Is CBD Really FDA Approved?
The answer is complicated, highly fluid, and evolving every day.
The CBD industry is growing at an astounding pace. According to a February 25, 2019 report from Cowen Inc., a multinational independent investment bank and financial services company, “The U.S. CBD market could represent a $16 billion opportunity by 2025.” That’s extraordinary for an industry where hemp production just became federally legal less than two years ago as part of the 2018 Farm Bill.
But the subsequent growth and explosive trajectory also caught regulators by surprise. The Food and Drug Administration (FDA), which normally has ample time and notice when regulating a new sector, is trying to react quickly to a train that has already left the station at breakneck speed.
How did we get here, and where are we going?
The FDA's Stance On Supplements
To understand the FDA's position on CBD, it's first necessary to understand the supplement landscape and how the FDA wields its jurisdiction in that sector.
While the FDA does have regulatory power over dietary supplements, they fall under a different set of guidelines than traditional food products or drugs. Supplements must comply with FDA regulations when they are being produced as it relates to ingredient safety, purity, manufacturing standards, health claims, and what ingredients can or cannot be included, etc, but the FDA does not have the authority to review dietary supplement products for safety and effectiveness before they are marketed," according to the FDA website.
Unfortunately, this creates a system where the FDA does not review and approve dietary supplements but takes enforcement action against those who violate regulations -- such as making false health claims. This translates into the FDA playing catchup after consumers have already purchased and consumed these products and then there is a complaint.
While the FDA has regulatory power over supplements, the FDA states, “that dietary supplements do not need approval from FDA before they are marketed, and manufacturers and distributors do not need FDA approval to sell their dietary supplements.” This means that nutritional supplements, like the ones that fill the shelves of stores like Whole Foods or GNC, are not FDA approved.
The supplement landscape gets more complicated when CBD enters the mix. The FDA has stipulated, “that THC and CBD products are excluded from the dietary supplement definition.” What!? So CBD can’t be included in supplements? The answer complicated, changing and evolving fast.
A July 2019 article by Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, and Lowell Schiller, J.D., Principal Associate Commissioner for Policy at the FDA, cited an “agency-wide, integrated, and collaborative approach to addressing the regulation of products made from CBD that fall under our jurisdiction.”
While the FDA continues to compile scientific data on CBD to inform a larger regulatory framework, they have cracked down on companies making false health claims or who sell products that are deceivingly mislabeled, containing little or no CBD at all. This seems to be the current status quo: the FDA is working to understand the cannabinoid compounds more thoroughly so they can properly administer new and updated guidelines. Just last week, new legislation was introduced that could require federal regulators to treat hemp-derived CBD as a dietary supplement.
What The CBD Industry Can Do
While Congress deliberates and the FDA continues to gather information about CBD and shares its research with the industry, CBD and all supplement companies must prove to consumers that they are making products with integrity and full transparency. This can be clearly demonstrated by investing in a wide range of verifications for everything they produce. Specifically, consumers should look for wellness products that are lab tested by an independent third party, Non-GMO certified, TruID Certified, and produced in a GMP certified food-grade facility. Our industry responsibility is to go above and beyond current regulations in order to provide products that are safe and contain exactly what they say they do. It's critical to build consumer trust in brands and the people behind so they can decide which supplement to buy.
After all, we’re not talking about a new consumer gadget, we’re talking about something that consumers put into their bodies. When someone trusts a company to enhance their well-being, it represents the highest responsibility for our industry.