Supplements & cosmetics
Voice AI for
supplements.
The consumer safety line, answered. Adverse events captured in the caller’s own words, filed as a structured record, and in front of your safety officer the same day.
Example
How an adverse event call is handled
Callspace takes the report, records the details, and sends them to your safety team. Your team decides whether the event is serious.
- Callspace
Thanks for calling Larkspur Naturals. How can I help?
- Caller
I started using your Shea Hand Cream about a week ago, and I’ve had an itchy rash on my hands for the last few days.
- Callspace
I’m sorry to hear that. I’ll take this down for our safety team. Do you have the tube? The lot number is printed on the crimped end, next to the expiry date.
- Caller
Lot 24B117. It expires March 2027.
- Callspace
Thank you. Can I take your name and the best number to reach you?
- Caller
Ana Reyes. 555-0142.
- Callspace
Thanks, Ana. I have Shea Hand Cream, lot 24B117, and an itchy rash on your hands for a few days. Someone from our safety team will call you back.
- ✓ Safety intake started
- ✓ Product and lot captured
- ✓ Consumer identified
- ✓ Details read back and confirmed
Callspace
- 01
Captured as a record
- Consumer
- Ana Reyes · 555-0142
- Reporter
- Same as consumer
- Product
- Shea Hand Cream · lot 24B117 · exp 03/2027
- Event
- “I’ve had an itchy rash on my hands for the last few days.”
- 02
Flagged for review
Matched your rule: any reaction after using a product.
- 03
Handed to your team
When the call ends, the summary reaches your safety team by email or text, with the recording and transcript one click away.
Your safety team
- 04
A person confirms
Your safety officer reviews the recording and decides whether the event meets the serious adverse event definition.
Serious
MedWatch 3500A within 15 business days
Not serious
Logged and followed up under your own procedure
Larkspur Naturals and its callers are fictional. Tags come from rules you write, and whether an event is serious stays your team’s call.
Coverage
The calls it takes off your team.
The number on your label is a regulatory obligation. Section 609 of the Federal Food, Drug, and Cosmetic Act, added by the Modernization of Cosmetics Regulation Act of 2022, has required cosmetic labels to carry a domestic address, a domestic phone number, or electronic contact information for adverse event reports since December 2024, and supplement labels have carried the same contact since the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Callspace answers that line at 2 a.m. on a Sunday, captures the event the way the caller describes it, and puts the recording in front of your safety team while the fifteen-business-day clock is still new.
- 01
Adverse event intake, structured on the call
The four elements a report is built on: an identifiable consumer, an identifiable reporter, the suspect product with lot number and expiry, and the event in the caller’s own words. Each one becomes a tagged record with those fields filled in and the recording attached, so the month’s reports are a list you can filter rather than a folder of voicemails. Whatever the caller declines to give is recorded as not given.
- 02
Serious adverse events escalated while the caller is still on the line
Hospitalization, infection, significant disfigurement — which under MoCRA includes serious and persistent rashes, second- or third-degree burns, and significant hair loss. You write the escalation rules; language like that reaches a person immediately, so the SAE clock starts with the facts already assembled.
- 03
Product complaints, triaged toward a qualified person
Subpart O of 21 CFR Part 111 puts every product complaint in front of a qualified person. The agent takes the intake — lot, purchase date, what went wrong, what the product looked or smelled like — and hands it over transcribed, with the audio as the source document.
- 04
The order and ingredient questions filling the same queue
Subscriptions, tracking, retailer locations, whether an ingredient is in a formula. Answered from your own product pages and documents, with Shopify order lookup by order number. The safety line stops being a place people wait behind shipping questions.
Boundaries
What it will not do
- It does not give medical advice, assess how serious a reaction is, or tell a caller what to do about one.
- It does not decide whether an event is reportable, and it does not file with FDA. The MedWatch 3500A and the fifteen-business-day deadline stay with your responsible person.
- It answers product questions from your approved structure/function copy and stops there. Treating, preventing, or curing anything is a claim it will not make.
- Anything urgent or ambiguous goes to a person immediately, with the recording and the full transcript attached.
Integrations
Connects to what you already run.
Live integrations are the ones the agent can act through today. The rest are on the way, and anything not listed reaches us through webhooks or a custom integration.
- Avaros EMR Soon
- Attio Soon
- Salesforce Soon
- HubSpot Soon
- Slack Soon
- Pipedrive Soon
- Zapier Soon
- Stripe Soon
- n8n Soon
Trust
Built for calls that become records.
An adverse event call is a record you may have to produce years later — six years of it under section 761 of the FD&C Act for supplements and section 605 for cosmetics, three for a small cosmetic business. Retention is a window you set, every purge writes a receipt, and these are the controls underneath it, built for our healthcare customers and running on the same platform your calls run on. A SOC 2 Type II audit is underway, and the report goes to every customer before they go live.
- 01
Compliance mode, one way only
PHIPA/HIPAA compliance mode is set per organization and cannot be turned back off. Behaviour that depends on it cannot be relaxed later, by your team or by ours.
- 02
Notifications carry no PHI
With compliance mode on, email and SMS call summaries carry a link and nothing else, and push notifications drop the preview entirely. Lock screens and inboxes are the two places this data most often leaks, so it never goes there.
- 03
Every access recorded
Reads of PHI-bearing records are written to an access log with actor, action, resource, request id, IP address, and timestamp — built to the content specification in PHIPA s. 10.1(4). Owner and admin only, viewable in the app and exportable as CSV.
- 04
Diagnostics log field names only
Field names carry no caller data, so they are logged everywhere. Values are never written to a log line under compliance mode.
Compared
Against what you have now.
A phone tree is cheap and everyone hates it. An answering service is human and stops at taking a message. Here is where the agent lands.
| Capability | Phone tree | Answering service | Callspace |
|---|---|---|---|
| Caller says what they need in their own words | Press 1 for… | Yes | Yes |
| Answers every line at once during a spike | Queues | Depends on staffing | Yes |
| Books into your calendar on the call | No | Sometimes, at extra cost | Yes |
| Looks up an order or a record mid-call | No | Rarely | Shopify, calendar, CRM, webhooks |
| Transfers with the context already gathered | Cold transfer | Message only | Warm, with transcript |
| Recording and transcript of every call | Sometimes | Rarely shared | Yes, searchable |
| Keeps PHI out of notifications and logs | N/A | Your problem | Compliance mode, one-way |
| Tells the caller what it is when asked | Obvious | Human | Yes, and transfers on request |
Rollout
Live on one line before it is live on all of them.
No big-bang cutover. You hear how it handles your actual callers on a narrow scope, then decide how far to take it.
- Step 01
Scope the calls
We go through the calls you actually get, decide which ones the agent should own, and agree what it must always hand to a person.
- Step 02
Build and connect
Your script, your escalation rules, your calendar, CRM, or store. If you need compliance mode, it is switched on here, before any real call is answered.
- Step 03
Test on real scenarios
We run the edge cases — the angry caller, the wrong number, the emergency, the caller who asks whether it is a person — and adjust until it holds up.
- Step 04
Go live on one line
Forward one number or one after-hours branch. You listen to a week of real calls, then widen the scope with evidence rather than optimism.
FAQ
Questions we get asked.
Does Callspace report adverse events to FDA for us?
No. It answers the call, captures the event in the caller’s own words, and hands your team a recording, a transcript, and a structured summary the same day. Submitting the MedWatch 3500A within fifteen business days, and deciding what meets the serious adverse event definition, stays with your responsible person.
What does it actually capture on an adverse event call?
An identifiable consumer, an identifiable reporter, the suspect product with lot number and expiry, and the event as described — plus onset dates, other products taken alongside it, and a callback number. It reads the details back before the call ends so the record is confirmed by the person who gave it.
How does it know a call is a serious adverse event?
You write the escalation rules and the statutory definition becomes language the agent escalates on rather than judges: death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, a congenital anomaly, infection, significant disfigurement, or an event requiring medical or surgical intervention to prevent one of those. Anything ambiguous escalates as well.
Can it answer questions about what a product does?
It answers from the copy you already publish — the structure/function statements on your label and product pages, with your DSHEA disclaimer where you use one. A question it cannot answer from your own material becomes a message for your team instead of an improvised answer.
Where do the reports end up?
In a list your team works, not an inbox they forward. Every adverse event call is tagged, so you can filter to them, sort by product or lot, and search the transcripts. Assign one and it reaches your safety officer or compliance lead by email, SMS, or push. Point a webhook at your safety database or quality system and each call arrives there as structured JSON the moment it ends — and ask us if you need a bulk export in another shape.
Is the recording something we can produce in an inspection?
Every call is recorded, transcribed, and summarised, and transcripts are searchable by lot number, product, or caller. Recordings sit in private storage behind five-minute signed links. You set the retention window, and each purge writes a receipt naming what was removed and on whose instruction, so the evidence outlives the data.
We put a phone number on the label for MoCRA. What changes?
A number on a label is a number that rings, including on the weekend and the week a post goes viral. Pointing it at Callspace means every one of those callers gets a conversation and a record, and your quality team gets the ones that matter with the audio attached.
Bring us the calls you were told needed a person.
We will go through your actual call volume, agree what the agent should never touch, and put it live on one line so you hear it on your own callers. A BAA is in place first if you need one.