16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?
To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2).
Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).
Questions and Answers
When this statutory prohibition applies to a substance, it 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. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.
 Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.
FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.
In states where recreational marijuana is legal, the list of cannabis-derived products greatly expands to include CBD with much higher THC content than 0.3%.
Hemp, marijuana and CBD are all related, but they differ in significant ways. Here’s what you need to know about their legality, effects and potential health benefits.
While the terms “CBD tincture” and “CBD oil” are often used interchangeably, the two are actually different. Tinctures are made by soaking cannabis in alcohol, while oils are made by suspending CBD in a carrier oil, like olive or coconut oil.
Hemp, marijuana and cannabanoidals
However, medical research on marijuana is severely restricted by federal law.
Brandon McFadden receives funding from U.S. Department of Agriculture.
As interest in other cannabinoids, like cannabigerol, or CBG – which some are touting as the new CBD – continues to grow, so too grows the need for further medical research into cannabis.
“Pure” CBD, also called “CBD isolate,” is called that because all other cannabinoids have been removed. So have terpenes and flavonoids, which give marijuana its strong aroma and earthy flavor.
The goal is to have a system in place that makes sure that all CBD products for sale are safe for consumption and actually feature high-quality CBD. The FDA also wants to be able to regulate the marketing claims made by CBD manufacturers, stopping distributors from making outlandish claims without evidence and data to back them up.
With the removal of hemp from the list of controlled substances, regulation of hemp and hemp-derived CBD now falls on the U.S. Food and Drug Administration (FDA). The agency is working to create a framework that would clearly regulate the creation, sales, and marketing of CBD products for consumers.
Medical Marijuana, Inc. is the first company to retail hemp-derived CBD products to customers nationwide in 2012. At that time, CBD did not yet have a clear legal status. However, recent legislation by the federal government in the U.S. has finally changed that. So, is CBD legal?
Is CBD Legal Outside of the United States?
Hemp legalization came to pass due to a provision added to the 2018 Farm Bill that would fully legalize the hemp industry in the U.S. The provision, officially known as the Hemp Farming Act of 2018 , was introduced by Senate Majority Leader Mitch McConnell (R-Ky.)
Since CBD products are now federally legal, you can safely take them through TSA checkpoints when flying without any fear of getting in trouble. As long as travelers have CBD products that adhere to the regulations outlined in the 2018 Farm Bill, the TSA will permit them on an airplane.
CBD is legal federally in the United States, but what about the rest of the world? CBD products are also legal internationally in many countries around the world. However, the level of legality and classification of CBD may vary. In some countries, they are listed as prescription medications. In others, CBD oil is sold as consumer products, just as they are here in the U.S.
Until this is implemented, responsible CBD oil manufacturers in the U.S. are taking it upon themselves to pursue quality measures to make sure the customer is always receiving reliable and safe CBD. This means adherence to the use of good manufacturing practices (GMP) and conducting strict product testing. At Medical Marijuana, Inc., we put every CBD product we sell through our industry-leading Triple Lab Tested® standard to ensure our customers only receive CBD products of superior quality.