Required conditions
Every application must satisfy six conditions before an award can be made:
- Authority and eligibility. The applicant is authorized and the product is within scope.
- Product identity. The formulation, version, label, and conditions of use are sufficiently defined and consistent.
- Reviewable evidence. Material evidence is available, traceable, and adequate for assessment.
- Resolution of material concerns. Issues affecting the scientific, safety, quality, or market context of the review have been addressed.
- Review integrity. Conflicts are resolved and the required independent assessments and decision check are complete.
- Accurate labeling and scope. The submitted information and proposed description do not create a misleading basis for recognition.
A condition marked unresolved or not met prevents an award, regardless of the total score.
Scoring
| Area | Available points | Minimum required |
|---|---|---|
| Scientific evidence and relevance | 25 | 20 |
| Formulation and conditions of use | 20 | 14 |
| Safety information and risk management | 20 | 16 |
| Quality documentation and traceability | 20 | 16 |
| Labeling and transparency | 15 | 11 |
| Total | 100 | 85 |
Each area comprises scored items worth up to five points. Integer scores reflect the strength, completeness, and relevance of the evidence. Meeting the individual minimums does not remove the requirement to reach 85 overall.
Assessment items
Each item below is scored from 0 to 5. Reviewers identify the evidence and record the reasons for the score.
| Area | Item | Assessment focus |
|---|---|---|
| Scientific evidence | E1 — Research quality | Study methods, limitations, uncertainty, and suitability for the question. |
| Scientific evidence | E2 — Ingredient correspondence | Whether the studied form, strain, species, or preparation corresponds to the product. |
| Scientific evidence | E3 — Conditions of use | Relevance of dose, duration, population, and outcomes to the submitted use. |
| Scientific evidence | E4 — The evidence as a whole | Consistency, contrary findings, and material funding or other limitations. |
| Scientific evidence | E5 — Limits of the conclusion | Whether the stated conclusion stays within the evidence, including any extrapolation to a combination. |
| Formulation | F1 — Purpose and ingredient roles | A defined adult population and rationale for each active ingredient. |
| Formulation | F2 — Amounts and exposure | Reconciled serving and daily quantities, with relevant overlapping exposures addressed. |
| Formulation | F3 — Combination rationale | The basis for combining ingredients and the treatment of redundancy or interactions. |
| Formulation | F4 — Format and directions | Consistency of dosage form, directions, duration, and supporting product information. |
| Safety information | S1 — Risk identification | Relevant hazards, contraindications, interactions, and sources. |
| Safety information | S2 — Exposure and population | Applicable reference information, intended users, exclusions, and uncertainty. |
| Safety information | S3 — Risk communication | Warnings, allergen information, and limitations reflected accurately on the label. |
| Safety information | S4 — Product experience | Relevant product events and the documented response and responsibilities. |
| Quality documentation | Q1 — Identity and specifications | Product-appropriate specifications, methods, and acceptance requirements. |
| Quality documentation | Q2 — Analytical correspondence | Traceable reports that identify the sample, batch, method, date, and relationship to the product. |
| Quality documentation | Q3 — Controls and traceability | Relevant supplier, manufacturing, and change-control documentation. |
| Quality documentation | Q4 — Stability and packaging | Support for the represented storage conditions, packaging, and shelf life. |
| Transparency | T1 — Label consistency | Agreement among the label, formulation, directions, market, and application. |
| Transparency | T2 — Claim clarity | Clear qualifications and limits without unsupported approval or outcome claims. |
| Transparency | T3 — Public identification | A record that accurately identifies the awarded product, version, and responsible company. |
Scoring guide
| Score | Meaning |
|---|---|
| 0 | Required evidence is missing, materially contradictory, or unreliable. |
| 1 | Information is supplied, but its relevance to the product is not established. |
| 2 | Some evidence is relevant, but substantial gaps remain. |
| 3 | The evidence can be assessed, with identified limitations or reliance on extrapolation. |
| 4 | Evidence is sufficient and directly relevant; material limitations are addressed. |
| 5 | Evidence fully supports the item, closely matches the product, and addresses key uncertainties. |
Scores reflect the relevance and strength of the evidence. Document volume, company reputation, patents, and test costs do not establish that a criterion is met.
Decision requirements
Reviewers record evidence and reasons for each finding. A separate decision reviewer resolves material differences and checks the complete record. Scores support the decision; they are not a public ranking or a percentage guarantee of product safety.
These thresholds are specific to the ASA awards program.
Assessment scope
ASA does not collect or test samples through this program. Existing laboratory reports may form part of an application, but their review does not establish that ASA tested the product or every batch.
Criteria version
PSA-1.0 is the criteria version described on this page. The acceptance notice identifies the version applied to an application. Material revisions are published with their effective date and are not silently substituted during review.