Purpose of the Law
To protect the public against dishonest or misleading advertising or promotion, and to ensure that every consumer acquires sufficient knowledge to be an informed consumer, particularly in the choice of the consumer products that he or she wishes to purchase or consume, the Food and Drug Administration (“FDA”) issued Administrative Order No. 2014-0030.
Administrative Order No. 2014-0030 provides for the labeling guidelines of prepackaged food products in order to protect the consumer against hazards to health and safety and provide information and education to facilitate sound choice in the proper exercise of their rights.
Scope and Coverage
The FDA regulation covers all types of food, including any processed substance, which is intended for human consumption, drinks for human beings, beverages, chewing gum, and any substance which have been used as an ingredient in the manufacture, preparation or treatment of food. It also covers prepackaged food, i.e., food that is packaged or made up in advance in a container, ready for sale to the consumer, or for catering purposes.
It requires manufacturers, importers, and distributors to comply with food product labelling requirements and standards. Under this regulation, manufacturers, importers, and distributors must disclose the required information in the product labels. As the most readily available material to inform the consumer about the product contents, shelf life and traceability, among others, the FDA strictly regulates the use and contents of product labels.
In labeling prepackaged food products, including food supplements, whether locally manufactured or imported into the Philippines, a food establishment has to be extra careful about the use of words or information pertaining to the food product being produced, sold, and marketed.
The FDA regulations strictly prohibit manufacturers, importers or distributors from describing or presenting prepackaged food labels in a manner that is false, misleading or deceptive or is likely to create erroneous impression regarding its character in any respect.
The FDA also prohibits the use of labels in prepackaged food containing words, pictures, or other devices, which refer to, or are suggestive either directly or indirectly, of any other product with which such food might be confused with, or might otherwise lead the purchaser or consumer to suppose that the food is connected with such other product.
Misleading Declarations, Representation or Prohibited Claims in Food Labels under FDA Regulations
The FDA defined the following representations or suggestions, whether directly or indirectly, if found in a food label, as a misleading, deceptive, and untruthful declaration:
- That the food because of the presence or absence of certain dietary properties, is adequate or effective in the prevention, cure, mitigation or treatment of any disease or symptom of an illness.
- That a balanced diet of ordinary foods cannot supply adequate amount of nutrients.
- That the food has dietary properties when such properties are of no significant value or need in human nutrition.
- That a synthetic vitamin in a food is superior to natural vitamin.
- Claims which could give rise to doubt about the safety of similar food or which could arouse or exploit fear in the consumer.
- Claims which highlight the absence or addition of any food additive or nutrient supplement, if the addition of such food additive or nutrient supplement is not permitted or prohibited.
- Claims on the absence of beef or pork or its derivatives or lard or added alcohol are prohibited if the food does not contain such ingredient.
- Claims on the absence of any substance when the food does not contain such ingredient.
- Claims that a product is superior to any other existing product of the same kind that cannot be substantiated.
- Claims stating that any given food will provide an adequate source of all essential nutrients, except in the case of well-defined products for which a Codex standard regulates such claims as admissible claims or where FDA have accepted, through an issuance, that the product to be an adequate source of all essential nutrients. (Codex General Guidelines on Claims CAC/GL 1-1979, Amended 2009, Section 3.1 on Prohibited Claims)
- Claims as to the suitability of a food for use in the prevention, alleviation, treatment or cure of a disease, disorder or particular physiological condition unless they are: 1. In accordance with the provisions of Codex standards or guidelines for foods as developed by the Committee on Nutrition and Foods for Special Dietary Uses and follow the principles set forth in these guidelines; or 2. In the absence of an applicable Codex standard or guideline, permitted by FDA.
- Meaningless claims including incomplete comparatives and superlatives.
- Claims as to good hygienic practice, such as “wholesome,” “healthful,” or “sound”
- Such other analogous cases as determined by the FDA.
Use of Photographs and Graphic Representations in Food Product Labels
- Photographs of fruits, vegetables, poultry, fish, meat or eggs whether fresh or cooked, whole or sliced shall not appear on the label unless the product contains such materials or substances naturally derived from them. If flavoring substances have been added to boost or reinforce the natural flavor of a given material, the words “Flavor Added” or any statement to that effect shall appear conspicuously and in close proximity to the photograph.
- Graphic representations used to depict the above-mentioned materials (fruits, vegetables, etc.) are acceptable provided these do not vividly illustrate the actual appearance of such materials.
- Pictures of food preparations or dishes may appear on the labels of products like sauce mixes or other similar food products that are used as ingredient(s) for the preparation of such food/dishes provided the statement “Serving Suggestion” or any other statement of similar importance appear with the picture.
Penalties for Misleading, Deceptive or Untruthful Declarations or Use of Prohibited Claims in Food Product Labels
Republic Act No. 9711 defines misbranding as misinformation or the use of misleading information on the label or other information materials required by the FDA.
If any misleading, deceptive, or untruthful declarations in food product labels are found, these declarations shall render the food product misbranded under the law. The misbranded food products, and the persons responsible for placing the misbranded food products in the market, shall be subject to actions and penalties available to the FDA under the law.
RA 9711 provides a 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) but not more than Five hundred thousand pesos (P500,000.00), or both, at the discretion of the court.
If the 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. 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.
About Nicolas and De Vega Law Offices
If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, registration of cosmetics, food supplements, licenses to operate or other applications with the Food and Drug Registration, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues, we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines. You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines. You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com.