Food Supplement Registration in Kenya

Regulatory Authority

Pharmacy and Poison Board

https://web.pharmacyboardkenya.org/

6 Months

1 Year

Food/Dietary/Nutritional supplement or Nutraceuticals means a product other than tobacco intended to supplement the diet and shall include all of the following characteristics

a) Contains concentrated source of one or more of the following: vitamins, minerals, amino acids, essential oils, natural substances of plants or animal origin, enzymes, substances with nutritional or physiological functions or contains any combination of these

b) Is intended to be taken orally in the form of tablet, capsule, powder, soft gel, granules or liquids

c) Is not presented for use as a conventional food or as a sole item of a meal of the diet

d) Is labeled as a food supplement and has NO medical claims on it.

For purposes of submission to PPB, an application for registration of food supplement shall include:

i. One duly filled application form and an electronic copy in MS Word on a CD-ROM including their supporting documents – see Annex I
ii. Three (3) samples of the smallest commercial pack(s) from one batch with batch certificates of analysis.
iii. Non refundable application fee for registration of food/dietary supplements and borderline products in Kenya.
iv. GMP inspection of the manufacturing site may be requiredincase of quality issues in the market

Food/dietary supplement and borderline product registrations are valid for one (1) year, unless PPB suspends or revokes them early or the applicant withdraws their application. When the Board suspends, revokes, or modifies the registration requirements, it will provide written justification.

Similarly, the applicant must provide justification for canceling the registration of dietary supplements, food items, and borderline products.