Late last month, in November 2019, the U.S. Food and Drug Administration (FDA) issued a second set of warning letters to companies across the country for illegally selling products containing cannabidiol (CBD) as dietary supplements. In its letters, the FDA warned that based upon the lack of scientific data supporting the safety of CBD in food, it could not conclude that CBD was generally recognized as safe for its use in human or animal food.
While avid consumers of CBD continue to dispute the FDA’s conclusions, those same consumers cannot fault the FDA for pursuing its mission to ensure that the food and drug products consumed by humans and animals are safe and effective. In fact, these warning letters highlight the dual nature of the FDA’s long history of protecting the public’s health and safety from products marketed or sold to the public as food or drugs.
Before the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals. A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances. During this period which became known as the Progressive Era, the public became concerned about the hazards of the marketplace. Spurred on by books such as Upton Sinclair’s, “The Jungle,” the public demanded increased federal regulations in matters pertinent to public safety.
Two years later in 1906, President Theodore Roosevelt signed into law the, “Food and Drug Act.” The Act prohibited the interstate transport of food which had been “adulterated,” colored to conceal “damage or inferiority,” or formulated with additives “injurious to health.” The Act also applied similar penalties to the interstate marketing of “adulterated” drugs, in which the “standard of strength, quality, or purity” of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopeia or the National Formulary. The Act also banned “misbranding” of food and drugs.
Today, under the Federal Food, Drug, and Cosmetic Act (the Act), the FDA is responsible for ensuring the safety of all food except for meat, poultry and some egg products; ensuring the safety and effectiveness of all drugs, including biological products (e.g., blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed. Cannabis could rightly be determined to be a drug in its raw form or a food in its component form. Under the Act, a drug is defined as any product intended to treat a disease or otherwise have a therapeutic or medical effect, or any product (other than a food) intended to affect the structure or function of the body of humans or animals.
Not surprisingly, the FDA has a regulatory mandate to test CBD to determine whether it can be used safely and effectively as a drug. This includes a testing protocol to determine whether a drug is effective for its intended use, what the proper dosage might be for the drug, how the drug might interact with other FDA-approved drugs, and whether there are dangerous side effects or other safety concerns for the general public regarding the drug. The FDA must also approve the manufacturing methods of any CBD product to assure the drug’s identity, strength, quality, and purity.
If a drug is permitted to be prescribed under state and federal criminal laws, the drug must have been approved by the FDA and placed within one of the permissible Controlled Substances Act (CSA) Schedules. To obtain that FDA approval, the manufacturer must demonstrate the drug’s safety and effectiveness during clinical trials according to criteria specified in law and agency regulations, ensure that the drug’s manufacturing plant passes FDA inspection, and obtain FDA approval for the drug’s labeling. Thus far, only one CBD product has been approved as a prescription human drug product – Epidiolex – an oral solution for the treatment of seizures associated with two rare forms of epilepsy.
Which brings the discussion back to where it originally started – does Cannabis promote health and wellness? Answer: It depends who’s asking. The FDA is the federal regulator for food and drugs in the United States. Food and drugs are only approved for manufacture and distribution if they have been deemed safe and effective by the FDA. Cannabis has been designated by Congress and the FDA as a Schedule I drug under the Controlled Substances Act of 1970 (with a high potential for abuse, no currently accepted medical use in treatment, and cannot be safely under medical supervision). Pursuant to that designation, no prescriptions may be written for Schedule I substances, and those drugs are not readily available for clinical use.
However, according to the political will of the States, Cannabis does have an accepted medical use. Thirty-three States and the District of Columbia have enacted laws that permit the use of Cannabis for medical purposes. Eleven States and the District of Columbia have enacted legal use of Cannabis for adults 21 and over. Given the fact that over two-thirds of the states have enacted medical use laws and two-thirds of the country’s population live in medical cannabis states, the FDA may one day soon be forced to abandon its political leanings and acknowledge the science that Cannabis (and all its component organic compounds) can promote health and wellness.