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What Does 'These Statements Have Not Been Evaluated by the FDA' Mean?
These statements have not been evaluated by the FDA means the agency did not review the claims on the product before it was sold. It does not say the product is unsafe or that it works. For Reviralis Complete, it means the claims are the maker's and seller's own and no study of the product is cited.
Written by the Reviralis label deskUpdated · 4 min read
The sentence01
What do statements not evaluated by the FDA mean?
They mean FDA did not look at the claims before the product went on sale. Supplements need no premarket approval from the agency (FDA, Questions and Answers on Dietary Supplements).
The full sentence on the Reviralis label reads: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." It is the notice that goes with a structure or function statement (FDA, Structure/Function Claim Notification).
Two halves02
What does each half of the sentence say?
The first half is about review. The second half is about purpose. Neither is a verdict on the product.
| Part | What it says | What it does not say |
|---|---|---|
| "have not been evaluated by the FDA" | No agency review of the statements | That they are false, or that the product is unsafe |
| "not intended to diagnose, treat, cure, or prevent any disease" | The product is not offered as a medicine | That the product does nothing |
The second half matters most to a buyer with a health condition. It says the capsule is not a medicine, so it cannot replace one.
Common mix-ups03
Does not evaluated mean unsafe, or banned?
No. It means unreviewed, not unsafe and not illegal. Safety is still the maker's duty, and adverse events can be reported to FDA.
It also does not mean the opposite. Some readers take the sentence as small print that can be skipped. It is the part of the label that tells you where the proof stops. After it, you need your own checks: the printed amounts, the cautions, and the studies behind each name.
- Read the cautions: under 18, pregnant or nursing, and the medicines listed.
- Look for printed amounts. The Reviralis blend prints none for single names.
- Report a reaction to MedWatch (FDA, MedWatch).
Reviralis: from $49 a bottle60 capsules a bottle · 2, 3 or 6 bottles · free US shipping on 3 and 6 · 60-day money-back guarantee
See packsCare first04
Why does the sentence matter for herpes questions?
Because it says the capsule is not meant to treat or prevent a disease, and that includes herpes. Herpes has no cure.
Prescription antivirals are the proven care, and a clinician can choose how to use them (CDC, About Genital Herpes). No source we found shows that Reviralis reduces outbreaks. Keep any antiviral you were prescribed, and see a clinician about sores near the eye or a fever with a stiff neck.
The wording of the seller's page is examined in the benefits review. For where supplements sit in law, see structure function claims and the site disclaimer.
FAQ05
Reviralis questions people ask
Is the FDA sentence required?
Yes, for a structure or function statement on a supplement, the notice must accompany it (FDA, Structure/Function Claim Notification). Its presence shows the statement is the maker's. It is not a sign of approval or of a problem.
Does not evaluated mean the ingredients were not tested?
Not exactly. It speaks of the statements, not of testing. The label prints no testing seal, and the lot and certificate references on this site are seller references, not lab proof. Ask the seller for a report tied to your lot.
Who checks supplements, then?
The maker is responsible for the product and its labeling, and FDA can act after a product is sold (FDA, Questions and Answers on Dietary Supplements). That is why reading the panel and the cautions yourself counts more than the front of the bottle.
Can I ignore the sentence if the product is natural?
No. Natural is not a safety term, and some natural ingredients carry real cautions. The Reviralis blend includes licorice root extract and green tea extract, both of which have documented cautions in the sources we cite.
Who wrote this06
Written and reviewed by
Pages built from the label, the order page and linked NIH, FDA, FTC, Mayo Clinic and peer-reviewed sources.
Last updated . Read our editorial standards and how we check reviews. This website is the information site for a USA Authorized Reviralis Retailer. It is not the manufacturer or the distributor named on the label. We earn money when you buy through our order links.
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