FDA Explains Management Principles for Products Containing Melatonin
2012/10/30
There have been recent cases of people selling melatonin-containing illegal products and being arrested by police and prosecuted. The Food and Drug Administration (FDA) reminds the public that melatonin is a hormone produced by pineal gland of the brain, of which natural level in the body is minimal. Melatonin has pharmacological activity and still lacks safety data about its long-term use. Therefore, the Department of Health (DOH) announced on October 15th, 1996 that products “labeled with melatonin” should be managed as medications. Unapproved importation, manufacturing or selling are subject to punishments for violating the relevant Pharmaceutical Affairs Act. Please do not purchase medications of unclear source through temples, street vendors, tour buses, underground radio stations or the Internet, in order to avoid hurting your wallet and your body!
After DOH announced on October 15th, 1996 that products “labeled with melatonin” should be managed as medications, there have been no melatonin products obtaining the drug permit license yet. Moreover, cow, sheep and pig pineal glands or dried pineal powder contain minute levels of melatonin, which are below 20 p.p.m. They can be only used as food ingredients.
The FDA reminds the public again that any person who manufactures or imports medications without approval is violating Articles 20 and 82 of the Pharmaceutical Affairs Act, hence subject to punishments such as imprisonment for a period of not more than ten (10) years and may, in addition thereto, be imposed with a fine of not more than NT$10,000,000. Any person who sells unapproved medication is violating Article 83 of the Pharmaceutical Affairs Act, hence subject to punishments such as imprisonment for a period of not more than seven (7) years and may, in addition thereto, be imposed with a fine of not more than NT$5,000,000. In addition, according to Article 69 of the Pharmaceutical Affairs Act, no advertisements or labels regarding the medical efficacy of any product other than the medicaments defined in this Act shall be made. Any person who violates these provisions shall be imposed, according to Article 91 of the Pharmaceutical Affairs Act, with a fine of not less than NT$600,000 but not more than NT$25,000,000.
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