Allay Consulting’s February Newsletter: FDA Will Not Use Existing Regulations for the CBD Industry
FDA Will Not Use Existing Regulations for the CBD Industry
The hemp industry has been in a bit of a pickle for several years: hemp derived cannabinoids are federally legal, yet not regulated and not allowed by the FDA to be added to foods or supplements. Consumers want safe access to CBD and other hemp derived cannabinoids, but the FDA has yet to dedicate time to creating a regulatory framework for the consumable side of the industry. The good news, the FDA finally publicly addressed the lack of applicable regulations for this industry. The not-so-good news, the administration revealed they will not regulate the CBD industry as a food additive or dietary supplement.
It seems the FDA is playing hot potato – passing the hot CBD topic to another – Congress. The FDA made a statement that the administration will not use existing food and dietary supplement regulations for CBD but will rather work alongside Congress on a new set of regulations. Although the FDA’s release is not the public announcement we were expecting, we see this as a momentum for the CBD industry.
Purportedly, the FDA’s hesitation is due to unknown potential human and animal risks when consuming CBD products. According to Dr. Janet Woodcock, studies have shown CBD has potential harm to the liver, interactions with certain medications, possible harm to the male reproductive system, and concerns when it comes to certain vulnerable populations such as children and those who are pregnant. In addition to the statement released, the FDA may have hesitation because of adverse reactions in Epidiolex patients (≥10% and greater than placebo). Keep in mind Epidiolex contains high CBD dosage which doesn’t equate to a much lower dose typical to consumer dosage.
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
Dr. Janet Woodcock
Accompanying the FDA having concerns about the safety of directly consuming CBD products, the FDA also stated concern for humans consuming animal products that were fed CBD within their diet. Specifically, the safety of meat, milk, and eggs from animals fed CBD were included in the FDA’s statement release. Traditional animal feed has studies supporting its use, CBD feed would need the same. According to the statement, there is not enough evidence to determine how much CBD can be safely consumed. Future regulations will be based on scientific studies for safety efficacy. Because reputable studies take time, the creation and release of the future CBD regulations will most likely drag on and seem like a lifetime.
Many states have approved hemp cultivation plans with the USDA, but since manufacturing firms are not included in FDA’s regulations, manufacturing facilities are lacking federal oversight. The new proposed regs will close that federal regulatory gap. The proposed new regulatory standard will include safeguards to minimize risk – similar to the food and dietary supplement FDA standards. According to the FDA statement release, “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.”
The statement explained new regulations are needed for the CBD industry because their existing food and dietary supplement regulations have gaps that do not cover risks associated with CBD products. The FDA sees value in creating a new set of standards for the CBD industry; although their future regulations may have aspects copied and pasted from the CFR 111 (dietary supplements) and CFR 117 (food), and maybe CFR 211 (drugs) as well. Time will tell how the new set of regulations differs from already well-established regulations.
Even when the federal CBD regulations are live, we are not so sure the FDA will have the resources to regulate the entire industry. With federal guidelines, more states may take these firms under their regulatory wing. Once the regulations are made available, we expect to see additional states get involved with regulating the manufacturing and infusion CBD industry.
What Do We Do Until the FDA & Congress Creates New Regulations?
The statement persuasively acknowledged the FDA’s intention with enforcement actions taken against CBD firms…“The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.”
Government is known for their regulatory sticky tape and taking forever – the new set of regulations will take time, so what can hemp firms do in the meantime? Focus on the “when appropriate” piece of the statement above – Don’t attract their attention! We suggest following FDA’s established cGMP’s for food and dietary supplements, follow THC potency restrictions, be weary when making health claims for hemp products, and make friends with the state or local authority who has jurisdiction over your establishment. Working with a third-party compliance firm is also a great idea, but this is a newsletter and not a sales pitch. We hope all of our readers already know Allay Consulting is here to support your firm’s compliance if the need ever arises.
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