Supplement Labels, Claims & NDI Notifications | Done Right
We help supplement brands navigate DSHEA compliance: structure/function claims that stay defensible, Supplement Facts panels that meet formatting rules, NDI notifications when required, and cGMP/label readiness so you can scale on Amazon, retail, and DTC without regulatory surprises.
Why Supplement Brands Get Flagged
Supplements are regulated as foods under DSHEA, but that doesn't mean "anything goes." The FDA enforces strict rules around claims, labeling, new dietary ingredients (NDIs), adverse event reporting, and manufacturing practices. Most enforcement comes from claims that cross into drug territory or labels that violate formatting requirements.
- Claims boundaries: Structure/function claims are allowed, but disease claims turn your product into an unapproved drug.
- Substantiation: All claims must have a reasonable basis in science—marketing language doesn't override this.
- NDI requirements: Ingredients introduced after October 15, 1994 may require a 75-day premarket notification to FDA.
- Label accuracy: Supplement Facts must follow exact formatting rules, and ingredient names must match FDA databases or accepted conventions.
- Platform enforcement: Amazon, Walmart, and other retailers have their own compliance layers on top of FDA requirements.
Supplement Compliance Programs
Clear deliverables, realistic timelines, and transparent pricing bands for each stage of your compliance journey.
Label Review & Supplement Facts Formatting
Typical range: $400–$1,200 per SKU
For brands that need their Supplement Facts panels and outer labeling reviewed for FDA formatting and content requirements.
- Supplement Facts formatting compliance (serving size, daily value %, ingredient order)
- Principal display panel (PDP) and information panel review
- Ingredient name verification against FDA databases and conventions
- Net quantity, allergen, and contact statement checks
Structure/Function Claims Review & Substantiation
Typical range: $600–$2,500
For marketing claims across labels, websites, Amazon listings, and social media that need to stay within legal boundaries.
- Claims audit: identify disease claims vs. permissible structure/function claims
- Substantiation review: assess whether existing studies support your claims
- Rewrite recommendations with compliant alternatives
- DSHEA notification preparation if not previously submitted
New Dietary Ingredient (NDI) Notification
Typical range: $3,500–$8,500
For ingredients introduced after October 1994 that require a premarket notification demonstrating safety.
- NDI status assessment (old dietary ingredient vs. NDI determination)
- History of use research and documentation
- Safety dossier compilation (manufacturing, specifications, toxicology)
- 75-day premarket notification drafting and submission strategy
cGMP Readiness & Manufacturing Alignment
Typical range: $1,200–$4,000
For brands working with contract manufacturers who need to ensure facility compliance and documentation alignment.
- cGMP requirement overview and gap assessment
- Master manufacturing record (MMR) review for supplement products
- Finished product specifications and testing alignment
- Certificate of analysis (COA) review and label claim verification
Amazon & Retail Compliance Package
Typical range: $500–$1,800
For brands selling on Amazon, Walmart, Target, or specialty retail who need platform-specific compliance support.
- Product listing claims audit across all channels
- A+ content, bullet points, and product description review
- Amazon Transparency enrollment guidance and GTIN/UPC strategy
- Retailer compliance requirement mapping (Vitamin Shoppe, GNC, etc.)
Adverse Event Reporting (AER) Setup
Typical range: $800–$2,200
For brands that need a compliant adverse event reporting system and training for customer service teams.
- AER policy and procedure documentation
- Serious adverse event (SAE) identification training
- 15-day reporting workflow and templates
- Customer service team training materials
Who We Help
DTC Supplement Brands
Fast-growing brands scaling Shopify, Amazon, or subscription models who need claims and labels buttoned up before regulatory scrutiny increases.
Formulators & White Label
Companies creating new formulations or private label products who need NDI assessments and Supplement Facts accuracy from the start.
Amazon FBA Sellers
Sellers facing listing suppressions, compliance holds, or platform flags who need defensible documentation and corrected claims.
Retail Distribution Expansion
Brands moving into brick-and-mortar retail (Whole Foods, GNC, CVS) who need compliance documentation retailers require.
Novel Ingredient Products
Brands using trending or novel ingredients (adaptogens, nootropics, exotic botanicals) that may require NDI notifications.
International Brands Entering US
Companies familiar with EU or other regulations who need to understand and comply with US DSHEA requirements.
How We Run Supplement Engagements
Systematic review, clear risk identification, and actionable compliance roadmaps.
Ingredient & Claims Assessment
We review your formula, ingredient sources, claims across all channels, and existing labels to identify compliance gaps and priorities.
Risk Mapping & Recommendations
We map regulatory risk by ingredient (NDI status), claims (disease vs. structure/function), and manufacturing (cGMP alignment).
Documentation & Submissions
We prepare compliant labels, substantiation files, NDI notifications (if needed), and platform-ready documentation packages.
Ongoing Compliance Support
We establish review protocols for new SKUs, formula changes, claims updates, and adverse event monitoring so compliance scales with growth.
Supplement Compliance FAQs
Do I need FDA approval before selling supplements?
No, supplements don't require premarket approval. However, you must comply with DSHEA requirements including: appropriate claims, Supplement Facts formatting, NDI notifications if applicable, adverse event reporting, and cGMP manufacturing. Non-compliance can lead to warning letters, product seizures, or marketplace removal.
What's the difference between a structure/function claim and a disease claim?
Structure/function claims describe the role of a nutrient or ingredient in maintaining normal structure or function (e.g., "supports immune health"). Disease claims state that a product treats, prevents, or cures a disease (e.g., "prevents colds"). Disease claims turn your supplement into an unapproved drug. The line can be subtle—we help you stay on the right side.
How do I know if my ingredient requires an NDI notification?
If your ingredient (or its manufacturing process, form, or purity) was not marketed in the US before October 15, 1994, it's likely an NDI requiring a 75-day premarket notification. We conduct NDI status assessments and handle the notification process if needed.
Can you help with Amazon listing suspensions related to compliance?
Yes, we frequently work with brands facing listing suppressions or compliance holds on Amazon. We review the issue, prepare corrected labels and claims documentation, and provide the compliance evidence Amazon requires for reinstatement.
What if my contract manufacturer says my product is "compliant"?
Manufacturers focus on cGMP and production; they don't typically review your marketing claims or label content for DSHEA compliance. That responsibility stays with you as the brand. We bridge that gap by reviewing the full compliance picture—manufacturing, labeling, and marketing.
Are these pricing ranges negotiable?
These are typical working ranges. After a discovery call we provide a fixed or milestone-based quote based on SKU count, ingredient complexity, existing documentation quality, and timeline. Multi-SKU portfolios often receive volume pricing.