The FDA Intends to Publish a Pathway for CBD Products!

In the letter that the Food and Drugs Administration (FDA) issued on November 25, 2019, the agent issued 15 warning letters to 15 different CBD manufacturers/ brands. In that letter, the FDA indicated that the agent is considering a “pathway” for the sale and marketing of CBD products. Based on the FDA comment, the agent intends to publish a guideline for CBD product pathway to market which will be similar to the Premarket of Tobacco Products (PMTA) application.

Since the introduction of e-cigarettes in the USA in 2009, the FDA, for years, has not taken any approach to regulate tobacco /vape products. Instead, the agent published the Premarket of Tobacco Products (PMTA) pathway application. In this application, FDA requires vape manufacturers to submit a lengthy and expensive application (estimated 1 million per product) which allows vape manufacturers/brands to continue to sell and market their products in the market.

Tobacco company such as Altria has invested heavily to capitalize on a multi-billion dollars vape industry by introducing a vape device (IQOS) which was cleared to sell and market through PMTA application in April 2019. In addition, Altria last year invested almost $13 billion in Juul to get a 35% stake.

In regulated industry; the FDA establishes and issues a set of guidelines and standards of Current Good Manufacturing Practices (cGMP) for each industry such as pharma (21-CFR-211), medical devices (21-CFR-820), dietary supplement (21-CFR-111), cosmetics ( 21-CFR-700), food (21-CFR-101), and beverages ( 21-CFR- 165). In these industries, manufacturers have to adhere to their set own of standards (cGMP) while the FDA is required to audit and inspect these manufacturers periodically (at least once a year) to ensure manufacturer’s compliance and adherence to the established standards.

To draw a parallel between vape and CBD products, the small and low-funded CBD companies will not survive such a pathway, and only well-funded and large size CBD companies will eventually, survive. However, whoever survives this pathway application, has to compete and go head-to-head with any pharmaceutical companies, that are interested in capitalizing on the multi-billion dollar CBD market.

All CBD companies (small and large) have to make an early decision whether to stay and invest in the non-regulated industry or to move on and leave large and well-funded companies to pave the way for one of the pharmaceutical companies that will eventually capture the highest market share of CBD market.