Non-Prescription Drugs, Devices & Treatments & Other Regulated Products & Services
NON-PRESCRIPTION DRUGS, DEVICES AND TREATMENTS AND OTHER REGULATED PRODUCTS & SERVICES
Section 1. GENERAL PROVISIONS
a. No pharmaceutical product may be advertised unless it has been duly registered with the DOH-FDA. Only non-prescription drugs may be advertised in the mass media.
b. Prescription only or ethical drugs (registered as RX) are not allowed to advertise in a medium where it is exposed to the general public, e.g. TV, RC, OOH, print publication of general circulation. Prescription drugs can only be advertised through publications solely intended for the medical and allied professions.
c. Where applicable, advertisements of pharmaceutical products must comply with the requirements of the Generics Act of 1988 (R.A. 6675) and its Implementing Rules and Regulations. Advertising & Promotions Guidelines of covered products is attached as Annex “C” to form part of these Standards.
d. Advertisements for non-prescription drugs, devices and treatments should not describe or dramatize distress (e.g., death or serious illness) in a morbid manner.
e. Advertisements of all non-prescription drugs should prominently carry the advice, “If symptoms persist, consult your physician”.
f. Advertisements of the benefits or use of non-prescription drugs, devices and treatments should be based on, or be within the context of and consistent with the indications and labeling of said products as approved by the DOH-FDA.
g. Advertisements should not depict consumers relying on, or otherwise encourage reliance on medicines as a solution for psychic, emotional or mood problems.
h. Advertisements of products designed to calm, sedate or stimulate should refer to the temporary symptomatic relief provided and should include a recommendation that label directions be followed.
i. Advertisements should not offer false hopes in the form of a cure or relief for the mentally or physically handicapped either on a temporary or permanent basis.
Section 2. SPECIAL TERMINOLOGY/CLAIMS
a. In advertising medical products, claims that a product will effect a cure and the use of such words as “safe”, “without risk”, “harmless”, “instant”, “effective” or terms of similar import shall not be permitted, unless based on or within the context of and consistent with the indications and labeling of said products as approved by the DOH-FDA.
b. As a general rule, the use of “safe”, “without risk”, “harmless” or words of similar import shall not be used for all products that have contra indications or warnings on use. The advertiser has the burden of proving the appropriateness of using the term “safe” through a DOH-FDA approval to use the claim.
c. Advertisements should not contain claims that a product or treatment will promote sexual virility, or be effective in treating sexual weakness, conditions associated with sexual excess or over-indulgence, or any ailment, illness or disease associated with these habits, unless officially so approved in writing by the DOH-FDA.
d. Non-prescription drugs devices treatments may not be directly or indirectly advertised as the answer to conditions of premature aging or loss of virility, unless officially so approved in writing by the DOH-FDA.
e. Advertisements should not offer any product or treatment for slimming/ weight reduction or figure control unless officially so approved in writing by the DOH-FDA.
f. The word “tonic” when used in advertisements shall state clearly the specific purpose for which the tonic is to be used or taken and shall not claim nor imply treatment or results related to sexual potency, inadequacy or the aging process.
Section 3. MEDICAL PRACTITIONERS
a. Advertisements of non-prescription drugs, devices, treatments and medical equipment with endorsements by a medical practitioner shall be subject to the Code of Ethics of the generally accepted organization of his/her profession and applicable laws and rules of his profession.
b. In any event, where allowed, such advertisements or endorsements may state only the professional’s name, address, office hours and licensed area of practice or specialization. Specialization shall mean the particular field of practice for which the professional has the appropriate education, training and expertise.
c. When endorsements, direct or implied, of non-prescription drugs, devices, treatments and medical equipment by a medical practitioner is prohibited by the Code of Ethics of the generally accepted organization of his/her profession and applicable laws, rules and regulations of this profession, endorsements by actors portraying the medical practitioner shall not be allowed.
d. Advertisements for the services of a medical practitioner shall be subject to the Code of Ethics of the generally accepted organization of his/her profession and applicable laws and rules of his profession. The advertisement may not mention any specific ailments. Unlicensed medical practitioners shall not be allowed to advertise their services.
e. No clinic or hospital shall be used or portrayed in advertisements without the knowledge of and the written permission from its proper authority/ies.
Section 4. VITAMINS & MINERALS WITH DRUG (DR) REGISTRATION FOOD/HEALTH/ DIETARY SUPPLEMENTS WITH FOOD (FR) REGISTRATION
a. Advertisements should not state or imply that vitamins and/or minerals, food/health/dietary supplements, and/or similar products alone can ensure or promote good health. Neither should advertisements state or imply that good health is likely to be endangered solely because people do not supplement their diet with vitamins and/or mineral or similar product.
b. The device “No Approved Therapeutic Claims” principally applies to Food/Health Supplements (and other Non-Drug /non-DR registered products) and not to DR-registered products, including DR-registered vitamins that can make therapeutic claims based on their FDA approved registration.
c. Advertisements of food/health/dietary supplements and/or similar products should not be presented in such a manner that negates the message of “No Approved Therapeutic Claims”.
d. The use of testimonials or endorsements portraying the product as a cure of, or relief from, an ailment or medical condition that is not substantiated by clinically based studies shall not be allowed.
e. The requirement for the device “if symptoms persist, consult your physician” principally applies to advertisements of DOH-FDA registered NON-PRESCRIPTION DRUGS.
f. The device “If symptoms persist, consult your physician” shall not be required in advertisements of DR-registered Vitamins unless the advertising material communicates the symptoms/illnesses/diseases that the DR-registered brand can address consistent with the labeling/indication approved by DOH-FDA.
Section 5. PROMOTIONS FOR PHARMACEUTICAL PRODUCTS (SUBJECT TO THE PROVISION ON ARTICLE IX OF THIS CODE)
a. Advertisements for propriety drugs, devices and treatment offering prizes, promotions, competitions and additional rewards or benefits other than those which can be reasonably expected from the product’s use, or otherwise involving any promotion must have the express written approval of the DOH-FDA.
b. A propriety drug, device or medicine may not be used as a promotional item for any product or services without the express written approval of the DOH-FDA.
Section 6. ALCOHOLIC BEVERAGES
a. Advertisements must not imply that alcohol beverage consumption is a requirement for social acceptance.
b. Advertising for alcoholic beverages should not present abstinence in a negative light or imply that it is wrong or foolish to refuse a drink.
c. Advertisements for alcoholic beverages should not depict the act of drinking such as the liquid entering the mouth and/or being swallowed.
d. Advertisements should not promote excessive and/or heavy drinking.
e. Advertisements should not promote excessive drinking nor should it imply that the behavior of heavy or rapid drinking or binge-drinking is attractive or appropriate.
f. Advertisements should not claim that drinking brings about medical or therapeutic benefits such as, sedative, tranquilizing or stimulating effects.
g. Advertisements should not promote that drinking enhances sexual prowess or appeal.
h. Advertising must not promote alcohol as a medicine. Advertising and promotional materials must not imply that alcohol has the ability to prevent, treat or cure any human disease. Nor should they create the impression that alcohol consumption enhances mental ability or physical performance, e.g. when engaging in sports. Advertising must not promote alcoholic brands as “energy drinks”.
i. Advertisements shall not be positioned as a health drink and/or as a therapeutic drink such as:
a. That it aids in maintaining or reducing weight
b. Being part of an exercise or fitness regime
j. Allowing irresponsible or excessive consumption because of their low (er) calorie or carbohydrate content.
k. Advertisements should not in any manner represent or imply that drinking and driving are safe compatible activities.
l. Advertising and promotional materials will not depict activities or locations where drinking alcohol beverages would be unsafe or unwise. In particular, no marketing communication should imply that the consumption of alcohol is acceptable before or while operating machinery, driving a vehicle or undertaking any other occupation that requires concentration in order to be carried out safely.
m. Advertisements for alcoholic beverages shall not be aimed at or directed to minors (below 18 years of age) as the target audience.
n. People shown in advertisements of alcoholic beverages must be 21 years old and must look adult.
o. Alcoholic beverage advertisements should carry the device “DRINK RESPONSIBLY”. For TV advertisements, it should be shown/flashed in a separate frame with no other copy or visual at the end of a material.
p. All brand web sites and other promotional activities on the internet must ask for confirmation that those who use the site are of the appropriate legal purchase age for alcohol beverages as prescribed by the law. In addition, all brand web sites must contain a social responsibility statement and links to those social aspects organizations e.g. The Portman Group and The Century Council.
q. Under no circumstances should alcohol advertisements be unethical, offend against generally prevailing standards of taste and decency or otherwise offend human dignity.
r. National sensitivities around specific issues, be it due to societal or religious reasons, should be respected. Issues around the portrayal of gender should be handled with care.
Section 7. CIGARETTES AND TOBACCO PRODUCTS
No direct or indirect advertising or marketing of cigarettes or tobacco products is allowed. Advertising materials shall only be at the Point of Sale/Purchase and in accordance with law.
Section 8. GAMBLING
The advertisement of gambling authorized by law is subject to the Code of Ethics of the media concerned.
Section 9. TELECOMMUNICATION PRODUCTS & SERVICES
Only telecommunication products and services that are authorized by the proper regulatory agency concerned are allowed to be marketed /advertised. The advertising materials must conform to the appropriate rules and regulations of the regulatory agency. (See Annex “___”)