FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer… However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk.
US Food & Drug Administration
The CBD industry is bristling after the release of new regulatory insights by the US Food and Drug Administration (FDA) on December 6th.
It may seem like the FDA is taking shots at the CBD industry– but does the agency really pose a threat to legal U.S. hemp businesses?
The answer is… complicated. In this post we’ll break down the recent FDA statements regarding the sale of CBD products and what it all means for your business.
Now is not the time to panic– it’s time to reassess where we’re at as an industry and examine the language we use to describe this plant and what it can do.
Don’t get us wrong: we are steadfast believers in the powers of cannabis.
But at the same time, and in light of the FDA’s recent warning letters to 15 companies for selling cannabidiol (CBD) products that violated the FD&C Act, we as cannabis marketers have a responsibility to be 100% transparent and honest about the current state of scientific evidence– and to adjust our rhetoric accordingly.
There’s a big difference between a research study suggesting a compound’s “therapeutic potential” and research that proves a compound is “effective for a particular application.” It’s within this distinction that the recent FDA regulations hold their weight regarding the sale and advertising of CBD, and where we as advertisers need to do our due diligence in ensuring our language reflects this distinction in our client work.
In truth, researchers around the world have been studying chemical compounds from cannabis for decades (the United States Department of Health and Human Services even holds a patent for non-intoxicating compounds derived from cannabis— how convenient).
An overwhelming proportion of that research supports the idea that this plant might just be the most versatile medicine in the history of mankind– but almost none of that research is FDA-approved to make any conclusive determinations about what chemical compounds actually do to the human body (like those in conventional, FDA-approved drugs). In other words, they have not been randomized double-blind, placebo-controlled studies. These studies are considered the “gold standard” for any sort of intervention-based research.
Instead, the vast majority of peer-reviewed (meaning proof-read by other academics in that field) articles on CBD and other cannabis compounds is considered “pre-clinical” evidence. This means the studies were conducted primarily using animals and tissue cultures in Petri dishes– not actual humans.
So, while the limited research we do have may indeed have enormous implications for the potential uses of CBD in the future, it’s still not considered conclusive enough for the FDA to deem CBD as a GRAS (generally recognized as safe) ingredient in dietary or therapeutic products.
Now let’s get into what the FDA actually said about all of this, and what it means for you.
In a speech given at the National Industrial Hemp Council meeting in August of 2019, the FDA’s Principal Associate Commissioner for Policy, Lowell Schiller, said the following:
“So what did the Farm Bill change at FDA? In a certain sense, the answer is not much. In the Farm Bill, Congress explicitly preserved FDA’s authorities to regulate products containing cannabis or cannabis-derived compounds, regardless of whether they are classified as marijuana or hemp. ”
While the Farm Bill of 2018 (also known as the Agriculture Improvement Act of 2018) removed hemp from the Controlled Substances Act (CSA) which rendered it legal to produce, study and distribute CBD, the FDA still has the power to determine whether or not CBD is safe to use as a dietary supplement, food additive, or drug.
“FDA regulates a lot of different types of products, and the rules vary by product type. For example, if you have a product containing hemp, or a hemp derivative like hemp seeds or CBD, and you market it as a human drug, then it’s subject to different rules than if you market it as a food, or a cosmetic, or a veterinary product – product types that all have their own rules. And if the hemp is developed into a product that FDA doesn’t regulate, like biodiesel or clothes or jewelry, then there may not be a role for FDA anywhere in the life cycle of the product, all the way from the farm to the ultimate end user.”
Basically, any ingredient that is meant to be ingested as a food, supplement or drug falls under the jurisdiction of the FDA. For an ingredient to comply with the rules of the FD&C Act, it must obtain a GRAS status for use in these kinds of products. This includes tinctures, oils, gummies, chocolates, and basically any other edible or drinkable hemp-derived CBD product on the market.
According to the FDA, it doesn’t matter whether CBD comes from cannabis or federally legal hemp– if its intended use is as a drug, food additive, or dietary supplement in human OR animal food– it’s considered illegal (convenient, again, considering US Patent No. 6,630,507).
In line with this ruling, the US Food and Drug Administration (FDA) recently issued 15 warning letters to companies that sold CBD in ways that violated the Federal Food, Drug and Cosmetic (FD&C) Act:
“…these particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.”
Under the FD&C Act, the FDA defines a “drug” as:
“Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.”
Cannabis-derived CBD has been approved by the FDA for use in one drug, Epidiolex, which can only be obtained with a prescription by licensed healthcare providers. Because of CBD’s use in the FDA-approved drug, the CBD molecule is “proven” to, as per their definition, “affect the structure or function of the body,” and therefore qualifies as a “drug,” and thus falls under their jurisdiction to regulate.
On December 6, 2019, the FDA released a statement titled: Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). The statement contains a comprehensive FAQ that covers the full spectrum of legal issues with marketing CBD as a food additive, dietary supplement, cosmetic and/or drug.
While the document does —technically— forbid businesses from making medical claims about CBD products, it openly acknowledges CBD’s enormous therapeutic potential and the need for further research into the compound. It even provides a list of resources for interested parties wanting to submit an application for the drug approval process.
“FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and the National Institute on Drug Abuse (NIDA).”
And there may be a few more silver linings to be found in this statement.
1. CBD may be fair game to use as a cosmetic:
“Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients.”
To market CBD as a cosmetic ingredient, you must be able to prove that your CBD is uncontaminated by pesticides and heavy metals (get your biomass tested by third-party labs!). But then again, you should probably able to prove that already.
The FDA defines “cosmetics” as:
“A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
2. Hemp-seed derived ingredients are fair game to market as food additives (like hemp seeds, hemp seed oils), provided they comply with other requirements for food ingredients.
“In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil.”
We will be closely monitoring FDA developments as they unfold. The agency stated that it plans to release updates on regulatory progress “plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.” It also stated that it will “monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns.”
The FDA makes it sound fairly threatening, but it may just be that the US Government is blowing smoke. It stated that the actual enforcement of these rules depends on a number of factors, including “agency resources” (AKA money) and “the threat to public health” (AKA how explicit the medical claims on a product are):
“When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.”
The hemp industry makes up a relatively a tiny fraction of their oversight, considering the FDA regulates products that total over $2.5 trillion (yes, trillion) of consumer spending; everything from human and animal drugs to medical devices, radiation-emitting products, vaccines, food products (including dietary supplements and animal foods) cosmetics, and tobacco products.
The chances they’ll scour every single webpage and every Instagram account of every CBD in the recent explosion? Slim.
Nevertheless, going forward we have a responsibility to do our research and acknowledge what is known– and what isn’t– and convey the facts appropriately.
None of this means that you can’t legally sell CBD. You just can’t make medical claims about ingestible CBD— or advocate for its use as a food additive, supplement, or replacement for conventional FDA-approved drug therapies that address specific medical conditions.
The legality of hemp products depends entirely upon their intended use. Make sure your products are tested for pesticides and heavy metals. Make sure they’re safe, pure, and clean. Don’t make medical claims. Research your content thoroughly and make sure you always link to peer-reviewed studies and primary sources of legitimate information.
December 2019: FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
November 2019: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
August 2019: Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit
December 2016: Botanical Drug Development: Guidance for Industry