Newsletter
Direction for Article 45 of the Act Governing Food Safety and Sanitation
I. Background
According to Article 45 of the Act Governing Food Safety and Sanitation, if an advertisement or promotion for a food product has "false, exaggerated or misleading" information, the offender shall be subject to a fine between NT$40,000 and NT$4,000,000, and the fine shall be increased to an amount between NT$600,000 and NT$5,000,000 if the advertisement claims medical efficacy. However, it has come to light that the actual amounts of the fines differ among each locality since each local health bureau has the discretion to determine the amount of the fines on its own; moreover, it appears that the amount of the fines is not adequate to deter violation. To align the amount of the fines and improve the effectiveness of the deterrent, the Food and Drug Administration of the Ministry of Health and Welfare promulgated the Direction for Article 45 of the Act Governing Food Safety and Sanitation (the "Direction") on May 7, 2018, as a fair and clear standard for each local health bureau to determine the amount of the fines for unlawful food advertisements.
II. Four Major Aspects of the Direction
To better achieve the purpose mentioned above, the Direction modified the original regulation in the following four aspects:
1. The amount of the fine is increased.
For the general offence of the food advertisements, the penalty shall be based on the frequency of the offence: a fine of NT$40,000 for the first offence, NT$80,000 for the second, NT$200,000 for the third, NT$400,000 for the fourth, and NT$1,000,000 for the fifth offence.
As for a food advertisement that claims to have medical efficacy, the penalty shall be a fine of NT$600,000 for the first offence, NT$700,000 for the second, NT$800,000 for the third, NT$1,000,000 for the fourth, and NT$1,250,000 for the fifth offence.
There are additional weighting factors designed for different scenarios of offences. If the offence is intentional, then the fine shall be multiplied by two. If the offence is committed out of negligence, the fine shall be multiplied by one. If the overall advertisement "tends to mislead the general public", the fine shall be multiplied by one. If the overall advertisement would "obviously mislead the general public", the fine shall be multiplied by two.
2. A food enterprise may be subject to a business suspension order for a repeated offence.
If a food enterprise repeatedly violates the food advertisement rule after receiving the sanction order from the competent authority in relation to the same food product, and has any of the following situations, the food enterprise may be subject to a business suspension order for a certain period of time: (a) the total sales of the product have amounted to NT$10,000,000 during the time when the unlawful advertisement was published, (b) the unlawful advertisement has misled the general public, resulting in actual harm to human health, or (c) the competent authority has determined that the product is as detrimental to consumers' rights as in the previous two situations.
3. A food enterprise may be ordered to be terminated or the relevant registrations of the food enterprise may be revoked for a repeated offence.
If a food enterprise repeatedly violates the food advertisement rule after receiving the sanction order from the competent authority in relation to the same food product, and has any of the following situations, the food enterprise may be terminated or the whole or part of the company, business or factory registrations or the food enterprise registration may be revoked: (a) the total sales of the product has amounted to NT$30,000,000 during the time when the unlawful advertisement was published, (b) the unlawful advertisement has misled the general public, resulting in death, or (c) the competent authority has determined that the product is as detrimental to consumers' rights as in the previous two situations.
4. For severe offences, a stop in sales and the publishing of corrective advertisements shall be ordered.
For (a) an advertisement that claims medical efficacy and the enterprise does not stop publishing or broadcasting the advertisement after receiving the sanction order, (b) an advertisement that misleads the general public and causes harms to human health or death, or (c) an advertisement that has been identified as detrimental to consumers' right as in the previous two situations, the competent authority is entitled to consider it a severe offence and shall order the offender to stop the sale, supply or display of the applicable product, and also to publish or broadcast a corrective advertisement of the same size and during the same time period as the original unlawful advertisement for a certain number of times within thirty days of receipt of the sanction order.
III. Other Factors to be Considered when Determining the Penalty and the Review Committee
In addition to the aforementioned four aspects which would affect the level of the penalty that applies to an offender, the Direction also stipulates other factors for consideration such as "the educational background of the offender", "the quantity, circulation coverage, and sale price of the product that is unlawfully advertised", "the duration of the offense", "the profits gained from the offence", "the level of harm to consumers' lives, body, health, or properties", and "the offender's attitude and actions to contain the harm or damage after the unlawful situation occurs".
Furthermore, to determine whether an offence is severe or not, a review committee comprising scholars, experts, and representatives from the authorities may be formed.