Replies to LegCo questions

LCQ1: Sale of dietary supplements containing ephedra

        Following is a question by the Hon Fred Li and a reply by the Secretary for Health, Welfare and Food, Dr Yeoh Eng-kiong, in the Legislative Council today (February 25):

 

Question:

 

        On the sixth of this month, the U.S. Food and Drug Administration imposed a total ban on the sale of dietary supplements containing ephedra.  In this connection, will the Government inform this Council:

 

(a) whether it has studied the reasons for the U.S. authority's banning the sale of such dietary supplements; if it has, of the conclusions of the study;

 

(b) which of the health foods currently on sale in Hong Kong contain ephedra; and

 

(c) whether it plans to ban the sale of health foods containing ephedra in Hong Kong; if so, of the details of the plan; if not, the reasons for that?

 

Reply:

 

Madam President,

 

(a) On December 30, 2003, the US Food and Drug Administration (FDA) issued a consumer alert on the safety of dietary supplements containing ephedra or alkaloids of ephedra.  FDA notified manufacturers that it intended to publish a final rule to ban the sale of these dietary supplements.  FDA subsequently issued the final rule on February 6, 2004.  The rule, subject to Congress review, will become effective on April 5, 2004.

 

        In the US, the concern is related to recent years' promotion of dietary supplements containing ephedra for weight reduction, enhancing sports performance and increasing energy.  FDA found little evidence for such effectiveness other than short-term weight loss.  Instead, studies showed that ephedra use is linked to adverse health effects like raised blood pressure, heart problems and strokes.  Cases of adverse effects were usually related to high dosage or long term or concomitant use with other drugs such as caffeine.  FDA's proposed ban targets at dietary supplements only and will not be applicable to traditional Chinese herbal medicines.

 

(b) In Hong Kong, any product which contains ephedra or alkaloids of ephedra is regulated as drug through either the Chinese Medicine Ordinance (CMO) (Cap. 549) or the Pharmacy and Poisons Ordinance (PPO) (Cap. 138).  Specifically, products containing ephedra and other Chinese medicines as active ingredients are considered as proprietary Chinese medicines (pCm); otherwise, products containing ephedra or alkaloids of ephedra are classified as pharmaceutical products subject to the control of the PPO. 

 

        As a Chinese herbal medicine, ephedra is included in Schedule 2 of the CMO.  It is a common ingredient in Chinese medicines for the treatment of cold and cough.  It is considered safe if taken under proper instruction and at the correct dosage.

 

        The registration system for pCm commenced on December 19, 2003 and traders are required to submit their applications for registration before June 30, 2004.  According to a market survey conducted by the Department of Health (DH) at retail premises of pCm in January 2004, 30 products containing ephedra were found.  DH also visited physical fitness centres in the same month, but no product containing ephedra was detected.

 

        For the protection of public health, any product containing ephedra or alkaloids of ephedra which is not regulated under the CMO is required to be registered with the Pharmacy and Poisons Board (a statutory body established under the PPO) before it can be manufactured or sold in Hong Kong.  At present, there are about 800 pharmaceutical products registered in Hong Kong as containing alkaloids of ephedra, most of which are indicated for the relief of common cold, nasal congestion, chronic rhinitis and hay fever.  In addition to this requirement on pre-market registration, pharmaceutical products containing alkaloids of ephedra, being Part I poisons, can only be sold by authorised sellers of poisons under the supervision of a pharmacist. 

 

(c) The Government and the drug regulatory bodies in Hong Kong have reviewed the control of ephedra in light of recent developments overseas.  In this regard, the Chinese Medicines Board under the Chinese Medicine Council has recommended that -

 

(a)Chinese medicinal products containing ephedra are considered as pCm and registration of such products is required;

 

(b)any pCm containing ephedra indicated for prolonged use must submit acute and long term toxicity studies in support of its safety; and

 

(c)all pCm containing ephedra must be labelled with advisory wordings to caution consumers against long term use of the products.

 

        The Pharmacy and Poisons Board has also reviewed the situation. While the existing control provided under the PPO on pharmaceutical products containing alkaloids of ephedra is considered adequate, robust enforcement actions such as inspections and test purchases will continue to be undertaken to ensure that only registered pharmaceutical products which fulfil efficacy, safety and quality requirements are sold by authorised sellers of poisons under the supervision of a pharmacist.

 

Ends/Wednesday, February 25, 2004

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