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25.01.2011 Health

"SE MENHYIA" herbal Products are unsafe - FDB

25.01.2011 LISTEN
By GNA

January 24, 2011 Accra , Jan. 24, GNA - The Food and Drugs Board (FDB) on Monday alerted the public on the activities of 'Se Menhyia' Herbal Centre located on the Obuom Road at Kasoa, saying its products are unsafe.

The FDB recalled that in August 2010, it ordered the immediate suspension of herbal medicine production activities at the facilities of Se menhyia herbal centre since the facility had not been licensed by FDB as required by the Food and Drugs Law.

A statement copied to the GNA said as at August 2010, twenty four (24) different herbal products that were being used on patients at the Clinic had not been certified by the Board in accordance with the FDB Law, PNDC Law 305B and therefore their quality, safety and efficacy could not be guaranteed.

According to the statement, the FDB directed further that until the products were duly tested and approved, they should not be offered for treatment since their safety; efficacy and quality could not be guaranteed.

It said the needed regulatory sanctions were accordingly applied to Se Menhyia Herbal Centre and further directed to bring their products into compliance (for testing and registration).

Subsequently, Se Menhyia Herbal Centre submitted some herbal products for registration and two of them were taken through the registration processes and found to be acceptable for which reason they were registered - the products (Sem Tonic and Sem Koo Bitters) were therefore given approval as per a letter dated December 16, 2010.

After the registration of the two, Se Menhyia herbal centre submitted additional samples of Seven products for analysis and registration but when the products were subjected to laboratory analysis all the products were found to be unwholesome due to unacceptable high levels of yeast and moulds contamination.

The FDB said there should be no yeast or moulds at all and that these unacceptable high levels of microbial contamination could cause very serious health hazards and could lead to life threatening infections including Phycomycosis, Aspergillosis, Systemic Candidiasis and other yeast infections.

"Systemic Candidiasis can lead to Endocardiatis (infection in the heart), Severe Osteomylytis (bone infection), Kidney problems and other systemic infections, all of which can lead to death" the statement said.

The FDB wishes therefore to caution the general public that in view of the above-mentioned concerns, the following herbal products from SE MENHYIA HERBAL CLINIC should not be patronized;

The products are Sem Herbal Mixture, Sem Press Mixture, Sem Women care, Sem Diabe, Sem Fibro Mixture, Sem Assme Mixture and Sem Ex. Man Bitters.

The statement noted that Section 11 of the Food and Drugs Law, PNDCL 305 B states that, "Any person who sells any drug, cosmetic, medical device or household chemical that has in or on it any substance that may cause injury to the health of the user when the article is used-according to the directions on the label accompanying such article; or (ii) for a purpose and by a method of use that is customary or usual; among others commit an offence."

Additionally, section 14 of the Law states that 'Any person who labels, sells, packages or advertises any drug, cosmetic, medical device or household chemical in contravention of any regulation made under this Law, or in a manner that is false, misleading or deceptive as regards its character, constitution, value, potency, quality, composition, merits or safety, commits an offence.'

Section 26 of the FDB Law further indicates that any person who is found guilty of an offence under the law shall on conviction be liable to a fine or imprisonment not exceeding two years or both.

The FDB acknowledges the medicinal values of plants and therefore shall continue to support genuine herbalist who are prepared to comply with the law in order to ensure that Ghanaians will have access to genuine herbal products.

The Board would also continue to weed out quack herbalist in order to bring sanity into the herbal industry, it added.

GNA

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