
5 AI Toys That Are NOT Safe For Your Kids

AI toys have been
AI toys sit in a regulatory black hole.
They're not medical devices (so the FDA doesn't touch them), they're not traditional toys (so CPSC standards don't apply), and COPPA was written before AI companions existed.
That means the products you give kids on their birthdays or Christmas have essentially zero oversight.
The 2025 U.S. PIRG "Trouble in Toyland" report and independent NBC News testing revealed serious safety and privacy issues with AI toys.
Here are the five that raised the biggest red flags.
🐻 FoloToy (Kumma/Sunflower Warmie) is a teddy bear that discussed sexually explicit topics with children, gave advice on how to light matches, AND find objects around the house.
🤖 Miko 3 is a toy robot that may share data with third parties and retain your child’s biometric information, including facial recognition scans, for up to 3 years.
🚀 Curio Grok is a stuffed rocket with a chatbot inside, and is constantly listening. During testing, the toy interjected into private adult conversations unprompted. Also, three companies may collect your child’s data from this one toy: KWS, Azure, and OpenAI.
🐶 Loona Petbot is a robot dog that uses facial recognition and records videos of your child and their surroundings as it roams your home. It was flagged because it creates a serious risk of capturing sensitive family moments - in bedrooms, bathrooms, anywhere it roams.
👶 Miriat Miiloo gave detailed instructions on how to sharpen a knife and light a match when asked. This plush toy with a child’s high-pitched voice has no parental controls or age verification.
Regulatory Affairs: Building A Career
What Matters Most: Experience, Certifications, Network?

The advice you gave was amazeballs
Okay, friends.
I threw a question out on LinkedIn a while ago and the RA community did not hold back. The question was: certifications, credentials, or hands-on experience…what actually gets you the job?
This is what you had to say:
Experience beats everything: almost every response pointed to hands-on RA work as the #1 deciding factor, no contest
Certifications are a nice-to-have, not a need-to-have: RAC, SOCRA, MS degrees rarely if ever were the deciding factor in getting an offer
They do help as a tiebreaker: when candidates are evenly matched, credentials signal commitment and seriousness about the field
Communication is the most underrated skill: knowing who to loop in, when to escalate, and what deserves an email vs. a meeting goes further than most people expect
The chicken-and-egg problem is real: getting that first RA role without prior RA experience is genuinely hard, especially outside major regulatory hubs
Geography matters more than people admit: market size and location heavily influence what roles are even available and what hiring managers prioritize
AI literacy is becoming a differentiator: one commenter flagged prompt engineering as an emerging skill worth developing in RA
Soft skills got people in the door: transferable skills, cross-functional exposure, and being able to explain the "why" behind regulatory decisions carried real weight in interviews
If you're trying to break in this year: find a way to touch real RA work, even if it's adjacent. Everything else can come later.
The Good Internet
🌎 Tech That Doesn’t Suck
A weekly roundup of the digital apps, products, and platforms that don’t..well..suck.

💤 8 Sleep is a smart mattress cover that uses dynamic temperature control, biometric tracking, and AI to personalize sleep. And while most know it as a premium wellness product, its most significant move right now isn't the $1.5B valuation — it's the active FDA filings for sleep apnea detection and mitigation. If cleared, the Pod would shift from a consumer device into a regulated health platform capable of screening and intervening at population scale, passively, every night. |
👶 Brick is a physical app-blocking device that flips the script on how we manage smartphone overuse. Instead of relying on self-discipline or easily bypassed software limits, it makes distraction physically inconvenient. The product is a small puck you place across the room; your blocked apps stay locked until you walk back to it and tap. It's a deceptively simple mechanic, and for healthcare and wellness professionals watching the behavioral science of habit change, it's a compelling one. |
In case you missed it
The Tea
The latest news on tech, health & wellness, and clinical research.

Longevity biohacker tries the first Ovarian Age Test
👩 Kayla Barnes-Lentz, female longevity biohacker, is the first woman in the world to have her ovarian age tested. Ovarian aging is arguably the single biggest driver of healthspan in women - and until now, there was no standardized way to measure it. That changes with MenoTime™.
🔬 FDA vs. Medtech Industry The medtech industry is sounding the alarm on MDUFA VI. RAPS reports that FDA's proposed TAP 2.0 structure, a scaled-down, permanent version of the pilot program, isn't sitting well with industry, which is calling for broader eligibility, better resourcing, and more transparency in the negotiations that will govern device approvals through 2032.
🩰 Ballerina Farm halts raw milk sale. The viral Utah dairy with millions of followers quietly paused raw milk sales after health inspectors found elevated bacteria levels in their products. Turns out, having an aesthetic farm and safely producing raw milk are two very different things. A Utah legislator is now pushing for stricter statewide raw milk regulations, with harsher penalties for producers whose milk makes people sick.
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That’s it for this week
I have been spending more time in Louisville's health innovation ecosystem lately.
Boy oh boy, are there certain things people get wrong about this place.
Startups in Kentucky had their most active deal-making year in a decade in 2025, recording 82 venture capital deals totaling $158.5 million. That's not huge by SF or NYC standards, but I will say:
Cost of living ~8–9% below national average → Your runway goes meaningfully further.
Healthcare is a core strength → Large, growing cluster with major systems and new med-manufacturing investments (e.g., surgical gloves HQ).
The network is relationship-driven → You can't parachute in and get funded. But if you engage, doors open fast
UofL + UK are producing talent → Thousands of tech workers + growing data/AI/cyber pipelines and research IP access.*
I moved to Louisville because the cost-benefit ratio is pretty decent. I can bootstrap, build relationships, and actually afford to live while doing it. The ecosystem isn't flashy..but flashy ecosystems are expensive and overhyped.
If you are a founder, investor, or innovator in the Louisville (or Kentucky) area, let me take you out for coffee.
If you’re not from Louisville, let’s get coffee..virtually!
Welcome home. See you in the next issue. 🖤
Until next week,
Kristina

