What Can Go Wrong With Supplement Manufacturers (And How To Catch It Early)
Summary (Key takeaways)
“Turnkey” isn’t turnkey. Many co-mans optimize for lowest quote and fast release, not long-term compliance or shelf life.
Watch for day-0 only formulas (no overages), packaging compliance misses, weak or missing product specs, and pathogen control gaps.
A great COA means little if the spec is bad. You need identity, purity, strength, and composition plus micro & chemical limits that match your claims.
Don’t rely on skip-lot testing or vague “visual ID” calls. Require fit-for-purpose methods and accredited third-party labs.
Vet with documents, not promises: finished-product spec, sample COA, audit/cert letters, T&Cs, and a facility tour (virtual is fine).
Put testing, acceptance criteria, and retention samples into your PO—that’s how you enforce quality.
The “turnkey” myth (and why incentives matter)
Most founders assume the contract manufacturer will “handle compliance.” In practice, many teams are geared to win quotes and hit ship dates. Regulatory, R&D, and packaging are often under-resourced, which leads to avoidable misses that become your problem later with FDA, retailers, or plaintiffs’ attorneys.
Problem 1: Formulating to pass day-0 (not month-24)
Some R&D teams build formulas that barely pass label claim at release. No stability model, no overages, and no plan to support the date code you print. Result: under-potency later in life or failed retailer testing.
What to require
Stability rationale (or study when you’re dating product).
Calculated overages for at-risk actives.
A spec that tests potency at release and defines stability commitments when claimed.
Problem 2: Packaging & component compliance blind spots
I still see recalls triggered by packaging––not the powder. Misses include food-contact suitability, allergen controls in the line that applies labels, wrong liners/closures, and labeling mechanics (UPC/lot/date layout) that don’t meet customer requirements. For specific cases, certain formulas require special packaging (e.g., child-resistant packaging for iron at defined levels under PPPA).
What to require
Component data sheets and compliance letters for food contact.
Closure/liner suitability, tamper-evident features, and print/readability checks.
Allergen & cross-contact controls where packaging is handled.
If iron is present, confirm child-resistant obligations.
Problem 3: Pathogen control and environmental monitoring gaps
We obsess about creatine grams and vitamin potency but overlook Salmonella, Listeria, STEC E. coli risk—especially in dry facilities handling botanicals, proteins, or contract repacks. Once entrenched, contamination is hard to eradicate and can idle lines for weeks.
What to require
Written Environmental Monitoring Program with routine swabs, zoning, and corrective actions.
Ingredient risk assessments (e.g., high-risk botanicals) and kill-step/validation where applicable.
Every-lot micro testing appropriate to risk (not only skip-lot).
Problem 4: Weak (or missing) finished-product specifications
FDA expects specs covering identity, purity, strength, and composition—plus appropriate micro/chemical contaminant limits. Too often I see: no spec, a copy-paste template, or a spec that only lists potency.
What to require
A product-specific spec that includes:
Identity methods (not just “visual”).
Strength (label claim) with method and acceptance range.
Purity & composition (incl. contaminant limits: micro, heavy metals, pesticides where relevant, residual solvents if used).
Any “free-from” limits (e.g., gluten thresholds) if you claim them.
Problem 5: Testing shortcuts and method mismatch
Red flags: “component testing only” for actives without meeting the exemption conditions, skip-lot for critical hazards, and COAs that list generic methods or labs with unclear accreditation.
What to require
Method references fit for the matrix and analyte (e.g., HPLC/ICP-MS where appropriate).
Accredited third-party labs (and documentation).
Clear policy on when component testing is allowed, and when finished-product testing is mandatory.
Problem 6: Label compliance is siloed
Manufacturers may provide a Supplement Facts panel and leave the rest to you. That’s where claims, disclaimers, and required statements go wrong—creating retailer rejections or demand letters.
What to require
An internal label content checklist across PDP, panels, claims, disclaimers, net quantity, firm info, lot/date, allergens, and any retail-specific rules (Amazon, etc.).
Claim substantiation files that match your label and PDP.
Problem 7: Transparency & documentation access
“When we have it, we’ll send it” isn’t a system. You need predictable access to batch records, COAs, release approvals, retention sample policy, and terms that don’t push all risk to you.
What to require
Document access SLAs.
Defined retention sample quantities and storage conditions.
Terms that specify what triggers rework/hold/reject and who pays.
How to vet a co-man before you wire a deposit
Ask for (redacted is fine):
Current certifications/registrations (dietary supplement GMPs; relevant food safety programs for foods).
Finished-product spec and sample COA for a similar product.
Terms & Conditions (payment, storage, label change policy, indemnities).
A virtual or in-person tour.
Score them on:
Spec completeness and methods.
Testing posture (every lot vs skip-lot; accredited labs).
Environmental monitoring and allergen control maturity.
Responsiveness and willingness to share documentation.
Put quality into the PO (or it won’t happen)
List the tests required for release (micro, heavy metals, potency, any claim-critical checks).
Name the lab (or accreditation requirements), methods (or class), and acceptance criteria tied to the spec.
Require retention samples and define COA contents (lot, methods, lab accreditation).
Align on stability expectations if you print a date code.
Summary
Most co-man problems trace back to incentives and gaps you didn’t define. Close the gaps with a solid spec, explicit PO quality terms, and a real supplier qualification. You can’t outsource responsibility—but you can structure it so quality is the path of least resistance.
Next steps (work with us)
Signature 1-on-1 Consultations — A focused session to pressure-test your concept and claims, align label content with regulations, map your manufacturer search, and define the quality/testing asks to put in your PO.
SSET: Supplement Startup Essentials Training — Founder-friendly training to understand which regulations apply, build your market brief, and learn how to find and vet co-manufacturers and labs.
When working with us, you’ll also be able to leverage our curated manufacturer list.