real claims. Each ran through the real engine and the shipped rule-set when this site was built.
FDA cleared device for hair growth.
- Warning
CG-REG-001Regulatory status. Matched: “FDA cleared”
Our FDA cleared laser treats everything.
- WarningCG-ABS-014Absolute promises. Matched: “treats everything”
- WarningCG-TRA-005Efficacy and proof. Matched: “treats everything”
- Warning
CG-REG-001Regulatory status. Matched: “FDA cleared”
FDA cleared for body contouring.
What to say instead
This version came back with no rule fired:
Ask us which uses this device is cleared for and read the device labeling.
What the rules themselves suggest:
- CG-ABS-014 Name the specific services you offer, who delivers them, and that outcomes vary by patient.
- CG-TRA-005 Remove absolute and miracle language. State specific, substantiated outcomes with appropriate qualifiers and do not claim to treat every condition.
- CG-REG-001 For an approved drug or cleared device, name the product, the cleared use and the FDA record number. For a supplement, remove it.
The rules behind this answer
Reason, source and citation for each rule that fired, in the checker's own words. Blocking rules come first.
CG-ABS-014 · Warns · Citation checked against stored text
Saying a product or provider can fix, heal or treat everything is an absolute claim with no possible substantiation.
Source: FTC Act section 5; FTC Health Products Compliance Guidance; 21 CFR 101.93(g)
Safer wording: Name the specific services you offer, who delivers them, and that outcomes vary by patient.
21 CFR 101.93(g) · Needs counsel review
CG-TRA-005 · Warns · Citation checked against stored text
Sweeping claims that a clinic fixes any condition, that results are miraculous, instant or permanent, or that no case is too hard, are unsubstantiated efficacy and guarantee claims.
Source: FTC Act section 5, substantiation requirement; FTC Policy Statement Regarding Advertising Substantiation (1984); FTC Health Products Compliance Guidance (2022)
Safer wording: Remove absolute and miracle language. State specific, substantiated outcomes with appropriate qualifiers and do not claim to treat every condition.
FTC Policy Statement Regarding Advertising Substantiation · Needs counsel review
CG-REG-001 · Blocks approval
Dietary supplements and most services cannot be FDA approved. For a drug or device the claim must be true, specific to the product and use, and sourced.
Source: FDCA 505 (drug approval) and 510(k)/PMA (devices); FDA promotional labeling and advertising rules; FTC Act section 5
Safer wording: For an approved drug or cleared device, name the product, the cleared use and the FDA record number. For a supplement, remove it.
See source text · Needs counsel review
Background: Off-label promotion in the glossary.
Questions
Which rule covers FDA clearance claims?
Rule CG-REG-001. The rule's reason: Dietary supplements and most services cannot be FDA approved. For a drug or device the claim must be true, specific to the product and use, and sourced.
What should I write instead?
The rule's own suggestion for rule CG-REG-001: For an approved drug or cleared device, name the product, the cleared use and the FDA record number. For a supplement, remove it.
Does the answer change for a drug, a supplement or a service?
Context changes the result. The same samples hit these blocking rules: 0 in a drug or device ad, 1 in a supplement ad, 0 in a clinical service ad. Pick the type that matches what you promote when you run the checker.
Next step
Check your own wording
Paste your copy into the free checker. Every flag names its rule and its source.