A. The FDA is aware that there are potential adverse health effects with use of cannabis products containing THC in pregnant or lactating women. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development. [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding.  Pregnant and lactating women should talk with a health care provider about the potential adverse health effects of cannabis use.
Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.
 Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71.
Research and Expanded Access
The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.
A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.
5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
A. A cosmetic is defined in 201(i) 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.”
Some of the measures European states are now taking can be illustrated by a recently adopted resolution proposed by the Agricultural Commission in the Italian parliament. It proposes a raise in the THC level in the industrial hemp that comes from EU varieties from 0.2 to 0.3 %. This would level it up with the rest of the global market since permitted levels of THC in CBD products in North America and Australia are 0.3 %. It also asks for the regulation on the sales of dried, chopped or pelleted biomass from the entire plant or its parts, with THC content not exceeding 0.2 %. There are no current guidelines on CBD or THC limits considering food in Italy, and this resolution calls for defining them.
The change in the form of the European Commission’s unbinding advice for the member states was disapproved by the European Industrial Hemp Association (EIHA). They called the measure ‘unnecessary, illogical and illicit’ and claimed that, although hemp extracts are not formally nor legally forbidden, many European states are now taking ‘disproportionate and unjustified’ measures. In 1998, the industry received a letter from the EU’s PAFF Standing Committee that encouraged many business decisions for the next twenty years. January’s decision marked the beginning of an important shift in legislation for the member states. At the level of the European Union, CBD is now considered to be the unauthorized new food.
What is CBD/THC Legislation in Germany?
Italians are not alone in this novel practice. Following the novel food change, many European companies approached the issue by relabelling their products. Austrian biotech company CannHelp recalled all of its CBD-based oils, foods, and cosmetics. The company has relabelled the oils so they are now categorized as “aromatic products” and, as such, placed back on the shelves.
In Romania, any consumable product originating from cannabis is controlled under criminal law. However, in 2019, a report by the European Monitoring Centre for Drugs and Drug Addiction showed that there are herbs, oils, and e-liquid at the Romanian market.
In June, the Swedish Supreme Court ruled CBD oil containing low levels of THC to be classified as a narcotic. Also, the court disagreed with the Swedish Medical Products Agency’s proposal to put the products for oral consumption or inhalation containing cannabidiol under pharmaceutical legislation. Industrial hemp is an exemption from Swedish anti-drug legislation, and it only applies to plants, not products. Since 2017, eight companies selling CBD oil as a dietary supplement have been banned from distributing their products by the Swedish Medical Products Agency. Sweden also leads the European Union’s member states in the number of CBD notifications submitted through the EU’s Rapid Alert System for Food and Feed (RASFF) portal. Out of 35 notifications, 14 are from Sweden.
Cannabidiol (CBD) is a substance derived from the cannabis plant that does not have the psychoactive properties that tetrahydrocannabinol (THC) does.
Hemp is defined under Texas law as "the plant Cannabis sativa L. and any part of that plant, including the seeds of the plant 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." In June of 2019, Texas passed laws creating a state industrial hemp program. The Texas Department of Agriculture and the Texas Department of State Health Services are in the process of creating rules to administer this program.
Texas and Federal Law
This page will provide you with information about CBD and the developing industrial hemp program.
Texas Department of Agriculture Commissioner Sid Miller has recorded this introductory video to Texas's industrial hemp program:
In the past two years, there have been changes in how CBD is viewed under the law at both the state and federal level. Below are links to read the text of this legislation. The federal bill became law on December 20th, 2018, and the state bill creating Chapters 121 and 122 of the Texas Agriculture Code was signed into law by the governor on June 10th, 2019.