Understand the FDA and other Rules and Regulations for Making CBD Food Products and Supplements

This is the second part of our series on legal issues involving CBD and THC, ingredients of cannabis and hemp. The first part of the series reviewed the definition of these chemicals and the evolution of California’s laws on medical marijuana and adult usage of marijuana. The article also covered some issue on the right to sell marijuana commercially, use prohibitions, and federal licensing of marijuana issues.

This article will cover California’s evolving laws on the licensing and other uses of CDB and THC products. It is estimated that, after the passage of the US Farm Bill which made hemp legal (and may make CBD products based on hemp legal) that the hemp-CBD business maybe become a multi-billion dollar business. The FDA may approve some drugs provided they are properly validated and don’t run afoul of other FDA provisions.

Current types of CBD products

There are many different types of CBD-infused natural food products being sold. These include:

• CBD pain cream
• An emu oil salve
• A tea-like drink with CBD
• CBD infused drinks from breweries, bars, and cafes
• Vegetable juices
• Raw fruits
• Tinctures
• Edibles
• Vape oils
• Sprays
• Capsules
• CBD bars
• CBD gummies

Some people are even using these products for their pets.

Note that we are simply reporting here and we are not endorsing any product, or the manufacture, sale, or possession of any product or service involving CBD, THC, hemp, marijuana, or anything else listed in these posts.

FDA approval of Epidiolox for forms of childhood epilepsy

One approved use of marijuana-based CBD is a chemical called “Epidiolox.” This is a syrup used to treat two different forms of childhood epilepsy.

The U.S. Food and Drug Administration announced that it:

Approved Epidiolox (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.

Subsequent to the FDA approval of Epidiolox,

The Drug Enforcement Administration (DEA) issued a Final Order placing “FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols” [such as Epidiolox] in Schedule V of the Controlled Substances Act,”  “Schedule V drugs are considered to have the lowest potential for abuse compared to other scheduled drugs and a low potential for psychological or physical dependence.

Why scientific studies can help convince the FDA to approve CBD products?

The FDA was persuaded to approve Epidiolox, in part, because studies confirmed its effectiveness. The FDA said that results from three studies showed strong evidence that the CBD product was effective for treating seizures that are associated with Lennox-Gastaut syndrome and Dravet syndrome. The FDA found that the risks involved with the CBD treatment were acceptable – especially considering how debilitating and life-threatening the syndromes are.

The FDA believes that scientifically valid research conducted under an Investigational New Drug (IND) application is the best way to determine what patients could benefit from the use of drugs derived from marijuana. This research includes:

• Clinical research using marijuana
• Setting requirements for developing drugs that are derived from marijuana plants
• Providing support for investigators who want to conduct such clinical research through the IND process and the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.

The US Farm Bill

In 2018, a new US Farm Bill was passed. Senate Majority Leader Mitch McConnell even used a hemp pen for his signature. McConnell said that he hoped the new law would help hemp farmers in Kentucky and across the country.

The new law makes it legal to grow, transport and produce industrial hemp. Essentially, it removes hemp from the list of controlled substances. The Farm Bill now defines hemp as an agricultural substance. That means that scientific researchers can now study hemp.

The Farm Bill may also increase the booming CBD industry which advocates tout for its health and wellness. Still, even with the passage of the 2018 Farm Bill, the status of CBD products is uncertain. CBD from marijuana/cannabis is generally illegal. The question now is whether CBD from hemp may be legal because hemp is now legal.

The new Agricultural Bill preserved the FDA’s authority to regulate cannabis products and cannabis-derived compounds pursuant to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. This means that developers of CBD products must comply with the FDA regulations.

Marijuana vs hemp and the US Farm Bill

Marijuana and hemp both contain CBD and THC. Both marijuana and hemp come from the cannabis sativa plant species. The main difference between marijuana and hemp is the strain of cannabis. Hemp was generally bred for industrial applications. Which means it has low amounts of THC, the psychoactive ingredient that causes the feeling of being high. Hemp typically has more CBD than marijuana.

With the passage of the Farm Bill, businesses believe that banks and investors are more likely to work with industrial producers of hemp. The Farm Bill should expand hemp extracts with a high amount of CBD.

Josh Hendrix, the director of domestic product business development for cannabis company CV Sciences, says the Farm Bill

will provide a higher comfort level for retailers and consumers and will lead to more investment and opportunity in the industry as it will continue to see rapid expansion.

Scientists, however, worry that they need to wait to see how the Drug Enforcement Agency (DEA) responds to the Farm Bill. Until the DEA approves CBD products, researchers expect to be fairly cautious about studying CBD-based products.

Possible FDA label requirements

Labels need to include more than just the ingredients. Companies that make and sell these products, if labels become required, may need to include the ingredients and some of these additional items:

• The total cannabinoid content – CBD, THC, etc.
• The ratio of CBD to other cannabinoids
• Indicate if the product hemp or cannabis based
• State where the ingredients were produced – in California or elsewhere

There may need to be separate labels for seniors, for medical marijuana users, and for recreational users.

Labels also contain claims, and these should be reviewed by legal counsel familiar with FDA rules, laws governing consumer advertising, and other relevant laws and regulations.

The FDA’s position on selling products that contain THC or CBD as dietary supplements?

Currently, the FDA does not approve dietary supplements that are made with THC or CBD

If a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under the relevant federal law, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.

The FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.

Currently, the FDA also states that it is illegal under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.

This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.

The FDA does state that it may be possible for the agency to consider by issuing a regulation “allowing the use of a pharmaceutical ingredient in a food or dietary supplement.” – if all the other provisions of the FD&C Act are met.

FDA approval of CBD products for their intended use

The FDA is concerned that many companies are making claims about CBD or other cannabis-derived compounds that haven’t been approved by the FDA. The FDA requires that cannabis products that are marketing as having health benefits should be approved for its intended use before being allowed into interstate commerce. The FDA considers such marketing deceptive marketing that places the health of the public in danger.

FDA warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD)

The FDA is sending warning letters to companies that illegally sell CBD products which make therapeutic claims such as an ability to cure cancer. In addition to warning the companies about the illegality of the sale, the FDA may further warn companies that these produces are being improperly marketed as dietary supplements or because they involved the addition of CBD to food.

State CBD laws

While the federal government has made most use of CBD ingredients illegal, many states, like Colorado and California have made the decision to make marijuana legal in some instances. Medical marijuana is now legal in at least 33 states, with the list continuing to grow. Recreational use is now legal in 10 states, including California, and the District of Columbia, and again the list is growing

• Colorado is allowing CDB to be extracted from hemp.
• CBD from hemp. California, which allows adult usage of marijuana and medical use of marijuana, has not chosen to legalize CBD from hemp. Instead, California is matching the FDA’s position – that CBD use of hemp is illegal.
  • In July, 2018, the California Department of Public Health declared unregulated CBD to be unfit as a food ingredient or dietary supplement for humans and animals. More precisely, the California Department of Public Health said that food, drink, and dietary supplements that are infused with CBD can’t be sold by non-licensed retailers.
• CBD from cannabis. The San Francisco Chronicle states that – In California, CBD derived from regulated and taxed cannabis is legal, available in psychoactive and non-psychoactive lab-tested products — flowers, joints, tinctures, capsules, balms, lotions and transdermal patches — sold in state-licensed cannabis stores, often priced higher than other products rich in THC.

Why CBD advocates support legalization and regulation of CBD-products

The net result of California’s laws and regulations is that at least as far as California law is concerned, not taking into account federal law, CBD products made from marijuana/cannabis can be sold at a licensed cannabis dispensary. CBD products made from hemp cannot be sold.

Adding to the confusion is that while governments often make various marijuana-related uses illegal, they don’t always strictly enforce these laws. Supporters of CBD-infused products claim that it would be better for the state to regulate these products than to expose consumers to the risks and dangers of buying adulterated products.

While there may be some logic in letting the Food and Drug Administration, the Drug Enforcement Agency, and other agencies, and federal laws drive the discussion because it’s an easier route for states – there are risks to consumers if such agencies are not actively regulating these products. Since many consumers believe CBD and THC products have health benefits (real and imagined), many consumers are willing to try these products – regardless of the laws. Advocates of CBD products say it is better to regulate and tax the products than just tell the consumers – “Buyer Beware.”

Adding to the confusion (how do the plants differ from oils and how do food products and supplements differ from plants and oils) is that, the California Department of Health even says,

CDPH is aware that there has been some confusion on the legal use of CBD and CBD oil since the legalization of medicinal and adult-use cannabis,” the agency said in a statement. “We will continue to work with all of our partners, including industry and local public health departments, in order to educate them on CBD and CBD oil and to assist manufacturers as needed to assure compliance.

The response to the California Department of Health’s ruling on forbidding CBD use in foods and supplements

The LA Times wrote that :

As of late October 2018, the state’s Bureau of Cannabis Control had not taken any action against businesses selling foods or supplements containing CBD. Products infused with hemp-derived CBD are still being peddled throughout the Golden State. They’re sold in corner stores and health food markets such as Lassens and Erewhon and in coffee shops that sling $8 lattes fortified with CBD oil. Although some stores stopped hawking ingestible CBD products after the state released its guidelines, others, like Topikal, say they will keep selling CBD goods until they are stopped.

Local law enforcement:

Local environmental health agencies are responsible for enforcing the state guidelines, but few counties are doing much in the way of actual enforcement. The Los Angeles County Department of Public Health, for example, had yet to issue any CBD-related citations as of late October. San Diego County has found one facility in violation. On the more heavy-handed side is Orange County, recording 10 violations during routine inspections.

The San Francisco Chronicle wrote:

What’s compelling about CBD is that its therapeutic potential highlights the contradictions in federal policy,” said Martin Lee, a Bay Area CBD activist who helped reintroduce CBD-rich strains among Northern California cannabis growers. “It’s a controlled substance, but it’s available everywhere. It’s federally illegal, but it’s in gas stations in Bakersfield.”

Advocates of CBD products want all CBD-infused products to be legal – not just those sold at licensed dispensaries. They want both marijuana and hemp products to be authorized. Currently, many CBD products are not correctly labeled. Better to label them like many other foods than to expose the consumer to unknown health risks.There are many conflicting signals regarding CBD products and many open questions. The California Department of Health ruled that CBD-infused foods and supplements are illegal. CBD oils, however, if they are made from marijuana appear legal. The passage of the 2018 US Farm Bill has taken hemp off the Schedule I list of illegal substances. Still, there is an open question whether CBD-based foods, supplements, and other products will be legal if hemp is now legal.

Adding to the confusion is that not only are the states split on CBD laws and regulations, counties and cities within states can have different laws and regulations.

The FDA does have the authority to regulated CBD and THC products. They have approved one such medication, Epidiolox, already. A key factor in obtaining approval of these new marijuana-based products is validating the effectiveness of the drug through accepted clinical research. The FDA’s regulations may include labeling and marketing requirements. Currently, approval of a CBD or THC product as a dietary supplement is problematic.

In addition to FDA rules, states such as California have their own law on CBD and THC product development.

Are you thinking of cultivating or selling hemp or marijuana to make CBD and THC infused products? Wondering what federal and state laws apply? Confused by the changing legal landscape across the country, within your state, and within your town?

An experienced healthcare attorney understands the applicable federal, state, and local laws. Such a legal expert can advise companies, nonprofits, and individuals on the legal opportunities for cultivating, distributing, and selling CBD and THC products. He can also explain what FDA and other regulations apply. To learn more about this complex and evolving area of the law, call Cohen Healthcare Law Group PC to speak with an experienced healthcare lawyer. You can reach us at 310-844-3173 or complete our online contact form to schedule an appointment.