Author: Carla Long, Account Executive, Life Sciences
Congressional passage of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) established a new category of cannabis as “hemp”—that is, cannabis and cannabis derivatives with extremely low concentrations (no more than 0.3 percent on a dry-weight basis) of the psychoactive compound delta-9-tetrahydrocannabinol (THC). This legislation also removed hemp from the Controlled Substance Act, meaning it’s no longer a controlled substance under federal law. [Marijuana remains classified as a high risk Schedule I controlled substance.]
Congress left unchanged the Federal Food, Drug and Cosmetic (FD&C) Act and section 351 of the Public Health Service Act, which grant the FDA authority to regulate products that contain cannabis and compounds derived from it, including cannabidiol (CBD).
Welcome to the world of CBD confusion! CBD companies and products are booming—and they’re operating in a regulatory haze of “TBD” federal regulations and a quagmire of conflicting state laws addressing medical and recreation use of marijuana.
A market in a constant state of flux
The FDA continues to evaluate potential regulatory pathways for products that contain or are derived from cannabis, as evidenced by an FDA Statement released April 2019 by former Commissioner Scott Gottlieb, MD. One thing is clear: FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit, i.e., prevent, treat, mitigate or cure any disease or condition, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. There’s no shortage of products on the market that are in violation of that rule—putting their manufacturers at risk of FDA enforcement including misbranding penalties. Note that in April 2019, the FDA issued warning letters to multiple companies regarding “unfounded and egregious” claims of their CBD products.
The FDA does allow food to contain parts of the hemp plant that do not contain CBD or THC. Specifically three ingredients: hulled hemp seeds, hemp seed protein and hemp seed oil have been considered by the FDA as Generally Recognized as Safe (GRAS) and therefore these products can be legally marketed in human foods without food additive approval, provided they comply with all other requirements and do not make disease treatment claims. This provision does not apply to foods, or dietary supplements, containing CBD or THC. It is currently unlawful to introduce such products into interstate commerce, although the regulations may change. In May 2019, the FDA conducted a public hearing regarding products containing cannabis or cannabis-derived compounds as part of an internal working group to explore potential future pathways for these products to be legally marketed (see FDA Cannabis Q and A).
Meanwhile, there’s another regulatory “gotcha” lurking for those that manufacture or distribute CBD products. Many products that contain CBD also contain other ingredients that have long been regulated as active drugs. Chief among them:
If you are a manufacturer or distributor with a product that uses any or all of those ingredients, you MUST list the product with the FDA. And your submission must be in what is known as the Structured Product Labeling (SPL) format.
Structured Product Labeling (SPL) has been a specialty of Reed Tech since the requirement’s inception in 2005. Through our outsourced conversion and submission services, expert staff at Reed Tech can guide you through the FDA’s Electronic Drug Registration and Listing (eDRL SPL) process. And we guarantee 100% accuracy on Drug Listing for Rx, OTC, Biologic and Homeopathic Products, Content of Labeling Review Submissions, Labeler Code Request/Registration, Establishment Registration and GDUFA Self-Identification.
While the rules governing CBD are still being written, evaluate the contents of every product you make or distribute. If appropriate, take a proactive step to ensure that you’re meeting longstanding SPL requirements around camphor, lidocaine, menthol and other active drug ingredients.
For questions about SPL solutions and services, get in touch with Reed Tech by email at Pharma@ReedTech.com