Recently, FDA has sent out several warning letters to CBD marketers and manufacturers because they market unapproved new drugs that allegedly contain cannabidiol (CBD).
FDA ran tests on the chemical content of the cannabinoids in the products. Most of the products do not contain the level of CBD that they claimed to contain.
We should take note that these products are not approved by the FDA for diagnosis, treatment, cure and prevention of any diseases.
Consumers should beware of purchasing and using any such products.
What is the FDA?
The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations. This goes for drugs, vaccines, and other biological products and medical equipment.
WHY IS IT IMPORTANT?
The FDA handles protecting public health by:
–– Assuring the safety, effectiveness, and security of humans. The same goes for veterinary drugs, vaccines, and other biological products, medical devices. The US nation’s food supply, cosmetics, dietary supplements, and products that give off radiation goes too.
– Regulating tobacco products
– Advancing public health by helping to speed product innovations
–providing the public with the necessary information needed before using medicine and food. The information is science-based and accurate.
FDA Approved Classification of Medical Devices.
Vaccines, blood, and biologics are being regulated by FDA’s Centre for Biologics Evaluation and Research (CBER). CBER protects and advances public health. It ensures that these products are safe and effective. They make it available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of these products.
Vaccines undergo rigorous and extensive testing to determine their safety and effectiveness. Trained scientists and medical personnel at FDA review all the information in a marketing application. This will take place before a vaccine can receive approval for use by the public. Following approval, FDA monitors the quality of vaccines.
FDA approved Classification of Animal & Veterinary
The Center for Veterinary Medicine (CVM) regulates the processing and distribution of food and drugs for animals.
These include animals used for human food, as well as food additives and drugs for pet (or companion) animals.
Who is the FDA for?
The FDA is for any organization working in or supplying products to the US for health and human services.
FDA’s warnings to CBD oil sellers.
On November 25th, 2019, FDA issued an immediate press release saying that it sent out warning letters to 15 CBD oil companies. They released a revised Consumer Update detailing safety concerns about CBD products more.
The FDA says it can’t conclude that all scientists approve of CBD as safe for use in human or animal food. This is due to the lack of adequate research to guarantee the safety of CBD in food. The FDA will have to research for more information on this.
There were lots of reasons why the FDA issued out these warnings for the CBD products. They include;
1). Lack of FDA review on products.
The FDA does carry out an evaluation on drugs before approving them. There is no evaluation of most of these CBD products on whether they are effective. This evaluation reveals the following;
- what the proper dosage might be
- how they could interact with FDA-approved drugs
- whether they have dangerous side effects or other safety concerns.
The FDA also has not gone through the manufacturing process of the CBD products for reviews. This is part of the human or animal drug approval process. All these false claims linked with CBD products will make consumers put off urgent medical care like diagnosis and care
2). Lack of Children Consideration.
Some of the CBD products are in the market for infants and children. This is a vulnerable population that may be at greater risk for adverse reactions. This is because they can’t absorb, metabolize, distribute or discharge a substance such as CBD.
3). The illegality of the CBD products
Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food that contains certain drug ingredients, such as CBD. Also, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food.
There also is no food additive regulation that authorizes the use of CBD as an ingredient in human food or animal food. The agency is not aware of any other exemption from the food additive definition that would apply to CBD. CBD is thus an unapproved food additive. its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient.
4). Unauthorized dietary supplements.
Some of the products are in the market as dietary supplements. But CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
5). Use of CBD products for Food producing animals.
One product outlined in a warning letter to Apex Hemp Oil LLC is in use for food-producing animals. The agency remains concerned about the safety of human food products (e.g. meat, milk, and eggs) from animals that consume CBD. there is a lack of data establishing safe CBD residue levels.
The FDA has also appealed to the public to be mindful of the type of CBD products they buy. You should always be on the lookout for the manufacturers, the amount of CBD or THC in it, and so on. In case of any suspicious CBD products that are not in line with the regulations of the FDA, you can report this to the organization.
There are still lots of ongoing research about the effectiveness of CBD oil but nothing is certain yet. CBD is not the cure for any terminal diseases or sicknesses like epilepsy, cancer, arthritis, and the rest. Though it helps with the symptoms we need more evidence before you use it for the treatment of diseases. Don’t forget to consult with your doctor before using CBD.