Approval For Listing Status By National Agency For Food And Drug Administration And Control (NAFDAC)

STATEMENT:

NAFDAC

NAFDAC is currently processing twenty one (21) herbal medicinal products for “Safe to use” or Listing status. Many of the applicants claim that their products are immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19.

However, no clinical study has been done yet on any of the products to prove their claim of efficacy.

Listing status involves the review of the composition of the formulation, the labelling of the product, the process of manufacture and “Safe to use” testing.
Once the product is able to meet all requirements, a listing status is granted with a clear DISCLAIMER that states clearly that claims have not been evaluated by NAFDAC.
The applicant can arrange for clinical trials that will involve use of human subjects in order to prove efficacy or claim for treatment following laid down procedures and with the approval of NAFDAC.
However, Listing of a herbal product is not a requirement for the conduct of Clinical Trials.

Most of the applicants that submitted herbal medicines that are currently undergoing processing have been issued compliance directives to provide additional information or/and evidence of Good Manufacturing Practice or environment fit for production of the medicines.

Paxherbal applied for Listing of Pax Herbal Cugzin capsule 290mg which was approved by NAFDAC and Listed as “Safe to use”.
The applicant claimed that it is an immune booster and an anti- infective.
However, as part of the labelling of the product, and in line with global practice, a Disclaimer is on the product label which clearly states that the claims have not been evaluated by NAFDAC.

Therefore, the statements circulating in the social media that NAFDAC has approved Paxherbal product “specifically for treating symptoms associated with Coronavirus” is WRONG and INACCURATE. Until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.

Prof Mojisola Adeyeye
Director General
NAFDAC