In the interest of service, the FDA Policy and Planning Service (PPS) requests your comments and inputs on the above subject draft FDA Circular. May we also inform all concerned stakeholders that the deadline for the submission of inputs is until 27 January 2022 only.
Please submit all comments through this google form link: https://bit.ly/33xTueI
For your information and guidance.
The Food and Drug Administration (FDA) regulates several health products falling under the definitions of drugs, devices, cosmetics, household/urban hazardous substances, and food as provided in Republic Act (RA) No. 3720, otherwise known as the “Food, Drugs and Devices, and Cosmetics Act” as amended by Executive Order (EO) No. 175 and RA 9711. In the course of the implementation of the law, through the different technical Centers, the Agency has encountered health products that share similar characteristics or are considered “borderline” between the different product categories. These “borderline” products present difficulties for regulated entities in determining the appropriate classification and appropriate regulatory framework which applies for these products they intend to market.
In order to ensure the effective implementation of health product regulation, the FDA acknowledges that clarity in the demarcation of the product categories must be established. In addition to the publication of identified “borderline” products, industry stakeholders will benefit from the provision of guidance to assist in the determination of the categories of borderline health products. Thus, this Circular is hereby issued to promote clarity in regulatory implementation and in pursuit of the agency’s mandate to protect consumer interest through appropriate health product regulation.
This Circular aims to provide guidance in the categorization of borderline health products under the jurisdiction of the FDA by:
A. Providing the preliminary list of borderline products and their designated product categories;
B. Reiterating the considerations in determining product classification; and,
C. Providing the appropriate transitory period to allow the proper reclassification of borderline health products.
This Circular shall apply to establishments engaged in the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products.
IV. GENERAL GUIDELINES
A. The determination of the product classification shall be primarily guided by the definitions of the health products as provided in RA 3720, as amended by EO 175 and RA 9711.
- ‘Cosmetics’ means any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/ or correcting body odor, and/ or protecting the body or keeping them in good condition.
- ‘Devices’ means medical devices, radiation devices and health-related devices.a. ‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body. This device does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in intended function by such means.b. ‘Radiation device’ means an electrical or electronic apparatus emitting any ionizing or non-ionizing electromagnetic or particulate radiation; or any sonic, infrasonic, or ultrasonic wave. It includes ionizing radiation-emitting equipment which is not intentionally designed to produce radioactive materials.
c. ‘Health-related device’ means any device not directly used in health care but has been determined by the FDA to adversely affect the health of the people.d. ‘In vitro diagnostic (IVD) medical device’ means any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination with any other reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, that is intended by its product owner to be used in vitro for examination of any specimen, including any blood or tissue donation, derived from the human body, solely or principally for the purpose of provided information:i. Concerning a physiological or pathological state or a congenital abnormality;ii. To determine the safety and compatibility of any blood or tissue donation with a potential recipient thereof; or,
iii. To monitor therapeutic measures and includes a specimen receptacle.
- ‘Drugs’ means:a. Articles recognized in official pharmacopoeias and formularies, including official homeopathic pharmacopoeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA;b. Articles intended in the diagnosis, cure, mitigation, treatment; prevention of disease for use in man or other animals;c. Articles (other than food) intended to affect the structure or any function of the body of human beings or animals; or,d. Articles intended for use as a component of any articles specified in (a), (b), or (c) but do not include devices or their components, parts or accessories.
- ‘Food’ means any processed substance, which is intended for human consumption and includes drinks for human beings, beverages, chewing gum and any substances, which have been used as an ingredient in the manufacture, preparation or treatment of food.
- ‘Food/Dietary Supplement’ means a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, amino acid, herb, or other dietary substance of botanical, animal, artificial or natural origin to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It is usually in the form of capsules, tablets, liquids, gels, powders or pills and is not represented for use as a conventional food or as the sole item of a meal or diet or a replacement for drugs and medicines.
- ‘Household/urban hazardous substance’ means:
a. Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shall not include agricultural fertilizers, agricultural pesticides, and agricultural insecticides and other economic poisons, radioactive substances, or substances intended for use as fuels, coolants, refrigerants and the like;b. Any substance which the FDA finds to be under the categories enumerated in paragraph (a) of this section;c. Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard. For this purpose, toys and other articles intended for use by children shall refer to those toys and articles specified to be for children less than fourteen (14) years of age; and,d. The term Household/urban Hazardous substance shall not apply to food, drugs, cosmetics, devices, or to substances intended for use as fuel when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself an agricultural pesticide but which is a hazardous substance, as construed in paragraph (a) of this section, by reason of bearing or containing such harmful substances described therein.
B. The determination of appropriate classification shall be based on the definition provided by law and other recognized and adopted references, product claim(s), product presentation, product composition (formulation), primary method the intended action is achieved, and route of administration.
C. Initial determination of product classification is the responsibility of the market authorization applicant or holder, as signified through the application of a market authorization with the respective FDA Centers. The market authorization applicant or holder shall exercise due diligence and check the FDA registry available at the FDA website and/or FDA Verification Portal for similar products which have been previously-registered with the FDA.
Should the Center find that, based on its evaluation, that the product is incorrectly classified by the market authorization applicant, the market authorization application shall be disapproved. A letter of disapproval stating the grounds for such shall be provided to the applicant.
D. If the market authorization applicant or holder becomes aware of changes, additional, and/or new information that is expected to affect the product’s classification, then the market authorization applicant or holder shall be responsible for informing the FDA and correspondingly filing the marketing authorization application following the appropriate product category.
E. ‘Borderline products’ are health products that share similar characteristics or are considered between the different product categories. In cases where the classification of a product is unclear, a market authorization applicant or holder may file an application for Product Classification, following the existing procedure. A request for re-classification is considered the same as a request for determination of product classification.
F. The FDA may initiate a review of the classification of products, in the event of updates in scientific evidence and for public health reasons.
G. The FDA shall publish and maintain a list of “borderline” products with their identified product classification, attached as Annex A. Products currently holding valid authorizations with the FDA requiring re-classification in accordance with this list shall be afforded a transitory period to allow sufficient compliance to this guideline.
H. The product classification determined through Items IV.E. and IV.F. does not constitute a demonstration of safety, efficacy, and/or quality of the product; In that, the evaluation for product classification does not take into account if a product meets the standards for safety, efficacy, and quality. As such, the product classification provided shall not be construed as a basis for the approval of any market authorization application.
I. With the clear classification of any one or more identified herbs or ingredients (e.g. halamang gamot) as drug products, these ingredients shall not be used in the manufacture of new food products/food supplements upon the effectivity of these guidelines except when such herbs/plants are used as ingredients for culinary purposes (e.g. garlic, guava) in conventional food products.
However, the manufacturers or food business operators of affected products with multiple ingredients, among which includes any of the halamang gamot, shall have the option to reformulate and replace such drug ingredient(s) to maintain classification as food products. The reformulated food product shall be applied under initial application.
J. Where a product has been found to fall under two product classifications constituting a “combination” product, the market authorization applicant shall secure a market authorization from the identified Centers.
K. During the course of post-marketing surveillance where it has been found that a product is misrepresented as a different product classification, with due process, the appropriate sanctions and penalties shall be levied.
V. SPECIFIC GUIDELINES
A. Reiteration of guidelines for product registration and other related authorizations, including guidance on the transitory period
- Prior to the application for product registration or notification, the applicant shall secure the appropriate License to Operate (LTO) with respect to the product classification of the “borderline” product.
- The applications for product registration/ notification shall follow the existing Rules and Regulations of the respective Centers.a. Products currently holding valid authorizations with the FDA requiring re-classification in accordance with this list shall be afforded a transitory period to allow sufficient compliance to this guideline. The market authorizations of such products shall be recognized as valid for the remainder of its validity or extended for one (1) year from the effectivity of this Circular, whichever is later. Subsequently, an application for renewal shall no longer be accepted for such products after the transitory period of one (1) year from the date of effectivity of this Circular and a new application shall be filed with the appropriate Center regulating the designated product classification.b. Processing of new applications. For products that will be transferred from the jurisdiction of one Center to the other, the application shall follow the initial product registration process and requirements of the latter.c. Processing of existing marketing authorization applications of re-classified products.i. During the transitory period. Products with initial and renewal applications filed with the FDA within the transitory period which require classification based on the list of borderline products shall be processed by the Center it has been applied with.ii. After the transitory period. At the end of the transitory period, any applications for product registration/notification incorrectly filed with a Center shall be disapproved.
iii. No transfer of applications shall be made from one Center to the other. Likewise, the payment shall not be transferred from one Center to the other.
- Accordingly, applications for Sales Promo Permits, Certificates of Free Sale, and other permits and certifications shall follow the rules and regulations instituted by the respective Centers.
B. Specific transitory provisions for products containing ingredients included in the list of Halamang Gamot and ingredients considered as drug
- All Market Authorization Holders (MAH) currently holding Certificates of Product Registration (CPRs) under a product category other than drugs for products falling under the Ingredients considered as Drug/Halamang Gamot shall file for application for LTO as Drug Establishment before the expiration of the products’ respective CPRs;
- All initial, renewal, and amendment applications for market authorizations for products falling under the Ingredients considered as Drug/Halamang Gamot shall file with the Center for Drug Regulation and Research (CDRR) through the FDAC, and shall be subject to the requirements set forth by CDRR.
- In cases wherein an initial, renewal, or amendment application for a CPR is still being processed by the Center for Food Regulation and Research (CFRR), the product application and payment of such applications shall be automatically transferred to CDRR. Correspondingly, the necessary requirements for drug product registration shall be submitted and the balance remaining for the appropriate fees shall be settled by the MAH;
- Once transferred, all Sales and Promo Permit Applications shall be filed with CDRR through FDAC, subject to the requirements set forth by CDRR.
C. Procedure for submitting applications for product classification of Borderline products. The application procedure, including the requirements, is attached as Annex B.
D. Listing of Borderline Products
The illustrative list of “borderline products” determined and classified for the purposes of this issuance, is hereto attached as Annex A. The list shall be made available on the FDA website and shall be maintained and regularly updated at least every 15th of June and December of every year.
To assist prospective applicants in the determination of the appropriate product classification, a supplementary document is attached as Annex C describing the application of the statutory definitions and the considerations in Item IV.B.
VI. REPEALING CLAUSE
All previous issuances which are inconsistent with the provisions of this Circular are hereby repealed, amended or modified accordingly.
VII. SEPARABILITY CLAUSE
In the event that any provision or part of this Circular is declared unauthorized or rendered invalid by any Court of law, those provisions not affected by such declaration shall remain valid and effective.
VIII. PENALTY CLAUSE
The FDA shall impose the penalty of cancellation and/or revocation of CPR as per Book II, Article I, Sec. 4. Grounds for Disapproval of Application and Suspension or Cancellation of License, Registration or Authorization of the IRR of RA No. 9711. The market authorization holder shall remain to be accountable/liable for any violations committed and are subject to the penalties levied and administrative sanctions imposed by the FDA.
This Circular shall take effect fifteen (15) days following the completion of its publication in a newspaper of general circulation and/or filing of a copy of which to the University of the Philippines Office of the National Register.