Label facts
Is Memodyne FDA Approved? Who Makes It? 4 Label Facts
No, Memodyne is not FDA approved, and no dietary supplement is. The FDA does not review supplements before sale. The label says made in the USA with globally sourced ingredients and names Gex Corporation LLP of Ogden, Utah as distributor. It names no factory and no testing lab.
Written by the Memodyne editorial team · Medically reviewed by Dr. Joette James, PhD, medical reviewerReviewed · Updated · 7 min read
Approval
Is Memodyne FDA approved?
No. And the same is true of every dietary supplement on the shelf.
The FDA cannot approve a supplement before it goes on sale (FDA, Supplement Q&A). The agency also says that registering a facility and approving a product are separate things (FDA, Approval myths). So a page that says "FDA approved" for a supplement is wrong, and a page that says "FDA registered facility" is talking about a building, not about the capsule.
Memodyne is a dietary supplement. It is not a drug, and it is not a treatment for memory loss, dementia or Alzheimer's disease.
Key facts
Which FDA and maker facts are printed on the label?
- Memodyne is not FDA approved. No supplement is.
- The label carries the standard FDA statement: not evaluated by the FDA, not intended to diagnose, treat, cure or prevent any disease.
- A brand badge says "FDA registered facility" but names no facility.
- The distributor on the label is Gex Corporation LLP, PO Box 12730, Ogden, UT 84404.
- The label says made in the USA with globally sourced ingredients. No factory is named.
- No testing lab or certificate is published.
Claim rules
What can a supplement label claim, and what can it not claim?
A supplement may say it supports a normal body function. It may not say it treats, cures or prevents a disease. The FDA statement on the bottle exists because of that line.
Support wording
Wording such as Cognitive Support Formula, placed beside the FDA statement. The FDA does not review it before sale (FDA, Supplement Q&A).
Disease claims
Any promise to treat or prevent dementia or Alzheimer's disease. The FTC and FDA wrote to sellers who made such promises in 2019 (FTC, Alzheimer's claims letters).
Memodyne's bottle stays on the support side of that line. It also says plainly that the product is a dietary supplement. Even support wording still needs solid science behind it, and the FTC says buyer stories do not count as that science (FTC, Health claims).
The wording
What does the FDA statement on the Memodyne label mean?
It reads, in short: these statements have not been evaluated by the Food and Drug Administration, and the product is not intended to diagnose, treat, cure or prevent any disease.
That line is standard on supplement labels. It does not grade quality. It tells you that nobody at the agency reviewed the claims. The bottle front says "Cognitive Support Formula," and the sales page says more than that. Those are the seller's words.
Supplements may describe support for normal body functions. They may not promise to treat or cure a disease. In 2019 the FTC and FDA sent warning letters to sellers who made Alzheimer's and dementia claims (FTC, Alzheimer's claims letters).
The label facts above are the same ones printed on the sales page next to the prices.
We earn money when you buy through our order links.
A fair reading
Does not FDA approved mean Memodyne is unsafe?
No. It means the FDA does not run an approval step for supplements, so no supplement can say it passed one. Safety for you depends on the ingredients, the dose and your medicines.
For Memodyne, the dose is small and the label is fully printed. The open safety question is L-arginine and the medicines it can stack with. Our post on the 7 medicine groups to check lists them.
The maker
Who makes Memodyne?
The label does not say. It names a distributor, not a maker.
| Question | What the label says |
|---|---|
| Who distributes it? | Gex Corporation LLP, PO Box 12730, Ogden, UT 84404, +1 (507) 448-8190, [email protected] |
| Where is it made? | "Manufactured in the USA with globally sourced ingredients" |
| Which factory? | Not named |
| Which lab tested it? | Not named |
This website is not the maker either. We are a USA authorized retailer. We earn money when you buy through our order links, and we say so on every page.
Made in USA
Is Memodyne made in the USA?
The bottle says so. It also says the ingredients are sourced from around the world. The source countries are not named.
"Made in the USA" names a country, not a plant you could look up. If country of origin matters to you, write to the distributor on the bottle and ask for the facility name. Replies that give names, dates and numbers count as documentation. Replies that repeat a badge do not.
Name check
Is Memodyne Corporation the maker of this supplement?
No. A 1970s company called Memodyne Corporation built digital cassette recorders. It has no tie to the capsule. The supplement shares only the name.
Name mix-ups are common here. The supplement is also not Melodyne software and not memantine, a prescription drug. Our post on lookalike names sorts them out.
Reporting
Where do you report a problem to the FDA?
Tell your doctor first. Then you can send a report to the FDA through its MedWatch online form or by phone at 1-800-FDA-1088. Write down the lot number, the start date, your symptoms and every other product you took that week.
The order desk at +1 (302) 200-3480 should hear about it too. A report on the record helps other buyers, and it gives your doctor something to work from.
Badges
What do the quality badges around Memodyne mean?
| Badge | What it rests on |
|---|---|
| Money-back guarantee | The 60-day terms on the sales page |
| Vegetarian | The hypromellose capsule; no certifier named |
| Good Manufacturing Practice | No facility, certifier or audit named |
| FDA registered facility | No facility named; registration is not approval |
| Physician formulated | No physician named |
We show only the badges we can match to something printed. We cannot check a badge that names no person and no test, and neither can you.
Ask them
What should you ask the Memodyne distributor?
- Which lab tested lot MEM-26/ME-3689?
- Can I see the certificate behind CoA MEM-3689-26-ME?
- Which plant fills the capsules, and who inspects it?
- Is the niacin nicotinic acid or niacinamide?
- Who is the physician behind the badge?
Direct them to the distributor named on the bottle. Real documents show names, dates and numbers.
Ask your doctor first if you have had a heart attack or take blood pressure, nitrate, ED, blood thinner, diabetes or potassium-sparing diuretic medicine. L-arginine can interact with all of them. Under 18, pregnant or nursing: consult a physician first, as the label says.
FAQ
Frequently asked questions
Is Memodyne FDA approved?
No. Memodyne is a dietary supplement, and the FDA does not approve supplements before sale. The label carries the standard statement that the claims have not been evaluated by the FDA.
Is an FDA registered facility the same as FDA approval?
No. Registration puts a facility on a list. It is not a review of the product. The Memodyne badge also names no facility.
Who makes Memodyne?
The label does not name a maker. It prints Gex Corporation LLP of Ogden, Utah as distributor and says the product is made in the USA with globally sourced ingredients.
Is Memodyne made in the USA?
The label says so. It does not name the factory or the source countries of the ingredients.
Is this website the maker of Memodyne?
No. We are a USA Authorized Memodyne Retailer. We earn money when you buy through our order links.
Was Memodyne Corporation involved?
No. Memodyne Corporation was a 1970s maker of digital cassette recorders. The supplement shares only the name.
Our view
Our view
The label is open about the parts it prints and silent about the parts it does not. Seven amounts, a distributor, a country. No factory, no lab, no trial.
Read that as a reason to ask questions, not as a verdict. And remember the plain rule: no supplement is FDA approved, so "approved" should never be the reason you buy.
If the label facts suit you, the sales page lists the packs and the refund terms. The distributor line is on the bottle itself.
We earn money when you buy through our order links.
Last updated
Who wrote this
Written and reviewed by
Plain-language pages built from the label, the sales page and linked public health sources.
Last updated . Read our editorial standards and how we check reviews. This website is run by a USA authorized retailer that sells Memodyne, not by the maker (the label says distributed by Gex Corporation LLP, Ogden, UT). We earn money when you buy through our order links.
