THE term “cosmeceutical” is not recognised by the Ministry of Health Malaysia (MOH), according to Datuk Eisah A. Rahman (pic), senior director of Pharmaceutical Services of the MOH.
It is not regulated as a product under the Sale of Drugs Act 1952, and the Control of Drugs and Cosmetics Regulations 1984.
“A product can be a drug or a cosmetic, but it cannot be a combination of both. A cosmetic product cannot have either medicinal or drug-like benefits,” Datuk Eisah says in a recent e-mail interview.
According to the above act and regulations, there is a clear definition whereby a “drug” includes any substance, product or article intended to be used or capable, or purported or claimed to be capable, of being used on humans or any animal, whether internally or externally, for medicinal purposes.
On the other hand, “cosmetic” means any substance or preparation intended to be placed in contact with the various external parts of the human body (including epidermis, hair system, nails, lips and external genital organs), or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to clean them, perfume them, change their appearance or correct body odours, protect them or keep them in good condition.
“Skincare products with functional claims such as anti-ageing can be considered as cosmetics in Malaysia as it is not categorised to have medicinal or drug-like benefit,” she clarifies.
She explains that the scope of anti-ageing claims, which is acceptable as cosmetics in Malaysia, generally covers products for improvement of the skin appearance such as reducing the appearance of wrinkle, skin hydration or even skin tone.
“Such products cannot be claimed to treat or prevent disease in humans; permanently restore, correct or modify physiological function by exerting a pharmacological, immunological or metabolic action,” she stressed.
Under the Control of Drugs and Cosmetics Regulations 1984, the beauty company responsible for placing a cosmetic product in the local market must notify MOH prior to manufacture, import, supply or sale of the products and must ensure the safety, quality and claimed benefit of the cosmetic product placed in the local market. Malaysia implemented the notification procedure for cosmetic products since Jan 1, 2008.
All notified cosmetics are subjected to the MOH Post Market Surveillance programme to ensure that only safe products are marketed in Malaysia, and failure to comply with the relevant authorities will result in punitive action such as notification cancellation and product recall.
“Even though the notification procedure is less stringent compared to registration of drugs, nevertheless, for a product to be classified as cosmetics it must comply with the definition of cosmetics, and it is prohibited to make any medicinal claims,” Eisah points out.
When beauty companies call their products “cosmeceuticals”, it may be misleading to the consumer if the consumer interprets the product to be similar to a pharmaceutical product.
In accordance to the Cosmetic Advertising Code as specified under the Guidelines for Control of Cosmetic Products in Malaysia, the cosmetics industry is required to ensure that the marketing and advertising of cosmetics to the public is conducted in a manner that promotes the quality and safe use of cosmetics.
“That manner must be socially responsible, and not deceive the consumer. Advertisements should not be framed so as to abuse the trust of the consumer, or exploit his or her lack of experience or knowledge,” Eisah explains.
Before purchasing a cosmetic product, she advises consumers to read the product labels thoroughly and make an informed decision.
“They should not be easily influenced by advertisements that promise spectacular results in a short time.”
Cosmetic products are only approved for external application, and should never be injected into the body or under the skin by any method.
“Consumers are encouraged to report any adverse reactions from the use of cosmetic products or any knowledge of improper cosmetic product promotion beyond its scope of use, to the National Pharmaceutical Control Bureau (NPCB) at MOH,” she concludes. – Sandra Low
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