FDA: Re-evaluate the safety of green dietary fiber ingredients

The "Green Dietary Fiber Capsules", which only received the health food certification from the Ministry of Health and Welfare in April this year, made over NT$400 million through hot sales due to the endorsement of celebrity Tao Jingying. However, it sparked controversy today after the media revealed that the aloin content exceeded the standard by 1,770 times, causing severe diarrhea in users. The Food and Drug Administration stated that regarding the issue of aloin content, it has asked the industry to provide additional experimental and other relevant information. Before the safety of the raw materials is clarified, the industry must preventively remove the product from the shelves and must not continue to sell it.

Domestic health food adopts an inspection and registration management system. Business operators must submit process quality control and scientific verification information and apply to the Ministry of Health and Welfare.

Green Diet Fiber has obtained the health food certification. Food and Drug Administration: Meets safety assessment

The Food and Drug Administration stated that health food is subject to an inspection and registration management system, and businesses must submit information such as process quality control and scientific verification and apply to the Ministry of Health and Welfare. The Ministry of Health and Welfare has established a "Healthy Food Review Group" and hired experts and scholars in the fields of food science, nutrition, biochemistry, toxicology, pharmacy and medicine to serve as review committee members to evaluate the safety and efficacy of the product's overall formula and all ingredients.

The "Green Dietary Fiber Capsules" product has been reviewed based on the attached "genotoxicity test" and "28-day feeding toxicity test" and other safety assessment reports. It has also passed the "efficacy assessment" and "stability assessment" reviews and obtained the "Ministry of Health Food License No. A00255" on April 18, 2014.

Aloe vera exceeding the limit caused controversy, expert meeting will be restarted for re-evaluation

2 Key points to be clarified: Is the aloe vera raw material peeled legally? Is concentrated extraction technology okay?

Regarding the aloin content in Green Dietary Fiber Capsules, the Food and Drug Administration stated that according to the "Compilation List of Raw Materials Available for Food Use", aloe vera raw materials can be used in food processing after being completely peeled, and products containing aloe vera should be labeled with a warning that "pregnant women should not eat" when sold; if the test product has an analytical certificate from a credible organization that shows that it does not contain "aloin", then the "pregnant women should not eat" warning can be exempted. The product packaging label has been annotated with the warning "Pregnant women should not eat" in accordance with regulations, which complies with relevant regulations.

In response to the controversy caused by the green dietary fiber aloesin, the Food and Drug Administration said it will convene an expert meeting for a re-evaluation after the unemployed provide additional supporting documents.

As for consumers' suspicion that diarrhea after consumption is related to excessive aloesin, the Food and Drug Administration stated that currently there are no limit standards for aloesin in food either domestically or internationally, but peeled aloe vera leaf pulp can be used as a food ingredient, and the process may cause trace amounts of aloesin to remain in the food.

We have asked the industry to provide additional information on raw materials and safety, but have not received any.

In response to this, the Food and Drug Administration has re-evaluated approved health foods in accordance with Article 9 of the Health Food Management Act. It has previously asked green dietary fiber companies to provide additional information on raw materials and safety, but has not received it so far. Once it receives the information, an expert review meeting will be held to evaluate the situation. The key points to be clarified will include whether the companies use qualified peeled aloe vera leaf pulp and process concentration extraction technology.

Until the doubts about the raw materials of the "Green Dietary Fiber Capsules" product are clarified, the product may no longer be put on the shelves for sale. If there are problems with the assessment, the "Little Green Man" health food certification will be revoked.