"Refreshing" and "Invigorating" Hangover Remedies? "Human Trials Mandatory from 2025"

From 2025, manufacturers intending to sell hangover relief products must scientifically prove their hangover relief functionality. According to the related notice from the Ministry of Food and Drug Safety (MFDS), only after proving the hangover relief functionality through human application trials can the related information be labeled or advertised on the products.

On the 3rd, industry sources reported that the human application trial guidelines for verifying hangover relief labeling and advertising, published by the MFDS, include detailed contents and precautions necessary for proving the functionality related to hangover relief. Specifically, it covers the definition of hangover, selection of biomarkers for measuring hangover relief ability, and principles of human application trials.

The MFDS issued these guidelines because, starting in 2025, scientific evidence from human application trials is required to label the hangover relief functionality of hangover relief products. According to the MFDS’s notice on “Regulations on Functional Labeling or Advertising of Foods Not Considered as Unfair Labeling or Advertising,” from January 1, 2025, only after undergoing human application trials can hangover relief-related information be labeled or advertised on products. Until December 31, 2024, existing hangover relief functionality labeling and related advertising can be executed, but thereafter, human application trials will effectively become mandatory.

Currently, most advertisements for hangover relief products on the market do not specifically disclose the results of human application trials. They simply emphasize that the product contains hangover relief ingredients or highlight the efficacy of the contained ingredients through academic research literature.

From 2025, companies must scientifically and objectively prove the hangover relief ability following the intake of hangover relief products through human application trials. The evaluation indicators for hangover relief ability disclosed by the MFDS guidelines include blood alcohol concentration, blood acetaldehyde concentration, and questionnaires to assess the degree of hangover. Additionally, the guidelines specify precautions for designing human application trials, selection of test groups, and methods of testing and observation in detail. However, even if the guidelines are not followed exactly, hangover relief ability can be proven through objective and scientific evidence.

Some companies have already conducted their own human application trials. HK inno.N, which produces the hangover relief product line ‘Condition,’ is a representative example. In a human application trial study conducted in August 2020 in collaboration with Seoul National University of Science and Technology and Bundang CHA Hospital, it was found that those who consumed the drink ‘Condition Hovenia’ showed lower blood alcohol concentrations at all time points compared to non-consumers. Notably, significant decreases in blood alcohol concentration were observed at 20 and 40 minutes after alcohol intake. Blood acetaldehyde concentration also showed significant improvement.

However, most companies explain that they conducted human application trials for internal efficacy verification and research or for marketing purposes to inform customers about the hangover relief effects. Since the clinical design of human application trials and criteria for hangover relief functionality were also independently established by the companies, they now need to prepare new human application trials according to the MFDS guidelines.

HK inno.N, which has already conducted human application trials, also carried out the trials for marketing purposes. An HK inno.N official explained, “We conducted human application trials based on our own standards for the raw materials of Condition to promote the hangover relief functionality.” A representative from Handok, which sells the hangover relief product ‘ReadyQ,’ said, “We conducted human application trials to independently verify the hangover relief effect,” and Samyang, the producer of ‘Sangkwaehwan,’ also stated, “We have data proving the hangover relief effect through human application trials during the product launch and upgrade process.”

However, since most companies stated that they are preparing human application trials in accordance with the MFDS’s notice and guidelines, there is expected to be no major issues in the distribution of hangover relief products after 2025. An HK inno.N official said, “We are planning clinical strategies for human application trials in line with the MFDS guidelines,” and a Samyang representative also explained, “We plan to conduct human application trials according to the MFDS guidelines.” A Handok representative said, “We have reviewed the recently released MFDS guidelines and will prepare human application trials based on the guidelines starting in the second half of this year,” adding, “Our goal is to complete human application trials that meet the standards by 2024.”