Improving CBD regulation compliance in the US and Australia

23 Jun 2020 --- The cannabidiol (CBD) sector is advancing its efforts to increase regulation across the globe. Nutritional software supplier ESHA Research will assist manufacturers selling cannabis edibles in Oregon, US, with regulatory-compliant product labeling and tetrahydrocannabinol (THC) and CBD tracking. Across the Pacific, the Australia-based Therapeutic Goods Administration (TGA) of the Department of Health is taking action by reviewing complaints of alleged non-compliant advertising of medicinal cannabis products.

ESHA Research’s Genesis R&D Cannabis Labeling module offers Oregon Liquor Control Commission (OLCC)-compliant Nutrition Facts label templates. These features can help calculate and report nutrient fields for tracking THC and CBD. When formulating a new cannabis edibles recipe, users can enter their own ingredients or use one of the more than 100,000 ingredients, recipes and other food items included in the database. The program then calculates the nutrient breakdown of the recipe and displays it on the Nutrition Facts label and product packaging report.

Click to EnlargeGenesis R&D Cannabis Labeling module uses symbols to indicate cannabis contents in products. (Source: ESHA Research)“The OLCC has specific guidelines for what information is required on packaging, and how it should appear. Manufacturers risk having their product application rejected if information is missing or incorrect. Genesis R&D offers tools and data checks to help businesses meet the requirements more easily and accurately,” explains Elizabeth Braithwaite, Product Manager at ESHA and Master of Public Health/Registered Dietitian.

Genesis R&D comes preloaded with the corresponding symbols for Recreational Marijuana Edibles, Medical Grade Cannabinoid Edibles and Hemp Edibles – at least one of which automatically appears on cannabis product packaging. The label also reports required nutrients in the product, such as calories, sodium, protein, added sugars, cholesterol, total carbohydrates, and total fat per serving. 

Combating CBD non-compliance complaints
Regulating medical cannabis has become a growing priority for the Australian Department of Health. The TGA has reached out to companies associated with the non-compliance complaints regarding medical cannabis and instructed them to “cease unlawful behavior.” Although most respondents have brought themselves into compliance, the TGA affirms it is “considering appropriate action” for those who have not.

The TGA’s compliance focus aims to prioritize complaints of medicinal cannabis products that have not been through regulatory checks and monitor poisonous substances as listed in Sections 4 and 8 of the Poisons Standard of the Therapeutic Goods Act 1989 (TG Act). “Finally, references to serious forms of a disease, condition, ailment or defect are either restricted or prohibited representations that require the prior approval of the TGA before being used in an advertisement for a therapeutic good. Use of these representations without authorization may also lead to a breach of the TG Act,” the TGA states.

To reflect how significant safe medical cannabis consumption is for public health, the TGA highlights that criminal offences and civil penalties apply to breaches of the TG Act. The TGA website also has specific advertising guidance material for businesses involved with medicinal cannabis products.

Edited by Anni Schleicher

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