(n) Clinical studies;
(o) Storage conditions;
(p) References.
(2) The labeling shall contain a "Product Title" section preceding the "Description" section.
Prohibition of Labelling of Herbal Medicines or Related Products for certain treatments
13 (1) No person shall label a herbal medicine or related product as a treatment, preventive or cure for any of the
diseases, disorders or abnormal states as identified in schedule 1 to the Food and Drug Act 1990 (as amended.)
2) No person shall sell, advertise, display or orally present any herbal medicine or related product to the general
public whose label contains such words as "for vitality”.
Penalty
14.(1) A person who contravenes any of the provisions of these Regulations shall be guilty of an offence and
liable on conviction:(a) in case of an individual to imprisonment for a term not exceeding two years or to a fine not exceeding
N50,000. or to both such imprisonment and fine.
(b) in the case of a body corporate to a fine not exceeding N100,000.
(2) Where an offence under this regulation is Committed by a body corporate, firm, or other association of
individual(a) every director, manager, secretary or other similar officer of the body
corporate; or
(b) every partner or officer of the firm; or
(c) every trustee of the body concerned;
or
(d) every person concerned in the management of the affairs of the
association; or
(e) every person who was purporting to act in a capacity referred to in
paragraphs (a) to (d) of this regulation is severally guilty of that offence and
liable to be proceeded against and punished for that offence in the same
manner as if he had himself committed the offence unless he proves that the act or omission constituting the
offence took place without his knowledge, consent or connivance.
Forfeiture
15. In addition to the penalty specified in regulation 14 of these Regulations, a
person convicted of an offence under these Regulations shall forfeit to the Agency, the herbal medicine or
related product and whatsoever is used in connection with the commission of the offence.
Herbal medicines and related products not for use in pregnancy
16. Both the inner and outer labels of all herbal medicines and related products shall carry a warning statement
directing pregnant women not to use them, except there is adequate evidence of safety in pregnancy.
Warning for Children
17. The label of all herbal medicines and related Products shall carry a warning "keep this medicine out of reach
of children".