National CBD Rules from Federal Government


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What are the Federal Government National CBD Rules?

For years, it has been up to each state to determine its own approach to rules applied to cannabidiol (CBD). Recently, however, regulations have been brewing at the federal level. In this article, we’ll explain what we know about these regulations as of now, with the caveat that this is a rapidly changing environment.

The Rise of the CBD Market

As laws related to the sale, possession, and use of marijuana continue to loosen up across the nation, products derived from the cannabis plant such as CBD have become more widely available. The big break that enabled the CBD market was the Farm Bill of 2018, which stopped the classification of hemp and its derivative products as controlled substances.

Many say the CBD market is “blowing up,” and while many have noticed CBD shops popping up in cities and towns everywhere, it’s worth remembering that only 17% of the U.S. population have ever tried a cannabidiol product, and an even smaller percentage are regular users. But it’s also true that those figures are on the rise as more people discover how they can safely find relief with CBD products, including pain relief, relaxation for stress relief, and better sleep.

The range of CBD products is also rapidly growing. It includes oils, juices, lotions, and gummies. Well-known brands such as Arizona Iced Tea and Ben & Jerry’s are testing whether and how to add it into their products. When you look at total sales of CBD products being well north of $13 billion, it becomes clear that the CBD market is now just too big to ignore. Unfortunately, more than one Washington DC agency is getting involved in creating federal government national CBD rules, which can make things confusing.

United States Department of Agriculture CBD Rules

The federal government of the United States agency that’s furthest along in creating CBD regulations is the Department of Agriculture (USDA). Back in October 2019 the Federal Register included draft interim final rules concerning hemp production. The final rules were just published on January 15, 2021. You can see a USDA press release about this, or even read the final rule(s) on the official website of the Federal Register, though we’ll provide a summary below, that takes effect on March 22, 2021.

These USDA rules are the ones that apply to hemp farmers, so they are the agricultural rules that help ensure the base crop is handled properly at the growing stage. One area that is always a concern is how much THC (tetrahydrocannabinol is the psychoactive component of a hemp plant) will be allowed. According to the rule, the base limit is 0.3 percent THC, which is the same limit allowed in Canada and a number of other countries.

How will the USDA verify that hemp produced by farmers is below the legal threshold of 0.3 percent THC? A sample of the hemp must be delivered and tested at a registered Drug Enforcement Administration (DEA) laboratory within 30 days before harvesting begins. The problem here, of course, is that there aren’t a lot of places where this testing can take place. For this reason, enforcement of this 30-day test-before-harvest for THC compliance aspect of the rules won’t be fully implemented by the DEA until December 31, 2022. There is also considerable leeway in how the sampling is done and which part of the plant is used in samples.

When a sample is tested and is found to be above the 0.3 percent THC threshold, it could be designated “negligent,” in which case the crop in violation would have to be destroyed. Two aspects about this have been tweaked in the final rule. First, the USDA has built in some leeway. As long as a given batch has less than 1% THC, it won’t be considered negligent. This additional flexibility is welcomed by hemp growers. Secondly, it used to be that non-compliant hemp crops had to be disposed or remediated by a government official from a federal agency such as the DEA, but in the final rule, growers themselves are allowed to dispose of the non-compliant crop through burning, composting, or burial.

Food and Drug Administration CBD Rules

While the USDA rules cover how hemp crops are grown, it will be the Food and Drug Administration (FDA) that comes up with rules to regulate the marketing and sale of CBD products intended for consumers. As more people discover or become interested in learning more about how CBD products can be used for a variety of health benefits and therapeutic properties (relaxation, stress relief, pain relief, better sleep, nausea control, appetite stimulation), they also want to know the products are both safe and effective.

Currently, the FDA does not regulate the marketing of CBD products, which means some pretty outlandish claims are being made about the wide-ranging benefits of CBD. Companies that make medical claims do put themselves in the regulatory crosshairs of the FDA, which has already issued warnings to some companies. FDA regulation could stop a lot of the misinformation about CBD products from bad actors who are currently taking advantage of consumers with subpar products that are neither safe nor effective.

The FDA situation is both curious and frustrating for those in the CBD market seeking clarification on how to make, market, and sell CBD products. The FDA does have regulatory jurisdiction over CBD because it is considered an active ingredient in the FDA-approved seizure drug Epidolex, but it has yet to establish broad regulations for other CBD products. What it can and does do in the meantime is combat what it considers false health claims by some companies who offer their CBD products as a treatment option for drug addiction, fibromyalgia, Alzheimer’s disease, and even cancer.

As far as the FDA is concerned, all CBD products meant to be consumed by people are essentially illegal at the federal level until they come up rules and regulations. This effectively shifts responsibility to state and local governments, which vary widely in how they’re handling CBD products. For the most part, there’s little to no enforcement of CBD products illegality, especially if the product has no TCH or very little.

The FDA had started on the draft guidance that it submitted to the Office of Management and Budget last July, but this has since been withdrawn as of late January. Why? The Biden administration put a freeze on all pending regulations because it wants to do a full review of everything to make sure all such rules are in line with its policy goals and priorities. While CBD companies want clarity, many are glad whatever the FDA was working on has been at least delayed. After all, the FDA could have easily just declared that CBD would not be allowed in any edible products whatsoever, which would be a disaster for the growing industry.

One thing that could move things forward is legislation by Congress. There is a bill that has been introduced in the House of Representatives to “make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the Federal Food, Drug and Cosmetic Act as an ingredient in a dietary supplement, and for other purposes.” This bill was first introduced in 2020 but never came to a vote but has been reintroduced in February of 2021. It’s H.R. 8179, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020.

What’s the status of CBD oil and other CBD products in Indiana? Indiana is extremely conservative when it comes to marijuana, cannabis, and hemp in all forms. Legislation that took effect in July 2017 allowed for CBD oil to be used in the treatment of those with resistant seizure conditions—a very small step in the right direction. In November of 2017 when Curtis Hill was Attorney General for the state, he noted that as far as state and federal laws were concerned, any product or substance containing cannabidiol is unlawful in Indiana. State laws were very clear in designating CBD as a Schedule I controlled substance in spite of the limited use of CBD oil to treat some patients with uncontrollable seizures.

Then in 2018 the federal Farm Bill came along and legalized industrial hemp in states that submit a hemp plan to the USDA for approval. Indiana submitted a hemp plan, and it was approved. Hemp production and processing in Indiana is regulated by the Office of the Indiana State Chemist (OISC). The hemp has to come in under the legal threshold for THC, but OISC notes it has no legal authority over hemp-derived CBD consumer products.

In February 2018, the Indiana legislature passed a bill legalizing CBD oil in Indiana. It was signed into law by the governor in March of that year and took effect in July. Any such low THC hemp extract must contain no more than 0.3 percent of delta-9 THC. Merchants retailing CBD oil must have a certificate showing their products meet the legal threshold for THC. Smokable hemp flowers have been an ongoing matter of debate because law enforcement claims they can’t easily distinguish marijuana from hemp. New legislation has been introduced to legalize smokable hemp flowers and create an open container law for cannabis.

The Pros and Cons of National CBD Rules from the Federal Government

These new and still-emerging rules regarding hemp production and CBD have their advantages and disadvantages. Up until this point, the CBD market has been a kind of “Wild West” situation where anything goes, which doesn’t inspire confidence on the part of consumers that the products are regulated for consumer safety. Consumers need to know that the CBD products they buy or would like to buy are safe and don’t contain ingredients or chemicals or toxins that might harm them.

The problem with regulation is that it comes at a cost to every producer, whether those are industrial hemp growers or CBD product manufacturers and retailers. Money must be spent on compliance practices, which could hold the market back at a time when financing is already difficult to obtain.

Without clear national CBD rules from the federal government, the result can be a confusing, debilitating maze of regulations that vary by state and even locale. This makes compliance next to impossible for producers who have to figure out what rules apply to them in each state or even specific municipalities. National rules take the guesswork out of compliance in a way that allows the market to grow within clearly defined parameters. The USDA rule covering the hemp industry was an important step in the right direction. If the FDA follows suit and creates reasonable safety and marketing regulations for CBD products, then the CBD market can continue to grow within a framework consumers can trust.

At Indy-CBD we are committed to providing a range of CBD oils and other products to help you achieve better health and optimal well-being. If you have questions about any of our products, please feel free to call us at (317) 961-0191. We’re always happy to assist you in any way we can!

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