CBD is not a foodstuff

13 July 2020. By FACTS in Regulatory & Nutrition

Since the Constitutional Court ruling in 2018 indicating that the provisions for cannabis in the Medicines and Related Substances (MRS) Act were unconstitutional, there has been much confusion about how to categorise cannabis-containing products. On 22 May 2020, new amendments to the scheduling of medicines were published to provide clarity.

Hemp is a strain of the Cannabis sativa plant and contains CBD (Cannabidiol) but almost no THC (Tetrahydrocannabinol), compared to marijuana which contains both. CBD has purported but unsubstantiated medicinal properties, and is sought after for these purported medicinal claims. THC is psychoactive, and only found in the marijuana strain of C. sativa. Levels can vary greatly. CBD on the other hand is found in both plants, but is only one of over 80 compounds. Whether CBD’s purported effects can be proven will also depend on whether the claimed health benefits are as a result of one of the compounds, or a particular mix of compounds.

The big changes:

THC is a Schedule 6 medicine, with a few exceptions.
CBD is a Schedule 4 medicine, with a few exceptions that are Schedule 0 Complementary Medicines.

THC is listed as a Schedule 6 medicine, unless it is:

in raw plant material and processed products manufactured from such material, intended for industrial purposes and not for human or animal ingestion, containing 0.2% or less of THC;
in processed products made from cannabis containing 0.001% or less of THC; or
raw plant material cultivated, processed and consumed by an adult, in private, for personal consumption.

CBD is considered a Schedule 4 medicine unless it is:

in complementary medicines containing no more than 600mg CBD per sales pack, providing a maximum daily dose of 20mg of CBD, and making general health enhancement, health maintenance or relief of minor symptoms (low-risk) claims; or
in processed products made from cannabis raw plant material intended for ingestion containing 0.0075% or less of CBD, where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product.

If 1 or 2 above applies, the CBD-containing product is considered Schedule 0.

Based on this amendment, the presence of CBD in a product will result in it falling under Schedule 4 or Schedule 0; and the presence of THC in a product will result in it falling under Schedule 6. Such products are therefore only suitable for sale as medicines, and would not be acceptable as foodstuffs. To be able to sell scheduled substances – even Schedule 0 – registration with the South African Health Products Regulatory Authority (SAHPRA) is required.

The use of hemp is still permitted without registration, when:

used as oil or fibre (textile), and not intended to be ingested
used as a foodstuff (e.g. hemp protein); however, THC and CBD levels must be tested

We have updated our infographic to include these amendments.

Before you start on your NPD process, always research the potential pitfalls regarding the ingredients, particularly when they are ‘novel’ ingredients.

FACTS offers regulatory support and training, as well as testing of CBD and THC levels. Contact us for more information.