approved facility for making cbd oil

FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress

Cannabidiol (CBD), a compound in the Cannabis sativa plant, has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness. However, limited scientific evidence is available to substantiate or disprove the efficacy of CBD in treating these conditions. In the United States, CBD is marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as electronic nicotine delivery systems (ENDS)—products that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). CBD is also the active ingredient in Epidiolex, an FDA-approved pharmaceutical drug.

The Regulation of Marijuana and Hemp

CBD is derived from the Cannabis sativa plant (commonly referred to as cannabis), which includes both hemp and marijuana. Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA, 21 U.S.C. §§802 et seq.) and is regulated by the Drug Enforcement Administration (DEA). Schedule I substances are subject to the most severe CSA restrictions and penalties. Except for purposes of federally approved research, it is a federal crime to grow, sell, or possess marijuana.

Until December 2018, hemp was included in the CSA definition of marijuana and was thus subject to the same restrictions. Legislative changes enacted as part of the 2018 farm bill (Agriculture Improvement Act of 2018, P.L. 115-334) removed longstanding federal restrictions on the cultivation of hemp. No longer subject to regulation and oversight as a controlled substance by DEA, hemp production is now subject to regulation and oversight as an agricultural commodity by the U.S. Department of Agriculture (USDA). The 2018 farm bill expanded the statutory definition of what constitutes hemp to include “all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers,” as long as it contains no more than a 0.3% concentration of delta-9 tetrahydrocannabinol (THC; 7 U.S.C. §1639o). All non-hemp cannabis and cannabis derivatives—including marijuana-derived CBD—are considered to be marijuana under the CSA and remain regulated by DEA.

Production and Marketing of Hemp Products

Legislative changes related to hemp enacted as part of the 2018 farm bill were widely expected to generate additional market opportunities for the U.S. hemp market. However, the farm bill explicitly preserved FDA’s authority under the FFDCA and Section 351 of the Public Health Service Act (PHSA, 42 U.S.C. §262), including for hemp-derived products. Following enactment of the farm bill, in a December 2018 statement, FDA stated that it is “unlawful under the [FFDCA] 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.” The agency has maintained this view in subsequent communications.

Despite FDA’s determination, CBD continues to be widely marketed and sold in both food and dietary supplements in the United States. To date, FDA has generally prioritized enforcement against companies and products that pose the greatest risk to consumers—for example, CBD products claiming to treat Alzheimer’s or stop cancer cell growth.

In 2014, total U.S. CBD sales were a reported $108 million. In 2018, more than 1,000 companies produced and marketed CBD for the U.S. market, and U.S. CBD sales were estimated at $534 million, according to the Hemp Business Journal. That dollar amount is projected to exceed $1 billion in 2020 and to reach nearly $2 billion in 2022. This amount includes sales from hemp-derived CBD, marijuana-derived CBD (currently a Schedule I controlled substance), and pharmaceutical CBD (currently only Epidiolex).

Congress has expressed concern about the proliferation of CBD products marketed in violation of federal law and has called on FDA to provide guidance on lawful pathways for marketing hemp-derived CBD in food and dietary supplements. In absence of a regulatory framework for hemp-derived CBD, in the explanatory statement accompanying the FY2020 enacted appropriation, Congress directed FDA to issue a policy of enforcement discretion with respect to CBD products that meet the statutory definition of hemp. In addition to the activities directed in the explanatory statement, Congress could also take further legislative action in the future, such as requiring FDA to issue a regulation, under its FFDCA authorities, expressly permitting CBD that meets the definition of hemp to be used as a food additive or dietary supplement. Congress also could amend the FFDCA provisions that FDA has identified as restricting marketing of CBD in food and dietary supplements. In determining whether a legislative approach is appropriate, Congress may consider the potential for adverse health effects and other unintended consequences.

FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress

Contents

Figures

Tables

Appendixes

Summary

Cannabidiol (CBD), a compound in the Cannabis sativa plant, has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness. However, limited scientific evidence is available to substantiate or disprove the efficacy of CBD in treating these conditions. In the United States, CBD is marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as electronic nicotine delivery systems (ENDS)—products that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). CBD is also the active ingredient in Epidiolex, an FDA-approved pharmaceutical drug.

The Regulation of Marijuana and Hemp

CBD is derived from the Cannabis sativa plant (commonly referred to as cannabis), which includes both hemp and marijuana. Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA, 21 U.S.C. §§802 et seq.) and is regulated by the Drug Enforcement Administration (DEA). Schedule I substances are subject to the most severe CSA restrictions and penalties. Except for purposes of federally approved research, it is a federal crime to grow, sell, or possess marijuana.

Until December 2018, hemp was included in the CSA definition of marijuana and was thus subject to the same restrictions. Legislative changes enacted as part of the 2018 farm bill (Agriculture Improvement Act of 2018, P.L. 115-334 ) removed longstanding federal restrictions on the cultivation of hemp. No longer subject to regulation and oversight as a controlled substance by DEA, hemp production is now subject to regulation and oversight as an agricultural commodity by the U.S. Department of Agriculture (USDA). The 2018 farm bill expanded the statutory definition of what constitutes hemp to include “all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers,” as long as it contains no more than a 0.3% concentration of delta-9 tetrahydrocannabinol (THC; 7 U.S.C. §1639o). All non-hemp cannabis and cannabis derivatives—including marijuana-derived CBD—are considered to be marijuana under the CSA and remain regulated by DEA.

Production and Marketing of Hemp Products

Legislative changes related to hemp enacted as part of the 2018 farm bill were widely expected to generate additional market opportunities for the U.S. hemp market. However, the farm bill explicitly preserved FDA’s authority under the FFDCA and Section 351 of the Public Health Service Act (PHSA, 42 U.S.C. §262), including for hemp-derived products. Following enactment of the farm bill, in a December 2018 statement, FDA stated that it is “unlawful under the [FFDCA] 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.” The agency has maintained this view in subsequent communications.

Despite FDA’s determination, CBD continues to be widely marketed and sold in both food and dietary supplements in the United States. To date, FDA has generally prioritized enforcement against companies and products that pose the greatest risk to consumers—for example, CBD products claiming to treat Alzheimer’s or stop cancer cell growth.

In 2014, total U.S. CBD sales were a reported $108 million. In 2018, more than 1,000 companies produced and marketed CBD for the U.S. market, and U.S. CBD sales were estimated at $534 million, according to the Hemp Business Journal. That dollar amount is projected to exceed $1 billion in 2020 and to reach nearly $2 billion in 2022. This amount includes sales from hemp-derived CBD, marijuana-derived CBD (currently a Schedule I controlled substance), and pharmaceutical CBD (currently only Epidiolex).

Congress has expressed concern about the proliferation of CBD products marketed in violation of federal law and has called on FDA to provide guidance on lawful pathways for marketing hemp-derived CBD in food and dietary supplements. In absence of a regulatory framework for hemp-derived CBD, in the explanatory statement accompanying the FY2020 enacted appropriation, Congress directed FDA to issue a policy of enforcement discretion with respect to CBD products that meet the statutory definition of hemp. In addition to the activities directed in the explanatory statement, Congress could also take further legislative action in the future, such as requiring FDA to issue a regulation, under its FFDCA authorities, expressly permitting CBD that meets the definition of hemp to be used as a food additive or dietary supplement. Congress also could amend the FFDCA provisions that FDA has identified as restricting marketing of CBD in food and dietary supplements. In determining whether a legislative approach is appropriate, Congress may consider the potential for adverse health effects and other unintended consequences.

Background

Cannabidiol (CBD) , a compound in the Cannabis sativa plant , has been promoted as a treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, inflammation, and sleeplessness . However, limited scientific evidence exists to substantiate or disprove the efficacy of CBD in treating these conditions . In the United States, CBD is being marketed in food and beverages, dietary supplements, cosmetics , and tobacco products such as electronic nicotine delivery systems (ENDS , the overarching term encompassing electronic cigarettes) —products that are primarily regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA). CBD is also the active ingredient in Epidiolex , an FDA-approved pharmaceutical drug used to treat seizures associated with two rare and severe forms of epilepsy .

CBD is derived from the Cannabis sativa plant (commonly referred to as cannabis), which includes both hemp and marijuana (defined further below). CBD and tetrahydrocannabinol (THC) are thought to be the most abundant cannabinoids in the cannabis plant and are among the most researched cannabinoids for their potential medical value. 1 THC—a psychoactive 2 compound—is found at high levels in m arijuana and low levels in hemp (see Figure 1). 3

Figure 1. Cannabis sativa

Source: Created by CRS.

Notes: This figure is intended to provide a high-level illustration of the relationship between cannabis, marijuana, and hemp, per the statutory distinction in the Controlled Substances Act (CSA).

CBD, on the other hand, is generally considered to be nonpsychoactive and may be derived from either hemp or marijuana. As described below, this distinction is relevant for purposes of oversight by the Drug Enforcement Administration (DEA), but generally not for FDA oversight. FDA has stated that it “treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products—meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other [non-cannabis] substance. 4 This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under [7 U.S.C. Section 1639o] as amended by the 2018 [f]arm [b]ill.” 5 In contrast, the DEA does not regulate cannabis or cannabis-derived compounds that meet the statutory definition of hemp.

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Botanically, marijuana and hemp are from the same species of plant, Cannabis sativa, but from different varieties or cultivars. 6 Marijuana and hemp have separate definitions in U.S. law and are subject to different statutory and regulatory requirements.

Marijuana (as defined in statute) generally refers to the cultivated plant used as a psychotropic drug, either for medicinal or recreational purposes. 7 Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA) 8 and is regulated by DEA. Schedule I substances are subject to the most severe CSA restrictions and penalties; with exceptions for federally approved research, it is a federal crime to grow, sell, or possess the drug. Thus, under the CSA, the unauthorized manufacture, distribution, dispensation, and possession of marijuana and its derivatives (including marijuana-derived CBD) are prohibited. 9

Hemp (as defined in statute separately from marijuana), on the other hand, may be legally cultivated under federal law, subject to oversight by the U.S. Department of Agriculture (USDA). 10 Hemp is generally grown for use in the production of a wide range of products, including foods and beverages, personal care products, dietary supplements, fabrics and textiles, paper, construction materials, and other manufactured and industrial goods (see Figure 2).

Figure 2. Products Derived from Cannabis

Source: Created by CRS.

Notes: While marijuana is cultivated to promote the development of flowering tops and leaves of psychoactive cannabis plant varieties with elevated concentrations of THC, hemp is cultivated depending on its intended use across three different crops: fiber, seeds, and flower. While not defined in statute, there are additional industry-developed terms that are used to describe hemp extracts (e.g., full spectrum and broad spectrum). Because these terms lack standardized definitions, they are not used in this report.

Until December 2018, hemp was included in the CSA definition of marijuana and was thus subject to the same restrictions as marijuana. The Agriculture Improvement Act of 2018 (2018 farm bill; P.L. 115-334 ) removed hemp and its derivatives (including hemp-derived CBD) from the CSA definition of marijuana. As a result, hemp is no longer subject to regulation and oversight as a controlled substance by DEA. Instead, hemp production is now subject to regulation and oversight as an agricultural commodity by USDA. CBD and CBD-related products that do not meet the statutory definition of hemp (in 7 U.S.C. §1639o) continue to be prohibited (aside from lawful use for research purposes) under the CSA and remain regulated by DEA.

Related CRS Products

Congressional Distribution memo on cannabis extraction methods is available to Congressional clients upon request

Changes enacted in the 2018 farm bill related to hemp were expected by many to generate additional market opportunities for hemp-derived consumer products such as hemp-derived CBD. However, the farm bill also explicitly preserved FDA’s authorities under the FFDCA and Section 351 of the Public Health Service Act, including for hemp-derived products. 11 As mentioned above, cannabis and cannabis-derived FDA-regulated products are subject to the same authorities and requirements as FDA-regulated products—including pharmaceutical drugs, food, dietary supplements, and cosmetics—containing any other substance (whether cannabis-derived or otherwise). As described below, FDA has determined that it is unlawful to introduce food containing added CBD into interstate commerce, or to market CBD as or in dietary supplements. 12 FDA has not made similar determinations for other FDA-regulated product categories (pharmaceutical drugs, cosmetics, and tobacco products).

FDA Regulation of CBD Products

In the United States, CBD is the active ingredient in the prescription drug Epidiolex. CBD is also being marketed in food and beverages, dietary supplements, cosmetics, and tobacco products such as ENDS. Each of these product types is governed by different statutory and regulatory requirements, primarily administered by FDA. The agency also shares regulatory authority with other entities; for example, the Alcohol and Tobacco Tax and Trade Bureau (TTB), 13 with regard to alcoholic beverages, and the Federal Trade Commission (FTC), with regard to the advertising and promotion of certain CBD products. This section provides an overview of how FDA regulates drugs, food, dietary supplements, cosmetics, and tobacco products, and the applicability of those requirements to products that contain CBD. Table 1 summarizes selected regulatory requirements by CBD product type.

Pharmaceutical Drugs

FDA, under the FFDCA, regulates the safety and effectiveness of prescription and nonprescription (over-the-counter, or OTC) drugs sold in the United States. Prescription drugs require health practitioner supervision to be considered safe for use—due to drug toxicity, potential harmful effect, or method of use—and may be dispensed only pursuant to a prescription. 14 In contrast, OTC drugs may be used without a prescriber’s authorization, provided they have an acceptable safety margin, low potential for misuse or abuse, and are adequately labeled so that consumers can self-diagnose the condition, self-select the medication, and self-manage the condition. 15 The statutory definition of the term drug includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals” and “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” 16 In general, a new drug may not be introduced into interstate commerce without FDA approval. 17

For purposes of new drug approval, except under very limited circumstances, FDA requires data from clinical trials to provide evidence of a drug’s safety and effectiveness. Before testing in humans—called clinical testing—the drug’s sponsor (usually its manufacturer) must file an investigational new drug (IND) application with FDA. Once a manufacturer completes clinical trials, it submits the results of those investigations, along with other information, to FDA in a new drug application (NDA). 18 In reviewing an NDA, FDA considers whether the drug is safe and effective for its intended use; whether the proposed labeling is appropriate; and whether the methods used to manufacture the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity. 19 The NDA process can be used to obtain approval of both prescription and OTC drugs. If a sponsor wants to transfer an approved drug from prescription to OTC status (called an Rx-to-OTC switch), the sponsor must submit to FDA an NDA (or a supplement 20 to an NDA) providing data to support the switch. 21 As part of an NDA for an OTC drug, FDA may require the sponsor to conduct label comprehension studies assessing the extent to which consumers understand the information in the proposed labeling. 22 FDA also may recommend that the sponsor conduct self-selection studies to assess whether consumers can appropriately self-select a drug based on the information on the labeling. 23

In June 2018, FDA approved an NDA for the prescription drug Epidiolex, submitted by GW Pharmaceuticals, for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years old and older. 24 The active ingredient in Epidiolex is CBD, although its mechanism of action—that is, the mechanism by which it exerts its anticonvulsant effects—is not known. 25 FDA approved Epidiolex in June 2018; at that time, the drug contained a chemical constituent of marijuana (CBD) that was considered a Schedule I controlled substance. 26 Therefore, it could not be marketed unless rescheduled by the DEA. Upon FDA approval, Epidiolex no longer met the criteria for placement in Schedule I, as it now had an accepted medical use in the United States. 27 On September 28, 2018, based on a recommendation from FDA, DEA issued an order placing FDA-approved drugs that contain cannabis-derived CBD and no more than 0.1% THC in Schedule V. 28 Epidiolex is available by prescription and only at specialty pharmacies. 29 It is the first (and only) pharmaceutical formulation of highly purified, plant-derived CBD available in the United States. 30 Because Epidiolex is designated as an orphan drug (i.e., a drug that treats a rare disease or condition), it was awarded seven years of marketing exclusivity upon approval. 31 This means that FDA cannot approve an NDA for the same drug—in this case, one that has CBD as its active ingredient—for the same disease or condition (i.e., for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years old and older) for seven years, with limited exceptions. 32

Foods and Food Additives

The FFDCA defines food to mean “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” 33 FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for oversight of human food, while FDA’s Center for Veterinary Medicine (CVM) is responsible for oversight of animal food (feed). The FFDCA requires that all human and animal foods are safe to eat, produced in compliance with current good manufacturing practices (CGMPS), contain no harmful substances, and are truthfully labeled, among other things. 34 Generally, food intended for human or animal consumption is not approved by FDA prior to marketing. However, any substance added to food is a food additive, subject to premarket review and approval by FDA. 35 An exception to this is if a substance is generally recognized as safe (i.e., GRAS) under the conditions of its intended use, among qualified experts, or unless the use of the substance is otherwise excepted from the definition of a food additive. 36 To obtain approval of a substance as a food additive, a person may submit to FDA a food additive petition, which proposes the issuance of a regulation prescribing the conditions under which the additive may be safely used. 37 Food additives are approved for specific uses (e.g., to improve taste, texture, or appearance; to improve or maintain nutritional value; or to maintain or improve safety and freshness). 38 If FDA determines, after reviewing the data submitted in a petition, that a proposed use of a food additive is safe, the agency issues a regulation authorizing that specific use of the substance.

The use of a food substance may be determined to be GRAS either through scientific procedures or, for a substance used in food before 1958, through scientific procedures or experience based on common use in food. 39 FDA established a voluntary GRAS notification process that permits any person to notify the agency of a conclusion that a substance is GRAS under the conditions of its intended use in human food. 40 A substance is considered GRAS on the basis of common knowledge about its safety for its intended use, and the data and information relied upon for the GRAS substance must be generally available. 41 This is in contrast to the data and information used to support a food additive petition, which are generally privately held and submitted to FDA for evaluation. Additional information about the food additive petition process and submission of GRAS notifications is available in Appendix A.

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Under the FFDCA, it is unlawful to introduce into interstate commerce a food (human or animal) to which a drug has been added—either an approved drug or a drug for which substantial clinical investigations have been instituted and made public. 42 There are several exceptions to this: (1) if the drug was marketed in food before it was approved as a drug or before clinical drug investigations were instituted; (2) if the Secretary has issued a regulation, after notice and comment, approving the use of such drug in the food; (3) if the use of the drug in the food is to enhance the safety of the food and not to have independent biological or therapeutic effects on humans, and the use is in conformity with specified requirements; or (4) if the drug is a new animal drug whose use is not unsafe under FFDCA Section 512. 43 FDA has concluded, based on available evidence, that none of these are the case for CBD, and because CBD is an active ingredient in an approved drug, FDA has taken the position that it is unlawful to introduce into interstate commerce food containing added CBD (i.e., to use CBD as a food additive). 44

However, according to FDA, cannabis-derived ingredients that do not contain CBD (or THC) may fall outside the scope of this prohibition. 45 Foods containing parts of the hemp plant that include only trace amounts of CBD (e.g., hemp seed and ingredients derived from hemp seed) may be lawfully marketed under certain circumstances—pursuant to FDA approval as a food additive or a GRAS determination. In December 2018, FDA announced that it had completed its evaluation of three GRAS notices related to hemp seed-derived ingredients (i.e., hulled hemp seeds, hemp seed protein, and hemp seed oil). 46 FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Thus, FDA allowed them to be marketed in human foods—without food additive approval—for the uses specified in the GRAS notices, provided they comply with all other applicable requirements. Intended uses of the hemp seed-derived ingredients include adding them as a source of protein, carbohydrates, oil, and other nutrients to beverages (e.g., smoothies, protein drinks, and plant-based alternatives to dairy products), as well as to soups, dressings, baked goods, snacks, and nutrition bars.

While FDA has determined that it is unlawful to introduce into interstate commerce food to which CBD has been added, independent of CBD’s status as a drug ingredient, CBD has not been approved as a food additive. FDA also has determined that “[b]ased on a lack of scientific information supporting the safety of CBD in food … it cannot conclude that CBD is [GRAS] among qualified experts for its use in human or animal food.” 47

Animal Food and Feed Considerations

As previously noted, the FFDCA definition of food includes animal food. Similar to food intended for human consumption, animal food is not subject to premarket approval by FDA unless it meets the definition of a food additive. In that case, it would be subject to the premarket requirements for food additives (or GRAS exemption). Depending on the claims made, certain animal feed/food may meet the FFDCA definition of a drug. 48 Like human drugs, animal drugs require FDA approval prior to marketing. 49 In some cases, animal food may be considered both a food and a drug simultaneously. 50 Although premarket approval by FDA is not required for most animal food (excluding animal drugs), other federal and state rules govern their manufacture and sale. These include, for example, labeling requirements and ingredient definitions. 51

As previously noted, it is a prohibited act, with certain exceptions, under the FFDCA to introduce into interstate commerce animal food to which a drug has been added—either an approved drug or a drug for which substantial clinical investigations have been instituted and made public. 52 Some cannabis-derived ingredients that do not contain CBD or contain only trace amounts of CBD (e.g., hemp seed and ingredients derived from hemp seed) may fall outside the scope of this prohibition and may be lawfully marketed pursuant to FDA approval as a food additive or a GRAS determination. 53 However, to date, FDA has not approved any food additive petitions or evaluated any GRAS notices related to use of hemp seed and hemp-seed derived ingredients in animal food. 54 In addition, as previously mentioned, FDA has stated that “[b]ased on a lack of scientific information supporting the safety of CBD in food … it cannot conclude that CBD is [GRAS] among qualified experts for its use in human or animal food.” 55

While FDA is the primary federal agency responsible for regulating the safety of food, the agency works with states and the Association of American Feed Control Officials (AAFCO) in the implementation of uniform policies for regulating the use of animal food products. For example, FDA provides scientific and technical assistance to the AAFCO ingredient Definition Request Process, the purpose of which is to “identify the safety, utility, and identity of ingredients used in animal feed.” 56 CVM recognizes ingredients listed in the Official Publication of the AAFCO as being acceptable for use in animal food. According to FDA, “there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food.” 57 AAFCO has issued guidelines on hemp in animal food, which are generally consistent with FDA’s policy. 58 The guidelines also note that, based on discussions with FDA and the hemp industry,

materials and products that are CBD-infused need to be treated as drugs because the intended uses are largely associated with drug claims. This means that parts of the hemp plant will not be appropriate for approval as an animal feed ingredient. As such, products that contain CBD as a feed ingredient could be labeled adulterated or misbranded and be subject to regulatory actions by state agencies. 59

Dietary Supplements

A dietary supplement is defined as a product (other than tobacco) that

  • is intended to supplement the diet;
  • is intended to be taken by mouth as a pill, capsule, powder, tablet, or liquid; and
  • contains one or more of the following dietary ingredients: vitamins, minerals, herbs or other botanicals, amino acids, and other substances or their constituents. 60

Dietary supplements are generally regulated as food under the FFDCA 61 and, as such, are not subject to premarket approval. Dietary supplements must comply with FDA’s regulations prescribing CGMPs related to manufacturing, packaging, labeling, or holding dietary supplements to ensure their quality. 62 A dietary supplement may not claim to diagnose, cure, mitigate, treat, or prevent a specific disease or class of diseases. 63

FDA does not evaluate the safety and effectiveness of dietary supplements prior to marketing; however, supplements are subject to various statutory and regulatory requirements. Among other things, a firm that seeks to market a dietary supplement containing a new dietary ingredient (NDI) must notify FDA at least 75 days prior to marketing. The manufacturer or distributor of the dietary supplement that contains an NDI subject to the notification requirements may not market the supplement until 75 days after the filing date. 64 An NDI is defined as a dietary ingredient that was not marketed as a dietary supplement in the United States before October 15, 1994. 65 An exception to the NDI notification requirement is if the dietary ingredient was “present in the food supply as an article used for food in a form in which the food has not been chemically altered.” 66 In this case, the dietary ingredient would still be considered an NDI because it was not marketed prior to October 15, 1994, but it would be exempt from the notification requirement. 67 An NDI notification must include a “history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe,” along with other information. 68 FDA acknowledges receipt of the NDI notification and notifies the submitter of the date of receipt, which is also the NDI notification filing date. FDA must keep the information in the NDI notification confidential for the first 90 days after receiving it. 69 If the manufacturer or distributor submits additional information in support of the NDI notification, FDA may reset the 75-day period and assign a new filing date. 70 FDA does not approve NDI notifications. Instead, the agency generally issues one of four response letters: (1) a letter of acknowledgment without objection; (2) a letter listing deficiencies that make the notification incomplete; (3) an objection letter raising safety concerns based on information in the notification or identifying gaps in the history of use or other evidence of safety; or (4) a letter raising other regulatory issues with the NDI or dietary supplement (e.g., the NDI or supplement is excluded from the definition of a dietary supplement). 71

Under the FFDCA, an article that is an active ingredient in an approved drug, or that has been authorized for investigation as a new drug and for which the existence of such clinical investigations has been made public, is excluded from the definition of a dietary supplement and may not be marketed as such. 72 An exception to this is if FDA issues a regulation finding that the use of such substance in a dietary supplement is lawful. An article that is approved as a drug or being investigated as a drug may be marketed in or as a dietary supplement if it was marketed as a dietary supplement or as a food prior to approval or clinical investigation (before the IND became effective). 73 According to FDA, CBD is an active ingredient in an FDA-approved drug (i.e., Epidiolex), and it was authorized for investigation as a new drug for which substantial clinical investigations had been instituted and made public before its marketing as a dietary supplement. As such, FDA has determined that CBD may not be sold as a dietary supplement unless FDA promulgates regulations concluding otherwise, regardless of whether the CBD is hemp-derived or marijuana-derived. 74 FDA has issued several public statements maintaining that it is unlawful to market CBD as, or in, dietary supplements. 75

FDA may issue a regulation, after notice and comment, creating an exception that allows CBD to be marketed as a dietary supplement. 76 Such a regulation may be requested by an interested person through the filing of a citizen petition. 77 If an interested party has evidence challenging FDA’s conclusion excluding CBD from the dietary supplement definition, the party may submit to FDA a citizen petition asking the agency to issue a regulation, subject to notice and comment, finding that the ingredient, when used as or in a dietary supplement, would be lawful. To date, FDA has not issued such a regulation for any substance (whether cannabis-derived or not) that is an active ingredient in an approved drug or is authorized for investigation as a new drug. 78 If FDA were to issue a regulation allowing CBD to be marketed as a dietary supplement, that product likely would be expected to comply with the various requirements governing lawful marketing of supplements, including compliance with CGMPs and NDI notification. Despite FDA’s determination that marketing CBD as a dietary supplement is unlawful, these products remain on the market.

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On November 14, 2019, the Consumer Healthcare Products Association (CHPA) submitted a citizen petition to FDA, asking the agency to “exercise its statutory authority and discretion to engage in rulemaking that establishes a regulatory pathway to legally market dietary supplements containing [CBD] derived from hemp (as defined in 7 U.S.C. §1639o(1))” and to require that manufacturers of CBD-containing dietary supplements submit NDI notifications. 79 It is unclear whether other citizen petitions have been submitted to FDA requesting that it issue a regulation allowing CBD to be marketed as a dietary supplement.

Cosmetics and Personal Care Products

The FFDCA defines cosmetics as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” 80 FDA has the authority to take certain enforcement action against adulterated or misbranded cosmetics. A cosmetic is deemed adulterated if, among other things, it contains a poisonous or deleterious substance, or if it has been made or held in unsanitary conditions. 81 A cosmetic is deemed misbranded if, among other things, “its labeling is false or misleading in any particular,” or if the label lacks required information. 82 In addition, if a product makes therapeutic claims (i.e., that its intended use is the cure, mitigation, treatment, or prevention of a disease), FDA generally considers that product to be a drug (or a drug-cosmetic) and subject to the FFDCA drug requirements. If a company has not obtained approval of a new drug prior to marketing, it is in violation of the FFDCA. For example, in October 2019, FDA sent a warning letter to a manufacturer marketing a CBD body butter with therapeutic claims. 83

However, FDA’s authority over cosmetic products is generally more limited than for the other products that the agency regulates. FDA does not have the authority to conduct premarket review of cosmetic ingredients, nor can FDA require cosmetics manufacturers to submit data substantiating the safety of their cosmetics. While FDA regulations prohibit or restrict the use of certain ingredients in cosmetics, the regulations do not apply to any cannabis or cannabis-derived ingredients (e.g., CBD). 84

Legislation has been introduced in the 116 th Congress that would expand FDA’s authority to regulate cosmetic products and would require a safety review of certain ingredients, among other things. 85 If CBD were included in such a review and found to be unsafe for use in cosmetics, that finding would likely affect whether CBD could be marketed in cosmetics.

[2022] 10 Cannabis Production Facilities Planned For Construction in the U.S.

As the decriminalization of cannabis sweeps through America, the demand for cannabis facilities is on the uptick.

In every U.S. state where cannabis is legal, companies are scratching and clawing to gain city approval and start building.

As such, there’s a cannabis facility construction boom in California, Massachusetts, and Michigan where it seems like new projects are being proposed weekly.

At first glance, these buildings resemble regular manufacturing facilities.

But the truth is that these cannabis facilities are more like research laboratories than anything else.

And there’s an opportunity for those that cater to these facilities.

These structures can be sophisticated and they may require complex plumbing, electrical, security services, alarm systems, POS systems, CCTV, waste collection, sanitization, and HVAC services to name a few.

Because it’s not yet legal in every state, expect cannabis facility owners, developers, and investors to continue building in states where they feel most welcome.

We’re going to be looking at ten facilities that are either being planned or in early construction throughout portions of the nation.

Geospex screenshot of cannabis cultivation facilities planned for construction across the US as of August 2021.

1. Massachusetts Medical Cannabis Center in Freetown, Massachusetts

Value $25-100 Million
Schedule Work is ongoing and all construction should be completed in late Q2 2022
Details Extraction and manufacturing space. Testing laboratory. Research facility. Training center. Corporate offices. 24-hour security and transportation infrastructure
Contacts Developer – AmeriCann, Inc.
General Contractor – Campanelli Companies
PropertyManager- Bask Cannabis

2. Little Morongo Cannabis Cultivation Facilities in Desert Hot Springs, California

Value $1-5 million
Schedule In planning and the developer has requested an extension of use permits.
Details Six new buildings. Total of 96,462 square feet. Mixture of cultivation and processing facilities.
Contacts Developer, Owner- DSH Enterprises, LLC
Engineer- Amir Engineering & Surveying Inc

3. Tradecraft Ventures Facility in Lancaster, California

Value $5-25 Million
Schedule The project has been recommended for approval by the Planning Commission.
Details 122,871 square feet. Space for cultivation and manufacturing.
Contacts Developer, Owner- Calandri Properties/Son Rise Farms

4. Cresco Cannabis and Medical Marijuana Facility in Ellenville, New York

Value $25-100 million
Schedule Cresco Labs have met with local and state officials to discuss the proposed facility.
Details 360,000-square-foot cannabis cultivation, processing, packaging and distribution facility.
Contacts Tenant, Cresco Labs LLC.

5. AT-CPC of Ohio Expansion in Akron, Ohio

Value $3.5 Million
Schedule Planning, a representative from the city of Akron (OH) stated this project has been approved.
Details two-level 30,000-square-foot expansion of a medical cannabis cultivation facility.
Contacts Owner- Klutch Cannabis

6. Focus Partners Dispensary in Kansas City, Missouri

Value $5-25 Million
Schedule Planning, and the project is under review with the Plan Commission
Details Two Phases. 96,680-square-foot building in each phase. Cultivation areas. Processing space. Dispensary facilities.
Contacts Developer – Focus Partners Kansas City LLC
Architect – Yaeger Architecture, Inc

7. SW Bartlett Avenue Cannabis Facility in San Bernardino, California

Value $>100 Million
Schedule Planning, the city reviewed the plans for this project.
Details 1,757,760 square feet of space in 39 greenhouse buildings.
Contacts Owner- Frontier Communities
Engineer- United Engineering Group

8. Flora High Tech Cannabis Campus in Buffalo, New York

Value $200 Million
Schedule Work on some small greenhouses is underway but there is no schedule for the larger buildings
Details Cultivation and manufacturing space. Distribution center. Research and development laboratories. Extraction laboratory and corporate office space.
Contacts Developer- Zephyr Partners
Architect- BMS Design Studio
Consultant- Roswell Park Cancer Institute

9. Glenwood Plaza Redevelopment in Pontiac, Michigan

Value $40 million
Schedule Groundbreaking
Details Between 500,000 and 1 million space for medical marijuana development. Cultivation center and growing facilities. 250,000 square feet of grocery and shopping space.
Contacts Developer – Rubicon Capital
Tenant – PharmaCo

10. Sensi Park in Battle Creek, Michigan

Value > $100 Million
Schedule In planning, and the developer has purchased the property.
Details Five million square feet. Space for growing and processing. Multi-level greenhouses. Research and development laboratories. Collaboration center and offices. 24-hour security
Contacts Developer, Owner- DB3 Agricultural Solutions

To get contact information for these cannabis facilities and dozens more, request a free trial or talk to a data expert now at 866-316-5300.

Manufacturing

Manufacturers extract cannabinoids and terpenes from cannabis plants and make products out of the extract. The types of products they make vary widely and include:

  • Food and beverages
  • Vape cartridges
  • Lotions and balms
  • Lozenges and sublingual sprays
  • Pills and tablets
  • Dab, shatter and wax

Cannabis manufacturers use techniques and processes common in other types of consumer product manufacturing. Manufacturing steps differ based on the type of manufacturing, but generally include:

  • Extraction of cannabinoids
  • Post-processing (refinement) of cannabis extract
  • Infusion of extract or plant material with other ingredients
  • Packaging and labeling cannabis products

Manufacturing licenses

You need a manufacturing license to make cannabis products in California. The type of manufacturing license you need depends on:

  • What activities you do
  • Whether you do extraction and post processing
  • What types of chemicals you use (if any)

You need a different license if you manufacture in a shared-use facility.

Good manufacturing practices

The Department of Cannabis Control’s regulations require manufacturers to follow good manufacturing practices (GMPs) when making products. GMPs help ensure products are:

  • Free of contaminants and safe for consumers
  • Produced consistently every time
  • Labeled correctly

Manufacturers must demonstrate GMPs by:

  • Maintaining a sanitary facility, equipment and utensils
  • Using written procedures and instructions
  • Documenting work
  • Protecting against contamination
  • Including controls in processes
  • Practicing personal hygiene

Documenting manufacturing processes

Manufacturers must keep up-to-date documents with their procedures and instructions for making products.

Product quality plan

A product quality plan includes:

  • An assessment of the potential hazards in your facility and manufacturing practices
  • The preventative measures you use to mitigate risks

You must have a product quality plan for each type of product manufactured.

Master manufacturing protocols

Master manufacturing protocols are step-by-step instructions for creating your product. They are the “recipe” that staff follow to ensure they make the products the same way each time. You must have a master manufacturing protocol for each formulation.

Use the master manufacturing protocol checklist to make sure your protocols include the required information.

Batch production records

Batch production records document all the steps you take to create your product. Most manufacturers create a template that their staff can fill out when they complete each step.

Use the batch production records checklist to make sure your templates include the required information.

Packaging and labeling

Manufactured cannabis products must be:

  • Packaged to prevent product contamination
  • Labeled so consumers know what they’re buying or using

Packaging

Packaging must be:

  • Child resistant
  • Tamper evident
  • Resealable (if it contains multiple servings)
  • Opaque (if it is an edible)

Use the packaging checklist to make sure your product is properly packaged. Learn more about child-resistant packaging requirements.

Labeling

Cannabis product labels have two parts:

  • Primary panel – the part of the label displayed to the consumer at retail; typically found on the front or the top of the package
  • Informational panel – any other part of the label that is not the primary panel

You must list certain information on each part of the label. Use the labeling checklists to make sure your product has the required information: