10.2.1 The Food Act
The Food Act, B.E. 2522 (1979) (the “Food Act”) imposes various
requirements, restrictions or prohibitions on manufacturers, importers
and sellers of food products. Apart from regulatory requirements
regarding product approval (e.g. the requirement to obtain a food
manufacture/import/product license for certain types of food, etc.), the
Food Act also addresses certain issues that relate to product liability.
The requirements, restrictions and prohibitions under the Food Act
cover matters including the types and amounts of ingredients which
may be used in foods, the labeling of the foods, the manufacture,
importation or distribution of impure or adulterated food, as well as
food that do not comply with standards stipulated by the Thai Food
and Drug Administration (FDA).
The Food Act also seeks to control the advertising of foods. In this
respect, food advertisements cannot contain false or deceptive
statements in relation to the benefits, qualities or properties of the
food. Additionally, any person wishing to advertise foods for
commercial purposes must first submit the advertising materials for
the FDA’s review and approval, and obtain a license from the FDA,
prior to being able to use and release the advertisement to the general
public. However, in practice, the FDA may have specific requirements
for certain types of foods which may not be outlined under the Food
Act.
Those that fail to comply with the requirements, restrictions and
prohibitions under the Food Act may be subject to fines and/or
imprisonment.
10.2.2 The Drug Act
Under the Drug Act, B.E. 2510 (1967) (the “Drug Act”),
manufacturers, importers or sellers of drugs are required to follow the
requirements regarding labels and package inserts.
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The Drug Act also prohibits persons from, amongst other things,
manufacturing, importing or selling counterfeit, substandard,
deteriorated or unregistered drugs.
As mentioned above, the Drug Act requires any person wishing to
advertise drugs through audio, visual or print media to first submit the
advertising materials for the FDA’s review and approval, and obtain a
license from the FDA, prior to being able to use and release the
advertisement to the general public, as well as to follow the conditions
set by the FDA.
Among other stipulations, the Drug Act prohibits drug advertisements
from:
x boasting that a drug or its ingredients are capable of
miraculous cures or total treatment; and stating that a drug can
relieve, cure or prevent diseases or illnesses, or use other
words with a similar meaning;
x exaggerating or falsely declaring the properties of the drug; or
x creating an understanding that the drug contains any
medicinal substance or ingredient it does not actually contain,
or, if it contains a particular medicinal substance or
ingredient, creating an understanding that it is in a quantity
other than that which it actually contains.
Moreover, drug advertisements cannot be impolite, contain singing
and dancing or show the suffering or distress of patients. The
prohibition relating to the advertising of drugs also extends to
advertising via the provision of gifts or lucky draws.
It should be noted that the advertising license which is issued by the
FDA only remains valid for as long as the drug’s ingredients or
properties remain the same as they were when the license was
originally granted.
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However, in practice, the FDA may have specific requirements for the
advertisement of certain types of drugs which may not be outlined
under the Drug Act.
10.2.3 The Medical Device Act
The Medical Device Act, B.E. 2551 (2008) (the “Medical Device
Act”) outlines specific requirements regarding labels and package
inserts for medical devices. Business operators who manufacture or
import medical devices must provide labels and package inserts that
conform to the rules, procedures, and conditions set out by the
Minister of Public Health in a Ministerial Notification. The most
important requirement is that the information placed on such labels or
package inserts cannot be false or contain exaggerated information.
Additionally, the Medical Device Act also prohibits persons from,
amongst other matters, manufacturing, importing or selling
counterfeit, substandard, deteriorated or unsafe medical devices. In
this respect, the FDA has the authority to request the manufacturer or
importer of a medical device to provide documents or evidence
regarding the quality, standards, efficacy or safety of the said medical
device, where there is reason to believe that the medical device does
not possess the required quality, standards, or efficacy, or is unsafe, or
there is a change in the standard.
Furthermore, the Medical Device Act also sets out regulations
governing the advertisement of medical devices. The term
“advertisement” is clearly defined under the Medical Device Act as
any form of action taken in order to allow the general public to see,
hear or know of a statement for commercial purposes and includes
sales promotion activities. In short, a license is required for persons
wishing to advertise medical devices. The Medical Device Act
stipulates that the advertising of medical devices must not show or
contain certain information, e.g. false or exaggerated properties or
qualities, a guarantee of the medical device’s properties by a particular
person, the offer of rewards by means of gambling, or any wording
that may cause a misunderstanding in relation to the medical device.
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The FDA has the authority, by virtue of the Medical Device Act, to
order the advertisement to be amended, to prohibit the use of certain
statements or matters which appear in the advertisement, or to order
the cessation of the advertisement in the event that the FDA deems
that the advertisement is in violation of the requirements under the
Medical Device Act.
However, in practice, the FDA may have specific requirements for the
advertisement of certain types of medical devices which may not be
outlined under the Medical Device Act.
Finally, the Medical Device Act contains interesting provisions
relating to product liability. It provides protection to consumers
harmed by unsafe medical devices by stipulating that manufacturers,
importers, or sellers of medical devices are responsible for damages
incurred from their use, unless they can prove that the damage was
caused by force majeure or the injured person’s own fault, rather than
defects in the medical device. However, consumers may wish to claim
damages under the Product Liability Act, as it offers more protection
and possibility for recourse.
10.2.4 The Cosmetics Act
All cosmetics under the Cosmetics Act, B.E. 2535 (1992) (the
“Cosmetics Act”) are now considered to be controlled cosmetics. This
means that the labels for all cosmetic products must now meet the
requirements of the Cosmetics Act, namely;
x the statement used on the label must be true and must not
contain any statements which may cause a misunderstanding
about the essence of the cosmetics; and
x must contain all necessary information, whereby if such
information was not stated then the consumer may
misunderstand the essence of the cosmetics.
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Additionally, no persons may manufacturer for sale, import for sale,
or sell unsafe, counterfeit or substandard cosmetics.
Lastly, the Cosmetics Act does not contain any specific provisions
regarding the advertising of cosmetics but stipulates that the
provisions of the Consumer Protection Act (as described in further
detail below) will apply.
10.2.5 The Consumer Protection Act
The Consumer Protection Act, B.E. 2522 (1979) (the “Consumer
Protection Act”), as amended in 1998, aims to protect the interests of
consumers, rather than to protect the economy or preserve business
competition. The Consumer Protection Board, established under the
Consumer Protection Act and chaired by the Prime Minister, is
responsible for protecting the rights of consumers and enforcing the
Consumer Protection Act. The Consumer Protection Act also
established three committees responsible for different matters: the
Committee on Advertisement, the Committee on Labeling, and the
Committee on Contracts. The Consumer Protection Board is charged
with considering complaints made by consumers, taking action against
those that infringe on the rights of consumers, and regulating the
performance of, and hearing appeals from, decisions of the three
Committees. The Consumer Protection Board is also empowered to
require a business operator who wishes to sell a particular product to
conduct tests, at the operator’s expense, to ensure that the product is
safe.
The Committee on Advertisement is empowered to prescribe the text,
warning, or advice that must be included in advertisements for
designated products. The Committee on Advertisement may also
impose advertising restrictions or entirely prohibit the use of
advertising for a particular product. The Consumer Protection Act is
specifically directed at protecting consumers from false, exaggerated,
materially misleading, illegal or indecent advertising, or advertising
that may cause harm to the public.