Purpose of the Law and Classification of Pharmaceuticals

Which of the following statements about the purpose stated in Article 1 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律, the PMD Act) is correct?

1. Taking measures for the regulation of designated substances is not included among the purposes of this Act.
2. This Act regulates only pharmaceuticals and medical devices, and does not cover quasi-drugs, cosmetics, or regenerative medicine products.
3. This Act aims to improve public health and hygiene by carrying out the regulation necessary for securing the quality, efficacy, and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medicine products, and for preventing the occurrence and spread of harm to public health and hygiene arising from their use.
4. This Act aims to carry out the regulation necessary for securing the quality, efficacy, and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, and regenerative medicine products, and does not include, among its purposes, matters concerning the promotion of research and development of pharmaceuticals, medical devices, and regenerative medicine products for which there is a particularly high medical need.

Which of the following statements about the duties and roles set out in the PMD Act is incorrect?

1. The duty of medical professionals under Article 1-5, Paragraph 1 of the Act applies only to physicians, dentists, pharmacists, and veterinarians, and a registered seller has no duty to endeavor to provide information.
2. Article 1-6 of the Act provides that citizens must endeavor to use pharmaceuticals and the like appropriately and to deepen their knowledge and understanding of their efficacy and safety.
3. A pharmacy owner, store-based retailer, or home-delivery retailer must have a registered seller engaged in the business take training provided by a training institution every fiscal year.
4. Article 1-4 of the Act provides that a business operator related to pharmaceuticals and the like must endeavor to secure the quality, efficacy, and safety of pharmaceuticals and the like by taking necessary measures such as exchanging information with related parties.

Which of the following statements about a registered seller is correct?

1. Once a person has passed the registered seller examination, that person legally becomes a registered seller without needing to receive registration to engage in sales.
2. The registered seller examination is administered by the Minister of Health, Labour and Welfare.
3. A person who has passed the examination administered by a prefectural governor to confirm that a person intending to engage in the sale or supply of over-the-counter medicines has the qualities necessary for that purpose, and who intends to engage in the sale or supply of medicines, must receive registration from the prefectural governor.
4. In taking the examination administered by a prefectural governor to confirm the necessary qualities for engaging in the sale or supply of over-the-counter medicines, a certain educational background or practical experience continues to be required even from fiscal year 27 of the Heisei era (2015) onward, and a person lacking these cannot take the examination.

Which of the following statements about applying for registration to engage in sales is correct?

1. The application form must be submitted to the prefectural governor of the location of the pharmacy or medicine-sales business store where the applicant engages in the sale or supply of medicines (or, for a home-delivery retail business, the governor of the prefecture whose area includes the area where the applicant intends to make deliveries).
2. The application form must be submitted to the prefectural governor of the applicant's place of residence.
3. The application form must be submitted to the prefectural governor of the location where the applicant took and passed the registered seller examination.
4. The application form must be submitted to the Minister of Health, Labour and Welfare via the prefectural governor of the location of the pharmacy or medicine-sales business store where the applicant engages in the sale or supply of medicines (or, for a home-delivery retail business, the governor of the prefecture whose area includes the area where the applicant intends to make deliveries).

Which of the following statements about a person who has applied to receive registration to engage in sales in two or more prefectures is correct?

1. The person can receive registration from two or more prefectural governors only if the stores where the person is engaged are located in multiple prefectures.
2. The person can receive registration from only one of the prefectural governors to whom the application was made.
3. The person can receive registration from two or more prefectural governors with the approval of the Minister of Health, Labour and Welfare.
4. The person can receive registration from every prefectural governor to whom the application was made.

Which of the following statements about the register of registered sellers and the items to be registered is incorrect?

1. The registered seller's place of residence is entered in the register of registered sellers.
2. The registration number and date of registration, the prefecture of the registrant's family register (or, for a person who does not hold Japanese nationality, that person's nationality), name, date of birth, sex, and other items are entered in the register of registered sellers.
3. When a prefectural governor has carried out registration to engage in sales, the governor must issue a certificate of registration to the person who received that registration.
4. When a change occurs in a registered item, a registered seller must report that fact within 30 days.

Which of the following statements about the deletion of registration to engage in sales, among other matters, is correct?

1. When a registered seller develops a mental function impairment that makes continuing the business extremely difficult, that person must notify the prefectural governor who granted the registration of that fact within 90 days.
2. When a registered seller no longer intends to engage in the sale or supply of over-the-counter medicines, that person must apply for deletion of the registration from the register of registered sellers within 60 days.
3. When a registered seller dies, no application concerning deletion of registration is necessary.
4. When a registered seller has died or been declared missing, the person under a duty to report the death or missing status under the Family Register Act must apply for deletion of the registration from the register of registered sellers within 30 days.

Which of the following statements about the definition of "pharmaceutical" under Article 2, Paragraph 1 of the Act is correct?

1. An item intended for use in diagnosing, treating, or preventing disease in animals is not included among pharmaceuticals.
2. The definition of "pharmaceutical" includes items that are machinery or instruments.
3. Among the pharmaceuticals listed in the Japanese Pharmacopoeia, none is sold as an over-the-counter medicine.
4. "An item listed in the Japanese Pharmacopoeia" falls under the definition of a pharmaceutical.

Which of the following statements about the regulation of the manufacture and sale, among other activities, of pharmaceuticals is correct?

1. A pharmaceutical can be manufactured and sold without receiving approval for each individual product.
2. An item never used directly on the human body, such as a diagnostic test kit, an insecticide, or a disinfectant for instruments, is not included among pharmaceuticals.
3. The prohibition on selling a mislabeled or an unfit pharmaceutical applies only to the manufacturing and marketing pharmaceutical company, and does not apply to a pharmacy or a medicine-sales business.
4. A pharmaceutical may not be manufactured and sold except by a person who has obtained "manufacturing and marketing business" authorization from the Minister of Health, Labour and Welfare.

Which of the following statements about the definition of "over-the-counter medicine" (Article 4, Paragraph 5, Item 4 of the Act) is correct?

1. It refers to a pharmaceutical supplied for the purpose of being used by, or used based on the prescription or instruction of, a physician or dentist.
2. It refers to a pharmaceutical whose effect on the human body, in terms of its efficacy and effect, is significant, and which is intended to be used based on the consumer's own choice made using information provided by a pharmacist or other medical professional (excluding a designated-guidance-required pharmaceutical and a prescription pharmaceutical).
3. It refers to a pharmaceutical whose effect on the human body, in terms of its efficacy and effect, is not significant, and which is intended to be used based on the consumer's own choice made using information provided by a pharmacist or other medical professional (excluding a designated-guidance-required pharmaceutical).
4. It refers to a pharmaceutical designated by the Minister of Health, Labour and Welfare, after hearing the opinion of the Pharmaceutical Affairs Council, as one for which in-person information provision and guidance based on pharmacological knowledge by a pharmacist are necessary for its appropriate use, and which is handled separately from over-the-counter medicines.

Which of the following statements about a designated-guidance-required pharmaceutical is correct?

1. A designated-guidance-required pharmaceutical is never reclassified as an over-the-counter medicine after a prescribed period has passed.
2. A designated-guidance-required pharmaceutical is designated by the Minister of Health, Labour and Welfare, after hearing the opinion of the Pharmaceutical Affairs Council, as one for which in-person information provision and guidance based on pharmacological knowledge by a pharmacist are necessary for its appropriate use.
3. A designated-guidance-required pharmaceutical is designated by the prefectural governor, after hearing the opinion of the Pharmaceutical Affairs Council, as one for which in-person information provision and guidance based on pharmacological knowledge by a registered seller are necessary for its appropriate use.
4. A designated-guidance-required pharmaceutical is designated by the prefectural governor after hearing the opinion of the Pharmaceutical Affairs Council.

Which of the following statements about the difference between over-the-counter medicines and designated-guidance-required pharmaceuticals on one hand, and prescription pharmaceuticals on the other, is correct?

1. A prescription pharmaceutical is a pharmaceutical supplied for the purpose of being used by, or used based on the prescription or instruction of, a physician or dentist.
2. The dosage of an over-the-counter medicine or a designated-guidance-required pharmaceutical is determined each time by a physician or dentist through examination, tailored to the patient's condition, and then supplied.
3. A prescription pharmaceutical is expected to be effective when used appropriately based on a predetermined dosage.
4. As for the wording of efficacy/effect statements, over-the-counter medicines and designated-guidance-required pharmaceuticals are usually indicated by a diagnosed disease name (such as gastritis or gastric/duodenal ulcer), the same as prescription pharmaceuticals.

Which of the following statements about over-the-counter medicines and designated-guidance-required pharmaceuticals is incorrect?

1. A test kit whose specimen collection carries a direct risk to the body, such as one using blood as the specimen, is also recognized as an over-the-counter medicine or a designated-guidance-required pharmaceutical.
2. A highly invasive method of use, such as injection, is not employed.
3. No efficacy/effect claim is recognized for a disease (such as cancer or heart disease) that generally cannot be expected to be cured without medical treatment by a physician or the like.
4. The efficacy/effect is indicated by a symptom that an ordinary consumer can judge (such as stomach pain, heartburn, nausea, or a feeling of fullness).

Which of the following statements about poisonous drugs (dokuyaku) and powerful drugs (gekiyaku) is incorrect?

1. A poisonous drug or powerful drug is designated not simply because of strong toxicity or potency/harmfulness, but also because, among other reasons, its therapeutically expected intake (medicinal dose) and its intake that risks poisoning (toxic dose) are close together, giving it a narrow margin of safety, so that handling it requires caution.
2. A "poisonous drug" refers to a pharmaceutical designated by the Minister of Health, Labour and Welfare, after hearing the opinion of the Pharmaceutical Affairs Council, as one with strong toxicity.
3. At present, there are poisonous drugs or powerful drugs that are over-the-counter medicines.
4. A "powerful drug" refers to a pharmaceutical designated by the Minister of Health, Labour and Welfare, after hearing the opinion of the Pharmaceutical Affairs Council, as one with strong potency/harmfulness.

Which of the following statements about the labeling required on the immediate container or wrapping of a poisonous drug is correct?

1. The product name of the pharmaceutical and the character "毒" (poison) must be indicated in black on a white background with a black border.
2. The product name of the pharmaceutical and the character "毒" (poison) must be indicated in white on a black background with a white border.
3. The product name of the pharmaceutical and the character "毒" (poison) must be indicated in white on a red background with a white border.
4. The product name of the pharmaceutical and the character "毒" (poison) must be indicated in red on a white background with a red border.

Which of the following statements about a powerful drug (gekiyaku) is correct?

1. The product name of the pharmaceutical and the character "劇" (powerful) must be indicated in white on a red background with a white border on its container, among other places.
2. The product name of the pharmaceutical and the character "劇" (powerful) must be indicated in red on a white background with a red border on its container, among other places.
3. The product name of the pharmaceutical and the character "劇" (powerful) must be indicated in white on a black background with a white border on its container, among other places.
4. A powerful drug that fails to meet the container labeling requirement may still be sold or otherwise distributed.

Which of the following statements about the storage and display of a poisonous drug or powerful drug by a person who handles it in the course of business is correct?

1. These provisions on the storage and display of a poisonous drug or powerful drug do not apply to a pharmacy owner or a medicine-sales business operator among those who handle these items in the course of business.
2. The place where a powerful drug is stored or displayed must be kept locked.
3. A poisonous drug and a powerful drug need not be stored and displayed separately from other items, and can be stored or displayed together with other pharmaceuticals in the same place.
4. A poisonous drug or powerful drug must be stored and displayed separately from other items, and, in particular, the place where a poisonous drug is stored or displayed must be kept locked.

Which of the following statements about restrictions on the transfer of a poisonous drug or powerful drug is correct?

1. Transferring a poisonous drug or powerful drug to a person under 14 years of age, or to any other person about whom there is concern regarding safe handling, is prohibited.
2. "A person about whom there is concern regarding safe handling" does not include a prospective purchaser suspected of intending to abuse or misuse a sleep aid.
3. A poisonous drug or powerful drug can be transferred to a person under 14 years of age if that person's guardian consents.
4. Transferring a poisonous drug or powerful drug to a person under 16 years of age is prohibited.

Which of the following is NOT a required entry in the document received from the transferee when a poisonous drug or powerful drug is sold or otherwise transferred to a member of the general public?

1. Product name and quantity
2. Transferee's age
3. Purpose of use and date of transfer
4. Transferee's name, address, and occupation

Which of the following statements about selling a poisonous drug or powerful drug with its seal broken is correct?

1. A medicine-sales business operator other than a store-based retailer whose store manager is a pharmacist, or a wholesale seller whose medicine business-office manager is a pharmacist, must not sell a poisonous drug or powerful drug with its seal broken.
2. A store-based retailer whose store manager is a registered seller, and a wholesale seller whose medicine business-office manager is a registered seller, are permitted to sell a poisonous drug or powerful drug with its seal broken.
3. Any medicine-sales business operator can sell a poisonous drug or powerful drug with its seal broken, regardless of whether its store manager or medicine business-office manager is a pharmacist or a registered seller.
4. A home-delivery retailer is permitted to sell a poisonous drug or powerful drug with its seal broken.

Which of the following statements about biological products (seibutsu-yurai seihin) is incorrect?

1. At present, there is no over-the-counter medicine or designated-guidance-required pharmaceutical designated as a biological product.
2. A biological product is designated with attention to the risk of infectious disease arising from the use of the product.
3. A pharmaceutical manufactured using a plant-derived item as a raw material or ingredient is also subject to designation as a biological product.
4. Even an item using a biologically derived raw material is not subject to designation if, based on current scientific knowledge, the probability of a risk of infectious disease is extremely low.

Which of the following statements about a Class 1 pharmaceutical (第一類医薬品) is correct?

1. It is a pharmaceutical designated by the prefectural governor, among pharmaceuticals presenting a risk of health harm to a degree that interferes with daily life due to a side effect or the like, as one requiring particular caution in its use, as well as a pharmaceutical that was found to fall under Article 14, Paragraph 12 of the Act at the time of application for manufacturing and marketing approval, and for which the prescribed period set by Ministry of Health, Labour and Welfare ordinance has elapsed since the approval for that application was granted.
2. A Class 1 pharmaceutical is an over-the-counter medicine with relatively low risk to public health and hygiene, presenting no risk of health harm to a degree that interferes with daily life due to a side effect or the like.
3. It is a pharmaceutical designated by the Minister of Health, Labour and Welfare, among pharmaceuticals presenting a risk of health harm to a degree that interferes with daily life due to a side effect or the like, as one requiring particular caution in its use, as well as a pharmaceutical that was found to fall under Article 14, Paragraph 12 of the Act at the time of application for manufacturing and marketing approval, and for which the prescribed period set by Ministry of Health, Labour and Welfare ordinance has not elapsed since the approval for that application was granted.
4. A so-called switch OTC medicine or direct OTC medicine is never classified as a Class 1 pharmaceutical.

Which of the following statements about a Class 2 pharmaceutical (第二類医薬品) and a designated Class 2 pharmaceutical (指定第二類医薬品) is correct?

1. A Class 2 pharmaceutical is an over-the-counter medicine other than a Class 1 pharmaceutical and a Class 3 pharmaceutical.
2. Among Class 2 pharmaceuticals, one "designated by the Minister of Health, Labour and Welfare as requiring special caution" is called a "designated Class 2 pharmaceutical."
3. A "designated Class 2 pharmaceutical" refers to one designated by the Minister of Health, Labour and Welfare, among Class 3 pharmaceuticals, as requiring special caution.
4. A Class 2 pharmaceutical is a pharmaceutical presenting no risk of health harm to a degree that interferes with daily life due to a side effect or the like.

Which of the following statements about a Class 3 pharmaceutical (第三類医薬品) is correct?

1. A Class 3 pharmaceutical is an over-the-counter medicine other than a Class 1 pharmaceutical and a Class 2 pharmaceutical, and one with relatively low risk to public health and hygiene.
2. A Class 3 pharmaceutical is an over-the-counter medicine with low risk to public health and hygiene, presenting no risk of a change or disorder in bodily condition due to a side effect or the like.
3. A Class 3 pharmaceutical is an over-the-counter medicine designated by the Minister of Health, Labour and Welfare as one with relatively low risk to public health and hygiene, in the same manner as a Class 1 or Class 2 pharmaceutical.
4. A Class 3 pharmaceutical is never reclassified into a Class 1 pharmaceutical or a Class 2 pharmaceutical.

Which of the following statements about the designation and change of the risk classification of an over-the-counter medicine is correct?

1. A pharmaceutical newly classified as an over-the-counter medicine is classified as a Class 3 pharmaceutical for a certain period after approval.
2. The designation of a Class 1 or Class 2 pharmaceutical is made without regard to the ingredient contained in the over-the-counter medicine or its intended purpose of use, and new knowledge concerning safety or the pattern of side-effect occurrence is never taken into account.
3. Once the risk classification of an over-the-counter medicine has been assigned, it is fixed and never changed, even if new knowledge concerning safety is obtained or the pattern of side-effect occurrence changes.
4. The Minister of Health, Labour and Welfare must endeavor to collect information on pharmaceuticals to assist in the designation of a Class 1 or Class 2 pharmaceutical, and must change such a designation as necessary.

Which of the following statements about the risk classification of over-the-counter medicines is incorrect?

1. A pharmaceutical newly classified as an over-the-counter medicine is classified as a Class 1 pharmaceutical for a certain period after approval, and is then classified as a Class 1, Class 2, or Class 3 pharmaceutical based on an evaluation of information collected during that period regarding side-effect occurrence and the state of appropriate use, among other matters.
2. Whether to state, on each product's outer box or the like, the matters prescribed for the assigned risk classification is left to the discretion of the pharmaceutical company.
3. The classification into a Class 1, Class 2, or Class 3 pharmaceutical is reviewed as appropriate based on new knowledge concerning safety and the pattern of side-effect occurrence, among other matters.
4. An over-the-counter medicine is classified into a Class 1, Class 2, or Class 3 pharmaceutical according to its risk to public health and hygiene.

Which of the following statements about labeling on a pharmaceutical's container, outer box, or the like is correct?

1. When a pharmaceutical's container is packaged for retail sale and the labeling on the container cannot easily be seen through the outer container or wrapping, the same matters must also be stated on the outer box or the like.
2. It is provided that, when a pharmaceutical's container is packaged for retail sale and the labeling on the container cannot easily be seen through the outer container or wrapping, there is no need to state the same matters on the outer box or the like.
3. The legally required labeling matters need not be stated on the pharmaceutical's immediate container or wrapping, and it is sufficient if they are stated in the package insert.
4. Labeling based on Article 44, Paragraph 1 or 2 of the Act concerning a poisonous drug or powerful drug is not included among the legally required labeling.

Which of the following statements about the legally required labeling matters for an over-the-counter medicine and a designated-guidance-required pharmaceutical is correct?

1. An over-the-counter medicine requires the characters "一般用医薬品" (over-the-counter medicine) to be stated.
2. Stating the name or designation and address of the manufacturing and marketing business operator, among others, is not required.
3. An over-the-counter medicine requires wording indicating its risk classification to be stated.
4. For a pharmaceutical other than one listed in the Japanese Pharmacopoeia, there is no need to state the name and amount of its active ingredient.

Which of the following statements about the legally required labeling matters is incorrect?

1. An over-the-counter medicine other than a home-delivery product requires the wording "For store sale only" to be stated.
2. A designated Class 2 pharmaceutical requires the numeral "2" to be stated within a box.
3. A pharmaceutical designated by the Minister of Health, Labour and Welfare as one that could cause health harm if accidentally sprayed, dispersed, or otherwise applied to the human body (such as an insecticide) requires the wording "Caution — do not use on the human body" to be stated.
4. Even a pharmaceutical whose properties and quality remain stable for more than three years under appropriate storage conditions is required to have an expiration date stated on all pharmaceuticals.

Which of the following statements about the legally required labeling matters is correct?

1. Stating the manufacturing (lot) number or manufacturing (lot) code is not required.
2. For a pharmaceutical listed in the Japanese Pharmacopoeia, the characters "Japanese Pharmacopoeia" or the like are required to be stated.
3. For a pharmaceutical listed in the Japanese Pharmacopoeia, the name stated is not the name established in the Pharmacopoeia, but the brand name.
4. Stating the net content, such as weight, volume, or count, is not required.

Which of the following is NOT a matter prohibited (under Article 54 of the Act) from being stated in a document attached to a pharmaceutical, or on its container or outer box, among other places?

1. An efficacy, effect, or performance for which approval has not been obtained
2. A method of use, dosage, or period of use that presents a danger to public health and hygiene
3. A matter concerning the pharmaceutical that is false or likely to cause misunderstanding
4. The pharmaceutical's manufacturing number or manufacturing code

Which of the following statements about the legally required labeling, among other matters, of a pharmaceutical is correct?

1. Even a mislabeled pharmaceutical may be sold by a pharmacy or a medicine-sales business.
2. The legally required labeling matters and the entries in the package insert, among other documents, must be placed in a location easier to see than other text, articles, pictures, or designs, and must be accurate, using terms that purchasers and others can easily read and understand.
3. It is provided that the legally required labeling matters and the entries in the package insert, among other documents, need only be accurate, using terms that purchasers and others can easily read and understand, and need not be stated with particular clarity, and may be stated in English rather than in Japanese.
4. The prohibition on selling a mislabeled pharmaceutical applies only to the manufacturing and marketing pharmaceutical company, and does not apply to a pharmacy.

Which of the following statements about a designated abuse-prevention pharmaceutical (指定濫用防止医薬品) is incorrect?

1. Ephedrine, codeine, and dihydrocodeine (in each case excluding an external preparation) are among the designated ingredients.
2. A designated abuse-prevention pharmaceutical is a pharmaceutical designated by the Minister of Health, Labour and Welfare, after hearing the opinion of the Pharmaceutical Affairs Council, as one presenting a risk, if abused, of causing central nervous system excitation or depression or hallucination, and requiring measures to prevent this.
3. An external preparation containing diphenhydramine as an active ingredient falls under a designated abuse-prevention pharmaceutical.
4. A designated abuse-prevention pharmaceutical requires the wording "confirmation required" or the like to be stated as legally required labeling.

Which of the following statements about a quasi-drug (医薬部外品) is correct?

1. An item used for the purpose of "preventing nausea or other discomfort, or bad breath or body odor" is not included among quasi-drugs, even if its effect on the human body is mild, and is instead handled as a cosmetic.
2. Manufacturing and marketing a quasi-drug does not require obtaining manufacturing and marketing business authorization, unlike a pharmaceutical.
3. A quasi-drug is permitted to display or claim a pharmaceutical-like efficacy or effect, on the condition that its efficacy/effect falls within a predetermined scope and that, in light of its ingredients and method of use, among other factors, its effect on the human body is mild.
4. Selling a quasi-drug requires obtaining medicine-sales business authorization, the same as for a pharmaceutical.

Which of the following statements about the labeling of a quasi-drug is correct?

1. Among the product groups used for controlling sanitary insect pests, one that was formerly a pharmaceutical but has been transitioned to a quasi-drug carries the identifying label "quasi-drug for pest control" (防除用医薬部外品).
2. A product group used for controlling sanitary insect pests (rats, flies, mosquitoes, fleas, and other similar organisms) carries the identifying label "quasi-drug for pest control" (防除用医薬部外品).
3. The provisions prohibiting the sale of an unfit or mislabeled quasi-drug do not apply to quasi-drugs.
4. Unlike a pharmaceutical, stating the characters "医薬部外品" (quasi-drug) on the immediate container or immediate wrapping of a quasi-drug is not legally required.

Which of the following statements about cosmetics is correct?

1. Selling a cosmetic requires obtaining medicine-sales business authorization, the same as for a pharmaceutical.
2. A cosmetic is defined as "an item intended to be used on the body by application, spraying, or a similar method, to cleanse and beautify the human body, add to its attractiveness, alter its appearance, or keep the skin or hair healthy, and whose effect on the human body is mild."
3. A cosmetic is permitted to display or claim a pharmaceutical-like efficacy or effect, as long as it stays within the scope of its definition.
4. A cosmetic is defined as "an item intended to be used on the body by application, spraying, or a similar method, to cleanse and beautify the human body, add to its attractiveness, alter its appearance, or keep the skin or hair healthy," and pharmaceutical ingredients may be freely blended into its essential composition (raw materials).

Which of the following statements about cosmetics and quasi-drugs is incorrect?

1. When manufacturing and marketing a cosmetic as a business, no notification or approval whatsoever is required for each individual product.
2. Some quasi-drugs, such as medicated cosmetic products, medicated soap, and medicated toothpaste products, are permitted to claim a cosmetic-like efficacy or effect.
3. If a pharmaceutical-like efficacy or effect is displayed or claimed for a cosmetic, this constitutes a false or exaggerated advertisement, and, depending on the content of the claim, the product may also be deemed a pharmaceutical or a quasi-drug and become subject to enforcement action as an unapproved, unauthorized pharmaceutical or quasi-drug.
4. Even where blending a pharmaceutical ingredient into a cosmetic is permitted, it is restricted to an amount at or below what could produce a pharmacological effect, such as when used as an additive.

Which of the following statements about a food for specified health uses (tokuho) is correct?

1. Neither a food for specified health uses nor a conditional food for specified health uses carries a mark indicating Consumer Affairs Agency permission or the like.
2. A food for specified health uses can be sold with a claim of a specific health-related use simply by having the business operator establish the scientific basis on its own responsibility and file a notification with the Commissioner of the Consumer Affairs Agency.
3. A conditional food for specified health uses is one that has received permission or approval from the Commissioner of the Consumer Affairs Agency in the same manner as an ordinary food for specified health uses, without any statement that the scientific basis is limited.
4. Making a claim of a specific health-related use requires undergoing an individual review of matters such as the physiological function or effect and safety of the specific health function, and obtaining permission or approval.

Which of the following statements about foods with health claims (hoken kino shokuhin) is correct?

1. Foods for specified health uses, foods with nutrient function claims, and foods with function claims are collectively called "foods for special dietary uses."
2. A food with function claims is one for which the business operator displays, on its own responsibility, the functionality of a functional ingredient based on scientific evidence, and for which the Commissioner of the Consumer Affairs Agency has granted individual permission, before sale, regarding information on the basis for its safety and functionality, among other matters.
3. A food with function claims is one for which the business operator displays, on its own responsibility, the functionality of a functional ingredient based on scientific evidence, and for which information on the basis for its safety and functionality, among other matters, has been notified to the Commissioner of the Consumer Affairs Agency before sale.
4. To display the function of a nutrient (such as a vitamin or mineral) as a food with nutrient function claims, the business operator must not make the claim on its own responsibility, but must instead undergo an individual review by the Commissioner of the Consumer Affairs Agency before sale and obtain that Commissioner's permission.

Which of the following statements about so-called "health foods" and the like is correct?

1. A product in the form of a tablet, pill, capsule, or the like is to be judged as falling under the definition of a pharmaceutical based on its form alone, even when it is clearly indicated to be a food.
2. A food other than a food with health claims may not have wording on its container or packaging that resembles the name of a food with health claims, or that indicates a nutrient's function or that a specific health purpose can be expected.
3. The term "health food" is a term defined by law or regulation.
4. A product sold, among other things, in the outward form of a food is never subject to enforcement action as an unapproved, unauthorized pharmaceutical, regardless of its essential composition or the content of any efficacy/effect claim.