The enactment of the federal Farm Bill of 2018, more formally called the Agricultural Improvement Act of 2018, has opened the door to all types of products that contain cannabis.
Hemp and marijuana are two different species of the cannabis plant. While the different strains have similarities, there are key differences. The main difference is the concentration of the chemical THC which causes the sensation of being high. The concentration of THC in marijuana generally exceeds 15% while the THC (tetrahydrocannabinol) level in hemp is usually .03 percent or lower. CBD, a popular cannabis ingredient, is a non-intoxicating cannabinoid found in cannabis.
Before the passage of the 2014 Farm Bill; the manufacture, sale, and possession of hemp was illegal – in most forms – at the federal level. The 2014 Farm bill made several key changes. Additional changes were made in the 2018 bill:
- Higher education institutes and state departments of agriculture could cultivate “industrial hemp” as part of an agricultural study or program – provided that the state also legalized that use.
- The Farm Bill of 2014 defined hemp as, “the plant Cannabis sativa L. and any such part of such plant … with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent …”
The 2018 Farm Bill determined that hemp and products derived from hemp would now not necessarily be illegal – at the federal level. This means that qualifying hemp products would not be illegal under the Controlled Substances Act, 21 U.S.C. § 802(16). The 2018 Farm Bill created a THC exemption for hemp, even though THC is still listed as a controlled substance. The exemption, which applies to hemp plants and products derived from hemp, is that the products and plants are legal provided – the THC concentration is .03 percent or less. The bill states that hemp includes, “the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
The 2018 Farm bill does not automatically mean that hemp-based products from cannabis can be made, developed, possessed, or sold. Higher education institutes and state agricultural departments can conduct research but the states where the products are developed, disturbed, and sold must also legalize the use.
Additionally, all products derived from hemp are subject to regulation by the Food and Drug Administration (FDA) which has the authority to regulate drugs, medical devices, foods, and lotions. The Federal Trade Commission (FTC) has the authority to regulate online and offline promotions and marketing of these products so the public is not deceived.
FDA authority to regulate cannabis-based foods, lotions, drugs, and dietary supplements
FDA regulates many different kinds of products including:
- Foods – human and animal. The US Department of Agriculture also regulates some aspects of meat, poultry, and egg products.
- Human drugs, veterinary drugs, and other biological products
- Medical devices intended for use by humans
- Dietary supplements
- Tobacco products
- Electronic products that emit radiation
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Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market – why?
So far, FDA has not authorized “any marketing application for cannabis for the treatment of any disease or condition.” FDA approval has been granted for the following three drug products which can only be used by a patient when a licensed physician writes a prescription:
- “Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means FDA has concluded that this particular drug product is safe and effective for the product’s intended use.”
- “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) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.”
Before food can be imported into the U.S., FDA must receive notification so FDA can properly target examinations and inspections of the food that is imported at the American ports of entry – and so FDA can investigate and review whether the imported shipment of food poses a public health threat or risk. Food that is imported must be in compliance with FDA regulations and laws regarding the labeling of food. Most prepared foods (canned and frozen, snacks, breads, snacks, desserts, cereals, and drinks) must have a proper label. Voluntary nutritional labeling is generally the norm for raw products such as vegetables, fruits and fish generally. The bottom line is that all labeling (mandatory or voluntary) must be accurate and informative.
FDA has the authority to regulate the substances added to food for safety. FDA authority also extends to the packaging and processing of food including food additives.
FDA information on food allergies, ingredients, color additives, food additives and GRAS (Generally Recognized as Safe) substances are available through FDA databases, listings, and certain educational resources.
Can food (human or animal) be sold in interstate commerce if CBD or THC has been added?
FDA authority applies to all the types of products that are made and sold – provided the sales are through interstate commerce. Companies that sell their products through the Internet are likely to be considered as using interstate commerce.
The FD&C Act, 21 U.S.C. § 331(ll), prohibits the introduction or the delivery for introduction (through interstate commerce foods (including animal food or feed):
“to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”
Exceptions are allowed for drugs that were marketed in food before the drug was authorized or
“before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling.”
For the purposes of CBD and THC review, FDA has determined that no exceptions apply for THC or CBD. This means, according to FDA, that it is currently illegal “to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.”
Further, FDA states:
“When this statutory prohibition applies to a substance, the statute also prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.”
A few food ingredient distinctions for hemp seeds
FDA does add that it may be legal to add ingredients to food – if the Ingredients come from parts of the cannabis plant – that do not contain either CBD or THC. Some hemp ingredients, according to FDA, may be legally added if the hemp ingredients otherwise comply with FDA regulations and laws.
By statute, substances which are intentionally added to foods are “food additives.” The food additives must then be analyzed for premarket review and FDA approval – unless:
The substance is generally recognized as safe (GRAS) by qualified experts under the conditions of the substance’s intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]).
So far, the only three cannabis or cannabis-derived ingredients that “have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA” are – hemp seed, hemp seed protein powder, and hemp seed oil.
In December 2018, FDA completed the Agency’s evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil – as generally recognized as safe (GRAS).
These three cannabis-related products can be legally marketed in human foods – according to the notices described in the applications submitted by Fresh Hemp Foods, Ltd.
So far, FDA approval for a GRAS notices for hemp-based ingredients has not been authorized for animal food – because no GRAS notices have been received.
“Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when the seeds are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.””
The FDA does have authority to regulate food products, made and sold in interstate commerce, that contain cannabis, hemp, CBD, and THC. So far, the FDA has only approved three drugs with cannabis and has not approved any foods with cannabis. The FDA suggest that hemp seed, hemp seed protein powder, and hemp seed oil may be permissible – if other FDA requirements are met.
Contact Cohen Healthcare Law Group, PC to discuss your federal and state regulatory compliance requirements and legal strategies in the cannabis industry