QuestionsQuestions (Republic Act No. 3720)
RA 3720 is titled the “Food, Drug, and Cosmetic Act.” Its policy is to ensure a safe and good-quality supply of food, drugs, and cosmetics, and to regulate their production, sale, and traffic to protect the health of the people.
It creates the Food and Drug Administration (FDA) under the Department of Health, placed under the Office of the Secretary.
Examples: (a) administer and supervise implementation of the Act; (b) collect samples; (c) analyze and inspect products; (d) establish analytical data and recommend standards of identity/purity/quality/fill; (e) issue certificates of compliance and spot-check establishments; (f) levy inspection/analysis/testing fees; (g) certify batches of certain antibiotics.
(1) Inspection and Licensing Division—inspects establishments engaged in manufacture and sale; (2) Laboratory Division—conducts tests/analyses/trials of products covered by the Act.
The Board includes representatives from DOH (Chair), Agriculture, Commerce and Industry, Customs, Office of the Solicitor-General, a technical member, and presidents/representatives of medical, dental, and pharmaceutical associations. It holds hearings/investigations and recommends standards; its decisions are advisory to the FDA Administrator.
Food includes articles used for food/drink and components. Drug covers substances recognized in official compendia and those intended for diagnosing/cure/mitigation/treatment/prevention of disease or affecting bodily structure/function (excluding devices). Device covers instruments/contrivances intended for diagnosis/cure/mitigation/treatment/prevention or affecting body structure/function. Cosmetic covers articles applied to the body for cleansing/beautifying/attractiveness/altering appearance, and components of such articles.
A “label” is written/printed/graphic matter on the immediate container (with rules on outside container/wrapper legibility). “Labeling” includes all labels and other written/printed/graphic matter upon any article/containers or wrappers, or accompanying the article.
Prohibited acts include manufacturing/selling offering for sale or transferring adulterated or misbranded foods/drugs/devices/cosmetics; adulteration/misbranding; refusing entry/inspection or refusing to allow sample collection; false guaranties/undertakings; forging/counterfeiting marks or labels; revealing trade secrets; altering labeling in ways that cause adulteration/misbranding; misleading therapeutic or compliance claims for drugs; and using references to reports/analyses contrary to the Act.
Upon conviction, imprisonment of not less than six months and one day to not more than five years, or a fine of not less than one thousand pesos, or both—discretionary with the court.
A person may avoid penalties if (1) the delivery was in good faith and the person furnishes, upon request, name/address of supplier and copies of relevant documents; or (2) the person established a guaranty/undertaking signed by and containing the name/address of the supplier; or (3) for coal-tar color adulteration, the person shows guaranty signed by and identifying the manufacturer of the coal-tar color that it is permissible under regulations.
When the Secretary has probable cause to believe, from facts found, that the misbranded article is dangerous to health, or that its labeling is fraudulent, or would be materially misleading to the injury/damage of purchaser or consumer.
Examples: (1) contains poisonous/deleterious substances injurious to health; (2) consists of filthy/putrid/decomposed substance or otherwise unfit; (3) prepared/packed/held under unsanitary conditions contaminating it or rendering it injurious; (4) product of diseased animal or animal died otherwise than slaughter; (5) includes disallowed coal-tar colors; (6) concealed damage/inferiority or added substances to increase bulk/weight or reduce quality.
Grounds include: labeling false/misleading; offered under name of another food; imitation unless label clearly says “imitation” and name; container designed to mislead; failure to bear required label info (manufacturer/place of business and accurate quantity); required statements not prominently placed/conspicuous; claims of conformity with standards when not conforming; missing common/usual names of food and ingredients; misleading special dietary use claims; absence of disclosure when artificial flavoring/coloring/chemical preservatives are present.
To allow temporary permits for manufacturers/processors/packers of a class of food found potentially injurious when injurious nature cannot be adequately determined after entering commerce—subject to conditions meant to protect public health, and with immediate suspension if conditions are violated.
No person may do so unless an application filed with the Secretary is effective with respect to the new drug, with required reports showing safety, composition, manufacturing controls/facilities, samples, and proposed labeling.
Examples include: required investigations do not include adequate safety tests; tests show drug is unsafe or fail to show it is safe; manufacturing methods/facilities/controls are inadequate; insufficient information to determine safety; lack of substantial evidence of claimed effects; or labeling is false or misleading.
The Secretary provides for certification of batches containing specified antibiotics only if the batch has the identity/strength/quality/purity characteristics prescribed; otherwise it is not certified (though before regulations take effect, the Secretary may issue a release). “Anti-biotic drug” includes any drug for human use containing a quantity of a chemical substance produced by micro-organism that can inhibit or destroy micro-organisms in dilute solution (including chemically synthesized equivalent).
A cosmetic is adulterated if it contains poisonous/deleterious substances injurious under labeled/customary use, consists of filthy/putrid/decomposed substance, is prepared/held under insanitary conditions, has poisonous/deleterious container components, or (if not a hair dye) contains disallowed coal-tar color. Coal-tar hair dye is excepted if labeled with a conspicuous caution legend and adequate directions for preliminary skin testing and not for dyeing eyelashes/eyebrows.
They may, with proper credentials and at reasonable hours, enter factories/warehouses/establishments where regulated products are manufactured/processed/packed/held for domestic commerce (or held after entry), and vehicles used for transport/holding; they may inspect in a reasonable manner equipment, materials, containers, and labeling.
Customs must deliver random samples from incoming shipments to the FDA, and the FDA informs Customs when samples/examination show the article is insanitary, forbidden/restricted in the producing country, adulterated/misbranded, or violates new-drug requirements. If so, admission is refused and destruction occurs unless exported within specified periods. Customs may allow delivery on bond pending determination and may authorize relabeling under FDA-supervised procedures in limited cases.