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Let’s continue our discussion on hemp and CBD

Why not? We got all excited when the farm bill passed in December 2018 removing the hemp plant from the controlled substance list. An explosion of products appeared on the market place. We saw hemp and one of its main cannabinoids, CBD, being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals. It is understandable that consumers seek out novel products for a variety of perceived health-related or other reasons. In this case, the cart was placed way before the horse.

The House of Representatives and the Senate had the right intentions in removing hemp from controlled substance list and allowing it to be farmed but no provisions were made on how to use hemp and hemp extracts in ingestible products (foods, drinks or supplements). And FDA who promulgates the rules on how to apply a new act was caught flat footed. Eighteen months after the signature of farm bill, no rules to use CBD or/and other cannabinoids (excluding THC above 0.3%) in dietary supplements have been establish by the agency. To make matters worse, purified CBD had been approved by FDA in June 2018 as a prescription drug approved to treat two rare, severe pediatric epilepsy disorders.

To date, any ingestibles in the form of food or supplement that contains CBD are illegal. FDA has a working group to explore potential pathways to allow CBD containing products to be lawfully marketed. I listened to the last webinar that FDA presented on the subject matter. Sharon May, Lawyer and Senior Advisor for Policy at the Office of Food Policy and Response at FDA indicated that it may FDA 2 to 3 years to issue rules on the matter. FDA’s main concern is the lack of available safety data for use of hemp containing products.

Therefore, if you are in this field, my best advice is to invest in studies geared toward establishing safety of your hemp extract when consumed orally. If you need advice on what to do, feel free to reach out via the contact page.