Jingpeisu Nearly Kills Infant Boy, Control Yuan Points to FDA "Food Safety Loophole," FDA: Food Safety Act Is Already Complete

At the end of last year, due to exaggerated and false advertising of the imported direct-sales food product "Jingpeisu," parents fed it to a four-month-old infant boy for four consecutive months, nearly causing death. The Control Yuan recently conducted an investigation report on this case, pointing out a "food safety loophole" at the Food and Drug Administration (FDA), and stated that prior review should be conducted for imported food labeling and advertising translations.

However, the FDA held a press conference today (the 16th) stating that prior review not only involves freedom of speech, but also because food production is diversified and advertising formats are complex, if even minor changes required review, it would affect food market launch. General food businesses are required to conduct self-management in accordance with the Food Safety Act. Advertising that is false, exaggerated, or likely to cause misunderstanding can be fined 40,000 to 4 million; for infant and young child food, there is also inspection and registration, so it is not without regulation.

Direct Sales Trademark Labeling Likely to Cause Misunderstanding, Control Yuan: Food Safety Management Loophole

After investigation by the Taipei City Department of Health, it was found that the food product "Jingpeisu" imported by Shaklee Corporation was not infant formula, and the product translation labeling was inconsistent before and after import. The original product labeling before import stated, "Should not be given to infants under 1 year of age without consulting a physician." However, after import, the product translation was weakened to, "Infants under 1 year of age should consume this product after consulting a medical professional."

Furthermore, the original labeling stated "This product is for use only as a nutritional supplement," but the domestic direct seller's advertisement stated, "The most nutritious breakfast, 3 tablespoons when nothing is wrong, 6 tablespoons when something is wrong, build your foundation."

The Control Yuan report directly pointed out that the FDA failed to conduct prior review of the translation of imported food labeling by Shaklee Corporation, or carry out other gatekeeping measures, allowing direct sellers to tamper with the original manufacturer's labeling regarding applicable and contraindicated populations, "forming a food safety management loophole that necessitates review."

Only 411 Health Foods Approved, Market Flooded with Health Supplements Exaggerating Efficacy

Foods claiming "health efficacy" not announced by the FDA frequently appear on the market, confusing consumers under the guise of "health foods." According to the Control Yuan investigation report, as of the end of May this year, only 411 health foods had been approved by the Ministry of Health and Welfare. The other tens of thousands of health supplements that have not undergone strict gatekeeping can only rely on the Food Safety Act's regulations penalizing false, exaggerated, or misleading labeling.

Food Safety Loophole? FDA: Penalties Imposed in Accordance with Food Safety Act

Regarding the Control Yuan's direct accusation that the FDA caused a "food safety loophole," the FDA also stepped forward to put out the fire. Regarding prior review of imported food advertising content, Chiang Chien-chi, Section Chief of the FDA's Enterprise and Technology Division, stated that Taiwan follows the market supervision approach of the European Union, the United States, Japan, South Korea, and others, with health authorities continuously monitoring various media, including the internet, television, radio, newspapers, and magazines.

If food advertising is found to be false, exaggerated, or likely to cause misunderstanding, a fine of 40,000 to 4 million may be imposed under the Food Safety Act; if it involves medical efficacy, a fine of 600,000 to 5 million may be imposed; repeat violations may result in an order for the business to suspend operations, and in serious cases, the product may not be supplied for sale, and a corrective advertisement must be published.

FDA: Food Safety Act Provisions Are Complete

Regarding the Control Yuan's questioning of the FDA's food safety oversights, Tung Ching-hsin responded that before the Food Safety Act was amended, it already stipulated self-management by businesses. Is this not equivalent to a loophole? "This is what the Control Yuan calls a loophole, but the Food Safety Act has always had relevant provisions, and the vast majority of businesses comply."

"The current provisions of the Food Safety Act are still fairly complete." Tung directly stated that general food labeling is self-managed by businesses, and businesses must bear responsibility for their own products; furthermore, relevant provisions are clear that when unlawful businesses violate the law, government agencies will also audit that business, and at the same time, through public reporting, strengthen food safety control.

Case of Infant Consuming Jingpeisu, FDA: 80,000 Fine Already Imposed on Direct Seller

Regarding the case of the infant who consumed Jingpeisu at the end of last year, Tung Ching-hsin explained, "It was because it was given to the infant as the sole staple food that a relatively large health problem occurred." The product was imported without inspection and registration because it simply does not belong to infant food. "Imported infant food all undergoes FDA review. If commercially available food is not labeled for infants and young children, special attention must be paid."

Currently, the direct sales company has been fined 80,000 by the Taipei City Department of Health in accordance with the Food Safety Act due to translation concerns that are likely to cause misunderstanding.

Consumers' Foundation: Most Countries Adopt Post-Market Review, but Businesses Are Not as Law-Abiding as the FDA Claims

You Kai-hsiung, Chairman of the Consumers' Foundation, Chinese Taipei, stated that most countries indeed adopt post-market review for food labeling or related regulations. "And considering the manpower of domestic health authorities, objectively speaking, enforcement is difficult." However, this does not mean the FDA has no room for review.

You pointed out that not all foods need to be changed to prior review, but there should be a prior review mechanism for food for infants and young children under one year of age. The FDA does conduct inspection and registration for infant and young child food, but whether this case was intentional or an accidental translation error is unknown.

You proposed whether in the future it could move toward issuing written guarantee statements to ensure the accuracy of translation content. If a problem occurs, showing that it was intentional, then penalties would be increased.

Do most domestic businesses follow the Food Safety Act's labeling provisions? "I don't quite agree." You stated that the Consumers' Foundation's surveys on food labeling found many non-compliant cases, and overall the proportion of non-compliant product labeling remains relatively high. "The state of business self-discipline has not reached the level of consumer trust."