Food and Drugs Board bans 24 products from Se Menhyia Herbal Centre

DR. STEPHEN K. OPUNI
FDB/MIS.23/VOL.1/10

ALERT
SE MENHYIA HERBAL PRODUCTS ARE UNSAFE
The Food and Drugs Board wishes to alert the public on the safety of some herbal products at Se Menhyia Herbal Centre located off the Obuom Road at Kasoa in the Central Region.

It would be recalled that the Food and Drugs Board (FDB), in August 2010, 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.

As at August 2010, twenty four (24) different herbal products that were being used on patients at the Se Menhyia Herbal Clinic had not been certified by the Food and Drugs Board in accordance with the Food and Drugs Law, PNDC Law 305B and therefore their quality, safety and efficacy could not be guaranteed.

The FDB directed further that until the products are duly tested and approved, they should not be offered for treatment since the safety, efficacy and quality cannot be guaranteed.
Accordingly the needed regulatory sanctions were 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.

Furthermore, SE MENHYIA HERBAL CENTRE submitted additional samples of Seven (7) products for analysis and registration.

The products were then subjected to laboratory analysis and all the products were found to be unwholesome due to unacceptably high levels of yeast and moulds contamination. There should be no yeast or moulds at all. 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 Food and Drugs Board (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;

- Sem Herbal Mixture
- Sem Press Mixture
- Sem Women care
- Sem Diabe
- Sem Fibro Mixture
- Sem Assme Mixture
- Sem Ex. Man Bitters

It must be 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

(a) has in or on it any substance that may cause injury to the health of the user when the article is used-
(i) 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;
(b) consists in whole or in part of any filthy, rotten, decomposed or diseased substance or any injurious foreign matter
(c) is adulterated; or
(d) is prepared, preserved, packed or stored under insanitary conditions;
commits 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 FDB shall however continue to weed out quack herbalist in order to bring sanity into the herbal industry.

Moreover, information from the general public on persons suspected to be in any practice with the potential of endangering public health and safety with respect to FDB's mandate is most welcomed through any of the following contact numbers; 0244337235, 0262689296, 0246809509 or 0208204968.

JAMES AGYENIM-BOATENG
DEPUTY MINISTER FOR INFORMATION
ACCRA
[January 23, 2011]

For further information, please contact:
James Y. Lartey
Communications
Food and Drugs Board
P. O. Box CT 2783
Cantonments, Accra
Tel. 233 302 233100, 235100
Mob. 233 244 337235