An emerging conundrum—CBD and the regulatory truthAn emerging conundrum—CBD and the regulatory truth
CBD is quickly becoming a mainstream byproduct of the cannabis revolution, but a conundrum is developing between the market demand and potential FDA regulatory action.
March 10, 2020
“You have to accept the rule of law, even when it’s inconvenient, if you’re going to be a country that abides by the rule of law.” − Jesse Ventura, former governor of Minnesota
Welcome back to the proverbial Wild West. As a “veteran” of the dietary supplement industry (one who was here before the Dietary Supplement Health and Education Act of 1994 [DSHEA]), it’s astonishing some people still think anything goes, while the regulatory agencies of the federal government continue to play enforcement catch-up. For years, this industry has experienced incredible growth while simultaneously seeking “the next big thing,” and compliance has been largely an afterthought, unfortunately.
Along comes the cannabis revolution. With it comes CBD—that “next big thing.” A conundrum exists where the industry questions how CBD products will be regulated at the federal level and what those outcomes portend for allowances in states with more progressive cannabis laws. A reckoning is yet to come.
The chemical entity commonly identified as CBD is a drug, full stop. The inclusion of the chemical CBD in a food or dietary supplement constitutes adulteration of the product due to the presence of a drug. FDA doesn’t allow CBD to be included in cosmetics. Not even cosmetic drugs (such as topical pain relievers) may be formulated with the addition of CBD.
However, products openly sold in the market describe the benefits of CBD in medical terms, thereby rendering the products drugs. This is the Wild West at its finest, where states have different laws, brands use promotional copy that is out of line with both substantiation and other allowances at the federal level, and mass market access crosses state and international lines to reach eager consumers all over the world.
The presence of CBD in food is not illegal, provided the proper component being used. This involves qualification of ingredient suppliers and the ingredient itself. The chemical CBD is present in the hemp that is now legally grown and processed, thanks to the latest passage of the Farm Bill. Maybe CBD is concentrated a little bit (or a lot), but “it’s still just hemp” is the argument commonly being made as long as “no THC is present,” thus the products are considered legal.
FDA’s view on red yeast rice can serve as a CBD precedent. Red yeast rice is an allowed ingredient that naturally contains the chemical commonly sold as the drug lovastatin. Dietary supplements and even foods have used red yeast rice or extracts as ingredients; this did not sit well with FDA and after legal and regulatory wrangling, the inclusion of red yeast rice was determined acceptable, provided the levels of the drug constituent do not exceed those found naturally in the food component without concentration.
Complicating all of this is whether the ingredients themselves are considered for inclusion in the food supply. Assume the easiest path is a new dietary ingredient (NDI) notification (NDIN) containing a “concentrated hemp (leaf, seed, flower) oil.” The requirements for demonstrating compliance are many, with the first major hurdle being FDA’s acceptance of hemp as a food. This has precedent, so we may set that aside with caution. Next checkbox to determine is whether the NDI is a drug. Here is where the NDI filing gets complicated. It’s due to this complication that the list of NDI filings for hemp extracts is paltry at best. Consider that each concentration step that does not involve water, ethanol or a combination of water and ethanol results in “chemical alteration,” according to FDA. This makes the NDIN requirement absolute. Including various concentrations of hemp extracts in conventional food products requires a food additive evaluation. Whether that evaluation is a self-determination or a formal food additive petition to FDA, the alteration of the makeup of unrefined hemp oil makes a substance a food additive. The regulatory path forward, therefore, must include the determination of safety. Even if by self-determination, the dossier should be “submission ready” as it is subject to formal review by the FDA at any time.
Compounding the above is the all-too-often lack of controls in the manufacturing of many of these products. Some enterprising individuals come up with their own unique, highly potent oil or other ingredient that is marketed as “incredible,” but has not been produced anywhere close to a compliant manner. Per GMPs (good manufacturing practices), raw material must be tested using scientifically valid analytical methods. Known contaminants, including THC along with a number of other possible contaminants, need to be controlled and compared to adequate specifications at each step of production. A single inspection by a small team of inspectors could find these basic GMPs aren’t met and remove hemp products that contain CBD from the market. The financial costs and legal risks involved are industrywide.
A conundrum exists because the market demand for CBD products, which is growing rapidly, and the federal government are at odds. The industry has the potential opportunity to move the regulatory needle, so to speak, but that cannot occur without open, direct conversations and actions within the regulatory framework that exists. The first step is to understand the realities and risks of the current situation, and determine a sound, permanent solution that maintains and potentially shapes the integrity of FDA’s actions. This is all while offering safe, meaningful products to the consuming public in a consistent and compliant fashion, and not just replaying the Wild West of the past.
To read related content, check out the “Hemp/CBD: Market evolution” digital magazine.
Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity, where he is COO. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries.
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