GROUP 4

Leilalyn Nicolas
Irish Rivera
Karl Michael Fiel
Takeru Oshimoto
Vincent Reyes
 Prohibitions in
the manufacture
of product
The Bureau of Consumer Protection stops unfair,
deceptive and fraudulent business practices by collecting
complaints and conducting investigations, suing
companies and people that break the law, developing rules
to maintain a fair marketplace, and educating consumers
and businesses about their rights and responsibilities
❤Article 40. Prohibited Acts.
– The following acts and the
causing thereof are hereby
prohibited:
★ a) The manufacture, importation,
exportation, sale, offering for sale,
distribution or transfer of any food,
drug, device or cosmetic that is
adulterated or mislabeled
 Food adulteration is the act of intentionally
debasing the quality of food offered for sale
either by the admixture or substitution of
inferior substances or by the removal of some
valuable ingredient.

  Adulterants are those substances which are

used for making the food products unsafe for
human consumption.
★ b) The adulteration or
misbranding of any food,
drug, device or cosmetic
POLICY: Any official drug which, when tested by compendial
methods, fails to conform to compendial standards for quality,
strength, or purity, is adulterated unless the differences from
such standards are plainly stated on the drug's label

A food item is said to be adulterated if:

*A substance which is added is injurious for human
consumption.
*An inferior substance substitutes wholly or partly.
*A valuable ingredient has been abstracted from the food
product, wholly or in part.
A device’s labeling misbrands the product if:
*Its labeling is false or misleading in any particular;

*It is in package form and its label fails to contain the name and place of
business of the manufacturer, packer, or distributor and an accurate statement of
the quantity of the contents in terms of weight, measure, or numerical count

*Any required wording is not prominently displayed as compared with other

wording on the device, or is not clearly stated

*Its label does not bear adequate directions for use including warnings against
use in certain pathological conditions or by children where its use may be
dangerous in health or against unsafe dosage, or methods, or duration of
administration or application

*It is dangerous to health when used in the dosage or manner or with the
frequency or duration prescribed, recommended or suggested in the labeling

*It does not comply with the color additives provisions listed under Section 706
of the FFDCA
★c) The refusal to permit
entry or inspection as
authorized by Article 36 to
allow samples to be collected
What is a Product Inspection?

Why Get a Product Inspection?

*Ensure product quality at every production stage
*Verify quality at the source and don’t pay for
defective goods
*Avoid recalls and reputational damage
*Anticipate production and shipment delays
*Optimize your quality control budget
★d) The giving of a guaranty or undertaking referred
to in Article 41 (b) hereof which guaranty or
undertaking is false, except by a person who relied upon
a guaranty or undertaking to the same effect signed by,
and containing the name and address of, the person
residing in the Philippines from whom he received in
good faith the food, drug, device, or cosmetic or the
giving of a guaranty or undertaking referred to in
Article 41 (b) which guaranty or undertaking is false
★e) Forging, counterfeiting, simulating, or
falsely representing or without proper
authority using any mark, stamp, tag, label,
or other identification device authorized or
required by regulations promulgated under
the provisions of this Act
"Counterfeit product" means any consumer product
which, or the container or labeling of which, without
authorization, bears the trademark, trade name, or other
identifying mark, imprint, or device, or any likeness
thereof, of a consumer product manufacturer, processor,
packer, distributor, other than the person or persons who
in fact manufactured, processed, packed or distributed
such product and which thereby falsely purports or is
represented to be the product of, or to have been packed
or distributed by such consumer product manufacturer,
processor, packer, or distributor.
★f) The using by any person to his own
advantage, or revealing, other than to the
Department or to the courts when
relevant in any judicial proceeding under
this Act, any information concerning any
method or process which as a trade
secret is entitled to protection;
A "trade secret" is broadly defined as
any formula, pattern, device or
compilation of information which is used
in a business, unknown to others, and
gives the business a competitive
advantage.
A document is a trade secret if there is:

WARNING: THIS DOCUMENT CONTAINS TRADE

SECRET INFORMATION OF ______________.
UNAUTHORIZED DISCLOSURE IS STRICTLY
PROHIBITED AND MAY RESULT IN SERIOUS
LEGAL CONSEQUENCES.
★ g) The alteration, mutilation, destruction,
obliteration, or removal of the whole or any part
of the labeling of, or the doing of any other act
with respect to a food, drug, device, or
cosmetic, if such act is done while such product
is held for sale (whether or not the first sale)
and results in such product being adulterated or
mislabeled
Labeling helps to provide the information about
a product to the prospective customer. Labels serve
as the identity of the products which allow
customers to distinguish one brand from another. 

In summary, a successful food label will have the

following:
*Appealing food label design (font, logo, images,
colors)
*Relevant information and appropriate phrasing
*Effective message to consumers
Importance of Product Labels:

*Product Contents
Labels  allow us to get to know the contents and
ingredients of the products we are using or
consuming.
*Product Instructions
Labels serve as guide on how to properly use the
product we purchased.
*Product Warnings
There are products that might yield side effects for
some people whenever used or consumed
★h) The use, on the labeling of any drug or in
any advertising relating to such drug, of any
representation or suggestion that an
application with respect to such drug is
effective under Article 31 hereof, or that such
drug complies with the provisions of such
articles
The effectiveness of an application with respect to any drug or
device shall, after due notice and opportunity for hearing to the
applicant, by order of the Department be suspended if it finds:

(1) that clinical experience, tests by new methods, or tests by

methods not deemed reasonably applicable when such
application became effective show that such drug or device is
unsafe or ineffective for use under the conditions of use upon the
basis of which the application became effective, or

(2) that the application contains any untrue statement of a

material fact. The order shall state the findings upon which it is
based.
★i) The use, in labeling, advertising or other
sales promotion, of any reference to any
report or analysis furnished in compliance
with Section 19 of Executive Order 175,
series of 1987
Sec. 19. A drug or device shall be deemed to be misbranded:
a)If its labeling is false or misleading in any particular.
b)If it is in package form unless it bears a label containing
(1) the name and place of business of the manufacture,
importer, packer, or distributor;
(2) an accurate statement of the quantity of the contents in
terms of weight, measure, or numerical count
 c)If any word, statement, or other information required by or
under authority of this Act to appear on the label or labeling is
nor prominently placed thereon with such conspicuousness
(d) If it is for use by man and contains any quantity of the
narcotic or hypnotic substance 
(e) If it has been found by the Secretary to be a drug liable to deterioration,
unless it is packaged in such form and manner, and its label bears a
statement of such precautions, as the Secretary shall by regulations require
as necessary for the protection of the public health.

(i) (1) If it is a drug and its container is so made, formed, or filled as to be

misleading; or 

(2) If it is an imitation of another drug; or 

(3) If it is offered for sale under the name of another drug.

(f) If it is dangerous to health when used in the dosage, or with the

frequency of duration prescribed, recommended or suggested in the labeling
thereof.
★j) The manufacture, importation,
exportation, sale, offering for sale,
distribution, or transfer of any drug or device
which is not registered with the Department
pursuant to this Act
★k)The manufacture, importation,
exportation, sale, offering for sale,
distribution, or transfer of any drug or
device by any person without the license
from the Department required in this Act
A drug company must have a license to
promote a medicine. The license states:

*which illness the medicine can be used for

*what dose can be used
*how the medicine should be given
*which group of patients it can be used for.
★l) The sale or offering for sale of any
drug or device beyond its expiration or
expiry date
Best-before date: The suggested date before which the
full quality of the product, as marketed, can be enjoyed.

Sell-by date: Refers to a product’s shelf life in-store –

the recommended time in which it should be sold to
retain marketed quality.

Use-by/Expiry date: The date after which food will

perish, and will no longer retain the marketed quality
★m) The release for sale or distribution of
a batch of drugs without batch certification
when required under Article 34 hereof.
According to Article 34, a batch of such drug shall be
certified if such drug has such characteristics of
identity, strength, quality and purity, as the Department
prescribes in such regulations as necessary to insure
adequately safety and efficacy of use and good quality,
but shall not otherwise be certified