Retail Trade Laws & Consumer Act Finals Reviewer PDF

LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 7 WEEK ELEVEN d) "Advertiser" means the client of the advertising -...

LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 7 WEEK ELEVEN d) "Advertiser" means the client of the advertising - Study of the Consumer Protection Act agency or CD Technologies Asia, Inc. © 2022 cdasiaonline.com the sponsor of the advertisement A. Read Arts. 1 to 47 of Republic Act No. 7394 and its Implementing Rules and Regulations. on whose account the advertising is prepared, conceptualized, presented, or disseminated. ARTICLE 1. Short Title. — This Act shall be known e) "Agricultural purpose" means a purpose related to as the "Consumer Act of the Philippines." the production, harvest, processing, manufacture, B. Discuss the state policy declared in RA 7394. distribution, storage, transportation, marketing, exhibition, or disposition of agricultural, fishery or ARTICLE 2. Declaration of Basic Policy. — It is the marine products. policy of the State to protect the interests of the consumer, promote his general welfare, and to f) "Amount financed" in a consumer credit sale establish standards of conduct for business and constitutes the cash price plus non-finance charges industry. Towards this end, the State shall implement less the amount of any downpayment whether measures to achieve the following objectives: made in cash or in property traded in, or in a consumer loan the amount paid to, receivable by a) protection against hazards to health and safety; or paid or payable to the buyer or to another person in his behalf. b) protection against deceptive, unfair, and unconscionable sales acts and practices; g) "Banned hazardous substance" means c) provision of information and education to facilitate (1) any toy or other articles intended for use by sound choice and the proper exercise of rights by children, which are hazardous per se, or which the consumer; bear or contain substances harmful to human beings; or d) provision of adequate rights and means of redress; and (2) any hazardous substance intended or packaged in a form suitable for use in the household, e) involvement of consumer representatives in the which the implementing agency by regulation, formulation of social and economic policies. classifies as "banned hazardous substance" notwithstanding the existence of cautionary C. What is the rule in construing and interpreting provisions of RA 7394? labels, to safeguard public health and safety: Provided, That the implementing agency may, ARTICLE 3. Construction. — The best interest of the by regulation, exempt from this Act, articles consumer shall be considered in the interpretation and which by reason of their functional purpose implementation of the provisions of this Act, including require the inclusion of the hazardous its implementing rules and regulations. substance involved and which bear appropriate labels giving adequate directions and warnings D. Discuss the terms defined in RA 7394. for their safe use. Procedures for the issuance, amendment or repeal of regulations pursuant a) "Advertisement" means the prepared and through to clause (2) or paragraph (g) of this Article any form of mass medium, subsequently applied, shall be governed by the rules and regulations disseminated, or circulated advertising matter. promulgated by the Department of Health; Provided, That if the Department of Health b) "Advertising" means the business of finds that the distribution for household use of conceptualizing, presenting or making available to the hazardous substance involved presents an the public, through any form of mass media, fact, imminent hazard to the public health, it may data or information about the attributes, features, publish in a newspaper of general circulation a quality or availability of consumer products, notice of such finding and such substance shall services or credit. be deemed to be a "banned hazardous substance" pending the issuance of regulation c) "Advertising agency or Agent" means a service formally banning such substance. organization or enterprise creating, conducting, producing, implementing or giving counsel on h) "Batch" means a quantity of any drug or device promotional campaigns or programs through any produced during a given cycle of manufacture. medium for and in behalf of any advertiser. FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 8 i) "Business name, firm name or style" means any o) "Consumer credit" means any credit extended by a name or designation other than the true name of a creditor to a consumer for the sale or lease of any person, partnership, corporation, or association consumer product or service under which part or all of which is used or signed in connection with his/its the price or payment therefore is payable at some business or in: future time, whether in full or in installments. a CD = > Technologies Asia, Inc. © 2022 cdasiaonline.com 1) any written or printed receipt, including receipt p) "Consumer loan" means a loan made by the lender · for tax CD Technologies Asia, Inc. © 2022 to a person which is payable in installments for which cdasiaonline.com on business; a finance charge is or may be imposed. This term includes credit transactions pursuant to an open-end- 2) any written or printed contract not verified by credit plan other than a seller credit card. a notary public; q) "Consumer products and services" means goods, 3) any written or printed evidence of any services and credits, debts or obligations which are agreement or business transaction; and primarily for personal, family, household, or agricultural purposes, which shall include but not 4) any sign or billboard kept conspicuously limited to food, drugs, cosmetics, and devices. exhibited in plain view in or at the place of the business, announcing a firm name or business r) "Consumer product safety rule" means a consumer name or style. product safety standard described in Article 78 or a rule under this Chapter declaring a consumer product j) "Cash price or delivered price", in case of trade banned hazardous product. transaction, means the amount of money which would s) "Consumer transaction" means (1) (i) a sale, lease, constitute full payment upon delivery of the property assignment, award by chance, or other disposition of (except money) or service purchased at the creditor's consumer products, including chattels that are place of business. In the case of financial transactions, intended to be affixed to land, or of services, or of any cash price represents the amount received by the debtor right, title, or interest therein, except securities as upon consummation of the credit transaction, net of defined in the Securities Act and contracts of insurance finance charges collected at the time the credit is under the Insurance Code, or (ii) grant of provision of extended, if any. credit to a consumer for purposes that are primarily k) "Chain distribution plans" or "pyramid sales personal, family, household or agricultural, or (2) a schemes" means sales devices whereby a person, upon solicitation or promotion by a supplier with respect to condition that he makes an investment, is granted by a transaction referred to in clause (1). & cd the manufacturer or his representative a right to recruit t) "Corrosive" means any substance which on contact for profit one or more additional persons who will also with living tissue will cause destruction of tissue by be granted such right to recruit upon condition of chemical action. making similar investments: Provided, That, the profits of the person employing such a plan are derived u) "Cosmetics" means (1) articles intended to be primarily from the recruitment of other persons into rubbed, poured, sprinkled, or sprayed on, introduced the plan rather than from the sale of consumer into or otherwise applied to the human body or any products, services and credit: Provided, further, That part thereof for cleansing, beautifying, promoting the limitation on the number of participants does not attractiveness, or altering the appearance, and (2) change the nature of the plan. article intended for uses as a component of any such article except that such term shall not include soap. l) "Closing out sale" means a consumer sale wherein the seller uses the announcement to create the v) "Counterfeit product" means any consumer product impression that he is willing to give large discounts or which, or the container or labeling of which, without merchandise in order to reduce, dispose or close out his authorization, bears the trademark, trade name, or inventory and business. other identifying mark, imprint, or device, or any likeness thereof, of a consumer product manufacturer, m) "Commerce" means the sale, lease, exchange, processor, packer, distributor, other than the person or traffic or distribution of goods, commodities, persons who in fact manufactured, processed, packed productions, services or property, tangible or or distributed such product and which thereby falsely intangible. purports or is represented to be the product of, or to n) "Consumer" means a natural person who is a have been packed or distributed by such consumer purchaser, lessee, recipient or prospective purchaser, product manufacturer, processor, packer, or · lessor or recipient of consumer products, services or distributor. CD Technologies Asia, Inc. © 2022 credit. cdasiaonline.com FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 9 w) "Credit card" means any card, plate, coupon book ac) "Distributor" means any person to whom a or other credit device existing for the purpose of consumer product is delivered or sold for purposes of obtaining money, property, labor, or services on credit. distribution in commerce, except that such term does not include a manufacturer or retailer of such product. x) "Credit Sale" means a sale of products, services or an interest in land to a person on credit where a debt is ad) "Drugs" mean payable in installments or a finance charge is imposed (1) articles recognized in the current official United and includes any agreement in the form of a bailment States Pharmacopoeia-National Formulary, official of products or lease of products or real property if the Homeopathic Pharmacopoeia of the United States, bailee or lessee pays or agrees to pay compensation for official National Drug Formulary, or any supplement use a sum substantially equivalent to or in excess of the to any of them; and aggregate value of the products or real property involved and it is agreed that the bailee or lessee will (2) articles intended for use in the diagnosis, cure, become, or for no other or a nominal consideration has mitigation, treatment, or prevention of disease in man the option to become, the owner of the products or real or other animals; and property upon full compliance with the terms of the agreement. (3) articles (other than food) intended to affect the structure or any function of the body of man or y) "Credit transaction" means a transaction between a animals; and natural person and a creditor in which real or personal property, services or money acquired on credit and the (4) articles intended for use as a component of any person's obligation is payable in installment. articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or z) "Creditor" means any person engaged in the accessories. The term "drug" when used in this Act business of extending credit and shall include any shall include herbal and/or traditional drug. They are person who as a regular business practice makes loans defined as articles from indigenous plant or animal or sells or rents property or services on a time, credit or origin used in folk medicine which are: (1) recognized installment basis, either as principal or as agent who in the Philippine National Formulary; (2) intended for requires as an incident to the extension of credit, the use in the treatment or cure, mitigation of disease payment of a finance charge. symptoms, injury or bodily defect for use in man; (3) other than food, intended to affect the structure of any aa) "Default or delinquency charge" means, with function of the body of man; (4) put into finishes, ready respect to a consumer credit transaction, the penalty to use form by means of formulation, dosage or dosage charge payable by the consumer-debtor for failure to directions; and (5) intended for use as a component of pay an amount or installment in full on the date the any of the articles specified in clauses (1), (2), (3) and same becomes due and demandable, or on or before (4) of this paragraph. Tcdasia ae) "Expiry or expiration the period specified for the purpose in the consumer date" means the date stated on the label of food, drug, credit sale documents. cosmetic, device or hazardous substance after which ab) "Device" means an instrument, apparatus, they are not expected to retain their claimed safety, implement, machine, contrivance, implant, in vitro efficacy and quality or potency and after which it is no reagent, or other similar or related article, including longer permissible to sell them. any component, part or accessory which is af) "Extremely flammable" means any substance which (1) recognized in the official United States has a flash point at or below negative six and six-tenths Pharmacopoeia-National Formulary (USP-NF) or any degrees centigrade as determined by the Tagliabue supplement to them, Open Cub Tester; and the term "combustible" shall apply to any substance which has a flash point of above (2) intended for use in the diagnosis of disease or other twenty-six and six-tenths degrees to and including condition or in the cure, mitigation, treatment, or sixty-five and five-tenths degrees centigrade as prevention of disease, in man or other animals; or determined by the Tagliabue Open Cub Tester: (3) intended to affect the structure or any function of Provided, That the flammability or combustibility of the body of man or other animals, and which does not solids and of the contents of self-pressurized containers achieve any of its principal intended purposes through shall be determined through methods found by the chemical action within or on the body of man or other implementing agency to be generally applicable to such - animals and CD Technologies Asia, Inc. © 2022 arou materials or CD Technologies Asia, Inc. © 2022 = cdasiaonline.com which is not dependent upon being cdasiaonline.com containers, respectively, and metabolized for the achievement of any of its principal established by regulations issued by it. intended purposes. ag) "Food" means any substance, whether processed, semiprocessed or raw, intended for human FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 10 consumption and includes chewing gum, drinks and al) "Highly Toxic" means any substance which has any beverages and any substance which has been used as of the following effects: an ingredient or a component in the manufacture, (1) produces death within fourteen days to one-half or preparation, or treatment of food. more than one-half of a group of ten or more laboratory ah) "Food additive" means any substance, the intended white rats each weighing between Two hundred and use of which results or may reasonably be expected to three hundred grams, at a single dose of fifty result, directly or indirectly, in its becoming a milligrams or less per kilogram of body weight, when component or otherwise affecting the characteristics of orally administered; or any food (including any substance intended for use in (2) produces death within fourteen days to one-half or producing, manufacturing, packing, processing, more of a group of ten or more laboratory white rats preparing, treating, packaging, transporting, or holding each weighing between two hundred and three food; and including any source of radiation intended hundred grams, when inhaled continuously for a for any such use), if such substance is not generally period of one hour or less at an atmospheric recognized, among experts qualified as having been concentration of two hundred parts per million by adequately shown through scientific procedures to be volume or less of gas or vapor or two milligrams per safe under the conditions of the intended use. liter by volume or less of mist or dust, provided such ai) "Generic name" is the identification of drugs and concentration is likely to be encountered by man when medicines by their scientifically and internationally the substance is used in any reasonably foreseeable recognized active ingredients or by their official generic manner; or name as determined by the Bureau of Food and Drugs (3) produces death within fourteen days to one-half or of the Department of Health. more of a group of ten or more rabbits, when tested in aj) "Guarantee" means an expressed or implied a dosage of two hundred milligrams or less per assurance of the quality of the consumer products and kilogram of body weight, or when administered services offered for sale or length of satisfactory use to through continuous contact with the bare skin for be expected from a product or other similar specified twenty-four hours or less. assurances. am) "Home solicitation sale" means consumer sales or ak) "Hazardous substance" means: (1) (i) Any leases which are personally solicited by any person or substance or mixture of substances which is toxic, organization by telephone, person-to-person contact or corrosive, irritant, a strong sensitizer, flammable or by written or printed communication other than combustible, or generates pressure through general advertising or consummated at the buyer's decomposition, heat or other means, if such substance residence or a place of business, at the seller's transient or mixture or substances may cause substantial injury quarters, or away from a seller's regular place of or substantial illness during or as a proximate result of business. any customary or reasonably foreseeable ingestion by an) "Immediate container" means the container or children; (ii) Any substance which the department package which is immediately after or near the finds to be under the categories enumerated in clause · substance but does CD Technologies Asia, Inc. © 2022 (1) (i) of this paragraph; (iii) Any radioactive cdasiaonline.com not include package liners. substance, if, with respect to such substance as used in a particular class of article or as packaged, the ao) "Imminently hazardous product" means a Department, upon approval of the Department consumer product which presents an unreasonable risk determines by regulation that the substance is of death, serious illness or severe personal injury. · sufficiently CD Technologies Asia, Inc. © 2022 cdasiaonline.com hazardous to require labeling in ap) "Irritant" means any substance not corrosive within accordance with this section in order to protect the the meaning of paragraph (t) of this Article which, on public health; (iv) Any toy or other articles intended for immediate, prolonged or repeated contact with normal use by children which the director may, by regulation, living tissue will induce a local inflammatory reaction. determine the presence of an electrical, mechanical or aq) "Label, labeling" means the display of written, thermal hazard. (2) This term shall not apply to food, printed or graphic matter on any consumer product, its drugs, cosmetics, and devices nor to substances immediate container, tag, literature or other suitable intended for use as fuels when stored in containers and material affixed thereto for the purpose of giving used in the heating, cooking or refrigeration system of information as to the identity, components, a house, but such term shall apply to any article which ingredients, attributes, directions for use, specifications is not in itself a pesticide but which is a hazardous and such other information as may be required by law substance, as construed in clause (a) of paragraph (1), or regulations. by reason of bearing or containing such harmful substances described therein. FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 11 ar) "Manufacture" means any and all operations handling and storage of packages which require special involved in the production, including preparation, care in handling or storage; and (ix) the statement propagation, processing, formulating, filling, packing, "keep out of the reach of children", or its practical repacking, altering, ornamenting, finishing or equivalent, if the article is intended for use by children otherwise changing the container, wrapper or labeling and is not a banned hazardous substance, with of a consumer product in the furtherance of the adequate directions for the protection of children from distribution of the same from the original place of the hazard involved. The aforementioned signal manufacture to the person who makes the final words, affirmative statements, description of delivery or sale to the ultimate consumer. precautionary measures, necessary instructions or other words or statements may be in the English as) "Manufacturer" means any person who language or its equivalent in Filipino; and ⑳ cd (2) on manufactures, assembles or processes consumer which any statement required under clause (1) of this products, except that if the goods are manufactured, paragraph are located prominently and in contrast by assembled or processed for another person who typography, layout, with other printed matters on the attaches his own brand name to the consumer label. · cdasia products, the latter shall be deemed the manufacturer. In case of imported products, the manufacturer's aw) "New Drugs" mean representative or, in his absence, the importer, shall be (1) any drug the composition of which is such that said deemed the manufacturer. drug is not generally recognized among experts at) "Mass media" refers to any means or methods used qualified by scientific training and experience to to convey advertising messages to the public such as evaluate the safety, efficacy, and quality of drugs as television, radio, magazines, cinema, billboards, safe, efficacious and of good quality for use under the posters, streamers, hand bills, leaflets, mails and the conditions prescribed, recommended, or suggested in like. the labeling thereof; or au) "Materially defective product" means a product (2) any drug the composition of which is such that said which, because of the pattern of the defect, the number drug, as a result of its previous investigations to of defective products distributed in commerce and the determine its safety, efficacy and good quality for use severity of the risk or otherwise, creates a substantial under certain conditions, has become so recognized risk of injury to the public. but which has not, otherwise than in such investigations, been used to a material extent or for a av) "Mislabeled hazardous substance" means any material time under new conditions.=>> CD Technologies hazardous substance intended, or packaged in a form e Asia, Inc. © 2022 cdasiaonline.com "New Drugs" shall suitable, for use in households, especially by children, include drugs the packaging or r o CD Technologies Asia, Inc. © 2022 · cdasiaonline.com labeling of which is in violation of (a) containing a newly discovered active ingredient; the special packaging regulation issued by the (b) containing a new fixed combination of drugs, either Department of Health under Article 91 or if such by molecular or physical combination; substance fails to bear a label which (1) states conspicuously (i) the name and the exact address of the (c) intended for new indications; manufacturer, packer, distributor or seller; (ii) the common or usual name of the hazardous substance or (d) an additional new mode of administration; or of each component which contributes substantially to (e) in an additional dosage or strength of the dosage the harmfulness of the substance, unless the form, which meets the conditions as defined under the Department by regulation approved by the new drug. The definition of "new drugs" covers to the Department permits or requires the use of the extent applicable, "new devices". recognized generic name; (iii) the signal word "danger" on substances which are extremely flammable, ax) "New Product" means a consumer product which corrosive, or highly toxic; (iv) the signal word incorporates a design, material or form of energy "warning" or "caution" on all other hazardous exchange which has not previously been used substances; (v) a frank statement of the principal substantially in consumer products and as to which hazard or hazards involved, as "flammable", "vapor there exists a lack of adequate information to harmful", "causes burns", "absorbed through skin", or determine the quality and safety of such product if used similar wording describing the action to be followed or by the consumers. avoided, except when modified by regulation by the ay) "Open-end-credit plan" means a consumer credit Department pursuant to Section 46; (vi) instructions, extended on an account pursuant to a plan under when necessary or appropriate, for first aid treatment; which: 1) the creditor may permit the person to make (vii) the word "poison" for any hazardous substance purchases or obtain loans, from time to time, directly which is defined as highly toxic; (viii) instructions for FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 12 from the creditor or indirectly by use of credit card, goods or services by representing that after the check or other device; 2) the person has the privilege of acquisition of the goods or services, he will receive a paying the balance; or 3) a finance charge may be rebate, commission or other benefit in return for the computed by the creditor from time to time on an submission of names of potential customers or outstanding unpaid balance. otherwise helping the seller enter into other sales, if the receipt of such benefit is contingent on an event az) "Package" or "packaging" means any container or occurring after the sale is made. wrapping in which any consumer product is enclosed for use in the delivery or display of that consumer bi) "Repair and service firm" means any business product to retail purchasers, but does not include: 1) establishment, engaged directly or indirectly, in the shipping containers or wrappings used solely for the repair, service or maintenance of any consumer transportation of any consumer product in bulk or in product. big quantities by manufacturers, packers, or processors bk) "Retailer" means a person engaged in the business to wholesale retail distributors thereof; 2) shipping of selling consumer products directly to consumers. containers or outer wrappings used by retailers to ship or deliver any product to retail costumers if such arou CD Technologies Asia, Inc. © 2022 cdasiaonline.com containers and wrappings bear no printed matter bl) "Sale or distribution" shall mean an act made by a pertaining any particular product; 3) The wrappers or manufacturer or seller, or their respective containers of consumer products sold in small representative or agent, to make available consumer quantities by small retail stores to the consumer which products, services or credit to the end consumers under by tradition are wrapped with ordinary paper. a consumer sale transaction. It shall not include sampling or any distribution not for sale. ba) "Person" means any individual, partnership, corporation or association, trust, government or bm) "Sales Promotion" means techniques intended for mutum governmental subdivision CD Technologies Asia, Inc. broad consumer participation which contain promises © 2022 cdasiaonline.com or any other legal entity. of gain such as prizes, in cash or in kind, as reward for the purchase of a product, security, service or winning bb) "Poisonous substance" means any substance in contest, game, tournament and other similar capable of destroying life or seriously endangering competitions which involve determination of winner/s health when applied externally to the body or and which utilize mass media or other widespread introduced internally in moderate doses. media of information. It also means techniques purely bc) "Price comparison" means the direct comparison in intended to increase the sales, patronage and/or any advertisement of a seller's current price for goodwill of a product. consumer products or services with any other price or bn) "Seller" means a person engaged in the business of statement of value for such property or services selling consumer products directly to consumers. It expressed in pesos, centavos, fractions or percentages. shall include a supplier or distributor if (1) the seller is bd) "Price tag" means any device, written, printed, a subsidiary or affiliate of the supplier or distributor; (2) affixed or attached to a consumer product or displayed the seller interchanges personnel or maintains in a consumer repair or service establishment for the common or overlapping officers or directors with the purpose of indicating the retail price per unit or service. supplier or distributor; or (3) the supplier or distributor provides or exercises supervision, direction or control be) "Principal display panel" means that part of the over the selling practices of the seller. label that is most likely to be displayed, presented, shown or examined under normal and customary bo) "Service" shall mean, with respect to repair and conditions of display for retail or sale. service firms, services supplied in connection with a contract for construction, maintenance, repair, bf) "Private labeler" means an owner of a brand or processing, treatment or cleaning of goods or of trademark on the label of consumer product other than fixtures on land, or distribution of goods, or a manufacturer of the product. A consumer product transportation of goods. bears a private label if (1) the product or its container is labeled with a brand or trademark of a person other bp) "Services" means services that are the subject of a than its manufacturer; or (2) the brand or trademark of consumer transaction, either together with, or separate the manufacturer of such product does not appear on from any kind of personal property, whether tangible such label. or intangible. bg) "Radioactive substance" means any substance bq) "Special packaging" means packaging that is which emits ionizing radiation. designed or constructed to be significantly difficult for children five years of age to open or to obtain a toxic bh) "Referral selling" means the sales device employed or harmful amount of the substance contained therein by the sellers wherein the buyer is induced to acquire FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 13 within a reasonable time and not difficult for normal Provided that in the absence of such standards, the adults to use properly but does not mean packaging concerned agencies shall form specialized technical which all such children cannot open or obtain a toxic committees composed of equal number of or harmful amount within a reasonable time. representatives from each of the government, business, and consumer sectors to formulate, develop and br) "Standard" means a set of conditions to be fulfilled propose consumer product quality and safety to ensure the quality and safety of a product; standards. bs) "Strong sensitizer" means any substance which will The said technical committees shall consult with the cause on normal living tissue, allergy or photodynamic private sector, which may, motu proprio, develop its quality of hypersensitivity which becomes evident on own quality and safety standards that shall be subject reapplication of the same substance, to be designated to review and approval of the concerned government um as such by the CD Technologies Asia, Inc. © 2022 agency or agencies after public hearings have been cdasiaonline.com implementing agency. Before conducted for the purpose. It shall likewise consider designating any substance as a strong sensitizer, the existing international standards recognized by the implementing agency, upon consideration of the Philippine Government frequency of occurrence and severity of the reaction, shall find that the substance has a significant capacity F. What is the declared policy involving consumer to cause hypersensitivity. product and safety bt) "Substandard product" means a product which fails ARTICLE 5. Declaration of Policy – In terms of to comply with an applicable consumer product safety quality and safety, the law provides that it shall be the rule which creates a substantial risk of injury to the duty of the State: public. 1. to develop and provide safety and quality bu) "Supplier" means a person, other than a consumer, standards for consumer products, including who, in the course of his business, solicits, offers, performance or use-riented standards, codes of advertises, or promotes the disposition or supply of a practice and methods of tests; consumer product or who other than the consumer, engages in, enforces, or otherwise participates in a 2. to assist the consumer in evaluating the quality consumer transaction, whether or not any privity of including safety, performance and comparative contract actually exists between that person and the utility of consumer products; consumer, and includes the successor to, or assignee 3. to protect the public against unreasonable risks of of, any right or obligation on of the supplier. injury associated with consumer products; bv) "Technical personnel of repair and service enterprise" shall mean a machine or technician or any 4. to undertake research on quality improvement of person who works or renders diagnosis or advice in products and investigation into causes and connection with repair, service and maintenance of the prevention of product related deaths, illness and consumer products in a repair and service firm. injuries; bw) "Toxic substance" means any substance other than 5. to assure the public of the consistency of a radioactive substance which can cause injury, illness standardized products. or death to man through ingestion, inhalation or absorption through any body surface. G. Who are tasked to implement consumer product quality and safety? bx) "Trade name" or "trademark" means a word or words, name, title, symbol, emblem, sign or device or ARTICLE 6. As to Implementing Agencies, the any combination thereof used as an advertisement, provisions of the law and its implementing rules and sign, label, poster or otherwise for the purpose of regulations on consumer product standards, shall be enabling the public to distinguish the business of the enforced by: person who owns and uses said trade name or trademark. 1. The Department of Health with respect to food, drugs, cosmetics, devices, and substances; E. Discuss Consumer Product Quality and Safety 2. The Department of Agriculture with respect to products related to agriculture; and RULE IV Consumer Product Quality and Safety 3. The Department of Trade and Industry with Standard (IRR of R.A. 7394) respect to other consumer products not specified SECTION 7. Product Quality and Safety Standards. above. — The following product quality and safety standards of the implementing agencies shall be adopted. FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 14 H. What is a consumer product safety rule? J. What should be done in case a consumer product is found to be injurious, unsafe, or dangerous? Consumer product safety rule means a consumer product safety standard described in Article 78 or a rule ARTICLE 10. Injurious, Dangerous and Unsafe under this Chapter declaring a consumer product Products. – Whenever the departments find, by their banned hazardous product. own, initiative or by petition of a consumer, that a consumer product is found to be injurious, unsafe or ARTICLE 78. Philippine Product Standard Mark. — dangerous, it shall after due notice and hearing, make The label may contain the Philippine Product Standard the appropriate order for its recall, prohibition or Mark if it is certified to have passed the consumer seizure from public sale or distribution: Provided, product standard prescribed by the concerned That, in the sound discretion of the department it may department. declare a consumer product to be imminently I. Discuss the minimum requirements for consumer injurious, unsafe or dangerous, and order is immediate product standards under Article 7. recall, ban, or seizure from public sale or distribution, in which case, the seller, distributor, manufacturer or ARTICLE 7. Promulgation and Adoption of producer thereof shall be afforded a hearing within Consumer Product Standards. — The concerned forty-eight (48) hours from such order. department shall establish consumer product quality and safety standards which shall consist of one or more The ban on the sale and distribution of a consumer of the following: product adjudged injurious, unsafe, or dangerous, or imminently injurious, unsafe, or dangerous under the a. requirements to performance, composition, preceding paragraph shall stay in force until such time contents, design, construction, finish, packaging of that its safety can be assured or measures to ensure its a consumer product; safety have been established. b. requirements as to kind, class, grade, dimensions, K. What happens if a consumer product is found to be weights, material; imminently injurious, unsafe, or dangerous? c. requirements as to the methods of sampling, tests ARTICLE 10. Injurious, Dangerous and Unsafe and codes used to check the quality of the products; Products. — Whenever the departments find, by their own initiative or by petition of a consumer, that a d. requirements as to precautions in storage, consumer product is found to be injurious, unsafe, or transporting, and packaging. dangerous, it shall, after due notice and hearing, make the appropriate order for its recall, prohibition or e. requirements that a consumer product be marked with or accomplished by clear and adequate safety seizure from public sale or distribution: warnings or instructions, or requirements Provided, That, in the sound discretion of the respecting the form of warnings or instructions, department it may declare a consumer product to be imminently injurious, unsafe, or dangerous, and order f. For this purpose, the concerned department shall is immediate recall, ban or seizure from public sale or adopt existing government domestic product distribution, in which case, the seller, distributor, quality and safety standards: Provided, that in the absence of such standards, the concerned manufacturer or producer thereof shall be afforded a department shall form specialized technical hearing within forty-eight (48) hours from such order. committees composed of equal number of The ban on the sale and distribution of a consumer representatives from each of the Government, product adjudged injurious, unsafe, or dangerous, or business and consumer sectors to formulate, imminently injurious, unsafe, or dangerous under the develop and purpose consumer product quality preceding paragraph shall stay in force until such time and safety standards. The said technical that its safety can be assured or measures to ensure its committees shall consult with the private sector, safety have been established. which may, motu proprio, develop its own quality and safety standards that shall be subject to review L. In case a department determines a consumer and approval of the concerned government agency product to be substandard or materially defective, or agencies after public hearings have been what must the department do under Article 11? conducted for that purpose; and shall likewise consider existing international standards ARTICLE 11. Amendment and Revocation of recognized by the Philippine Government. Declaration of the Injurious, Unsafe or Dangerous Character of a Consumer Product. — Any interested person may petition the appropriate department to commence a proceeding for the issuance of an amendment or revocation of a consumer product FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 15 safety rule or an order declaring a consumer product 16 November 2020. (Discuss also application of injurious, dangerous, and unsafe. Art. 15) In case the department, upon petition by an interested N. Discuss the rules involving imported consumer party or its own initiative and after due notice and products under Article 15. hearing, determines a consumer product to be substandard or materially defective, it shall so notify ARTICLE 15. Imported Products. – the manufacturer, distributor or seller thereof of such finding and order such manufacturer, distributor or a) Any consumer product offered for importation into seller to: the customs of the Philippine territory shall be refused admission if such product: a) give notice to the public of the defect or failure to comply with the product safety standards; and 1. fails to comply with an applicable consumer product quality and safety standard or rule; b) give notice to each distributor or retailer of such product. 2. is or has been determined to be injurious, The department shall also direct the manufacturer, unsafe, and dangerous; distributor, or seller of such product to extend any or all of the following remedies to the injured person: 3. is substandard; or a) to bring such product into conformity with the requirements of the applicable consumer product 4. has material defect. standards or to repair the defect in order to conform with the same; b) Samples of consumer products being imported into the Philippines in a quantity necessary for purposes c) to replace the product with a like or equivalent of determining the existence of any of the above product which complies with the applicable causes for non-admission may be obtained by the consumer product standards which does not concerned department or agency without charge contain the defect; from the owner or consignee thereof. The owner or consignee of the imported consumer product under d) to refund the purchase price of the product less a examination shall be afforded an opportunity to a reasonable allowance for use; and hearing with respect to the importation of such products into the Philippines. If it appears from e) to pay the consumer reasonable damages as may examination of such samples or otherwise that an be determined by the department. The imported consumer product does not conform to manufacturer, distributor or seller shall not charge the consumer product safety rule or is injurious, a consumer who avails himself of the remedy as unsafe and dangerous, is substandard or has a provided above of any expense and cost that may material defect, such product shall be refused be incurred. admission unless the owner or the consignee thereof manifests under bond that none of the M. What is a certification of conformity to consumer above ground for non-admission exists or that product standards? measures have been taken to cure them before they are sold, distributed or offered for sale to the ARTICLE 14. Certification of Conformity to general public. Consumer Product Standards. — The concerned department shall aim at having consumer product Any consumer product, the sale or use of which standards established for every consumer product so has been banned or withdrawn in the country of that consumer products shall be distributed in manufacture, shall not be imported into the commerce only after inspection and certification of its country. quality and safety standards by the department. c) If it appears that any consumer product which may The manufacturer shall avail of the Philippine not be admitted pursuant to paragraph (a) of this Standard Certification Mark which the department Article can be so modified that it can already be shall grant after determining the product's compliance accepted, the concerned department may defer with the relevant standard in accordance with the final examination as to the admission of such implementing rules and regulations. product for a period not exceeding ten (10) days, m.1. Discuss Dept. of Trade and Industry v. Steel and in accordance with such regulations as the Asia Manufacturing Corporation, G.R. No. 238263, department and the Commissioner of Customs shall jointly promulgate, such product may be FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 16 released from customs custody under bond for the consumer product which is not in conformity with purpose of permitting the owner or consignee an an applicable consumer product quality or safety opportunity to so modify such product. standard promulgated in this Act; d) All modifications taken by an owner or consignee b) manufacture for sale, offer for sale, distribute in for the purpose of securing admission of an commerce, or import into the Philippines any imported consumer product under paragraph (c) consumer product which has been declared as shall be subject to the supervision of the concerned banned consumer product by a rule in this Act; department. If the product cannot be so modified, or if the owner or consignee is not proceeding to c) refuse access to or copying of pertinent records or satisfactorily modify such product, it shall be fail or refuse to permit entry of or inspection by refused admission and the department may direct authorized officers or employees of the redelivery of the product into customs custody, and department; to seize the product if not so redelivered. d) fail to comply with an order issued under Article II e) Imported consumer products not admitted must be relating to notifications of substantial product exported, except that upon application, the hazards and to recall, repair, replacement, or Commissioner of Customs may permit the refund of unsafe products; destruction of the product if, within a reasonable time, the owner or consignee thereof fails to export e) fail to comply with the rule prohibiting stockpiling. the same. f) All expenses in connection with the destruction ARTICLE 19. Penalties. – provided for in this Article, and all expenses in a) Any person who shall violate any provision of connection with the storage, cartage, or labor with Article 18 shall upon conviction, be subject to a respect to any consumer product refused admission fine of not less than One thousand pesos under this Article, shall be paid by the owner or (P1,000.00) but not more than Ten thousand pesos consignee and, in default of such payment, shall (P10,000.00) or imprisonment of not less than two constitute a lien against any future importation (2) months but not more than one (1) year, or both made by such owner or consignee. upon the discretion of the court. If the offender is an alien, he shall be deported after service of O. Discuss the rules involving exported consumer sentence and payment of fine without further products under Article 16. deportation proceedings. ARTICLE 16. Consumer Products for Export. – The b) In case the offender is a naturalized citizen, he preceding article on safety not apply to any consumer shall, in addition to the penalty prescribed herein, product if: suffer the penalty of cancellation of his a) it can be shown that such product is manufactured, naturalization certificate and its registration in the sold, or held for sale for export from the civil register and immediate deportation after Philippines, or that such product was imported for service of sentence and payment of fine. export, unless such consumer product is in fact distributed in commerce for use in the Philippines; c) Any director, officer, or agent of a corporation who and shall authorize, order or perform any of the acts or practices constituting in whole or in part a b) such consumer product or the packaging thereof violation of Article 18, and who has knowledge or bears a stamp or label stating that such consumer notice of noncompliance received by the product is intended for export and actually corporation from the concerned department, shall exported. be subject to penalties to which that corporation P. Discuss the prohibited acts and penalties stated in may be subject. Articles 18 and 19. In case the violation is committed by, or in the PROHIBITED ACTS AND PENALTIES interest of a foreign juridical person duly licensed to engage in business in the Philippines, such ARTICLE 18. Prohibited Acts. – It shall be unlawful license to engage in business in the Philippines for any person to: shall immediately be revoked. a) manufacture for sale, offer for sale, distribute in commerce, or import into the Philippines any - END OF WEEK ELEVEN SYLLABUS - FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 17 WEEK TWELVE under this clause if the quantity of such substance Study of the Consumer Protection Act does not ordinarily render it injurious to health; A. Discuss regulations involving consumer food, drugs, cosmetics, and devices. 2) if it bears or contains any added poisonous or deleterious substance other than one which is: ARTICLE 22. Rules and Regulations on Definitions and Standards. — Whenever in the judgment of the a. a pesticide chemical in or on a raw agricultural Department such action will promote honesty and fair commodity dealing in the interest of consumers, it shall promulgate rules and regulations fixing and establishing a b. a food additive reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable c. a color additive, for which tolerances have standard of fill of containers for food, drugs, cosmetics, been established and it conforms to such or devices. tolerances; B. What is the declared policy under Article 20? 3) if it consists in whole or in part of any filthy, putrid or decomposed substance, or if it is otherwise unfit ARTICLE 20. Declaration of Policy. — The State for food. shall ensure safe and good quality of food, drugs, cosmetics, and devices, and regulate their production, 4) if it has been prepared, packed, or held under sale, distribution, and advertisement to protect the unsanitary conditions whereby it may have health of the consumer. become contaminated with filth, or whereby, it may have been rendered injurious to health; C. Which agency is tasked to implement the policy in Article 20? 5) if it is, in whole or in part, the product of a deceased animal or an animal which has died other than by ARTICLE 21. Implementing Agency. — In the slaughter implementation of the foregoing policy, the State, through the Department of Health, hereby referred as 6) if its container is composed, in whole or in part, of the Department, shall, in accordance with the any poisonous or deleterious substance which may provisions of this Act: render the contents injurious to health; or a. Establish standards and quality measures for foods, 7) if it has passed its expiry date drugs, devices, and cosmetics; a. If any valuable constituent has been, in whole b. Adopt measures to ensure pure and safe supply of or in part, omitted or abstracted therefrom and foods and cosmetics, and safe, efficacious, and the same has not been substituted by any good quality of drugs and devices in the Country; healthful equivalent of such constituent; c. Adopt measures to ensure the rational use of drugs b. if any substance, not a valuable constituent, and devices, such as, but not limited to, banning, has been added or substituted or in part recalling, or withdrawing from the market drugs therefore; and devices which are unregistered, unsafe, inefficacious or of doubtful therapeutic value, the c. if damage or inferiority has been concealed in adoption of an official National Drug Formulary, any manner; or and the use of generic names in the labeling of drugs; d. if any substance has been added thereto or packed therewith so as to increase its bulk or d. Strengthen the Bureau of Food and Drugs. weight, reduce its quality or strength, or make it appear better or of greater value than it is. D. What is an adulterated food? 8) if it is, or bears or contains a color additive which ARTICLE 23. Adulterated Food. — A food shall be is unsafe under existing regulations: Provided, deemed to be adulterated: That the Department shall promulgate regulations 1) if it bears or contains any poisonous or deleterious providing for the listing of color additives which substance which may render it injurious to health; are harmless and suitable for use in food for which but in case the substance is not an added substance, tolerances have been established; cda such food shall not be considered adulterated FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 18 9) if it is confectionary, and it bears or contains any F. Discuss the rules involving poisonous ingredients alcohol or non-nutritive article or substance except in food. harmless coloring, harmless flavoring, harmless resinous glass not in excess of four-tenths (4/10) of ARTICLE 25. Tolerance for Poisonous Ingredients one per centum (1%) natural gum and pectin: in Food. — Any poisonous or deleterious substance Provided, That this clause shall not apply to a safe added to any food shall be deemed to be unsafe, except non-nutritive article or substance if, in the when such substance is required or cannot be avoided judgment of the Department as provided by in its production or cannot be avoided by good regulations, (1) such article or substance is of manufacturing practice. In such case, the Department practical functional value in the manufacture, shall promulgate regulations limiting the quantity packaging or storage of such confectionery, (2) if therein in such extent as he finds necessary for the the use of the substance does not promote protection of public health, and any quantity exceeding deception of the consumer or otherwise results in the limits so fixed shall be deemed to be unsafe. In adulteration or mislabeling in violation of any determining the quantity of such added substance to be provision of this Act, and (3) would not render the tolerated in different articles of food, the Department product injurious or hazardous to health: shall take into account the extent to which the use of Provided, further, That this paragraph shall not such article is required or cannot be avoided in the apply to any confectionery by reason of its production or manufacture of such articles and the containing less than one-half (1/2) of one per other ways in which the consumer may be affected by centum (1%) by volume of alcohol, derived solely the same or other poisonous or deleterious substance. from the use of flavoring extracts, or to any chewing gum by reason of its containing harmless G. What is a food additive? When is it allowed? non-nutritive masticatory substance: Provided, finally, That the Department may, for the purposes ARTICLE 26. Unsafe Food Additives, Exceptions of avoiding or resolving uncertainty as to the for Conformity with Regulation. — A food additive, application of this clause, promulgate regulations with respect to any particular use or intended use, shall allowing or prohibiting the use of particular non- be deemed unsafe unless: nutritive substances; a. it and its use or intended use conforms to the terms 10) if it is oleomargarine, margarine, or butter and any of an exemption for being solely intended for of the raw materials used therein consists in whole investigational use or in part of any filthy, putrid or decomposed substance, or such oleomargarine, margarine or b. it and its use or intended use is in conformity with butter is otherwise unfit for food; a regulation issued by the Department prescribing the conditions under which such additives may be 11) if it has not been prepared in accordance with safely used. current acceptable manufacturing practice established by the Department through H. Discuss petition for regulation of food additive. regulations. ARTICLE 27. Petition for Regulation of Food d.1 Discuss Department of Health v. Nestle Additive. — Any person may, with respect to any Philippines, Inc., G.R. No. 244242, 14 September intended use of a food additive, file with the 2020. Department a petition proposing the issuance of a regulation prescribing the conditions under which such E. Who regulates unprocessed food? additives may be safely used. ARTICLE 24. Regulation of Unprocessed Food. — The Department shall (1) establish a regulation The provincial, municipal, and city governments shall prescribing, with respect to one or more proposed uses regulate the preparation and sale of meat, fresh fruits, of the food additive involved, (i) the conditions under poultry, milk, fish, vegetables, and other foodstuff for which a food additive may be safely used including, but public consumption, pursuant to the Local not limited to, specifications as to the particular food, Government Code. or classes of food, in which such additive may be used, (ii) the maximum quantity which may be used, or permitted to remain in or on such food; (iii) the manner in which such additive may be added to or used in or on such food, and (iv) any directions or other labeling or packaging requirement for such additive deemed necessary to assure the safety of such use, and shall FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 19 notify the petitioner of such order and the reasons for d) If a drug or device and any substance has been such action; or (2) deny the petition and notify the mixed or packed therewith, or any substance has petitioner of and the reasons for such action. been substituted wholly or in part thereof, so as to reduce its safety, efficacy, quality, strength or The Department may, at any time upon his own purity. initiative, issue a regulation prescribing, with respect to any particular food additive, the conditions under e) If the methods used in, or the facilities or controls which such additive may be safely used and the reasons used for its manufacture or holding do not conform thereof, and cause the publication of the same. to or are not operated or administered in conformity with current good manufacturing I. What are considered as adulterated drugs and practice to assure that such drug meets the devices? requirements of this Act as to safety, quality, and efficacy, and has the identity and strength, and ARTICLE 29. Adulterated Drugs and Devices. — A meets the quality and purity characteristics which drug or device shall be deemed to be adulterated: it purports or is represented to possess. a) (1) if it contains in whole or in part of any filthy, J. Discuss Article 30 regarding exemptions. putrid, or decomposed substance which may affect its safety, efficacy or good quality; or (2) if it has ARTICLE 30. Exemption in Case of Drugs and been manufactured, prepared or held under Devices. — unsanitary conditions whereby it may have been contaminated with dirt or filth or whereby it may a) The Department is hereby directed to promulgate have been rendered injurious to health; or (3) if its regulations exempting from any labeling or container is composed, in whole or in part, of any packaging requirement of this Act drugs and poisonous or deleterious substance which may devices which are, in accordance with the practice render the contents injurious to health; or (4) if it of the trade, to be processed, labeled or repacked in bears or contains any color other than a permissible substantial quantities at establishments other than one as determined by the Department, taking into those where originally processed or packed, on consideration standards of safety, efficacy or good condition that such drugs and devices are not quality. adulterated or mislabeled under the provisions of this Act upon removal from such processing, b) If it purports to be or is represented as a drug, the labeling or repacking establishment. name of which is recognized in an official compendium, and its strength differs from, or its b) 1) Drugs intended for use by man which: safety, efficacy, quality or purity falls below the i. are habit-forming; standards set forth in such compendium, except that whenever tests or methods of assay as ii. because of their toxicity or other potentiality prescribed are, in the judgment of the Department, for harmful effect, or method of their use is insufficient for the making of such determination, not safe for use except under the supervision the Department shall promulgate regulations of practitioner licensed by law to administer prescribing appropriate tests or methods of assay in such drug; accordance with which such determination as to strength, safety, efficacy, quality or purity shall be iii. are new drugs whose applications are limited made. No drug defined in an official compendium to investigational use; shall be dispensed only shall be deemed to be adulterated under this (a) upon written prescription of a practitioner paragraph because it differs from the standards of licensed by law to administer such drug, or strength, safety, efficacy, quality, or purity therefor (b) upon an oral prescription of such set forth in such compendium, if its difference in practitioner which is reduced promptly to strength, safety, efficacy, quality, or purity from writing and filed by the pharmacist, or (c) by such standards is plainly stated in its label and refilling any such written or oral prescription approved for registration as such. if such refilling is authorized by the prescriber either in the original prescription or by oral c) If it is not subject to the provisions of paragraph (b) order which is reduced promptly to writing and its strength differs from, or its efficacy, quality and filed by the pharmacist. The act of or purity falls below, that which it purports or is dispensing a drug contrary to the provisions represented to possess. of this paragraph shall be deemed to be an act which results in the drug being mislabeled while held for sale. FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 20 2) Any drug dispensed by filling or refilling a written device; and (7) such other requirements as may be prescription of a practitioner licensed by law to prescribed by regulations to ensure safety, efficacy administer such drug shall be exempt from the and good quality of such drug or device. requirements of Article 89, except paragraphs (a), (h), (2) and (3), and the packaging requirements of c) Within one hundred eighty (180) days after the paragraphs (f) and (g), if the drug bears a label filing of an application under this sub-article, or containing the name and address of the dispenser, such additional period as may be agreed upon by the serial number and date of the prescription or its the Department and the applicant, the Department filling, the name of the prescriber and, if stated in shall either (1) approve the application if he then the prescription the name of the patient and the finds that none of the grounds for denying approval directions for use and cautionary statements, if specified in sub-article (d) applies, or (2) give the any, contained in such prescription. applicant notice of an opportunity for a hearing before the Department under sub-article 3) The Department may, by regulation, remove drugs (d) on the question whether such application is subject to Article 89(d) and Article 31 from the approvable. requirements of sub article (b)(1) of this Article, when such requirements are not necessary for the d) If the Department finds, after due notice to the protection of the public health. applicant and giving him an opportunity for a hearing, that (1) the reports of the investigations 4) A drug which is subject to sub-article (b)(1) of this which are required to be submitted to the Article shall be deemed to be mislabeled if at any Department pursuant to sub-article (b) hereof, do time prior to dispensing, its label fails to bear the not include adequate tests by all methods statement "Caution: Should not be dispensed reasonably applicable to show whether or not such without prescription." A drug to which sub-article drug or device is safe, efficacious and of good (b)(1) of this Article does not apply shall de deemed quality for use under the conditions prescribed, to be mislabeled if at any time prior to dispensing, recommended or suggested in the proposed its label bears the caution statement quoted in the labeling thereof; (2) the results of such test show preceding sentence. that such drug or device is unsafe, inefficacious or of doubtful therapeutic value for use under such K. Discuss the requirement of certificate of product conditions or do not show that such drug or device registration and license to operate. is safe, efficacious or of good quality for use under such conditions; (3) the methods used in, and the ARTICLE 31. Licensing and Registration. — facilities and controls used for the manufacture of such drug or device are inadequate to preserve its a) No person shall manufacture, sell, offer for sale, identity, strength, quality and purity; or (4) upon import, export, distribute or transfer any drug or the basis of the information submitted to him as device, unless an application filed pursuant to sub- part of the application, or upon the basis of any article (b) hereof is effective with respect to such other information before him with respect to such drug or device. drug or device, he has insufficient information to determine whether such drug or device is safe, b) Any person may file with the Department, through efficacious or of good equality for use under such the Department, an application under oath with conditions; or (5) evaluated on the basis of the respect to any drug or device subject to the information submitted to him as part of the provisions of sub-article (a) hereof. Such persons application, and any other information before him shall submit to the Department: (1) full reports of with respect to such drug or device, there is a lack investigations which have been made to show of substantial evidence that the drug or device will whether or not such drug or device is safe, have the effect it purports or is represented to have efficacious and of good quality for use based on under the conditions of use prescribed, clinical studies conducted in the Philippines; (2) a recommended or suggested in the proposed full list of the articles used as components of such labeling thereof; or (6) based on a fair evaluation of drug or device; (3) a full statement of the all material facts, such labeling is false or composition of such drug or device; (4) a full misleading in any way; he shall issue an order description of the methods used in and the facilities disapproving the application. and controls used for the manufacture of such drug or device; (5) such samples of such drug or device e) The effectiveness of an application with respect to and of the articles used as components thereof as any drug or device shall, after due notice and the Department may require; (6) specimens of the opportunity for hearing to the applicant, by order labeling proposed to be used for such drug or of the Department be suspended if it finds (1) that FINALS REVIEWER DOMINGO, A. PANTANGCO, C. (4LM2 – A.Y. 2023-2024)  LM 31822 RETAIL TRADE LAWS/CONSUMER ACT/E-COMMERCE LAW 21 clinical experience, tests by new methods, or tests Department shall monitor the presence in the market by methods not deemed reasonably of such drugs and cause the maintenance and regular publications of an updated consolidated list thereof. f) The Department shall promulgate regulations for exempting from the operation of this Article drugs N. Discuss certification of drugs containing and devices intended solely for investigational used antibiotics. by experts qualified by scientific training and experience to investigate the safety and ARTICLE 34. Certification of Certain Drugs. — effectiveness of drugs and devices. a) The Department shall, by regulations, provide for g) No person shall manufacture, sell, offer for sale, the certification of batches of drugs composed import, export, distribute or transfer any drug or wholly or partially of any kind of antibiotic. A device without first securing a license to operate batch of such drug shall be certified if such drug has from the Department after due compliance with such characteristics of identity, strength, quality technical requirements in accordance with the and purity, as the Department prescribes in such rules and regulations promulgated by the regulations as necessary to insure adequately safety Department pursuant to this Act. and efficacy of use and good quality, but shall not otherwise be certified. Prior to the effective date of h) No drug or device shall be manufactured, sold, such regulations the Department, in lieu of offered for sale, imported, exported, distributed, or certification, shall issue a release for any batch transferred, unless registered by the manufacturer, which, in his judgment, may be released without importer, or distributor thereof in accordance with risk as to the safety and efficacy of its use. Such rules and regulations promulgated by the release shall prescribe the date of its expiration and Department pursuant to this Act. The provisions of other conditions under which it shall cease to be Article 31 (b), (d) and (e), to the extent applicable, effective as to such batch and as to portions thereof. shall govern the registration of such drugs and For purposes of this Article and of Article 89 (j), devices. the term "antibiotic drug" means any drug intended for use by man containing any quantity of any i) The Department shall promulgate a schedule of chemical substance which is produced by a micro- fees for the issuance of the certificate of product organism and which has the capacity to inhibit or registration and license to operate provided for destroy microorganisms in dilute solution under this Article. (including the chemically synthesized equivalent of any such substance). L. What are the rules involving dangerous drugs under Article 32? b) Whenever in the judgment of the Department, the requirements of this Article and of Article 89 (j) ARTICLE 32. Dangerous Drugs. — The with respect to any drug or class of drugs are not importation, distribution, manufacture, production, necessary to insure safety and e