Source: The Senate Weekly
Individuals involved in the manufacture or import of tobacco products will have to obtain approval from the Cabinet Secretary for Health before they supply their products, according to a proposed law before the House. The Tobacco Control (Amendment) Bill, 2024, proposes that the manufacturers or importers will have to obtain the approval at least six months before the date on which they intend to supply the product.
Where such individuals were in business before the proposed law comes into force, and they intend to continue supplying the product, they will have to make the request for approval within three months. The Bill, which is sponsored by Senator Catherine Mumma, proposes that the application for approval will contain the name and contact details of the person who manufactures the product, the importer of the product, where applicable, and if neither is based in Kenya, a responsible person in Kenya.
The application will also include the ingredients contained in, and emissions resulting from the use of, the product by brand and variant name, including quantities. Toxicological data regarding the product’s ingredients, in heated form and emissions, their effects on the health of consumers when inhaled and taking into account any addictive effect, information on the nicotine dose and uptake when consumed under normal conditions.
It will also include a description of the components of the product, including the opening and refill mechanism of the electronic cigarette or refill container, the production process and whether it ensures conformity with the requirements of the law and a declaration that the manufacturer shall bear full responsibility for the quality and safety of the product when supplied and used under normal conditions. “Where the information submitted is incomplete, the Cabinet Secretary may request the manufacturer to provide such further information as may be necessary for the determination of the application,” states Clause 14D (2) of the Bill, which was introduced in the House last week.
Senator Mumma seeks to amend the Tobacco Control Act to make further provisions on the regulation of smoking and production and sale of tobacco products, including electronic nicotine delivery systems. The Bill also aims to ensure that the advertising of tobacco products is regulated and that the sale of tobacco products, including electronic nicotine delivery systems, to persons under the age of eighteen years is prohibited. “The Bill seeks to ensure that no products, particularly electronic nicotine delivery systems are manufactured, distributed, imported or sold in Kenya without the prior authorisation of the Cabinet Secretary responsible for health,” says the Senator in the reasons of the Bill.
She says the amendment is necessitated by the current situation where products have been introduced into the market and distributed without authorisation or understanding of the public health impact of such products. The Senator seeks to amend Section 14 of the Act on conformity with requirement so that no person shall manufacture or place on the market for sale, distribution or use an electronic nicotine delivery system or refill container. She proposes that the sale or use of nicotine delivery system only if the nicotine-containing liquid is contained in a dedicated refill container not exceeding a volume of ten millilitres, in a disposable electronic cigarette or in single use cartridge and that the cartridges or tank does not exceed a volume of two millilitres. Besides application for approval, the manufacturers will have to submit samples of the product for which approval is being sought.
The samples will be tested for conformity with the requirements and the accuracy of the information submitted in the request for approval. The Bill empowers the Cabinet Secretary to prescribe fees payable for testing of samples and confirmation of information on the product. The Cabinet Secretary may ban any product which does not conform to the requirements of the law from being manufactured or sold and will have power to publish a list of products that have been approved or banned from sale, the name of the authorised manufacturer or importer of the product, the date the product was approved or banned and the duration and validity date of the approval.
No manufacturer will be allowed to produce or supply tobacco products containing vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks. The Senator cites the case of caffeine or other additives and stimulant compounds that are associated with energy and vitality additives which have colouring effects on emissions. In the case of tobacco products for smoking, the lawmaker cites additives that facilitate inhalation or nicotine uptake, additives which increase the toxicity or addictiveness of the product or additives which result in a characterising flavour.