FDA Regulatory Compliance Consulting
Turn non‑compliant into market‑ready.
Cospliance helps cosmetics, food & beverage, and dietary supplement brands register with the FDA, correct labels before they become violations, and stay ahead of MoCRA, DSHEA, and 21 CFR changes.
Where we work
Three industries, three sets of rules.
Each sector answers to a different regulatory framework — we specialize in all three so nothing falls through the cracks.
Cosmetics
The Modernization of Cosmetics Regulation Act introduced facility registration, product listing, and adverse event reporting requirements for the first time.
- Facility & product registration
- Label & ingredient review
- Safety substantiation records
Food & Beverage
Domestic and foreign food facilities must register with the FDA and, if importing, appoint a US Agent to receive regulatory communications.
- FDA food facility registration
- US Agent representation
- Nutrition & allergen labeling
Dietary Supplements
Supplements are regulated as a food category with their own labeling rules — Supplement Facts panels, structure/function claims, and NDI notifications.
- Supplement Facts panel review
- Structure/function claim screening
- New Dietary Ingredient (NDI) support
What we do
Compliance work, itemized.
FDA & US Agent Registration
We register your facility and, where required for foreign companies, act as your US Agent — the point of contact the FDA needs on file.
Label & Claim Review
Line-by-line review of packaging and marketing claims against the relevant framework before you print — catching drug claims, formatting errors, and missing disclosures early.
Ongoing Regulatory Monitoring
Rules change. We track updates to MoCRA, DSHEA, and 21 CFR that affect your product category and flag what needs to change on your end.
Import & Customs Support
Guidance on FDA prior notice requirements and customs holds for shipments entering the US market.
How it works
Four steps, start to compliant.
Assess
We review your product, label, and target market to identify which regulations apply.
Register
We handle FDA facility registration and US Agent appointment where required.
Review
Labels and claims are redlined against the applicable framework before you go to print.
Monitor
We track regulatory changes on an ongoing basis so you're not caught off guard.
Our approach
Why brands work with us.
Direct access to specialists
You talk to the person handling your file, not a rotating support queue.
Plain-English guidance
We translate CFR citations into what you actually need to change.
One partner, three frameworks
Cosmetics, food, and supplements — no need to juggle separate consultants.
Client results
Client stories, coming soon.
This space is reserved for real client feedback.
As Cospliance takes on its first clients, verified reviews and case studies will go here — we don't publish placeholder testimonials.
Awaiting first reviewsCommon questions
Frequently asked.
Do foreign companies need a US Agent?
Yes — foreign food and cosmetics facilities exporting to the US are generally required to designate a US Agent as their point of contact for the FDA. We can act as your US Agent as part of a registration engagement.
What changed with MoCRA for cosmetics companies?
MoCRA (2022) introduced mandatory facility registration, product listing, adverse event reporting, and updated safety substantiation requirements for cosmetics — the first major update to US cosmetics law in decades.
Can a supplement label make health claims?
Supplements can generally make structure/function claims (e.g. "supports immune health") but not disease claims (e.g. "treats arthritis") without triggering drug regulation. We screen claims against DSHEA before you print.
How long does FDA facility registration take?
Timelines vary by category and completeness of your submission — we'll give you a specific estimate once we've reviewed your product and target market during the assessment step.
Get started
Request a compliance review.
Tell us about your product and target market — we'll follow up with what applies to you.
Industries served
Cosmetics · Food & Beverage · Dietary Supplements
Response time
We aim to reply within one business day.