NAFDAC HERBAL MEDICINE AND RELATED PRODUCTS ADVERTISEMENT REGULATIONS 2019

Commencement:

In exercise of the powers conferred on the Governing Council of the National Agency for Food and Drug Administration and Control (NAFDAC) by Sections 5 and 30 of the NAFDAC Act Cap N1 LFN 2004 and Section 12 of the Food, Drugs and Related Products (Registration, Etc.)

Act Cap F33 LFN 2004 and of all the powers enabling it in that behalf, THE GOVERNING

COUNCIL OF THE NATIONAL AGENCY FOR FOOD AND DRUG

ADMINISTRATION AND CONTROL with the approval of the Honourable Minister of

Health hereby makes the following Regulations:-

1. Scope:

These Regulations apply to all advertisements or promotion of herbal medicine and related product

manufactured, imported, exported, distributed, advertised, sold, or used in Nigeria.

2. Prohibition

(1) No person shall advertise any:–

(a) herbal medicines and related products unless it has been registered by the Agency;

(b) herbal medicines and related products unless the advertisement has approval of the Agency;

(c) extemporaneous herbal medicines and related products; and

(d) herbal medicines and related products as a cure, prevention, treatment for any disease

conditions listed in Schedule 1 or as may be prescribed by the Agency.

3. Nature of advertisement

The advertisement of any herbal medicine and related product shall be accurate, complete, clear

and designed to promote credibility and trust by the general public and health care practitioners,

therefore statements or illustrations shall not mislead directly, indirectly or by implication.

Also read: How to get NAFDAC number for your products

4. Non-referential advertisement

(1) No advertisement of a herbal medicine and related product shall-

(a) imitate the general layout, text, slogan or visual presentation of another Herbal medicine

and related product in a way likely to mislead or confuse the consumer; or

(b) be framed in such a manner as to exploit any superstitions or be calculated to induce fear

among consumers causing them to purchase the herbal medicine and related product being

advertised.

(2) All herbal medicine and related products advertisement shall strictly be in line with claimed

indications as registered by the Agency

5. Application for the Approval of Advertisements

All advertisement materials for Herbal medicine and related product including scripts, storyboards, art work, radio scripts and any other such advertisement material as may be required by the

Agency shall be submitted along with an application, to the Agency.

6. Particulars of An Application

(1) An application for herbal medicine and related product advertisement submitted by an

advertisement agent, distributor, manufacturer or the sponsor of the advert shall contain the

following information

(a) artwork containing the product name of the herbal medicine and related product

(b) botanical name of the Herbal medicine and related product

(c) dosage form available

(d) place of importation or local manufacture

(e) name and location address of manufacturer

(f) name and location address of local distributor

(g) name and location address of the advertising company

(h) date of first introduction of the herbal medicine and related product to the Nigerian market

(i) previous advertisement of the Herbal medicine and related product in Nigeria if any

(j) copy of the scripts, story-boards, art work, radio scripts of the advert

(k) the proposed media for the advertisement

(l) a copy of the certificate of registration of the herbal medicine and related product

(m) a copy of the registration certificate of the premise of the sponsors and

(n) justification for any special claims on the product

7. Validity of Approval

(1) The approval of herbal medicine and related product advert shall be valid for a period of one

year beginning from the date of the approval.

(2) Subsequent advertisement applications shall be valid for two (2) years provided no alteration is

made and conditions of renewal approval remain the same.

8. Withdrawal of an approval

The Agency may withdraw the approval for an advertisement of herbal medicine and related

product products if-

(1) The grounds on which the approval is granted was later found to be false or incomplete; or

(2) Any of the conditions under which the approval was granted has been contravened; or

(3) In the light of new scientific evidence against claims contained in the advertisement can no

longer be substantiated or are no longer correct.

9. Advertisement to effect caution in product usage specified

Herbal medicine and related product shall reflect an overall attitude of the caution in respect to the

herbal medicine and related product usage with emphasis on rational therapy and shall also provide

sufficient and balanced information to permit assessment of risk or benefit.

10. Cautionary label or disclaimer statement

Cautionary label or disclaimer statement must be displayed on the label and advertisement materials

of herbal medicine and related products.

11. Product Advertisement stating that it is “Safe or non-toxic”.

(1) No advertisement for herbal medicine and related product shall state or imply in absolute terms

or by quotation out of context, that any herbal medicine and related product is “safe” or has

“guaranteed efficacy” or special status.

(2) Any statement claiming or implying a superlative function such as “most effective” “least toxic,

“best tolerated” or other special status such as “herbal medicines and related products’ of

choice” shall not be used.

12. Product launch and Press release

All product launch materials or press release of herbal medicines and related products shall be as

approved by the Agency for the product advertising materials.

13. Restriction

(1) No advertisement for any herbal medicine and related product shall contain –

(a) any false or misleading information;

(b) half-truths, inadequate qualification and limitations regarding safety or effectiveness of the

herbal medicine and related product;

(c) vague, unsubstantiated statements, or suggestions of superiority over other competing herbal

medicine and related product;

(d) any false impression that the advertised herbal medicine or related product is for universal

cure or should be regarded as a more effective and safer alternative to other herbal medicine

and related product in the same category.

(2) No herbal medicine and related product advertisement shall:

(a) contain such word as “magic” “miracle’’ or an exotic description such as “upper potency” or

such other words as to induce the daily or continuous use of the product;

(b) contain a message that if the reader/viewer or listener does not use a particular product his

disease/ailment shall be aggravated;

(c) over dramatize any symptoms by way of drawing a picture of a pregnant woman, patient with

backache, or use throbbing sounds like heartbeats, coughing or agonizing cries;

(d) disparage or attack unfairly, any competitive products, goods or services.

14. Penalty.

(1) Any person who contravenes any of the provisions of these Regulations shall be guilty of an

offence and liable on conviction. In case of :

(a) an individual, to imprisonment for a term not exceeding one year or to a fine not exceeding

N50,000 or to both such imprisonment and fine; and

(b) a body corporate, to a fine not exceeding N100, 000.

(2) Where an offence under these Regulations is committed by a body corporate, firm or other

association of individuals every:-

(a) director, manager, secretary or other similar officer of the body corporate; or

(b) partner or officer of the firm or

(c) trustee of the body concerned ;or

(d) person concerned in the management of the affairs of the association ;or

(e) 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.

15. Forfeiture after conviction

(1) A person convicted of an offence under these Regulations shall forfeit to the Federal

Government-

(a) any asset or property constituting proceeds derived from or obtained, directly or indirectly,

as a result of the offence;

(b) any of the person’s property or instrumentalities used in any manner to commit or to

facilitate the commission of the offence.

(2) In this section, “proceeds” means any property derived or obtained, directly or indirectly,

through the commission of the offence.

16. Interpretation.

In these Regulations, unless the context otherwise requires:

“Advertisement” is a form of communication through the media about products, services or ideas

paid for by an identified sponsor. It is used to encourage, persuade or manipulate an audience

(viewers, readers or listeners) to continue with or take some new action.

“Advertising” means the publicity of goods and description of all products (which includes any

form of notices in circulars, handouts, labels, wrappers, catalogues and price lists, bill boards,

posters, newspapers, magazines, digital and social media, and any other documents) made orally,

online or otherwise or by means of projected light and sound recordings;

“Agency” means the National Agency for Food and Drug Administration and Control;

“Claim” means any representation, which states, suggests or implies that the product has

particular qualities relating to its origin, nutritional properties, nature, processing, composition or

any other quality;

“GMP” means Good Manufacturing Practice.

“Herbal medicine and related product” means:

(a) finished medicinal product containing plant and their preparation presented with therapeutic

or prophylactic claim and includes all preparations containing a plant material in part or

wholly.

(b) preparation or admixture of herbal medicinal products presented with prophylactic or

therapeutic claim; and

(c) preparation or admixture used for restoring, correcting or modifying organic functions in man

or in animal.

“Justification” means written explanation in respect of any claim, which shall be in the light of

current knowledge acceptable to the Agency;

“Label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed,

stenciled, marked, embossed or impressed on, or attached to, a package (container) of a herbal

medicine or related product.

“Location Address” means a place where the business of manufacture, sale, distribution, storage

and display of herbal medicine and related products is carried out which includes the house

number, plot number, street name, town or city, state, country etc, and

“Media”: means newspaper, magazine, medical/journal, television, radio, the internet; Out of

home, vehicle branding, posters, handbills, cinema, point of sale material; online, digital and social

media, any form of projected light and sound recordings or any of such means of communication.

17. Repeal of Herbal Medicines and Related Products (Advertisement) Regulations 2005

(1) The Herbal Medicine and Related Products (Advertisement) Regulations 2005 is hereby

repealed.

(2) The repeal of these Regulations specified in Regulations 17(1) shall not affect anything done or

purported to be done under the repealed Regulations.

18. Citation

These Regulations may be cited as the Herbal Medicines and Related Products Advertisement

Regulations 2019.