On the Upcoming FDA 2020 CBD Enforcement Policy

VIRUS VIBES

Health and wellness. Lifestyle. Beauty. Recreation. Good vibes. For 48 million American CBD consumers, product branding under the aforementioned delightfully nebulous benefits should come as no surprise. However heads are turning more recently in response to a new CBD use being advertised: COVID19 medicine. On 20AUG2020, the FDA updated its Warning Letters and Test Results for Cannabidiol-Related Products with a new cease and desist warning to a CBD manufacturer for false medical claims. Most of the FDA warning letters have historically involved those CBD companies doing business beyond the safety of their statutory regulations (e.g. online, across state lines), with labeling and advertisements alleging unvalidated curative, medicinal properties for their cannabidiol products. But this new risk may unequivocally associate CBD with snake oil.

The FDA has documented some commercial CBD products misbranded as Corona crushing, shown to “BOOST your Immune System . . . FORTIFY your bodies [sic] defense against viral Infections . . . SUPPRESS flu-like symptoms”. While that is bound to generate interest in your product, it could potentially place customers in harm’s way. Moreover, these product claims damage the overall industry reputation. If CBD genuinely has medicinal potential, as we believe it does, advertising an unvalidated application for medical treatment before the requisite supporting clinical data is generated, is deleterious to realizing ANY of its medicinal potential.

As much as we’ve come to understand anything COVID-related requires literal myth-busting on a global scale, likewise, it’s clear that there’s very little we as 48 million consumers conclusively understand about CBD’s mythos as a medicinal application. In these early years of legal CBD, who has conclusively come forward to say whether the applications of CBD are without danger, or without limit? The CBD industry is coming to understand that the FDA does not run on good vibes.

LIMITLESS MEANS INCOMPLETE

At least in the US, those limits, the standards and regulations enforced to achieve them, are ultimately the responsibility of the FDA to assign.

Before the FDA over 100 years ago, a certain modern branding goliath was advertising its flagship product as “brain tonic, and a cure for all nervous affections”. Now, despite thousands of metadata analyses showing soft drinks negatively influence nutrition and health, what began as a medicine brand could only with generous grace be called a lifestyle brand. Haven’t we learned since then what happens when we wait for the general population to become the clinical study? One would expect that ever since the 2018 Farm Bill loosed the deluge of CBD products to US market, the FDA had been enforcing a standard regimen of GMP and product development practices just as strenuous as any other product intended for human ingestion listed amongst the code of federal standards (CFR) title 21. In actuality, that road has not been paved. One year ago this month, the USDA in their 2018 Farm Bill Interim Final Rule expressed their concerns that if the “FDA does not provide clarity about their plans for future regulation of CBD, there will continue to be uncertainty and downward pressure on the CBD portion of the hemp market. This is important because the Hemp Business Journal estimates appear to assume that there are no prohibitions on adding CBD to consumer products”. Given this is a 2019 statement, was it prophetic, or merely informed? The first COVID advertisements would come only a couple months later.

Removing hemp from the marijuana drug classification is not the same as providing the standard and reproducible framework of a regulated manufacturing industry. Having the market outpace the regulation is not without precedent in the United States. Think early automobiles. When Henry Ford introduced the assembly line in 1913, there were 1.3 million vehicles and 2 million drivers. However, the first stop sign would not exist until 1915, road traffic signs in general were without federal standardization until early 1920s, and seatbelts would not be federally mandated in the US until the 1980s.

As of 2018, greater than a century of progressively more understanding of how the automobile is to be used by American consumers, only 1.42 people die for every 10,000 vehicles. 1913 had 33.38 people die for every 10,000 vehicles. That’s a 96% improvement of consumer safety, compared to those early days of piecemeal enforcement[1].

Can all car safety improvements be attributable to the federal government? Absolutely not. But having the federal government engage the industry, assign resources to understand and promote standards, ultimately empowered the consumer to become more educated about the product. The manufacturers in turn came to define opportunities for efficiency within the regulations and assign quality and safety as key customer requisites.

If you’re wondering, the US code of federal regulations for transportation and vehicles can be found in CFR title 49.

PUMP THE BRAKES

I am not suggesting we will be talking statistical deaths caused by CBD in 100 years. In fact, the WHO has repeated surmised that CBD is generally well tolerated and safe. But they also confirmed there have been documented adverse effects with drug-drug interactions, including blood thinners. CBD’s natural drowsiness and fatigue effect is of concern, given that if a consumer ingests a higher potency than they expected, they may unintentionally incapacitate themselves to a degree, which is especially concerning if operating heavy machinery or any other task requiring delicate caution and deliberate judgement.

The FDA is especially keen on the prevalence of unreliable CBD content versus product label claims, having presented the following data to the US House & US Senate Committees on Appropriation:

· 66% of CBD products sampled (2019) do not contain CBD within 20% potency advertised

· 30% of CBD cosmetics tested contained THC but did not indicate THC on label

The report concludes that the FDA has seen enough to surmise a new long-term study must be performed.

Considering the current prevalence of CBD products, can the 48 million American CBD consumers afford to wait any longer for national oversight? If like the automobile, could we potentially wait half a century for full development of federally enforced conventional safety regulations?

IS THE GRASS GREENER?

Given the nature of the FDA warning letters, an apparent disconnect between what CBD manufacturers intend their products to be used for, and what regulators are communicating is adequate industry diligence, persists even now. Upon deeper inspection, the FDA’s CBD warning letters paint a vivid picture that, depending on your vantage point, either suggest an entrenched federal body combatting an illicit

market of what amounts to snake oil in the conventional medicine sense, or, it suggests an underdog industry motivated to achieve medicinal relevance with its sister pharmaceuticals despite the void of standardized guidance.

· If the latter is true, why hasn’t the industry managed to substantiate what they believe to be the utmost propensity of CBD federally (or, dare to dream, on the internationally relevant stage)?

· If the former is true, what does the FDA achieve by further delaying CBD-relevant Code of Federal Regulation for an industry that has legally existed to some degree since 1996, federally monitored and punitized since early 2015, and federally legalized since 2018 under the Farm Bill, but to date, is still without federal standard?

Novel consumer products don’t come about often, but CBD didn’t appear overnight, and to declare what had previously been included in a Schedule 1 narcotic classification Generally Regarded As Safe (GRAS) disregards what cannabis data the US has extensively documented: its criminal enforcement.

FDA MOVEMENT 2020

In retrospect, the inclusion of “all derivatives, extracts, cannabinoids,” in the 2018 Farm Bill may have been an underrepresentation of the intentions of the $688 million US hemp market, of which hemp-CBD comprises approximately 20% [2]. Now, during a pandemic, economic unsurety, and weeks until a particularly contentious election, the FDA moves to remediate the vacuum of CBD regulation behind closed doors. The FDA’s highly anticipated Cannabidiol Enforcement Policy; Draft Guidance for Industry was received by the Office of Information and Regulatory Affairs 22JUL2020. Not to be confused with H.R.8179 – Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020, the FDA’s draft enforcement is currently being reviewed at the executive level.

Not much is known about this draft, however according to the EO 12866 records, the CBD manufacturing industry has presented their comments, starting with the supplement and “hemp is food” proponents in early August 2020, and ending with the pharmaceutical proponents in late September 2020. Chief of those pharma proponents is Greenwich Pharmaceuticals, who have the only FDA approved drug with CBD as the main active ingredient. Not only is Epidiolex FDA-approved, but it has recently had the intended usage expanded by the FDA. To me, this indicates the pharmaceutical case will be the freshest case in the minds of the executive branch considering the draft enforcement.

As the USDA confirmed in their Interim Final Rule on 2018 Farm Bill, the mystery of enforcement is leaving the domestic CBD industry struggling. State-to-state and international, until an appropriate stance of GMP can be reproduced by the industry and enforced by the federal government, the US may fail to be internationally competitive performers in the burgeoning CBD industry, which could have lasting consequence not just on CBD processors but on local governments doing the taxing, domestic hemp farmers doing the growing, law enforcement spending resources on the wrong focuses, and the safety of the CBD consumers themselves.

– Richard Sordello 

We encourage all members and the general public to do their own due diligence on any business or product, and understanding their state’s and federal laws, before choosing to purchase any product or contracting for any service.