3 Things You Must Know Before Starting a Dietary Supplement Company
If you’re a health enthusiast ready to launch your own supplement brand, there’s more to success than a great formula and a Shopify theme. After 15+ years leading Regulatory Affairs and Quality Assurance across U.S. dietary supplements and foods, I’ve watched great brands stall because they misunderstood the rules—or delegated responsibility they legally own.
Here are the three fundamentals to get right before you spend big on R&D, inventory, and design.
Key Takeaway
The U.S. dietary supplement industry is regulated (labeling, claims, ingredients, and GMP manufacturing).
You cannot outsource your legal responsibility to a contract manufacturer.
If your brand name is on the label, the FDA treats you as the manufacturer for compliance and enforcement purposes.
Get these straight up front and you’ll avoid costly relabels, inventory write-offs, platform takedowns, and reputation damage.
1) Supplements Are Regulated (Despite What Headlines Say)
A persistent myth is that “supplements aren’t regulated.” They are. U.S. regulations cover:
Labeling (statements of identity, net quantity, Supplement Facts, ingredients, warnings, disclaimers)
Claims (what you can/can’t say; substantiation standards)
Manufacturing (21 CFR 111 GMP: specs, testing, batch records, complaints, recalls)
Enforcement capacity is finite, but expectation of compliance is universal. If you’re out of bounds—misbranded labels, impermissible claims, missing specs/testing—the risk ranges from warning letters and stop-sale to platform suspensions and retailer bans.
What to do now: Bake compliance into development: draft labels early, decide allowable claim language, and define finished product specifications and testing plans before first production.
2) You Can’t Contract Out Your Legal Responsibility
Most founders use contract manufacturers. That’s normal. What’s not normal is assuming they’ll “handle compliance.” Manufacturers optimize for throughput and margin; their template labels and COAs may not cover your risk.
If something’s wrong—claims, allergens, potency, stability—your brand is on the hook. Contracts often push liability back to you.
What to do now:
Set your specifications (identity, purity, strength, contaminants) and require COAs with methods that match those specs.
Establish change control so no ingredient/dose/label change happens without your approval.
Get a stability strategy if you print best-before/expiration dates.
Run an independent label/claims review before artwork is locked.
3) If Your Name Is on the Label, You’re the “Manufacturer”
For FDA purposes, the brand owner on the label is treated as the manufacturer. That means you must be able to produce, on request:
Product specs, supplier qualification, batch records/COAs
Complaint/AER logs and investigations
Recall plan and traceability
Substantiation files for claims
What to do now: Stand up a lean quality system: document templates, intake channels for complaints/AERs, investigation workflow, and a recall playbook—even if you’re small.
Frequently Asked Questions
Isn’t my manufacturer responsible for GMP?
They’re responsible for their operations, but you must ensure your product meets specs, labels are compliant, and claims are substantiated. Regulators and retailers look to the brand owner.
What’s the biggest early mistake?
Designing labels last. Draft labels and claims first, align them to allowed language, then build the product and testing plan to match.
Do I need stability data to use an expiration or best-before date?
Yes—have a rationale or data set appropriate to your dosage form and packaging. Don’t print dates you can’t support.
How early should I think about recalls and AERs?
Day one. Set collection channels (email/phone), triage rules, and investigation SOPs now. You can scale the process later.
Next Steps
Use this sequence to start right:
Draft your label and allowable claim language.
Define specs and testing, including any stability approach if you’ll print a date.
Set change control and complaint/AER intake before first production.
If you’re ready for hands-on help, I can partner with you as your advisor / compliance partner to:
Review labels and claims before artwork is locked.
Build your quality essentials (finished product specs, COA workflow, stability/dating policy, change control).
Stand up a lean complaint/AER and recall framework.
Vet manufacturers and align documentation to retailer expectations.
Action steps:
Book a Signature Consultation to get a tailored 30-day plan for your brand and current supplier model. (Link: Book a Signature Consultation)
Or enroll in Supplement Startup Essentials Training (SSET) for step-by-step modules, exercises, and a full breakdown of the supplement industry that you can implement immediately. (Link: Join SSET)
Let’s launch your supplement brand swiftly and on solid regulatory footing.