In Response to Recent FDA Actions

In Response to Recent FDA Warning Letters

We have received a lot of questions from customers and consumers about CBD issues around safety and legality as a result of the recent warning letters put out by the FDA to 15 companies producing CBD products, and the last Consumer Update regarding the use of CBD. There is a lot to address here, but I will try to keep this brief.

Part 1. Warning letters.

To be clear, we have not received one of these letters, but 15 companies did, mostly for making drug claims, or for using CBD isolate as a food additive. In regards to the letters issued, these are not unusual or unexpected. Hemp products, including those naturally containing cannabidiol (CBD), are subject to the same regulations as other plant-based consumer products. In all cases, these are a continuation of the pattern the FDA has shown towards drug claims and medicinal herbs as food additives.

While not as well covered in the media as drug claims, the prohibition against using medicinal herbs in food products is not a new issue for the FDA, who have warned against these uses for decades. While culinary herbs are allowed in food, the use of herbs for functional use, i.e., to change the structure or function of the human body, is prohibited. Adding functional herbs to food to support health is also prohibited. It gets even more serious with CBD isolate, as that crosses into the use of a drug in food. To quote from an FDA warning letter: “it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public."

This is where the GW Pharma patent on CBD as a drug comes into play. CBD isolate is an approved drug with recognized clinical investigations and recommended drug use, so CBD Isolate in food is prohibited. Unless there is a significant change regarding the patent rights for CBD Isolate, consumers should expect to see a lot of food choices change over to full-spectrum hemp extract, rather than isolate. While we disagree with the granting of the patent, these letters are consistent with prior regulatory efforts with herbs.  

For those who may not be familiar with how herbs are regulated for sale in the U.S., the simple story is, we are allowed to sell herbal products, but we cannot tell people how to use them as drugs. According to the FDA, any claim to treat, cure, or mitigate a disease or disease state in a man or animal is a drug claim. It does not matter if there is scientific evidence or validity to the claim. Making a claim means the product is being marketed as a drug and is subject to the regulations for drugs.

It is worth noting that the warning letters confirm that websites and social media posts are subject to labeling laws against making drug claims. One of the warning citations was for referencing research. The statement "U.S. government-funded research proves the CBD helps relieve inflammation, chronic pain, anxiety, psychosis, seizures, spasms, arthritis, diabetes, alcoholism, Multiple Sclerosis, schizophrenia [sic], PTSD, depression, antibiotic-resistant infections, epilepsy, and other neurological disor-ders [sic]." was found to be a drug claim for the use of CBD.

Consumers are advised to avoid companies making wild disease claims or references to using CBD to treat diseases in their marketing, websites, and social media. Companies making these claims are showing their lack of experience and professionalism, and their actions raise legitimate questions about their professionalism in general. In a wild west environment with a lot of shady actors, we support efforts to bring professionalism and safety to the CBD market. False claims should raise red flags for consumers.

Part 2. FDA Consumer Update

We agree that companies should not make false claims, but the same expectation should apply to the FDA, who have crossed over from their legislated regulatory authority into making false claims of their own, based on specious arguments. The FDA released a Consumer Update on November 25th, 2019, with many assertions and opinions that are poorly supported. These assertions and views have not been defended in court, and reveal a bit of a power struggle between Congress and the FDA. The concerning comments are that the FDA has not approved Hemp Extracts as a dietary supplement and that CBD has the potential for liver toxicity, drug interaction, and unintended side effects. Here is our opinion on their opinion, with a preface that I am not an attorney, and the legal status for hemp derivatives is somewhat of a gray area as this all gets worked out.

The update states that they have not approved CBD as a dietary supplement, making it illegal, but fail to note the protections given for the sale of Hemp Extracts in the Farm bill, or that their opinion has not been evaluated by the courts. The FDA is at odds with Congress on this issue. In passing the 2018 Farm Bill, Congress redefined Hemp to include its "extracts, cannabinoids and derivatives." Section 10113 provides that "the term 'hemp' means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis" thus making it clear that the intent of Congress is to make these products available. Additionally, according to an opinion from Venable Law firm, the use of "hemp producer" in the proposed Bill rather than "hemp grower" indicates that the THC cap in the definition of Hemp extends beyond cultivation to manufacturers of hemp extracts and derivatives.

Upon publishing the proposed final rules on Hemp by the USDA, the FDA immediately pushed back asserting their position that they had not approved CBD as a dietary supplement. Senators Mitch McConnel and Chuck Shumer sent a letter to the FDA commissioner asserting their intent for these hemp products to be available, and the expectation that the FDA will comply with the law they passed, to which the FDA responded they would find a way to comply. In short, while the FDA may not like it, Congress writes the laws, and Congress has changed the law on Hemp. The FDA gets to make regulations, but their regulations do not supersede the law. Laws have precedence over regulations, so we know how this will ultimately work out.

As for the remainder of the update, the FDA makes a lot of assertions and shares opinions that have not been defended in court. They are sharing bad science, and frankly, this amounts to fear-mongering. The authors fail to differentiate between Isolate and full-spectrum hemp products or to look at levels of consumption by consumers vs. clinical use or animal studies. They fail to acknowledge that there is significant experience with this herb with millions of consumers, and the statement from the World Health Organization that CBD is safe and shows no signs of addiction or abuse. The claims on liver health are not consistent with reports from clinical practice and are based on a single in vitro study. In short, this update seems like a way to make consumers afraid, as an effort to try and put the genie back in the bottle.

At Green Earth Medicinals, we believe hemp-derived CBD should be a consumer choice, but we recognize the need for regulation. There have been humans who would hurt each other for personal gain since the time of Cain and Abel. We should acknowledge that the hemp industry is as likely to have bad actors like any other industry. We encourage and support a regulatory framework that allows and supports access for safe, effective Hemp-derived CBD products in an honest and transparent process. There are legitimate concerns that need to be addressed. The use of toxic solvents is a problem. The practice of adulteration is a bigger problem than people recognize, and the industry is rife with companies whose products fall below label claims on potency. We have rules because history teaches we need them, but these rules and regulations should be based on facts and science, not fear.

Doug Williams, National Sales Director
Green Earth Medicinals
Jan 3, 2020