Despite the fact that hemp is federally legal, it bears little in common with commodity crops such as cotton or bananas. Hemp is a Cannabis Sativa plant that contains all of the same therapeutic—and illicit—compounds as marijuana, including CBD and THC. That means if hemp plants mature for long enough, their THC content can rise above the legal threshold of 0.3% THC.
Thus, at any given time in the growth cycle, hemp is only one decimal point away from being categorized as a Schedule 1 controlled substance. Because of this, the USDA has enacted strict regulations to ensure farmers are growing and testing it properly.
So Many Uses
Additionally, hemp is a multi-use crop. Along with its commercial and industrial value, hemp is also used in health and wellness products, making it of key concern across various regulatory organizations.
Hemp’s most famous derivative today (and in the foreseeable future) is CBD, from which products include ingestible oils and isolates, smokable vapes, and topical creams. Such products are sold to consumers as well as to patients in medical marijuana treatment centers.
These uses take hemp outside the purview of the USDA and into the world of state health departments and the FDA, which regulates cosmetics, food, medicine, and supplements. And the FDA isn’t thrilled with the fact that this brand-new substance is everywhere, from gas stations and yoga studios, to boutique markets and beauty stores.
According to the FDA, there is simply not enough evidence to prove that CBD is safe for consumption. With that, the federal government, states’ governments, and local municipalities are scrambling to enact legislation regarding hemp growth, acceptable products, and third-party laboratory testing.
Let’s explore further.
The THC Issue
The USDA recently issued interim rules for growing, sampling, and testing hemp to ensure all crops remain under the legal limit of 0.3% THC. From dictating the allowable number of plants per acre, to acceptable equipment, to the type of third-party laboratory tests required, the rules are extensive. And they make sense, considering how easy it is to accidentally grow a “hot” (illegal) crop.
In 2019, hemp CBD farmers lost countless plots because they accidentally harvested crops that exceeded the acceptable level of THC. For example, 40% of Arizona’s 2019 “hot” hemp crops had to be destroyed due to high THC levels.
To prevent such needless loss this year, farmers are cutting samples of their crops early in the growth cycle before it’s too late to mitigate the issue. They are also sending samples to multiple third-party laboratories throughout the growth cycle to verify the results.
Hemp-derived CBD products are everywhere, from online shops to local health-food stores, and in various products, from oils and powders, to topical creams, supplements, coffee, and energy bars.
Countless labels contain content explaining the potential health and wellness benefits of these products. But in marketing their products as therapeutic, companies are going against the FDA.
The FDA determined that there is not enough evidence to make therapeutic claims and is currently investigating whether or not hemp-derived CBD is safe for ingestion. In November 2019, the FDA issued a news release stating it sent warning letters to 15 companies for illegally selling CBD products in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). IS THERE ANY NEW DEVELOPMENTS ON THIS?
One example is Natural Native, which marketed one of its CBD products for babies with brain damage. Other violations include marketing any CBD products as a supplement or adding CBD to food, regardless of what the label says. That’s why CBD companies must be very careful about the types of products they sell, the way they design labels, and the language they use to market products.
If companies go too far, they may suffer brand reputation damage and financial loss related to FDA crackdowns.
As of January 9, 2020, the U.S. News & World Report cited 57 deaths resulting from a vape-related respiratory illness. And as of this blog, mounting scientific evidence shows that vitamin E acetate may be the culprit. Vitamin E acetate has been used as a cutting agent by several vape-cartridge manufacturers due to its ability to both dilute THC oil and thicken the substance, making it more convenient to add into vape cartridges.
This feature allows companies to sell toxic THC and CBD vapes that look pure and smoke smoothly. Most reported issues have stemmed from THC vapes, particularly those purchased illegally, but vitamin E can be used in hemp products as well, if left unchecked. To tackle this problem, ACS Laboratory acted quickly.
Working with its R&D scientists to develop a test for vitamin E acetate, ACS has been testing vapes for this deadly cutting agent since September 2019.
In addition to vape-related illnesses, the federal government is also worried about flavored vapes due to their appeal to young people. The number of minors smoking vapes increased significantly last year, causing the FDA to issue a nonbinding guidance in which it states the intention to ban flavored cartridges that appeal to children.
While the notice is directed toward nicotine vape cartridges, it may also apply to flavored CBD vape products in some cases. For example, if the CBD vape also contains nicotine or is explicitly marketed toward youth.
E.coli, lead, mold, bacteria, pesticides, and poisonous chemicals such as hydrogen cyanide are just a few of the possible toxins that can contaminate hemp as it goes from plant to product. One major issue is that hemp is a bioaccumulator, which means it can absorb pesticides, heavy metals, and toxins from the air and soil. When ingested, these contaminants can cause illness, brain damage, and even death.
Moreover, mold can grow on almost any substance where moisture is present, producing spores that can cause slight odor, spoilage, or significant illness to the end user if inhaled. Contamination can become an even greater health risk once the hemp is heated and smoked. For example, myclobutanil becomes poisonous hydrogen cyanide when heated.
Myclobutanil is the active ingredient found in most pesticides. It is incredibly dangerous to humans when inhaled. To protect human health and provide safety from common contamination, states are creating rules related to hemp quality testing.
Florida, for example, explicitly documents its testing requirements for all major contaminants along with the acceptable safety limits. In order to sell hemp in Florida, farmers, processors, and manufacturers must ensure its quality through testing with a third-party accredited laboratory.
Safety and potency tests rely on precision to guarantee the product is ready for market. Yet in a study of 10 laboratories in the famous 2011 Ring Test, Project CBD found that three labs produced results that deviated by 25% or more in over half the samples it tested. Some inconsistency is expected due to the fact that hemp is a plant that naturally varies in potency from batch to batch.
However, gross miscalculations can only occur as a result of faulty equipment, lack of experience, and at times downright falsified results. For example, Marijuana Business Times reported that Sequoia Analytical Labs surrendered its license in late 2018 after the Bureau of Cannabis Control discovered the company was falsifying results for at least four months.
Due to human safety concerns and the risk of inaccurate laboratory results, state governments are cracking down on laboratory regulations. As of January 2020, Florida submitted stringent requirements, which include a nearly $63,000 application fee that only ISO17025 certified laboratories can qualify for. The requirements state that such third-party laboratories must have standard operating procedures in place, pass proficiency testing, and maintain a high level of facility and staff standards.
Whether smokable, ingestible, or topical, hemp products are being used to treat symptoms and ailments that include insomnia, PTSD, Alzheimer’s disease, autism, dementia, and menopause. While the federal government has yet to enter this market, states where medical cannabis is legal are drafting stringent regulations to ensure these medicines are safe. Many states require every hemp plant, product, and derivative to be tracked as it moves through the supply chain, to ensure patients are receiving a legitimate product.
Moreover, states are requiring that medical treatment facilities work with certified laboratories to guarantee the product is free from contaminants and contains the precise amount of cannabinoids stated on the label. While medical hemp and cannabis regulations vary from state to state, they undoubtedly require an extra level of testing. Often states will also require that medical marijuana treatment centers obtain a Certificate of Analysis from verified laboratories before selling the product.
COAs generally state which third-party laboratory performed the test, the cannabinoid profile by weight percentage, and the results of the toxins analysis. This information is vital to quality patient care.
Due to hemp’s brand-new legal status and widespread uses, it is one of the most heavily regulated crops in U.S. history. Regardless of the state where it grows, the product it’s in, or the government body investigating it, all hemp regulatory roads lead to quality testing. Hemp cultivators, manufacturers, and treatment centers must all partner with an accredited third-party laboratory to ensure their products are safe and compliant.
ACS Laboratory’s testing panel and protocol is compliant with Florida’s Hemp Program. ACS meets federal requirements by testing to the standards of Florida, the strictest state. The compliance panel consists of: Cannabinoid Potency, Pesticides, Residual Solvents (unless its flower), heavy metals, mycotoxins, moisture, microbiology.
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