The medical community and pharmaceutical industry have raised suspicion that Handok unfairly evaded regulations to promote Souvenaid, a new drink to improve memory in patients with dementia and Alzheimer’s disease. The product is categorized as a “food for special medical purposes” in Korea.

Healthcare professionals criticized the drugmaker for misleading consumers and patients by inserting content in the Souvenaid advertisement that they might confuse the drink as a pharmaceutical product.

Handok’s advertisement for Souvenaid

Souvenaid under criticism from the get go

The dementia treatment market is rapidly growing in Korea, particularly with the accelerating pace of the population aging.

Seeing the potential, Handok in August rolled out Souvenaid to target patients with mild cognitive impairment and mild Alzheimer’s disease.

In the Souvenaid advertisement, Handok introduces the drink as “the first local food for special medical purposes to help patients with mild cognitive impairment and mild Alzheimer’s disease.”

The company combined nutrients needed for patients with mild cognitive impairment and mild Alzheimer’s disease, based on scientific clinical results, the ad says.

Also, the company is advertising that Souvenaid provides nutrients that patients with the diseases could lack and the product arrived in the market after “four multinational, multi-center clinical trials conducted on 1,322 patients.”

However, people started to file online petitions to the government, asking whether the advertisement of Souvenaid was legal. They claimed that Souvenaid’s efficacy has not been verified and that people might confuse the product as a medicine.

Almost simultaneously with the market launch, the medical drink has come under scrutiny over the advertisement and its efficacy.

Recognizing the controversy, the Ministry of Food and Drug Safety on Friday said it would enact a law that includes specific enforcement degree and enforcement rules for food labeling, advertisement targets, and methods.

The new legislation will complement the content on food labeling and advertisement under the Food Sanitation Act, the Livestock Products Sanitary Control Act, and the Health Functional Foods Act, the ministry said.

In detail, the new law will define the following cases as unjustified advertising: indicating or advertising that it is effective to treat a disease, using the ad to show or advertise that it could be recognized as a drug, promoting in a way that people might recognize it as a functional food, falsely promoting or exaggerating, deceiving consumers, slandering other companies or other products, unfairly comparing it with other sellers without objective grounds, and encouraging speculation.

Some observers said Souvenaid’s advertisement might be in breach of the upcoming legislation.

Handok says ‘no problem’ in Souvenaid’s ad

However, Handok said there was no problem in the Souvenaid’s ad because it was food for special medical purposes.

The food and drug safety ministry decided to let companies make autonomous decisions for food for special purposes.

In the proposed legislation, the ministry allowed the industry to make self-assessment on special purpose foods and functional foods, instead of requiring them to receive the government’s review.

Foods for special purposes refer to foods manufactured or processed by incorporating foods and nutrients for specific people requiring special nutritional care such as infants, toddlers, the sick, the obese, the pregnant, and breastfeeding mothers.

The new legislation states that an ad saying, “the product can provide nutritional support for women during pregnancy or breastfeeding period, nutrition supply for recovery after sickness, nutritional provision for the elderly, and nutritional support for patients,” will not be regarded as illegal marketing or advertisement.

In an interview with Korea Biomedical Review, Handok’s director Chang Hee-hyun said although Souvenaid was food, it was clinically useful as a product in the specialized category. She said the company was actively taking advantage of the special purpose food category as a good marketing tool.

However, a pharmaceutical source said, “Handok was using a clinical study to promote Souvenaid.”

“The company is delivering its claims that the drink improves memory and cognitive function in various marketing routes,” he said. “Handok’s strategy to make use of the special purpose food category is feeding the demand.”

The source warned, however, that the company might think twice about the ad because consumers might confuse it with treatment if similar products come out in the market.

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