Evidence checklist
Prepare the documents below for the formulation and label you intend to submit. The application’s evidence table connects each claim to its supporting sources. No product samples are required.
Company and authorization
Provide the responsible company’s legal name, business address, authorized contact, and permission to submit the materials. Identify relevant manufacturers, laboratories, consultants, and relationships requested in the application.
Product and label
Include the product name, brand, category, dosage form, version, sales markets, intended users, and current label panels.
Supply the quantitative formulation, ingredient forms and sources, serving size, daily directions, and intended duration of use. Reviewers need access to ingredient identities and quantities, including confidential formulations.
Scientific evidence
For each claim or formulation rationale, identify:
| Information | What to include |
|---|---|
| Source | Publication or report, with the relevant page or section. |
| Study details | Design, population, ingredient or preparation, dose, and duration. |
| Findings | Results relevant to the product’s intended use. |
| Limitations | Uncertainty, contrary findings, and funding relationships. |
| Product relevance | How the evidence applies to this formulation and serving pattern. |
Explain differences between a study and the marketed product. A reference list alone does not establish that connection.
Safety information
Address known risks, daily exposure, relevant reference levels, interactions, contraindications, allergens, and warnings. Include significant product safety events and the action taken in response.
Keep patient-identifiable information out of the submission.
Quality records
Include raw-material and finished-product specifications, analytical methods and results, batch identification, traceability, and support for storage and shelf life.
Identify the report issuer, whether it is the manufacturer or an independent laboratory, and any relevant laboratory credentials. Explain how each report corresponds to the submitted formulation; identify differences in the tested sample or batch.
Information for the Award Registry
Provide a concise public product description, the responsible company name, sales markets, version details, and a product image you have permission to publish. Keep confidential formulation details out of these public fields.
File requirements
Upload PDF documents or PNG and JPEG images. Export spreadsheet data to a readable PDF, keeping column headings, units, and source references visible.
Each file may be up to 25 MB; the total allowance is 500 MB per application. Use the secure upload fields in the application. General inquiries are not a channel for confidential evidence. Executable files, archives, and macro-enabled spreadsheets are not accepted.
Final check
Check that product names, version identifiers, ingredient amounts, directions, and labels agree across the documents. You can save the application as a draft before submitting it.