FDA’s new guidance on general wellness

Yesterday's release by FDA on wellness vs medical device leaves me with a bitter aftertaste. Why?

I'm usually enthusiastic about policies that lower the barrier to market entry for health products. I'm less enthusiastic about those that eliminate the quality drivers from it..

My main concerns under this guidance:

> General wellness products have no QMS requirement, especially digital ones. So when the guidance says you can now display biomarkers even with some disease reference as long as "the product has validated values" for those biomarkers, it doesn't really mean anything. How do they validate? According to what? Where? Claims get bolder and accountability weaker.

> We will see more products being Class IIa medical devices in EU (with QMS auditing and device file review) while facing zero expectations in the US as general wellness.

> The gap between EU and US regulatory approach gets wider. EU released a "similar" guidance in Sep 2025 emphasising the opposite, with increased focus on mechanism of action and technology rather than relying on claims only. US heads the other way, making it all the more complicated for us RA 🥴

> It will be harder for startups to design their product and strategies for the two main western markets simultaneously. They will be pushed even heavier towards wellness-first but in my experience they get easily stuck there.

> This bold approach may be (too) specific of this administration. Will it then outlive it? It is also clearly result from the WHOOP controversy, given the number of references to Blood Pressure measuring wrist-worn devices. Pretty solid legal and lobby teams there.

One example that puzzles me in particular is the one about glucose monitoring via "minimally invasive microneedle technology" for which FDA says they will apply enforcement discretion as a low risk device. Since I'm currently working on the biocompatibility testing requirements for a device that is hand held by doctors using gloves (👀), I cannot help but finding it unfair towards the rest of the sector.

So I hope you will excuse my slightly less upbeat post this time.

I'm generally excited about the expansion of the definition and agree with the rationale of most of the examples provided.

I'm curious to see what it will mean for international harmonisation and for the opportunities it will open for my clients at this interface!

What can we learn from… Canada?

What am I doing sitting in a bilingual English-French panel at the Embassy of Canada | Ambassade du Canada in Paris??

Talking femtech regulatory compliance trends (in English) while listening (mostly in live-translated French) to the perspectives of brilliant entrepreneurs, investors, researchers and diplomats!

This would be for my series of "What can we learn from... Canada?"
The Canadian Trade Commission runs the Canadian Technology Accelerators | Accélerateurs technologiques canadiens, a programme to support Canadian startups to expand to other markets. By collaborating with global Canadian embassies they provide eligible startups with local mentorship, contacts and partnerships to boost their growth.

As part of this, I had the privilege to mentor Élan Healthcare Inc. run by Pari (Parvaneh) Saharkhiz, MD, MBA, a doctor turned founder and manufacturer of supplements especially designed to tackle the nutritional imbalances that are often root to PCOS and infertility. Around 10% of women are affected by PCOS, 70% go undiagnosed, and even those who have it diagnosed struggle to find treatment. Check them out: https://elanhealthcare.ca/

Grateful for the invitation to Trade Commissioner Frederic Chieux and Fiona Thwaites. A pleasure to sit on the panel with collaborator, friend and amazing host Erica Perrier, PhD, MS, CSCS as well as great copanelists Régine Brielle Juliette Mauro Andrea Guest Andréa Saragoussi Keshiv Kaushal - thanks for sharing your knowledge.

Greatest success to the impressively advanced startups in the mentee cohort Cogni Cosm Medical Emovi Juno Technologies™ Mino Care My Normative LoOoP SYNG Pharmaceuticals Inc, I look forward to staying in touch!

If “wellness” cosmetics are regulated, why isn't “wellness" tech?

While diving into a new cosmetics project, I saw this angle, then tilted my head and... "I couldn’t help but wonder": do people realise cosmetics carry real compliance duties despite no medical claims?

Cosmetics must show, at mininum:
▶️ Manufacturing quality: GMP (ISO 22716) + national rules (e.g., EU 1223/2009, FDA 21 CFR 700)
▶️ Safety & testing: microbial load, stability/shelf life, toxicological assessment
▶️ Accountability & traceability: labelling, INCIs disclosure, product registration (e.g., EU CPNP), adverse event reporting
▶️ Governance: a designated Responsible Person, inspection-ready procedures & technical documentation

In principle, not at all far from medical devices, just rightly lighter in scope and depth.

I’m seeing both directions lately: wellness products drifting into medical territory and claim downgrades to step out of it (especially post-MDR transition end). As medical regulations tighten, new categories - and opportunities - emerge at the edges. The fluid interface is such an exciting place to be ❤️‍🔥.

My view:
Health/body-affecting products should meet proportionate standardisation and accountability. I’d favour a distinct “health and wellness-tech” category with its own rules (as cosmetics have, as the FDA is exploring) over forcing medical device frameworks around them.

Do you agree? Do you also see a rise in review of claim strategy by health product manufacturers (whether upwards or downwards)?

The WHOOP saga

WHOOP ’s current FDA row is properly binge-worthy. Material for the next Lincoln Lawyer season on Netflix?
But until then, some personal reflections on why it matters for digital health and wearables.

This season’s hottest episodes:
🎞️ Ep. 1 : WHOOP launches Blood Pressure Insights (BPI) as a Wellness feature but claiming medical grade insights.
🎞️ Ep. 2 : FDA’s surveillance picks it up and issues a Warning Letter (made public with exceptional urgency) arguing against the medical disclaimers given the “inherent association” of BP with the diagnosis of hypo/hypertension,
🎞️ Ep. 3 : WHOOP refuses to pull the feature and takes it public/political, meeting with RFK Jr and attacking FDA’s integrity on social media.

I get it, it’s tough to live on the line. Enjoying the aura of “medical-grade” without the burden is the dream of many, but it's getting harder. I’ve been there with multiple startups, and deeply empathise with some of the operational and financial challenges they faced in getting that balance right - often in absence of clear guidelines.

But now: guidance is there, WHOOP already has an FDA-cleared ECG feature (i.e. a QMS) and likely the budget... then why not route the BPI feature under their existing regulated org? Whether from the start or in response to the warning. How is taking up this massive fight a better strategy?

In smaller cases, it would ring a quality culture and integration issue. But in this one, it’s seems a fight on principle - while enjoying the extra PR of being the torch bearer for the freedom of wearables worldwide.

Meanwhile, Hilo by Aktiia quietly secures BP clearance with medical indication for its bracelet without the fuss. 👀

If you’re in the borderline medical space, this is a defining moment.
➡️ Disclaimers may be shorter-lived than ever, careful if you’re relying on those.
➡️ Not all companies are the WHOOP or SPACEX of the ton. Don’t assume this aggressive strategy would work for you, play smart yes, but sustainable. PR and legal repercussions can be devastating for fundability.
➡️ Hire QARA professionals who know how to navigate the redlines vs the negotiables of borderline products.

As Blythe Karow put it in her BEAUTIFUL long read on this story:

“The art lies in reading between the lines and addressing the specific compliance issues rather than fighting fundamental regulatory doctrine.”

Meanwhile, in real life: A friend told me "my sleep/stress score from my watch is looking weird... am I sick??". Familiar? Apparently, WHOOP had an internal policy in place during COVID that employees should stay home if their score was lower than a certain threshold - they either had the virus or could easily get it. If this is how we use these tools, what's so bad in providing assurance of quality and accuracy in the first place?

Only time will tell.. For now, pass the popcorn 🍿