This article first appeared on LinkedIn
Over 5,000 years ago, the ancient Egyptians would ingest gold for mental, physical and spiritual purification. They believed that gold was the "perfection of matter" and that its presence in the body would cure a multitude of diseases. This practice continued throughout antiquity in ancient China, medieval Europe, through the Renaissance with Paracelsus and even today with things like gold flaked cupcakes. While most of history has shown anecdotal proof of the health claims for gold, there was one thing that clearly stood out; particles within gold are highly toxic. While Pharaohs, Emperors and Kings would be administered "pure" gold, alchemists went about the countryside using lower quality gold filled with impurities including lead, to treat the masses. Many of these folks died from gold's toxicity (including some of the "elite") instead of their original ailment. So why the history lesson? In the pet food industry the FDA is the Regulatory agency responsible with enforcement and adherence. Each state has their own regulatory functions and operate collectively as AAFCO. While not perfect, they are in place to vet ingredients (including definitions and proper, safe usage) and to create a common platform. The problem is that the pet industry is so popular/profitable and the barrier to entry is so low that hundreds of new entrants hit the market each year and these agencies are understaffed to handle it all...and EVERYONE knows it! The problems arise when people and companies choose to selectively (if at all) follow the rules and regulations. They would prefer to "roll the dice"and proceed without authorization, touting marketing and anecdotal information rather than scientific facts.
Today's "gold" in the pet industry is cannabidiol (CBD) oil. While CBD is supported by vast amounts of marketing and anecdotal stories, very little scientific research is available in the public domain. While some consumers may be ok with, "Trust me, Fifi was cured of cancer, diabetes, arthritis and even hunger," as an industry, we need to get back to Edward Deming's adage of "In God we trust, all others bring data."
The cannabis plant contains more than 100 different chemical compounds known as cannabinoids, the two most well known are CBD and THC (tetrahydrocannabinol). THC is a psychoactive compound whereas CBD is not. There is no debate that the effects of THC on a dog are unpleasant and range from lethargy, wobbling gait, dribbling urine and saliva as well as extreme sensitivity to light and noise. Dogs also don't have the mental faculties to understand what is happening or how long it will last. In larger quantities, it can be deadly. According to the ASPCA, while most CBD treats are labeled to contain between 2.5 and 5.0 mg/treat of CBD oil, there is "likely to be some THC in the products." Rather than dance around what may or may not be included or to what level (if any) THC is present, lets get to the bottom line. According to the DEA, CBD is technically illegal because it is a Schedule 1 drug which is defined as "having no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse." While it is true that the FDA approved a CBD based product called Epidiolex for two specific forms of epilepsy, the DEA ruled that only Epidiolex (and not CBD in general) would be placed in Schedule 5 - the least restrictive classification. “DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” acting DEA administrator Uttam Dhillon said in a press release. “DEA is committed to continuing to work with our federal partners to seek ways to make the process for research more efficient and effective.” And make no mistake, CBD is still illegal under federal law! If we engage in the game of "what if...?", lets say CBD was approved as a drug. It would now fall under the laws and regulations of similar class drugs. It would NOT be allowed as a supplement, it would NOT be allowed as a food additive or ingredient. The California Department of Public Health (CDPH) released a statement that read in part, "The use of industrial hemp as a source of CBD to be added to food products is prohibited. CBD products are not an approved food, food ingredient, food additive or dietary supplement." This stance was supported by the FDA when they asserted that any products containing CBD cannot be sold as dietary supplements. They also determined it is not legal to sell in interstate commerce food to which CBD has been added."
In the CDPH release, they make a distinction between cannabis and industrial hemp as the source for CBD. THC makes up between 5-10% of cannabis whereas industrial hemp (Cannabis Sativa L.) contains 0.3-1.5%. The 2014 Farm Bill is often cited as evidence that CBD derived from industrial hemp was legal. But the legislation legalized only a very narrow set of hemp cultivation activities. In June of 2018, Senate Majority Leader Mitch McConnell (R-KY) introduced a new Farm Bill which would legalize industrial hemp in the US as an agricultural commodity, similar to corn and soybeans. The final vote is set to take place during the current session and is expected to pass with bipartisan support. The key takeaway is that industrial hemp will be legal, allowing thousands of acres of hemp to be planted which in turn will give ample opportunity to formulate, test and research products! It is important to note however that CBD will still be ILLEGAL!
STOPPING THE CBD CHARLATANS
With CBD being illegal, some would say that Regulatory agencies are "anti-health". Quite the contrary, they are pro-health and want to make sure that what we eat and what we feed are safe. From the FDA.gov website, “Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.” Even the Drake Center for Veterinary Care issued a statement/warning, “Due to the lack of research and regulation surrounding CBD pet products, we are not currently recommending them to pet owners. However, we are awaiting the results of the clinical trials to see the effectiveness or ineffectiveness of these products, as well as their safety.” Much like the gold cures offered to the commoners in medieval Europe, not all elixirs are created equal. The sourcing, purification process, THC levels and levels of CBD are all (currently) unchecked. In a statement from FDA Commissioner Scott Gottlieb, M.D., he said, "[There is a pathway] that includes a robust clinical development program along with careful review. This process includes a review of purity while conducting rigorous scientific research through adequate and well-controlled clinical trials; this includes the understanding of safe and effective treatment for a particular condition, what the proper dosage is, the proper populations served and whether the drug has any interactions and if it is free of side effects and other safety concerns."
I think the potential of CBD oil for pets and humans is tremendous. At Guardian Pet Food, we have paper formulations waiting in the wings to be made and tested but won't until it is legal. If I don't agree with a set of guidelines, regulations or laws, I do not have the right to selectively choose which ones to adhere to and which ones to ignore. "I don't think the speed limit here should be 35 so I'm going to go 50." In making that decision, I will have no one to blame but myself if and when I a) get caught speeding and b) cause harm to another's person or property. I understand that the general distrust and paranoia of government entities is at an all time high (pun intended) but rather than ignore them, work within the system to change it. If we don't, we will only bring about more regulations and laws and less tolerant enforcement. The pet industry, at times, resembles the wild west. There is the "law of the land" but some go about and do what they want until the Sheriff and his posse roll in to town.
While this article was dedicated towards CBD in the pet industry, you should look in to the claims that companies make, the ingredients they use and how it is labeled on their packaging. Many out there are using ingredients that are not approved by AAFCO; some are using approved ingredients in a manner that has not been approved and many more are misleading consumers with their ingredient decks using copy that is not allowed or by not following the FDA labeling requirements. At the end of the day, I'm not sure what is worse; ignorance of the law or the blatant circumvention of the law.