Supplement Compliance.
Don't let a formatting error trigger a detention. We verify your Supplement Facts panel, New Dietary Ingredient (NDI) status, and Structure/Function claims.
The Facts Panel.
Formatting matters. Hairlines must be 1/4 point. Type sizes are mandated. “Serving Size” logic is complex. We generate a pixel-perfect template ready for your designer.
Supplement Facts
New Dietary Ingredients.
Is your star ingredient an “Old Dietary Ingredient” (ODI) or a “New” one (NDI)? If it's an NDI, you must notify the FDA 75 days before marketing. We check the status.
Check NDI StatusStructure vs. Disease.
You can say “Supports joint health” (Structure/Function). You CANNOT say “Cures arthritis” (Disease Claim). We line-edit your packaging to keep you in the safe zone.
Analyze ClaimsProprietary Blends.
You don't have to list amounts for each ingredient in a blend, but you MUST list them in descending order of predominance by weight. We verify your formula logic.
Undeclared Allergens.
The #1 cause of recalls. We check your source ingredients (e.g., Whey, Glucosamine) to ensure all major allergens (including Sesame) are properly declared.
Heavy Metal Limits.
California Prop 65 limits for Lead, Cadmium, and Arsenic are strict. We check your COA (Certificate of Analysis) against these thresholds to see if a warning is required.
Mandatory Warnings.
Iron supplements need a fatal poisoning warning. St. John's Wort needs interaction warnings. We ensure your label protects your customers and your company.
Label specs must match the Master Manufacturing Record (MMR) exactly.
Manufactured Correctly.
Your label must accurately reflect the Master Manufacturing Record (MMR). We verify that your finished product specs match your label claims to ensure cGMP compliance.
Adverse Event Contact.
Just like MoCRA, supplement labels MUST list a domestic address or phone number for consumers to report serious adverse events. Missing this is an immediate misbranding violation.
Made in USA?
The “Made in USA” standard is incredibly strict (all or virtually all). If you use imported Vitamin C, you likely need a qualified claim like “Made in USA with global ingredients.”
Organic Claims.
Using the USDA Organic seal requires 95%+ organic ingredients AND certification. “Made with Organic” has different rules. We prevent unauthorized seal usage.
Amazon Approval.
To sell supplements on Amazon, you need a Certificate of Analysis (CoA) from an ISO 17025 lab and strict label compliance. We prepare your package for Seller Central approval.
Get Amazon ReadyDrink or Supplement?
Liquid products are tricky. If it looks like a beverage (canned energy drink), FDA may regulate it as conventional food (Nutrition Facts), not a supplement.
FDA EXCLUSION RULE
The CBD Problem.
FDA maintains that CBD cannot be sold as a dietary supplement because it was studied as a drug first. We help you navigate the risk landscape for hemp-derived products.
Probiotic Labeling.
Probiotics must be labeled in Colony Forming Units (CFUs), not milligrams. And the count must be valid through the end of shelf life, not just at time of manufacture.
Shelf Life Data.
You don't legally need an expiration date, but if you use one, you MUST have stability data to back it up. We review your testing protocols.
Claim Notification.
If you make a structure/function claim, you must notify the FDA within 30 days of marketing the product. We handle this submission for you.
File 30-Day NoticePlatform vs. Hourly Fees.
Regulatory compliance shouldn't cost as much as product development.
Launch without the lawsuit.
Ensure your supplement facts panel is pixel-perfect and legally sound.
Full Supplement Audit
Everything you need to launch a compliant dietary supplement.
Disclaimer Check
Verifying the mandatory FDA disclaimer box is present and correct.
Net Quantity
Checking weight declarations match the format (US and Metric).
Identity Statement
Ensuring 'Dietary Supplement' is prominent on the PDP.
FALCPA Scan
Scanning for all 9 major food allergens.
SOP Review
Checking for required cGMP procedure documents.
Prop 65
Heavy metal threshold analysis.
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.