Cautionary Statement and Concomitant Use Precaution Labeling Standard
JHFC-A-008 Enacted: 3 September 2026 / Effective: the same day
Japan Certified Health Food Council (JHFC) — English translation of the standard. In case of discrepancy the Japanese text prevails. Japanese original
Japan Certified Health Food Council (JHFC)
Enacted: 3 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
Cautionary labeling for health foods serves to communicate information on raw material characteristics, allergens, methods of intake, users' conditions and concomitant use with medicinal products and other substances, both before purchase and during use. However, lists of unsupported stock phrases or poorly visible placement do not make clear who should act and in what circumstances. This Standard is established to collect risk information for individual products and reflect it in cautionary labeling that clearly identifies the persons concerned, events and responses.
Article 1 (Purpose)
The purpose of this Standard is to assess the management of cautionary statements and labeling of precautions for concomitant use for health foods with respect to the evaluation of supporting information, descriptions for specific groups of users, visibility, guidance on consultation or discontinuation of intake, and information updates.
Article 2 (Scope)
This Standard applies to precautions for intake, precautions concerning specific groups of users, allergen labeling, prevention of excessive intake or misuse, and precautions for concomitant use with medicinal products or other foods, as presented on health food containers and packaging, package inserts, sales pages and information provided after purchase. Statutory labeling requirements shall take precedence over this Standard.
Article 3 (Terms and Definitions)
- 1. Cautionary statement information: Information necessary to decide on actions such as avoiding or discontinuing intake, checking the amount or method of intake, or consulting a professional.
- 2. Concomitant use precaution: Labeling that prompts verification or consultation regarding simultaneous use with medicinal products, other health foods or specific ingredients.
- 3. Persons concerned: Groups of users to whom cautionary information is relevant because of age, pregnancy or breastfeeding, disease, allergies, medication use or other conditions.
- 4. Signal information: Information obtained from complaints, literature, announcements by public authorities, supplier notifications or similar sources that warrants consideration of whether labeling needs to be reviewed.
- 5. Action instruction: A response required of the user, such as refraining from intake, discontinuing intake, observing the labeled amount, or consulting a physician, pharmacist or other professional.
Article 4 (Requirements)
- 1. The business operator shall identify factors requiring precautions across all raw materials in the formulation, additives, manufacturing processes and forms of intake. Supplier documentation, cautionary information from public authorities, peer-reviewed literature, complaints and voluntary recall information shall be recorded by source, and the reasons for adopting or rejecting information shall be retained in a product-specific assessment form.
- 2. Cautionary text shall, to the extent possible, present the persons concerned, the ingredient or situation requiring caution, the anticipated event and the action instruction together as a single unit. Important precautions shall not be replaced solely by general phrases such as "if the product does not agree with you." The assessment form and final labeling shall be cross-checked to verify that no information has been omitted.
- 3. Precautions for concomitant use addressed to persons taking medication or undergoing treatment shall not rely solely on a blanket warning about all medicinal products. They shall identify ingredient groups or circumstances of use that can be distinguished on the basis of the evidence and shall prompt consultation with a physician or pharmacist. Sources of interaction information, the dates consulted and the persons responsible for assessment shall be recorded, and definitive clinical judgments shall not be stated in the labeling.
- 4. Separate statements shall be provided for pregnant or breastfeeding persons, children, older adults, persons with specific allergies or persons under care for specific diseases where there is evidence relevant to the product concerned. Where evidence is insufficient, that insufficiency shall be noted in the assessment record, and wording that unnecessarily excludes entire groups of users shall be avoided.
- 5. Precautions specific to the dosage form and method of use shall be labeled, including the number of units to be taken, frequency of intake, dilution, handling after opening and aspiration. Materials encouraging intake above the labeled amount shall not be prepared. Intake instructions on containers and packaging, enclosed materials and sales pages shall be cross-checked to verify that they do not contradict one another.
- 6. Important precautions shall be placed in a legible form on pages used to make purchase decisions and in locations where they can be checked when the product is actually taken. Where only a reference to another page is provided, the route to that page shall be clear. Device displays, printed samples and packaging proofs shall be checked to verify that information is not hidden, omitted or inappropriately emphasized.
- 7. A contact point for consultation regarding abnormalities after intake, misuse or concomitant use shall be provided, and the information received, relevant lot, circumstances of use and response shall be recorded. Information suggesting a serious event or trend shall be promptly communicated to the responsible manager, and decisions on investigations, labeling revisions, communications to sales recipients and other necessary measures shall be retained.
- 8. Signal information shall be collected periodically, and additional assessments shall be conducted when public announcements, raw material specifications, formulations or complaint trends change. When revisions are made, their impact on relevant lots, products bearing previous labeling, web media and customer guidance shall be determined. The reasons for the changes, approvers, implementation dates and follow-up results shall be verified in version control records.
Article 5 (Assessment Categories)
- Conformity: The persons concerned and action instructions are derived from product-specific evidence, are consistently indicated across all media, and are supported by records of updates and consultations.
- Partial conformity: The principal precautions are reflected, but there are deficiencies in some aspects of placement, dates consulted or version control, and corrective procedures have been initiated.
- Nonconformity: Important information that has been identified is not indicated, precautions contradict one another across media, or there is no system assigning responsibility for evaluating and following up on consultation information.
Article 6 (Implementation)
The business operator may make a self-declaration of conformity using product-specific assessment forms, labeling proofs and update records. Upon application, the Council may verify the published cautionary text, its supporting evidence and its revision history. This Standard shall be reviewed in light of cautionary information from public authorities, actual patterns of use and changes in labeling media.
Supplementary Provisions
This Standard shall take effect on 3 September 2026.
Note: This Standard provides assessment criteria for information disclosure and quality management practices and does not guarantee the efficacy, effects or safety of individual products.