NutraFormula review uses gateway requirements and a 100-point rubric. Every qualifying formulation must satisfy the gateway criteria, earn at least 80 points overall, meet the stated category floors, and have no critical failure. Recognition is available to every application that meets the standard; applications do not compete for a limited annual quota.
Applications: Rolling
Application fee: None
Recognition term: 24 months or until a material change or status action
Criteria version: Display the current adopted version and effective date
Eligible tracks
Market-Ready Formulation
A fully defined formula with stable quantities, intended use, target population, label draft, evidence record, safety rationale, specifications, and quality plan. Recognition in this track does not state that commercial manufacturing or market performance has been assessed.
Marketed Product
A named, currently marketed product with its current quantitative formula, label, claims, quality documentation within scope, and applicant authority. The registry identifies the responsible entity and exact version.
Concept-only ideas, incomplete formulas, and submissions that withhold information material to the criteria are not eligible.
Applicant eligibility
The applicant must:
- be a verified legal entity or authorized institution;
- control or have documented authority to submit the formulation record;
- identify the responsible company and relevant product or formula rights;
- accept the review, disclosure, confidentiality, mark, change, surveillance, and correction terms;
- provide accurate and complete information;
- disclose material relationships and requested legal, safety, regulatory, recall, or enforcement information;
- cooperate with clarification and post-recognition review.
ASA membership is not required and does not affect scoring.
Evidence package
Formula identity
- exact formula and version identifier;
- ingredient common or usual names and material identity;
- chemical, botanical, microbial, or other relevant characterization;
- source, form, standardization, carrier, overage, and relevant excipients;
- amount per serving and maximum daily exposure;
- serving size, format, directions, and intended duration.
Intended use
- target population;
- intended purpose and user need;
- exclusions and vulnerable populations;
- expected conditions of use;
- market-ready or marketed-product track.
Rationale and evidence map
- role of each active ingredient;
- rationale for the combination;
- evidence linked to ingredient identity, amount, population, outcome, and use;
- assessment of evidence quality, consistency, limitations, and contrary findings;
- explanation of material extrapolation.
Safety record
- hazard and tolerability assessment;
- cumulative daily exposure;
- upper-level or other safety-reference considerations where relevant;
- contraindications, interactions, allergens, and sensitive-population limits;
- relevant postmarket or product information for marketed products;
- proposed label warnings and communication.
Quality plan
- ingredient and finished-product specifications;
- identity and other analytical methods;
- supplier and material controls;
- contaminants, adulterants, microbiological, physical, and chemical risks as applicable;
- manufacturing or process considerations material to the formula;
- stability, packaging, storage, and shelf-life rationale;
- traceability and change-control approach.
Label and claims
- current or proposed label panels;
- complete claims within the requested review scope;
- substantiation and material qualifications;
- directions, warnings, responsible party, and other information relevant to consistency review;
- proposed public registry description.
Gateway criteria
All gateways must receive Meets before recognition.
G1 — Reviewable identity
The formula, version, ingredient forms, quantities, serving, and directions are complete and internally consistent. Confidentiality does not prevent ASA reviewers from assessing material criteria.
G2 — Safety basis
The submitted record identifies and addresses material foreseeable safety considerations for the intended population and use. A critical unresolved hazard, misleading omission, or unsupported assurance fails the gateway.
G3 — Label and record consistency
The formula, label, directions, warnings, claims, evidence record, and registry description do not materially contradict one another.
G4 — Applicant integrity and authority
The applicant’s identity and authority are verified, material requested information is complete, and attestations are supportable.
G5 — Program scope and lawful presentation
The review can be conducted within ASA’s defined competence and without creating a materially misleading implication of medical, regulatory, or certification authority.
Scored criteria
A. Formulation rationale — 20 points; minimum 14
| Element | Points | Review question |
|---|---|---|
| Defined purpose and population | 4 | Is the intended use specific enough to assess? |
| Ingredient roles | 5 | Does each active have a relevant, explained role? |
| Combination logic | 5 | Is the combination coherent, with overlap and interaction addressed? |
| Format and use fit | 3 | Do dosage form and directions support intended use? |
| Simplicity and burden | 3 | Are complexity, redundancy, and user burden justified? |
B. Evidence alignment — 25 points; minimum 18
| Element | Points | Review question |
|---|---|---|
| Material and form relevance | 5 | Does the evidence concern the submitted material or justify extrapolation? |
| Amount and use relevance | 5 | Are dose, duration, and conditions sufficiently aligned? |
| Population and outcome relevance | 4 | Do participants and outcomes match the intended purpose? |
| Study quality and totality | 6 | Are methods, consistency, precision, directness, and bias considered? |
| Limits and contrary evidence | 5 | Are uncertainty, negative findings, and extrapolations handled accurately? |
C. Dose and use logic — 15 points; minimum 10
| Element | Points | Review question |
|---|---|---|
| Quantitative basis | 5 | Is each amount tied to a supportable rationale? |
| Total exposure | 4 | Are all servings and overlapping sources considered? |
| Timing and duration | 3 | Are directions and duration coherent and evidence-aligned? |
| Practical adherence | 3 | Is the regimen usable for the intended population? |
D. Safety assessment — 15 points; minimum 10 plus G2
| Element | Points | Review question |
|---|---|---|
| Hazard identification | 4 | Are material known and reasonably foreseeable hazards identified? |
| Exposure and uncertainty | 4 | Are total exposure, references, gaps, and uncertainty addressed? |
| Population and interactions | 4 | Are vulnerable groups, contraindications, interactions, and allergens addressed? |
| Risk communication | 3 | Are directions, warnings, and limitations clear and proportionate? |
E. Quality plan — 15 points; minimum 10
| Element | Points | Review question |
|---|---|---|
| Identity and specifications | 4 | Are material and finished-product criteria fit for purpose? |
| Supplier and process controls | 3 | Are controls appropriate to risk and role? |
| Methods and acceptance | 3 | Are methods and acceptance criteria identified and justified? |
| Contaminant and adulteration risks | 3 | Are relevant risks and controls addressed? |
| Stability and packaging | 2 | Does the plan support the represented stage and shelf life? |
This category assesses the submitted plan and records. It is not a facility audit or lot certification.
F. Label and responsible communication — 10 points; minimum 7 plus G3
| Element | Points | Review question |
|---|---|---|
| Formula-label consistency | 3 | Do identity, amount, serving, and directions agree? |
| Claim-evidence fit | 3 | Do reviewed claims stay within the submitted evidence? |
| Qualifications and warnings | 2 | Are material limits presented clearly? |
| Recognition language | 2 | Can the award be described without implying broader approval? |
Critical failures
An application cannot be recognized, regardless of score, when the record contains:
- a failed gateway;
- material falsification, concealment, or irreconcilable data;
- an unresolved safety issue within the intended use;
- an unlawful or materially misleading intended claim that the applicant will not remove or correct;
- inability to identify the formula or responsible entity;
- a reviewer conflict that cannot be managed;
- insufficient evidence for ASA to reach a responsible conclusion;
- refusal to accept public scope, status, change notification, or mark limits.
Scoring decisions
Each element receives documented points and reasoning. Reviewers may use a scoring manual with anchors, but the public weights and floors control. “Not applicable” requires a rationale and an approved scoring treatment that does not inflate the application.
At least two qualified reviewers assess material criteria. Material scoring divergence is reconciled through cited discussion or an additional review; scores are not simply averaged when the reviewers disagree about a gateway or critical fact.
Review stages
1. Scope and completeness screening
ASA verifies the entity, authority, track, formula identity, terms, disclosures, and required evidence. An incomplete submission receives a specific request and response date.
2. Reviewer assignment and conflicts
Reviewers are matched to the formula and complete issue-specific disclosures. The applicant may identify a documented conflict but may not choose a favorable reviewer.
3. Independent review
Reviewers apply the current rubric and record sources, questions, scores, gateway findings, limitations, and proposed public language.
4. Consolidated clarification
ASA may request focused clarification or a limited correction. The process is not product-development consulting and does not permit repeated material reformulation within one application.
5. Decision consistency review
A conflict-screened decision lead or panel confirms thresholds, gateway findings, handling of disagreement, disclosures, and registry language.
6. Notice and publication
ASA sends the decision and criterion-level findings appropriate to the outcome. Recognized applicants verify factual registry fields and accept mark terms before publication. ASA controls required limitations and disclosures.
Decision types
- Recognized: All requirements are met.
- Recognized after specified pre-publication correction: The criteria are met subject to a limited factual or labeling correction completed before the registry becomes active.
- Deferred: A defined evidence, scope, or procedural matter prevents a decision. Deferral is not recognition.
- Not recognized: One or more criteria, gateways, or integrity requirements are not met.
ASA publishes only recognized and subsequent public-status records, not unsuccessful applicants.
Reconsideration
An applicant may request reconsideration within 30 calendar days of the decision for:
- material factual error;
- evidence submitted by the deadline but demonstrably overlooked;
- inconsistent application of the published rubric;
- an undisclosed reviewer conflict;
- material procedural failure.
The request identifies the criterion, record, error, and requested remedy. It cannot add a substantially revised formula. At least one reviewer who was not the sole original decision maker participates. The written outcome is final under the program unless the charter provides a narrow Board-level procedural appeal.
Recognition term and renewal
Recognition remains active for 24 months from the decision date unless a material change or status action occurs sooner. Renewal is a new assessment under the criteria current at renewal. The application remains free under the program’s no-fee rule.
Change notification and surveillance
Recipients must report material changes to formula identity, source, form, amount, serving, directions, population, claims, quality plan, packaging or shelf-life basis, responsible entity, safety record, recall, or regulatory status. ASA may request evidence, correct the registry, require limited or new review, place the record Under Review, suspend it, restore it, accept withdrawal, or revoke it.
Meaning and limits of recognition
NutraFormula recognition applies only to the named record, version, track, criteria version, term, and scope. It is not government approval, medical endorsement, a therapeutic conclusion, a guarantee, a facility audit, or certification of every manufacturing lot.
Criteria changes
ASA publishes rubric changes with a version, rationale, approval, and effective date. A material change applies prospectively; an active application continues under the criteria stated at acceptance unless correction of a clear error or a serious safety or legal issue requires another approach with notice.
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Before using or relying on recognition, read recognition limits.