Treatment with CBD

Cannabis regulation - the laws and regulations of cannabis products

Since 1970, cannabis is controlled as the drug class “Marihuana” (marijuana) as Schedule I under the Controlled Substances Act (CSA) due to its abuse potential because of the psychoactive effects of THC. 

CBD is Schedule I, except for the medication Epidiolex, which the FDA rescheduled as Schedule V.

Substances are classified into five schedules depending on the drug’s acceptable medical use and the drug’s abuse or dependency potential.
Controlled Substances Act schedules

Marijuana vs. hemp – the 2018 Farm Bill

The 2018 Farm Bill (the Agriculture Improvement Act of 2018, Pub. L. 115-334) makes a distinct difference between marijuana and hemp.

  • It defines hemp as the Cannabis sativa plant and any parts of the plant (including all seed and extracts) that has a dry weight THC concentration of 0.3% or less.
  • Any hemp that fulfills this requirement is exempt from under the effect of the CSA and is no longer considered under federal law as controlled substances.

Consequently, the 2018 Farm Bill removed hemp from the list of scheduled substances.

Nonetheless, the 2018 Farm Bill explicitly authorizes the FDA to regulate cannabis and products that contain compounds derived from cannabis under the Public Health Service Act. As such, cannabis and cannabis-based products are subjects to FDA authorities, requirements and regulations, regardless of their classification as hemp under the 2018 Farm Bill.

Whether it is legal or illegal to sell CBD products depends on the intended use and the labeling of the product. Even if the CBD product is “hemp” according to the 2018 Farm Bill, it still must comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws.

State laws bypassing FDA cannabis regulations

Several states have passed laws to enable the medical use of cannabis and its derivatives. Additionally, several other states are considering passing such laws in the future. Such laws bypass FDA regulation and allow the use of marijuana and CBD for medical conditions, subject to a prescription by a physician.

Regulations of the interstate commerce of cannabis products

It is illegal to sell food (human or animal) that contain THC or CBD in interstate commerce.

  • In other words, it is illegal to sell and buy animal or human foods containing THC or CBD across state boundaries or in transactions that involve more than one state.

Foods that are made from cannabis but do not contain THC or CBD might be sold in interstate commerce.

  • They still have to comply with all laws and regulations about food products though.

Any ingredient added to food requires FDA approval as a food additive. As such, qualified experts have to recognize this ingredient as “generally recognized as safe” (GRAS).

Importing and exporting cannabis products

For information on importing and exporting cannabis-derived products and foods, please consult:

World map symbolizing import and export of cannabis products

Regulation of CBD as a dietary supplement

A picture of a fork and a bottle of pills symbolizing the regulation of CBD and other cannabis products as a dietary supplement

It is illegal to market CBD products as dietary supplements. It is because according to the FD&C Act, CBD products are not dietary supplements for these reasons:

  • If a substance is an ingredient in an FDA approved medication or investigative drug, it cannot be sold as a dietary supplement.
  • Except: if the substance was on the market as a dietary supplement before the FDA approved it as a medication – but the FDA decided that no exception applies for THC or CBD.
    • The FDA has the authority to lift the exception, but they have not issued such regulations to date.

Regulation of cannabis products other than CBD as dietary supplements

Products that are derived from cannabis but do not contain THC or CBD might be marketed as dietary supplements.

  • They still have to comply with all laws and regulations about dietary supplements though.
  • This usually involves FDA approval as a dietary supplement and adherence to Current Good Manufacturing Practices and labeling.
  • The also have to be “generally recognized as safe” (GRAS).

Medical claims for non-FDA approved CBD products

Some firms though might market CBD products claiming to treat diseases and have therapeutic uses. Such claims are illegal and unfounded. Adding CBD to food or selling cannabis-related products as dietary supplements are violations of the FD&C Act.

The FDA first issues warning letters to them to discontinue using these claims. If the recipients of such letters take no action, the FDA initiates legal action against them.

“It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”  “Failure to promptly correct violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.”

Judge with a mallet symbolizing FDA legal action about medical claims for non-FDA approved cannabis and CBD products

Regulation of cannabis products in food and cosmetics: GRAS – Generally Recognized as Safe

GRAS” is an acronym for Generally Recognized As Safe. Federal Food, Drug, and Cosmetic Act (FD&CA) calls food additive anything added to food.  As such, the FDA has to review and approve all food additives, unless they are already GRAS.

There are no cannabinoids inside the cannabis seeds.  Therefore, of all cannabis products, the FDA considers only three hemp seed-derived food ingredients as generally safe (GRAS) for human consumption:

  • hulled hemp seed,
  • hemp seed protein powder, and
  • hemp seed oil.

In essence, these three hemp seed-derived products can be legally added to and marketed in human foods, but only:

  • for the uses approved by the FDA, and
  • provided they comply with all other requirements.

On the other hand, pet food or animal feed in the United States may not contain either whole cannabis or hemp, or cannabis or hemp products, because:

  • the 2018 Farm Bill doe snot allow it, and
  • the FDA does not allow it either – they do not consider them generally safe for animals.

Regulation of foods with hemp seed-derived products

If the manufacturing of foods containing hemp follows the legal requirements and FDA specifications, then GRAS conclusions apply to them. Indeed, hemp and hemp products can be a source of:

  • carbohydrates
  • protein
  • oil
  • other nutrients

As such, hemp can be an ingredient in:

  • beverages
  • soups, sauces, dressings, spreads
  • plant-based products that are alternatives to meat
  • baked goods, cereals, snacks, desserts
  • any other food
Hemp flour in a wooden spoon, hemp seed in a bag and on the table, hemp oil in a glass jar, hemp leaves on the background of wooden boards.

However, products that contain hemp must declare them by name and spell them out in the list of ingredients.

Regulation of THC and CBD in hemp seed-derived foods

Hemp contains only miniscule amounts of THC and CBD (remember: 0.3% dry weight benchmark for cannabis vs. hemp). As such, hemp products will not make you high.

Additionally, as we said before, there are no cannabinoids inside the cannabis seeds. Makers of seed-derived foods, therefore, must follow good manufacturing practices to avoid contamination of the seeds with the rest of the plant that may contain cannabinoids, such as THC.

Information on food containing THC and CBD is available here.

Regulation of cosmetics with cannabis-derived ingredients

The definition of cosmetics

The FD&C Act, sec. 201(i) defines cosmetics as articles that are not soap and are intended:

  1. to be:
    1. rubbed, poured, sprinkled or sprayed
    2. into or onto the human body or parts of it
    3. for the purposes of cleansing, beautifying, promoting attractiveness or altering appearance
  2. for use:
    1. as a component of such articles

If a product has the purpose of affecting the body’s function or structure; or to prevent, diagnose, or treat a disease, then is the FDA considers it a drug, even if it is both a cosmetic and a drug. In that case, FDA requires approval to be produced and marketed.

The regulation of cosmetics

Regulations do not restrict or prohibit cosmetics with cannabis or cannabis-derived ingredients.

  • The FD&C Act does not require premarket approval of cosmetics by the FDA
  • No ingredient can be used if it causes the adulteration or the misbranding of the product
    • Adulteration is defined as containing poisonous substances that might cause injury if used as customary or as prescribed in the labeling.
    • Misbranded means that the label of the product is false or misleading.

References

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