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Product Regulation

I. Food and Drug Administration Administrative Order 2014-0030 - Revised Rules and Regulation
Governing of Prepackaged Food Product
The labels of alcoholic beverages shall bear the following mandatory information:
1. Product Name / Name of Food
o The product name shall be specific and not generic and shall indicate the true nature
of the food.
o The product name/name of the food shall be presented prominently on the principal
displace panel in bold type letters and shall be in a size reasonably related to the
biggest printed matter on such panel, e.g., trade mark or brand name.
2. Use of Brand Name and/or Trademark
o If an establishment has a registered brand name or trade mark, it shall be mandatory
for the holder or owner of the same to indicate such correct brand name or trade
mark in the label of its product, but may not be declared if the product will be used
for further processing.
3. Complete List of Ingredients
o The complete list of ingredients shall be declared in descending order of proportion
on either the principal display panel or information panel, including the additives,
flavorings, colorings, and preservatives.
4. Net Content
o The net content shall be declared using the metric system of measurement or SI
(International System of Units) on either the principal display panel or the information
panel and in parallel to the base of the package.
o For multi-unit retail packages, a statement of the quantity of contents on the outside
package shall include the number of individual units, the net content of each
individual units, and in parenthesis the total quantity of contents of the multi-unit
package. A multi-unit retail package may thus properly be labeled: 6 x 300 ml bottles
(1.8L or 1800ml).
5. Name and Address of Manufacturer, Packer, Distributor or Importer
o The name and address of the manufacturer, repacker, packer, importer, trader or
distributor of the food shall be declared on the label of locally manufactured
products.
o If the prepackaged food is not manufactures by the person or company whose name
appears on the label, the name must be qualified by Manufactured for or Packed
for or similar expression.
o For imported products, the complete name and address of importer and the country
of origin shall be declared.
o In the case of products carrying foreign brand or manufactures under license by a
foreign company, the name and address of the foreign company, the name and
address of the foreign company, shall be in letters of type and size not bigger than
those used for the local company.
6. Lot Identification
o The lot identification code shall be embossed or otherwise permanently marked
individually on the immediate packages or containers.
7. Storage Conditions
o For products that need special storage condition other than normal room
temperature, the storage condition other than normal room temperature, the
storage condition shall be printed clearly, conspicuously and indelibly on all product
label or labelling.
8. Food Allergen Information
o Food allergen information on the label of products containing the following
ingredients but not limited to those listed below shall be indicated clearly,
conspicuously and indelibly, located directly below the List of Ingredients.
o The following ingredients known to cause hypersensitivity shall always be declared:
a. Cereal containing gluten, i.e. wheat, rye, barley, oat, spelt, or their hybridized
strain and product of these;
b. Crustaceans and product of these;
c. Eggs and egg products;
d. Fish and fish products;
e. Peanuts, soybeans and products of these;
f. Milk and milk products (lactose included);
g. Tree nut and nut products;
h. Sulphite in concentration of 10mg/kg or more;
i. Such other ingredient as may be included by FDA through appropriate issuance.
9. Direction / Instruction for Use
o Direction for use shall also be printed, where applicable or as necessary to ensure
correct utilization of food.
10. Alcohol Content
o The alcohol content in terms of percentage (%) volume or proof units shall be
indicated on the label of alcoholic beverages.
11. Language
o The language used for all information on the label shall either be in English or Filipino
or a combination thereof. For food products intended for export, the language
acceptable to the importing country shall be used. In case of imported products,
labels where in the information are declared in a foreign language shall always carry
the corresponding English translation.
A violation of the labelling requirement provisions of this Administrative Order shall render
the food product misbranded under Republic Act No. 97111, and such misbranded food
products and the responsible persons shall be subject to actions and penalties available to
the Food and Drug Admiration (FDA) as provided under Republic Act No. 37202, as amended
by Executive Order No. 1753 and further amended by Republic Act No. 9711.
o If the food product is rendered misbranded, the responsible person/s shall, upon
conviction, suffer the penalty of imprisonment ranging from one (1) year but not
more than ten (10) years or a fine of not less than Fifty thousand pesos (P50,000.00)

1
An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Food and Drugs (BFAD) by
Establishing Adequate Testing Laboratories and Field Offices, Upgrading its Equipment, Augmenting its Human
Resource Complement, Giving Authority to Retain its Income, Renaming it the Food and Drug Administration (FDA),
Amending Certain Sections of Republic Act No. 3720, as Amended, and Appropriating Funds thereof.
2
An Act to Ensure the Safety and Purity of Foods and Cosmetics, and the Purity, Safety, Efficacy and Quality of Drugs
and Devices being Made Available to the Public, Vesting the Bureau of Food and Drugs with Authority to Administer
and Enforce the Laws Pertaining thereto, and for Other purposes.
3
Further Amending Republic Act 3720, Entitled "An Act to Ensure the Safety and Purity of Foods, Drugs, and
Cosmetics Being Made Available to the Public by Creating the Food and Drug Administration which shall administer
and enforce the Laws Pertaining thereto", as Amended, and for other Purposes.
but not more than Five hundred thousand pesos (P500,000.00), or both, at the
discretion of the court.
o If offender is a manufacturer, importer or distributor of any health product, the
penalty of at least five (5) years imprisonment but not more than ten (10) years and
a fine of at least Five hundred thousand pesos (P500,000.00) but not more than Five
million pesos (P5,000,000.00) shall be imposed.
o An additional fine of one percent (1%) of the economic value/cost of the violative
product or violation, or One thousand pesos (P1,000.00), whichever is higher, shall be
imposed for each day of continuing violation.
o Should the offense be committed by a juridical person, the Chairman of the Board of
Directors, the president, general manager, or the partners and/or the persons directly
responsible therefore shall he penalized.
o Should the offense be committed by a foreign national, he/she shall, in addition to
the penalties prescribed, be deported without further proceedings after service of
sentence.
The enforcing agency is the Food and Drug Admiration (FDA).

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