English
Caplet Supplement Adverse Event File
For small brands selling libido and sexual-enhancement dietary supplements

The company on the label is the one that reports.

Caplet logs every health complaint, judges it serious or not, counts down the 15 business days to FDA, tracks new medical information for a year after, keeps every record six years - and will not put a supplement on sale without a U.S. contact on its label.

Opens in this browser with an invented brand already in it. No account, no email address, nothing installed. No customer name or medical record is ever kept.

The problem

No small-business exception.

Federal supplement law puts the duty on whoever is named on the label: a serious adverse event goes to FDA within 15 business days with a copy of the label, new information follows within a year, and every complaint is kept six years for an inspector.

15 business days

to report a serious adverse event to FDA.

Natural Products Association →
6 years

every adverse event record is kept, open to FDA inspection.

Natural Products Association →
A copy of the label

goes with every serious adverse event report.

Natural Products Association →

Will not close a complaint, or sell a supplement, half done.

Not a reminder. Close refuses, naming the reason, while a complaint is unjudged, called not serious with no reason, serious and unreported, or owed new information. Reported today refuses without the MedWatch reference and the label copy. Put on sale refuses a supplement with no U.S. contact on its label. Records cannot be deleted inside six years. There is no override.

How it works

Log, judge, report

Log the complaint

The product, what happened in plain words, a customer reference - no names.

Judge it

Serious and which outcome, or not serious and why.

Report and follow up

The MedWatch reference and the label copy, any new information for a year, then it closes and is kept six years.

What it will never do

It keeps the record. Never the customer.

Caplet holds products, dates and plain descriptions, nothing more.

No customer name or medical record.A reference you choose stands in for them.
It files nothing with FDA.You file the MedWatch form; Caplet keeps the date, reference and deadline.
It makes no health claims.It holds the record of what customers reported.
It is not legal or medical advice.It is the record and the gates.

Pricing

One plan

For one brand.

One brand

Brand

$25/mo

Every complaint, every supplement.

  • 15-business-day FDA clock
  • One-year follow-ups tracked
  • Six years kept for you
  • Close and sale gates

Monthly, per brand. Your bank statement says Caplet Software. Your licence key is on your screen as soon as the payment confirms.

Pay by card through Square, on Square’s own checkout page — we never see or store your card number. Or pay with bitcoin through our own bitcoin server. Either way you come back here, type your business name, and your licence key is on the screen — no email, no waiting on us.

Questions

The ones we actually get asked

We are a small brand. Does this apply?

Yes. The law has no small-business exception: whoever is named on the label reports and keeps the records.

Do we keep the complaints that were not serious?

Yes. Every adverse event report is kept six years, serious or not, and Caplet asks you to write why one was not serious.

Does it keep customers' details?

No. A reference stands in for the customer; what happened is written in plain words.

Is this legal advice?

No. It is the record and the gates in front of closing a complaint and selling a supplement.

What do I actually get when I pay?

The demo on this page is the whole program, running on invented records. Paying gets you a licence key — one line of text, on your screen as soon as the payment confirms: the checkout brings you back to our thank-you page, you type your business name and the key appears. Paste it into the program and from then on it keeps your own records. Until then, nothing you type into it is kept.

The key is checked inside the page, on your own machine. It never calls us, so there is still no account and nothing about your business goes anywhere. If you ever stop paying, your records stay exactly where they are, read-only, and Export still hands you every one of them.

Open the demo before the next complaint

A hospital stay is past its 15 business days unreported, and one supplement has no U.S. contact on its label.