Exploring hemp products and the regulations that apply to them.

Maine Department of Agriculture, Conservation and Forestry sent this bulletin at 08/02/2021 12:59 PM EDT

Hemp Program

Exploring Hemp Products & The Regulations That Apply To Them

Hemp is an impressive crop plant with myriad uses; however, almost all hemp grown in Maine since 2016 has been for its flower and the CBD content of its biomass. Hopefully, there will be more diverse opportunities for this new Maine crop. Toward that end, we thought it would be helpful to offer information about the larger regulatory environment impacting the manufacture, marketing, and sale of hemp and CBD products. Warning: State and federal hemp laws and rules have changed a lot in the last five years, making this a complicated topic. We welcome your feedback.

Cannabidiols (CBD). In 2018, the US Federal Food and Drug Administration (FDA) approved cannabidiol (CBD) as a prescription drug (Epidiolex) to treat certain pediatric seizure disorders. FDA further explained that approving a drug containing purified CBD isolate should not be interpreted as broad approval of the substance. Before CBD can be considered a legal food or dietary supplement by FDA, additional evaluation is required to classify CBD as a GRAS or “Generally Regarded as Safe” substance. The timeline for FDA completing this evaluation is not known. In addition, FDA has not declared any other consumer CDB product as an approved drug. It considers producers who make medical or therapeutic claims about their CBD products to be in violation of federal law. FDA has issued dozens of letters to companies who have made claims that their CBD products can treat diseases and ailments in humans and animals. You don’t want to receive one of those letters.

CBD-containing edibles. For those producing foods, beverages, and other edibles with CBD ingredients, bear in mind that the FDA has not declared these ingredients as GRAS. In Maine, CBD-containing edibles are legal, and according to Maine’s food laws, must be made in Maine.

The CBD extracts and isolates (ingredients) used to make these edibles are considered the same as hemp (when they contain no more than 0.3% total THC); they can legally cross state lines into Maine and can be used to make edibles in Maine. Hemp is, after all, a legal crop, thanks to the 2018 Farm Bill.

Finished CBD edibles, however, are different from the CBD ingredients they contain. Interstate commerce of finished edibles falls under FDA’s jurisdiction, and remember that FDA has not declared CBD a safe food or supplement.

Here is a summary of what Maine producers need to do to comply with state regulations for CBD foods.

In Maine, packaged food, food additives, or food products containing hemp or CBD must be clearly labeled by including:
- the ingredient it contains (hemp or CBD) and amount by weight or volume;
- name and address of the source of the hemp from which the cannabidiol was derived;
- in the case of extracts (such as CBD oil) or tinctures, indicates the batch number; and,
- a disclosure statement that the food, food, additive or food product has not been tested or evaluated for safety; or
In Maine, unpackaged food, food additives or food products must:
- clearly note the inclusion of CBD on a notice next to the food, food additive or product; next to the pertinent listing on a menu; or in an open manner where the food product is served, and
- have a conspicuously displayed directory for use by customers with information on the contents of all unpackaged food products sold/served that contain CBD from hemp. The food product label, menu, advertising, and any other related information must not include health claims that items with hemp or CBD can diagnose, treat, cure or prevent any disease, condition or injury
- The food product label, menu, advertising, and any other related information must not include health claims that items with hemp or CBD can diagnose, treat, cure or prevent any disease, condition or injury without approval pursuant to federal law.
- Source CBD may be from Maine or brought into Maine from another state; keep records of the source CBD provider including hemp grower license number.
- The THC content of any hemp, CBD extract, or product must be less than 0.3%.
Ingestible products (food) may not be imported from out of state if they already contain CBD, since that is still a violation of federal law and the Maine Food Code.

Food producers in Maine need to make sure they have the proper licensing. Please contact the Quality Assurance & Regulations division of DACF for more information.

CBD tinctures, extracts, oils, infusions, isolates. These are by far the most common products made with hemp in Maine.

CBD tinctures and CBD oils are similar, and the terms are sometimes used interchangeably, which is confusing. Very broadly speaking, a tincture is made by soaking an ingredient (e.g., dried hemp flower) in a liquid, which allows the chemicals in the ingredient to be released into the liquid solvent. Usually, tinctures are made with alcohol, and oils are made with a carrier oil (e.g., olive or coconut). Extracts are generally regarded as a more concentrated form of a tincture.

Whenever you are heating and concentrating these CBD products you need to be testing the THC concentrations and make sure that your final product contains no more than the legal limit for hemp (0.3% total THC). We also strongly recommend that you test for contaminants such as metals (e.g., lead, arsenic, mercury) and pesticides. These substances find their way into hemp crops by a variety of routes and can also become concentrated in the final products. Metals, pesticides, and other contaminants are detrimental to a line of products that are popularly consumed to promote health and healing. Be mindful of product quality! Maine currently does not regulate the processing of hemp or the contents of CBD tinctures, extracts, isolates, etc., although many predict this is needed and will happen eventually.

Hemp and CBD smokable products. While the US Food and Drug Administration (FDA) has the authority to regulate tobacco products, it seems that CBD smokables may avoid FDA oversight so long as these products are devoid of nicotine or tobacco. Note that all drugs are regulated by FDA and require pre-market approval. Any health or therapeutic claims made about CBD smokables will be treated by FDA as a drug.

Smokable flower. If this is simply dried/cured hemp flower, then no additional state regulations apply.

Pre-rolls. These are hemp joints or cigarettes. Because rolling paper is used, a retail tobacco license may be required. See Maine tobacco rules and the tobacco application on line.

Blunts. This cigar-type product contains both hemp and tobacco. A retail tobacco license is required see Maine tobacco rules and the tobacco application on line.

CBD vape oil, vape juice, CBD cartridges. These items are for inhalation of CBD using small battery-operated vaporizers, often referred to as pens and e-cigarettes, that vaporize “juice” at temperatures ranging from approximately 320 to 430°F. The vape oil used in these products contains a mixture of CBD extract and other ingredients or carriers. All ingredients comprising the vape oil and all materials used in the cartridges/devices should be scrutinized very carefully to ensure the safety of consumers.

If you intend to sell hemp-derived vape oil/juice in Maine, please contact Devon Dobbins, Tobacco Enforcement Coordinator, to discuss state policy and regulations. Her contact info is devon.l.dobbins@maine.gov or (207) 626-8574.

Livestock feed and pet food. Although animal feeds are a practical market for byproducts like leaves, residual plant fiber, poorer quality seed, and seed oil cake, it is officially not legal to feed anything arising from hemp to animals. FDA approval is required, and this is carried out through the Association of American Feed Control Officials (AAFCO) and/or the FDA-Center for Veterinary Medicine (CVM), and it can be a very slow process. In early 2021, following two years of work with industry experts and researchers, the Hemp Feed Coalition, announced that AAFCO and FDA-CVM accepted their petition to approve hemp seed meal and cake as a commercial feed for laying hens. It could be another couple of years before a decision is made by FDA. Kansas State University received a USDA grant to study how cattle digest hemp stover and whether THC ends up in beef. States have the ability to pass legislation to allow some hemp materials to be used as feed in pet foods.

Cosmetics, skin care products, health & beauty aids. Maine DACF does not regulate these products. Although states may establish laws and regulations regarding the contents and labeling of cosmetic products, very few states have done so. The FDA is the principal regulatory agency for cosmetic products and it neither licenses producers nor approves products before they go to market. Color additives are the only ingredients that must be FDA-approved. FDA does have labeling requirements. Inspections, warning letters, product seizures and injunctions are among the enforcement actions that FDA may use. Companies manufacturing cosmetics can participate in FDA’s Voluntary Cosmetic Registration Program (VCRP).

Claims that a product can treat, relieve, or prevent medical conditions are regulated by FDA. With regard to hemp ingredients, it is a violation of federal law to make any therapeutic claims for hemp or CBD products.