Dietary Supplement Compliance.
The complete GMP & Registration engine. We handle Facility Registration, Label Review, and Structure/Function Claims in one platform.
Cert
Reg
VERIFIED COMPLIANT
Blocked by Amazon?
Amazon's Dietary Supplement Policy now requires a Certificate of Analysis (CoA) from an ISO 17025 accredited lab and valid FDA registration. We provide the documentation you need to get reinstated.
Get Amazon compliant
Listing Deactivated
Your dietary supplement listing has been removed. You must submit a Certificate of Analysis (CoA) from an ISO 17025 accredited laboratory.
The 75-day clock.
If your ingredient wasn't marketed in the US before October 15, 1994, you MUST file a New Dietary Ingredient (NDI) notification 75 days before marketing. Failure renders your product adulterated.
Start NDI assessmentDon't say “cure”.
One wrong word turns your supplement into an unapproved drug. Our AI auditor flags high-risk terms like “treats”, “prevents”, or “pain relief” and suggests compliant alternatives.
Master manufacturing records.
“If it isn't written down, it didn't happen.” FDA inspectors demand Master Manufacturing Records (MMR) and Batch Production Records (BPR) for every lot. We digitize your compliance.
Who is responsible?
Using a contract manufacturer does NOT absolve you of GMP liability. You must have a written Quality Agreement defining who tests raw materials, who releases finished batches, and who handles complaints.
Download agreement templateThe ”Dirty List“
FDA Enforcement Priorities
Avoid the dirty list.
Using ingredients like DMHA, Phenibut, or Kratom? The FDA considers these unsafe food additives. We screen your formula against the latest warning letters and import alerts.
Screen my formula30-day notification.
If your label makes structure/function claims (e.g., “Supports joint health”), you must notify the FDA within 30 days of first marketing the product. We handle this submission for you.
File notificationProve it's pure.
You must verify the identity of every dietary ingredient. We connect you with ISO 17025 accredited labs for ID testing (FTIR, HPLC) and heavy metal screening (Prop 65).
The heavy metal risk.
Supplements are the #1 target for Proposition 65 lawsuits. If your product contains Lead > 0.5 µg/day, you need a warning label or you face penalties of $2,500 per violation per day.
Check heavy metalsSerious adverse events.
You must report serious events (hospitalization, death) to FDA within 15 days via the Safety Reporting Portal. Our dashboard manages the timeline for you.
Action: Refusal of Admission
Trapped on the
Red List?
An Import Alert isn't just a delay—it's a blockade. FDA has authorized customs to detain your shipments automatically. We engineer the scientific petition required to secure your Green List exemption.
The formatting test.
Formatting errors on the “Supplement Facts” panel are the #1 trigger for class-action lawsuits. We verify font sizes, hair, heavy lines, and %DV calculations.
Get a label reviewSupplement Facts
Serving Size 2 Capsules
Shelf life data.
You cannot put an expiration date on your bottle without data to back it up. We coordinate accelerated (3-month) and real-time stability studies to validate your “Best By” date.
Start stability studyThe FDA regulates the label.
The FTC regulates the ad.
Your website, social media, and Amazon A+ content are all subject to FTC truth-in-advertising laws. We review your marketing materials to ensure they match your label claims.
Audit my websiteEnforcement triggers
The FDA is aggressively targeting the supplement industry. Here are the top risks.
New Dietary Ingredients
Using an NDI without a 75-day pre-market notification renders your product adulterated.
Disease Claims
Claims like 'lowers blood pressure' or 'relieves pain' are drug claims. Immediate Warning Letter.
Heavy Metals
Lead, Arsenic, Cadmium, Mercury. Failure to test for these is a GMP violation and Prop 65 risk.
The Registration Evolution
Stop fighting 2003-era government portals.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.