The FDA and DSHEA – Federal Regulations So Far


The U.S. Food and Drug Administration (FDA) regulates both finished dietary supplement products and dietary ingredients, including CBD, under a different set of regulations than those covering conventional foods and drug products. These regulations, known as the Dietary Supplement Health and Education Act of 1994 (DSHEA), include prohibiting manufacturers and distributors of dietary supplements and dietary ingredients from marketing products that have been debased by adding inferior materials/elements, or that are misbranded.  DSHEA defines the term dietary supplement as “. . . any product (other than tobacco) intended to supplement the diet that bears or contains one or more dietary ingredient, including a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.” Furthermore, a dietary supplement must be labeled as a dietary supplement, be intended for ingestion, and must not be represented for use as conventional food or as the sole item of a meal or of the diet.  CBD oil products meet the definition of a supplement because CBD is an extract of a botanical and because it is used by people to supplement their diets.

Under the act, supplement manufacturers do not need FDA approval to market dietary supplements that were being marketed in the United States before 1994. However, dietary ingredients which are not so grandfathered are defined as “New Dietary Ingredients,” and are required to provide reasonable evidence of, or reasonable expectation of, their safety.  Furthermore, new dietary ingredients must be reviewed (not approved) by the FDA before they are marketed. In other words, for a manufacturer to make medical claims about the efficacy of CBD products in the treatment of any medical condition or symptom is a strict violation of the FDA/DSHEA guidelines. Although preliminary research has demonstrated tremendous potential for CBD oil to help people in remarkable ways, legitimate CBD companies will not make any direct medical claims.

Third Party Evaluation

Always limit consideration of CBD products to those that have undergone third party evaluation.  The goal behind independent third-party lab testing is to have a neutral, unbiased source examine the content and quality of a company’s products. This is incredibly important in today’s market, as the current lack of regulation of cannabis products has essentially allowed manufacturers and distributors to participate in sales efforts that are not particularly impressive with regard to ethical business practices. 

However, in terms of the cannabis industry, federal regulation has always been somewhat of a double-edged sword. On the one hand, the majority of manufacturers don’t want the government dipping their hands into revenues or telling them what they can and cannot do, sell, market, distribute, etc.  On the other hand, quality manufacturers know that an industry without rules and regulations will quickly become overrun with scams, false advertising, and out-and-out lies – making it very hard for consumers to make educated purchases or to receive quality, reliable information. To that end, honest businesses with quality products will always find a way to rise to the top, and in the current marketplace, most of them are accomplishing this through third party testing. Companies that know they are manufacturing and selling high-quality products don’t shy away from having an unbiased, outside source verify it for them.

With cannabis products, and CBD oil in particular, becoming more and more popular by the day, it’s becoming increasingly critical for companies to establish a reliable and reputable name within the industry. Consumers increasingly know and understand that quality CBD oil is capable of generating some notable improvements in terms of chronic pain, anxiety and depression, insomnia, and a whole range of other conditions.  Smart consumers are certainly not going to spend their hard-earned money on a brand that’s not even confident enough to have their products laboratory tested.

Uncertain Legality

CBD Oil is not a pharmaceutical drug. Pharmaceutical drugs should be understood as drugs that are used to diagnose, cure, treat, or prevent disease. While it is likely that, in the future, CBD will be used in pharmaceutical drugs, there is currently only one FDA approved pharmaceutical that contains CBD – Epidiolex, produced by GW Pharmaceuticals.  In June of 2018, the FDA approved Epidiolex as a treatment for seizures associated with two rare forms of pediatric epilepsy.  The approval marked the first time the FDA has approved a medication that contains a purified drug substance derived from Cannabis.  That approval forced the Drug Enforcement Agency (DEA) to reclassify the medication, allowing the manufacturer to finalize the medication’s product label.

The FDA has also approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC).  Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC but is synthetically derived.  Other companies developing such treatments include Axim Biotechnologies, which is developing a cannabinoid-based chewing gum delivery method; KannaLife Sciences, which is researching oxidative and neuro-toxic stresses born from a variety of ailments and illnesses including Chronic Pain and Chronic Traumatic Encephalopathy; CURE Pharmaceuticals, which is developing cannabinoids for the treatment of a wide range of sleep disorders; and Columbia Care, which struck a licensing agreement with Australia-based nasal respiratory company Rhinomed for the collaborative development of nasally-delivered cannabis-based medicines.

Prior to the approval of Epidiolex, the DEA considered all forms of CBD as Schedule I according to the Controlled Substances Act, a class reserved for drugs with a high potential for abuse and no accepted medical use. But, following the approval of Epidiolex, the DEA announced it would be placing the drug in Schedule V, the least restrictive class. However, any form of the drug that is not specifically FDA-approved remains in Schedule I.

In the meantime, the times are definitely changing.  On April 4, 2019, a bipartisan group of lawmakers proposed legislation that would end the federal prohibition on marijuana by allowing each state or territory to decide their own pot policy.  The legislation — dubbed the STATES (Strengthening the Tenth Amendment Through Entrusting States) Act — would amend the Controlled Substances act to limit federal action against those operating legally in states with legalized medical and/or recreational programs. Earlier, in March, 2019, Canopy Growth, a Canadian company, signed a $3.4 billion agreement to acquire the medical marijuana firm Acreage Holdings. The basis of the agreement is that as soon as the U.S. government ends marijuana prohibition, Canopy will assume the Acreage properties and storm onto the U.S. market as the most powerful cannabis seller in the United States.

There are a few rather interesting aspects of this arrangement, the first of which is the fact that Constellation Brands, maker of the beers Corona and Modelo, owns 37 percent equity stake in Canopy, and has an opportunity to take controlling interest in the next few years. So, it is conceivable that, regardless of how much the cannabis industry fights to become its own entity with its own set of unique rules, one of the largest brewers in the world is poised to become the most significant cannabis producer in the United States. Considering that Constellation is already working with Canopy to devise THC-beverages for the Canadian market, all of which is being done in experimental preparation for when the United States goes fully legal, it is difficult to see the point where they might opt out. It appears that Big Alcohol is becoming Big Cannabis.

On December 20, 2018, the Agriculture Improvement Act (the Farm Bill) of 2018 was signed into law. Among other things, this new law changed certain federal authorities relating to the production and marketing of hemp, defined as cannabis and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.

The 2018 Farm Bill is expansive, allowing hemp to be cultivated broadly, not simply through pilot programs for studying market interest in hemp-derived products. It explicitly allows the transfer of hemp-derived products across state lines for commercial or other purposes. It also puts no restrictions on the sale, transport, or possession of hemp-derived products, so long as those items are produced in a manner consistent with the law.  However, the new Farm Bill does not create a completely free system in which individuals or businesses can grow hemp whenever and wherever they want. There are numerous restrictions.  First, as noted above, hemp cannot contain more than 0.3 percent THC.  Any cannabis plant that contains more than 0.3 percent THC would be considered non-hemp cannabis—or marijuana—under federal law and would thus have no legal protection under this new legislation.

Second, there will be significant, shared state-federal regulatory power over hemp cultivation and production. Under section 10113 of the Farm Bill, state departments of agriculture must consult with the state’s governor and chief law enforcement officer to devise a plan that must be submitted to the Secretary of USDA. A state’s plan to license and regulate hemp can only commence after the Secretary of USDA approves that state’s plan. In states opting not to devise a hemp regulatory program, USDA will construct a regulatory program under which hemp cultivators in those states must apply for licenses and comply with a federally-run program.  This system of shared regulatory programming is similar to options that states have had in other policy areas such as health insurance marketplaces under ACA, or workplace safety plans under OSHA—both of which had federally-run systems for states opting not to set up their own systems.

Third, the law outlines actions that are considered violations of federal hemp law (including such activities as cultivating without a license or producing cannabis with more than 0.3 percent THC). The law details possible punishments for such violations, pathways for violators to become compliant, and even which activities qualify as felonies under the law, such as repeated offenses.  Ultimately, the Farm Bill legalizes hemp, but it does not create a system in which people can grow it as freely as they can grow tomatoes or basil. This will be a highly regulated crop in the United States for both personal and industrial production.

One big myth that exists about the Farm Bill is that CBD is legalized. It is true that section 12619 of the Farm Bill removes hemp-derived products from its Schedule I status under the Controlled Substances Act, but the legislation does not legalize CBD generally.  The Farm Bill creates exceptions to this Schedule I status in certain situations.  The Farm Bill ensures that any cannabinoid derived from hemp will be legal if, and only if, that hemp is produced in a manner consistent with the Farm Bill, associated federal regulations, associated state regulations, and by a licensed grower. All other cannabinoids, produced in any other setting, remain a Schedule I substance under federal law and are thus illegal.

There is one additional gray area of research moving forward. Under current law, any cannabis-based research conducted in the United States must use research-grade cannabis from the nation’s sole provider of the product, the Marijuana Program at the University of Mississippi School of Pharmacy’s National Center for Natural Products Research. That setup exists because of cannabis’s Schedule I status.  However, if hemp-derived CBD is no longer listed on the federal schedules, it will raise questions among medical and scientific researchers studying CBD products and their effects, as to whether they are required to get their products from Mississippi. This will likely require additional guidance from the FDA,  the DEA (the Drug Enforcement Administration, who mandates that research-grade cannabis be sourced from Mississippi), and NIDA (National Institute on Drug Abuse, who administers the contract to  research-grade cannabis) to help ensure researchers do not inadvertently operate out of compliance.