Hemp products are in something of a transition period. It wasn’t too long ago that hemp was treated as a controlled substance in the United States, so most farmers didn’t get their start on growing hemp until after the passage of the 2018 US Farm Bill. Federal and state governments are still figuring out what to do with this new industry, and part of that process is figuring out how to regulate it.
The US Food and Drug Administration is in charge of regulating food, tobacco, dietary supplements, prescription drugs, and various other human health products. Therefore, the FDA is the agency that has to develop rules for hemp products meant for human consumption and topical use, including CBD tinctures, salves, and edibles. Right now, they’re debating what to do with the burgeoning CBD market. The decisions the FDA makes will have a major impact on the way the hemp industry evolves in the future.
The FDA Hearing on CBD
The FDA held a public hearing on CBD regulations on May 31. The daylong hearing had over 100 speakers including researchers, doctors, and industry advocates. This hearing is the first step as FDA officials decide if the current regulatory framework around CBD products is adequate. Industry insiders all seem to agree that some changes are on the way, but it’s difficult to say what those changes will look like.
The hearing did establish a few themes that give us insight into what officials are concerned with, which gives us a rough idea of what regulators are likely to address.
- Unpredictable, inconsistent dosages and fraudulent labeling: FDA officials asked questions about terms like full spectrum and isolate, and toxicologists pointed to the varying effects CBD has based on administration method. Inconsistent and inaccurate product labeling was also a concern, as was the amount of companies making false or misleading claims on their packaging.
- Potential harm to vulnerable populations:The FDA also expressed concern about how CBD could affect children, elderly consumers, and pregnant women.
- Drug development:Some FDA panelists see commercially available CBD products as a potential threat to further scientific research, saying they could lessen the incentive in developing cannabis-based medications.
- The need for more data:FDA officials want to review all available safety and efficacy data regarding CBD. One area of concern is the standards companies use to test their products for pesticides and heavy metals, although the FDA didn’t offer any guidance on which standard should be used.
What Does this Mean for CBD?
What all of this means is hard to say, and industry experts are divided on how substantial of an impact FDA regulation will have on the hemp industry. Some say it won’t have much of a visible impact for consumers, who will most likely still have access to plenty of CBD products of all kinds. One area that may be affected is CBD-infused food and beverages, which could change things for some larger companies like Mondelez International (the makers of Nilla wafers and Chips Ahoy cookies) who are considering getting into the CBD game.
While large corporations won’t sweat the loss of CBD edibles in their product line, it would likely be a blow tosmaller companies that rely on food and drinks as an essential part of their product line. Farmers who converted their entire business model to cash in on the hemp industry are also worried that strict regulation could decimate the industry right as it’s getting off the ground.
Regardless of whether people want more or less regulation on the CBD industry, everyone can agree on one thing: the FDA needs to make a decision soon. Officials need to set their guidelines in stone now so growers and manufacturers can adjust their practices before they’re too well-established to change.
Is CBD Regulation a Good Thing?
Regulation isn’t always a bad thing, though. As we’ve mentioned before, there are a lot of inconsistencies and inaccuracies in hemp product labeling. These fake oils can be a massive problem for customers that rely on a certain dosage of CBD. Some degree of FDA regulation on dosages and the use of terms like full-spectrum, broad-spectrum, and isolate would make it much easier to spot fake products. Consistency in labeling would ultimately help consumers and save a lot of the hassle involved with researching products to find out if they’re really what they say they are. (It’s worth noting here that we require third-party testing from all of our brands and curate only trusted, legitimate products in the Apotheca store.)
Strict regulations could potentially make the hemp industry cost-prohibitive for small businesses or squeeze them out entirely in favor of large companies. If the FDA decides to treat hemp derivatives as a prescription drug it could make it impossible for independent hemp companies to exist at all. Given the fact that hemp is a massive global industry projected to reach $5.7 billion dollars in global sales by 2020, it doesn’t seem likely that the FDA would put a halt to one of the most popular products in the market.
It’s also worth mentioning that the FDA regulating CBD products is not a new thing. When CBD is added to food, a cosmetic, or marketed as a drug or dietary supplement, it falls under FDA jurisdiction. These rules are why CBD companies cannot make health-related claims in their marketing or on their website. The FDA has also approved Epidolex, a CBD-based medication, as an epilepsy treatment.
What Can I Do?
Right now, we’re in a waiting game. Experts expect the FDA to release a statement in the late summer or early fall. Public comment is still open until July 2, 2019. Details on the submission process and video of the entire live hearing can be found on the FDA’s website.
We’ll be watching these developments closely and will keep you posted on any major announcements. In the meantime, we’ll continue to stock the same CBD products you know and love. It’s business as usual and Apotheca will grow and adapt to whatever changes come our way while still providing you a trusted outlet for education and information on the hemp and CBD industry.
