CBDs and the FDA. Collision course or Consumer Protection?

Many believe that CBDs are simply legal, over-the-counter products now. As I’ve written, and as reality is confirming, it is not that simple. That aside, the current, winter/spring 2019 immediate new challenge is a little different.

Once the 2018 Farm Bill was passed federally this Fall, the landscape changed. Regardless of the contradiction with the Farm Bill and the Controlled Substances Act, changing by the day, hemp is de facto legal. In many ways it might as well be. BUT IT IS NOT THE SAME THING!!  Do many truly believe it is? Yes. Are many of those very smart, “in tune” pot lawyers? Yes!. Is the question clear? No! And the landscape is changing fast.

The latest issue this winter/spring 2019, may be the FDA. Once the Farm Bill said “hemp is a legal legitimate crop for many reasons,” the FDA, the Food and Drug Administration, took a sincere interest in hemp. They may well have been looking at this issue for years.

So what is the FDA? What is their Mission Statement? In other words, do we care what they think? The answer is “yes we probably do care what they think and do.” They may be well within their assigned mission when it comes to some CBD products. While they don’t “own” CBD, they do have rather broad powers.

From the FDA Website of the Federal Government, https://www.fda.gov/AboutFDA/WhatWeDo/

FDA Mission

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

To me, that seems to apply to many types of CBD products as currently being marketed and advertised and used. As to moral/intellectual judgments, if the FDA saw this coming, they should have said something. On the other hand, if the CBD industry saw this coming, they should have been planning for FDA approval for a while.

The reality may be that the FDA was sending them away, and is now saying “you can do nothing without our approval.” Do I really want to know the facts? Here’s what I’m pretty clear on. The FDA and the CBD courses of action are headed on a collision course. I hope I’m completely wrong.

Is CBD legal or not??

Is CBD legal in all states? In some states?

As we already know, Cannabidiol, CBD, a single cannabinoid of the 105+ cannabinoids naturally occurring in marijuana,  appears to have significant health benefits in many studies. It also has no “get you high” effect. While arguably “psycho-active,” because it appears to reduce anxiety for example, it does not get one “high.”

2/13/2019, I see the following confirmation of a trend I predicted, without joy. I’ve written that the legality of the cannabinoid CBD, or cannabidiol, is ambiguous. I predicted that because of the ambiguity, some people, believing CBD to be nationally legalized, will be prosecuted criminally. I immediately learned of friends whose clients were suffering that very fate. Today  Civilized Life reports that NYC is cracking down on “main stream” CBD products. According to the article, the  New York City Health Department is cracking down on restaurants and coffee shops selling products with CBD in them. The Health Department is claiming that CBD isn’t approved as safe to eat or drink, and therefore establishments in the city are not allowed to use it as an ingredient in their products. This of course mirrors the FDA involvement I’ve written about.

Some lawyers argue well that hemp, and CBD made from hemp, is legalized by the 2018 Farm Bill. 

An excellent way to track the status of the various pending federal bills which have already been put forth to solve the problem, the status can be specifically tracked on the NORML website.

Recently, increasingly, CBD has been treated as legal, and has to a large degree become de facto legal. Legal because everyone thinks its legal. This misperception has become stronger after the passage of the Federal Farm Bill this year. Bring the Federal Farm Bill, passed in late 2018, and the FDA appearing at the table, and the near future trend is worthy of attention. It poses great danger to those already invested in the CDB business. While many elected to office are siding with the populace, with the votes and with the money, ignoring or supporting the “legality” of CBD, the Federal Food and Drug Administration is not taking a laissez-faire attitude. On the heals of the Farm Bill passage, the FDA announced that it now came into their bailiwick, being a substance for human consumption, application, etc., and possibly meeting the criteria to support the assertion of FDA jurisdiction.

While long-term, I see no question that CBD will be legalized and regulated nationally and beyond, short term, some people will get caught in the meat grinder we call “law.” People following the advice of attorneys will sometimes find themselves being prosecuted for doing what they truly believe is legal.

The legal conundrum is this. First, marijuana is still a Federal Controlled Substances Act Schedule One Controlled Substance (with contradictions appearing in many places legally). That includes CBD, which comes only from the cannabis plant. Second, and what is looming as the most critical impending problem is this.

Once the Farm Bill passed, the FDA Food and Drug Administration jumped in immediately, asserting their power over things to be consumed or applied to the body. The current  range of purported CBD products  are available everywhere from truck stops to Amazon to legal cannabis stores.

Some  CBD products are produced in states where it is at least “state-legal,” regulated and lab-tested. The labels are hopefully and probably fairly accurate as to the product actually found in the container. No extra ingredients, and no missing ingredients. No extra THC, pesticides, molds, and the like.

In states in which Cannabis is legalized, regulated, and monitored including laboratory testing for ingredients, the consumer can be pretty confident that the product contains generally what is claimed on the label.

In other states, there is simply no way to know if a product on the shelf or website resembles its label contents or not.

Not only might there be zero CBD, but there may be THC present in higher amounts than per the label. Products which appear “legal” on the label in fact may not be. A tractor trailer of purported hemp, with very very low THC, was stopped, and the drivers held in jail for 30 days. While they are now out on bond, the case continues, and more testing in a different laboratory is being pursued.

Conclusion: During this transition period, I believe we can have more confidence in CBD labels on products from states which have legalized and regulated CBD and other cannabis products. Otherwise, there is simply no way to tell what the product really contains. It could be high in THC, resulting in failing urine drug testing, may contain harmful ingredients, and may contain little or no CBD. This is an excellent example of a legitimate need for government involvement to protect consumers, whether they are using marijuana medically or recreationally or both.
When one takes a medicine, one needs to have confidence in the contents of the product. That comes with legalization and regulation.