No. Audifort is sold as a dietary supplement, and the FDA does not approve dietary supplements before they reach the market. The agency says so directly: "Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed." The label line "This product has been manufactured in an FDA registered facility" is about the factory's registration. Under federal rules, a registration number doesn't mean the FDA approves the plant or what it makes.
What does the FDA check before a supplement goes on sale?
Very little, and that's by law. The Dietary Supplement Health and Education Act of 1994 (DSHEA) put supplements under a different system from drugs. According to the FDA's questions and answers on dietary supplements, a company generally doesn't have to show the agency its safety evidence, before or after launch. The exception is a supplement with a new dietary ingredient, which needs a notification first. The FDA also "does not test dietary supplements before they are sold to consumers," and it generally doesn't approve claims or other labeling before use.
The responsibility sits with the companies that make and sell the product. The FDA steps in afterward: it inspects facilities, watches the market, and can enforce the law when adulterated supplements reach shelves. Its rules also require makers to follow current good manufacturing practices.
| Question | Short answer | Where it comes from |
|---|---|---|
| Did the FDA approve Audifort before sale? | No. It has no authority to approve supplements before marketing. | FDA supplement Q&A |
| Did the FDA test it? | No. The FDA does not test supplements before they're sold. | FDA supplement Q&A |
| Did the FDA review "Supports healthy hearing"? | No. The label carries the required note that the FDA has not evaluated it. | Audifort label |
| Did the factory have to register with the FDA? | Yes, before it began making, packing or holding supplements for US sale. | FDA supplement Q&A; 21 CFR 1.225 |
| Does registration mean approval? | No. A registration number conveys no approval or endorsement. | 21 CFR 1.242 |
| Does the FDA hand out registration certificates? | No, and it doesn't recognize certificates sold by private firms. | FDA notice on registration |
| Can the FDA act once it's on sale? | Yes. It inspects and can enforce the law against adulterated products. | FDA supplement Q&A |
What does "manufactured in an FDA registered facility" mean?
It means the plant filed the registration that the law requires of facilities making, processing, packing or holding food for US consumption, supplements included, unless an exemption applies. That duty comes from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and the details are in 21 CFR 1.225. In practice it works like a listing.
The regulation that defines a registration number, 21 CFR 1.242, is short and blunt. Being assigned a number "means that the facility is registered with FDA," and it "does not in any way convey FDA's approval or endorsement of a facility or its products." The FDA has also published a notice on registration fees and private businesses. It says registering costs nothing and that the agency "does not issue a certificate of registration." It also warns that private registration services are not affiliated with the FDA.
Registrations aren't permanent, either. Under 21 CFR 1.230, facilities renew every other year, between October 1 and December 31 of each even-numbered year. 2026 is one of those years, so the renewal window is open as we write this.
- 1994
- DSHEA, the law that defines dietary supplements and leaves out premarket approval
- 2002
- the law that requires supplement facilities to register with the FDA
- $0
- the FDA fee to register a food facility
- Oct 1 to Dec 31
- renewal window in even-numbered years, open now in 2026
Sources: FDA, Questions and Answers on Dietary Supplements; 21 CFR 1.230; FDA notice on registration fees.
Who makes Audifort?
The label doesn't say. It names a distributor with an address in Miami, Florida, and it states "Made in the USA with globally sourced ingredients." No factory or manufacturer is named anywhere on it.
That's within the rules. The FDA requires a supplement label to give "the name and place of business of the manufacturer, packer, or distributor," so one of the three is enough. Labels must also list a US address or phone number for reporting serious adverse events, and the Miami address is the one printed. At checkout, the order page footer names ClickBank as the retailer; our where to buy page explains how that works.
We'd like to see the manufacturer named. Its absence doesn't break any rule we found, but it does mean "FDA registered facility" refers to a plant you can't identify from the bottle.
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What can you check on your own?
- Follow the asterisk after "Supports healthy hearing." It should lead to the FDA disclaimer and the line saying the product isn't meant to diagnose, treat, cure or prevent any disease. Audifort's label has both.
- Look for approval wording. Audifort's label never says "FDA approved" and carries no FDA logo, which the FDA reserves for its own official use.
- Find a company name with a US address. Here it's the Miami distributor on the left side panel.
- Look for amounts. The 200 mg blend gives none per item, and our proprietary blend page explains why that's allowed.
- Know where to report a bad reaction. The FDA says anyone may report an adverse event linked to a supplement through its Safety Reporting Portal.
Hearing aids sit in a different lane. FDA rules for over-the-counter hearing aids took effect on October 17, 2022, and our Audifort vs OTC hearing aids page lays out the difference. And if an ad or a reseller ever calls Audifort "FDA approved," read that as a problem with the seller, since the FDA's own Q&A rules it out and the bottle doesn't claim it.
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