The benefits of CBD oil are becoming well known, and people are wondering, “Is CBD oil legal to order online?” The short answer at the time this was written is yes, CBD is legal to order online, while the longer answer is of course, more complex and dependent on ever-changing laws.
Industrial Hemp vs. Cannabis
The 2018 Farm Bill made it possible for domestic farmers to farm industrial hemp legally. The Farm Bill also included sufficient language to make it legal to buy and sell oil extracted from this hemp. This language, and making it legal to transport hemp across the United States was key to igniting a booming industry. No longer do farmers have to worry about police stopping their hemp on the way to its destination.
The Farm Bill defines hemp as a variety of cannabis plant that does not contain more than 0.3% of the psychoactive compound THC. Hemp can’t get you high, yet for decades federal law has not differentiated CBD from hemp vs. CBD from cannabis plant variations like marijuana. The Marihuana Tax Act and subsequent Controlled Substances Act of 1970 made THC-containing marijuana illegal.
The Farm Bill is especially crucial because it ends the blanket prohibition of all cannabis and legally differentiates hemp. The bill doesn’t necessarily provide an answer to “Is CBD oil legal?” What it does do however is explicitly allow for hemp-derived products to be transferred and sold across state lines (in accordance with state law).
“(a) Rule Of Construction.—Nothing in this title or an amendment made by this title prohibits interstate commerce of hemp (as defined in section 297A of the Agricultural Marketing Act of 1946 (as added by section 10113)) or hemp products.”
2018 Farm Bill Effects on CBD
This will require states to clarify their policies around hemp-derived product transport and sale. It will also require consideration of the genetics of the cannabis plant. Hemp varieties like Finola have long-standing genetics. Hemp growers are now creating high-CBD/low-THC cannabis varieties to increase the extracted amount of CBD from a crop.
The provocative question around this breeding is, “Can you turn marijuana into hemp?” At this time, there is no clear legal answer, but from a biological perspective, it would seem possible.
Summary of CBD Federal Law 2019
Many have come to know hemp oil as “CBD oil,” but that term has come under fire by the FDA following the approval of Epidiolex – a pharmaceutical comprised of isolated CBD.
A 2018 FDA statement dictated that CBD isolates are not allowed to be added to ingestible (food) products, and prohibited CBD containing products from being labeled as a dietary supplement.2 This statement effectively means that most CBD products on the market do not have compliant labeling because they use the term “CBD oil” instead of “hemp extract.”
The FDA knows it must work with CBD producers to give CBD products a practical classification. Meanwhile, many CBD producers are relabeling CBD oil as hemp extract since that term that falls under the protection of the Farm Bill’s legal language.
In recent times, the following significant events have occurred:
- The Farm Bill has allowed:
- Extraction, sale, and transport of hemp
- Hemp-extract as a dietary supplement
- Hemp to be defined as cannabis with no more than 0.3% THC
- FDA does not allow mixing of CBD isolate with food
- FDA does not allow CBD-isolate as a dietary supplement
- States can further dictate hemp transport and sale rules
- State marijuana legislation may allow for more leniency with CBD products
- Many producers are voluntarily testing and producing products under GMP
- FDA expects to yield to market demand for CBD supplements
Is CBD Legal in all 50 States?
Cannabis is entirely legal in Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, and Washington. In these states, CBD oil from cannabis that contains more than 0.3% THC is legal in addition to CBD-containing products from hemp.
As of mid-2019, Idaho, Nebraska, and South Dakota restrict all cannabis and cannabis-derived products, including hemp:
- In Idaho, hemp extracts must not contain any THC at all.
- In South Dakota, CBD has moved to a Schedule IV controlled substance.
- South Dakota only allows FDA approved CBD products (Epidiolex).
- In Nebraska, all cannabis products except Epidiolex will be list as a Schedule I drug.
- Nebraska legislation currently conflicts with the Farm Bill’s federal legislation of hemp.
CBD – Drug, Supplement, or Food Ingredient?
By regulatory definitions, drugs are substances intended to treat or cure health conditions. Dietary supplements have a legal meaning of being ingredients used for dietary purposes. These would include vitamins, minerals, amino acids, herbs or botanicals, and other substances that can be used to supplement a diet. A whole-plant hemp extract should fall under the dietary supplement definitions and allow producers to use the dietary supplement production guidelines.
The FDA and DEA are maintaining that CBD remains a Schedule I drug because of the approval of the pharmaceutical Epidiolex and its active ingredient CBD.1 In their view, CBD companies should only be allowed to operate as pharmaceutical drug companies. That would mean CBD producers would have to pay the extremely high costs of performing clinical trials and applying for FDA approval as a drug.
Only large pharmaceutical companies can afford the approval processes and clinical trials needed to produce CBD as a drug. The FDA believes that a CBD oil company cannot make claims that CBD oil is safe, effective, or claim to treat or cure any condition without undergoing those cost-prohibitive processes.
Companies will need CBD to be regulated as a dietary supplement or under food ingredient regulations that are not financially cumbersome. If that isn’t possible, the result is that small to mid-sized CBD businesses will not be able to afford to do business and cease to exist.
Consequences of Regulating CBD as a Drug
The jury is still out with the FDA as to how CBD will be regulated and if it will remain legal to produce and sell without having to go through formal drug approval. Commissioner (now former) of the Food and Drug Administration (FDA) Scott Gottlieb recently resigned his post. His resignation leaves the legal status of CBD in limbo as we await his replacement.
If the FDA holds to their current opinion that CBD is an active pharmaceutical ingredient (drug), we may see the following impact across the industry:
- CBD product production and sales will stop
- People depending on CBD will no longer be able to buy it
- May become a black market product, void of quality assurance and testing
- Will become extremely expensive
- Will require a prescription
- Employers may institute a CBD drug test, which could be failed
- Most CBD producers will go out of businesses leading to job loss
- Insurance companies lack guidance in what they can cover
- CBD companies may face taxation complications
The stakes are high for CBD producers, employees, and consumers. Business owners may go out of business. Children with epilepsy may not be able to afford CBD for seizure relief. An older person may no longer be able to afford to buy CBD for pain and more. It is evident that regulating CBD as a drug would be extremely detrimental to the American public.
CBD Producers in the FDA Crosshairs
Safety and effectiveness do matter to CBD producers; at the end of the day, it would just be bad business to produce a product that could be harmful or ineffective. The industry has begun to self regulate to an extent by voluntarily conducting testing for contaminants and cannabinoid levels, and publishing the results for each batch.
One issue that remains is how CBD producers talk about their products and market them. The FDA can (and has actively been) issue warning letters to producers if they use language that suggests CBD can cure or treat conditions. Likewise, the issuing of these letters is also true if producers provide dosing suggestions in the wrong way.
The FDA began issuing warning letters in 2015. Some popular CBD producers have already started to receive these letters for reasons such as marketing claims and test results not matching the claimed CBD content:
- Green Roads (2017)
- Stanley Brothers (2017)
- Healthy Hemp Oil (2016)
- Green Gardens Gold (2016)
- CannaPets, LLC (2015)
- And more!
The CBD industry is coming a long way quickly. Third-party lab testing is becoming a voluntary standard through the CBD industry. The industry has learned from companies that were not accurately representing the mg of CBD in a bottle. Testing is now becoming standard practice for CBD companies.
Doing What is Right
Companies like Stanley Brothers have taken significant steps to correct the issues behind their citations. Also, CBD producers are looking to the cannabis industry for guidance in performing testing for pesticides and heavy metals.
More than ever, CBD producers are voluntarily taking up the challenge to produce safe, high-quality products by using Good Manufacturing Practices (GMP). GMP is a set of regulatory guidance from the FDA that applies to food, cosmetics, supplements, medical devices, and drugs. Additional guidance exists for each product type. This guidance dictates how every kind of product should be produced, labeled, stored, tested, and sold to ensure maximum public safety.
At a minimum, GMP requires the production of products in facilities that are inspected by the FDA for cleanliness, record keeping, and contamination prevention and testing. GMP ensures that full traceability through records of each batch in case products need testing in the face of an issue.
The Legality of CBD Marketing Claims
The question remains, “What can a CBD producer tell you about their product?” Speaking to the benefits of CBD could be interpreted by the FDA as making claims of efficacy. Even dosing suggestions aren’t allowed for a non-pharmaceutical product that hasn’t gone through dosing studies.
Consumers need to remember that the particular information gathered from a study may have been an animal model or a limited number of people. Despite those limitations, research and repeated studies are speaking volumes about CBD’s benefits and CBD oil dosage and administration.
Currently, the details of what a CBD producer can tell a consumer on their website or in their product description will remain vague and unclear until the FDA provides more guidance. Many sites must refer customers to do private research and read educational content.
The Future of CBD Legality
2019 is going to be a big year for cannabis. In Canada, the federal legalization of cannabis under the Cannabis Act is beginning to roll out. This will provide a model for ending federal cannabis prohibition. Cannabis faces a complicated process of acceptance in the US.
Finally, the state and federal interpretation of the Farm Bill will face further clarification from the federal government. CBD oil producers and consumers experiencing CBD oil benefits are hoping that the next head of the FDA will have views that align better with the American public.
For now, consumers need to be aware that CBD oil labeled as “hemp extract” requires research into the product’s formulation. Producers may not be legally able to clarify, but here are some helpful tips for consumers of CBD products:
- If made from hemp seed, the product will not have the same CBD benefits
- Check the producer’s website for published laboratory results
- Look for producers that use hemp from the US or Europe, avoid Chinese hemp
- Look for research-based educational resources on the producer’s website
- Write your local government to support CBD legality
References
- Fife, T. D., Moawad, H., Moschonas, C., Shepard, K., & Hammond, N. (2015). Clinical perspectives on medical marijuana (cannabis) for neurologic disorders. Neurology. Clinical practice, 5(4), 344-351. DOI: 10.1212/CPJ.0000000000000162. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4549715/
- Knight, R. (2019 March 06). FDA commissioner’s resignation raised questions about CBD regulation. Retrieved from: https://cannabusiness.law/fda-commissioners-resignation-raises-questions-about-cbd-regulation/
- Lee, MA. (2016 March 08). Sourcing CBD: Marijuana, industrial hemp & the vagaries of federal law. Retrieved from https://www.projectcbd.org/politics/sourcing-cbd-marijuana-industrial-hemp-vagaries-federal-law
- Warning Letters and Test Results for Cannabidiol-Related Products. US Food and Drug Administration. Retrieved from https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm
