Introduction

1. On 26 January 2011, media reported that three sixteen-year-old girls in Singapore suffered from abdominal pain and diarrhoea after consuming "F-cup Cookies" which said to contain Pueraria mirifica, in an attempt to boost their breast size.

Pueraria mirifica

1. Pueraria mirifica (also known as Thai kudzu or "野葛根"), unlike the traditional Chinese medicine "葛根" (root of Pueraria lobata (Willd.) Ohwi) or the "粉葛"(root of Pueraria thomsonii Benth.) consumed locally in Hong Kong, which is native to the area around northern Thailand. The roots of Pueraria mirifica, which is said to be consumed by the native Thai for generations for relief of postmenopausal symptoms, contain several phytoestrogens, including isoflavones, deoxymiroestrol, miroestrol (葛雌素) etc.
2. Pueraria mirifica products have been used traditionally in Thailand. Pueraria mirifica is used as health food or in dietary supplements for improving flushes and night sweats in perimenopausal / post-menopausal women, and reducing blood lipids etc. Health food using Pueraria mirifica as an ingredient is available in some Asian countries, including Hong Kong, and can be ordered through internet shopping websites.

Safety and Public Health Significance

1. Some researches and toxicological evaluations, mainly conducted by Thai and Japanese researchers, had been published on the content, efficacy and safety of Pueraria mirifica crude root extract. The major adverse effect of Pueraria mirifica is its reproductive and endocrine toxicity in experimental animals, including monkeys. A human study showed that some subjects developed anaemia and affect liver function. However, scientific paper on the effect of Pueraria mirifica on breast enlargement cannot be found.

Overseas Regulatory Control

1. In Thailand, Pueraria mirifica is more commonly available fresh or processed as a dietary supplement than in other countries. Pueraria mirifica is apparently a traditional source of postmenopausal remedy.
2. In Japan, the Ministry of Health, Labour and Welfare revealed that products similar to "F-cup Cookies" can be sold in Japan in principle provided that they comply with the food safety requirements and cause no harm to human health. However, there is no guarantee on the functional effect claimed. Consumers should be aware of the potential adverse effects before they consider taking this type of food.
3. In Singapore, Pueraria mirifica is not included in the "List of Chinese Medicinal Materials Commonly Used in Food" of Agri-Food and Veterinary Authority (AVA) of Singapore. AVA had rejected a request for approval on the use of Pueraria mirifica in food because of the lack of safety information on its use in food.
4. In Australia, Pueraria mirifica is considered a novel food in 2005. However, documented concerns associated with increased intake of phytoestrogens need to be addressed before the safety of the product can be determined.
5. In United States, the Food and Drug Administration had refused an application for use of Pueraria mirifica as a new dietary ingredient for post-menopausal women since there was inadequate information to assure that the ingredient did not present a significant or unreasonable risk of illness or injury.
6. In European Union, safety assessment is required under the Novel Food Regulation if Pueraria mirifica is introduced into the EU market.

Advice to public

1. Individual response to Pueraria mirifica food varies, and is depended on the intake dosage and individual characteristics. Consumers should be aware of the potential adverse effects before they consider taking Pueraria mirifica food. Please seek medical advice if in doubt.
2. The Pueraria mirifica products are often not recommended for women under 18 years old, women using birth control drugs or prescription estrogen and pregnant or nursing mothers.
3. Maintain a balanced diet with a variety of food.

Advice to trade

1. In Hong Kong, all food available for sale in the market must be fit for human consumption. The trade should ensure that the food they sell or import is fit for human consumption and comply with relevant legal standards.

Risk Assessment Section
Centre for Food Safety
March 2011