The Importance Of FDA Guidelines When Packaging CBD Products And How Manufacturers Can Adhere To It
What is CBD?: An Introduction
The CBD market has been a growing industry in the past few years and has gained more and more attention. The CBD industry is projected to experience a significant surge in the next few years. The global market is expected to grow to over $5 billion by 2025.
What is CBD, then? Why is it so popular? Cannabidiol, widely known by its acronym, CBD, is one of the two most common cannabinoids or compounds found in the cannabis plant.
The cannabis plant belongs to the same family as the marijuana plant, though they are not entirely the same. However, cannabidiol is not responsible for the “high” feeling and the other psychoactive or intoxicating traits commonly linked to the cannabis plant.
The cannabinoid that produces the “high” resulting from marijuana use is called THC, formally known as delta-9-tetrahydrocannabinol. It is also the compound that produces delusions, hallucinations, and other various psychological effects.
Although cannabis may seem to give off a negative image to the uninformed public, research shows that cannabidiol has much potential for its health benefits, garnering much attention in recent years. It is linked to treatments for inflammation, anxiety, and even rare types of epilepsy experienced by young children.
CBD comes in three different types. The first is CBD Isolate, which as the name states, CBD Isolate products only contain cannabidiol and no other cannabinoids. The second type is Broad Spectrum CBD which contains other compounds aside from cannabidiol but usually doesn’t contain THC. Lastly, Full-Spectrum CBD contains all the other cannabinoids derived from the plant, including THC—in levels less than 0.3%. Many companies offer full-spectrum CBD oil for sale as well and emphasize its benefits.
What Are The State And Federal Regulations For CBD Products?
The Food and Drug Administration, often referred to as the FDA, oversees the safety and efficacy of food, drugs, cosmetics, biological products, and medical devices. It is essential to be informed about the legalities concerning cannabidiol products.
The 2018 US Farm Bill emphasizes that the cannabis plant and derivatives should contain no more than 0.3% of THC for them to no longer belong to the controlled substances under federal law. This bill also emphasizes that the FDA has the authority to regulate cannabis-containing products and cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, section 351.
The FDA also addresses cannabis-containing products and products with cannabis-derived compounds the same way it treats other FDA-regulated products, which means they have similar requirements as well.
On the other hand, state regulations should also be considered because each state has its regulations for CBD products. These regulations change so often, so companies and manufacturers should always keep themselves updated to ensure that the products they sell adhere to the updated regulations.
FDA Packaging Guidelines for CBD Products
The FDA has yet to release CBD-specific packaging and labeling guidelines, which is why companies are urged to read on the regulations and requirements under which their products fall.
Since CBD products don’t fall under the food and dietary supplements section of the FDCA or Federal Food, Drug, and Cosmetics Acts of the FDA, what is the best way to go about packaging CBD products?
First of all, make sure to be updated with the current CBD regulations per state because, as previously mentioned, these change quite often. Second, make sure to use child-resistant packaging for cannabidiol products.
Most companies use glass containers like vials for products like CBD oil. Others opt to use plastic containers for soft gels, tablets, and topicals like creams and salves. Choosing quality containers and packaging ensures the quality of these products.
Packaging and labeling is a duo that cannot be separated as they are so closely related to each other. It is also necessary for your products to follow suggested labeling guidelines under the requirements and regulations of the FDA, although these are not CBD-specific.
Here are some statements that your CBD label should include:
- Identity Statement - The identity statement is responsible for one thing: telling the consumers what it is. “Vegan CBD Gummies, Broad Spectrum—THC Free” is an example of an identity statement.
- Net Quantity of Contents - The net quantity of contents states the amount of product in a container. Some examples of this could be “300 mg”, “30 gummies—10 mg hemp-derived CBD per gummy.”
- Nutrition Statement - Also known as the “supplement label” or “nutrition facts.” It is a list of ingredients the product contains and the amount of each ingredient arranged in descending order.
Suppose you are beginning to explore and know about CBD products. In that case, it is advisable to consult a health care professional beforehand to avoid any allergies or other complications that might arise. Consumers must also take it upon themselves to read the products’ labels, including ingredient information and warning statements.
Why should you include a CBD FDA Disclaimer?
Including a CBD disclaimer on the packaging and labeling of your products is necessary because it informs consumers whether or not the FDA has evaluated the product. It would be best to write the CBD FDA disclaimer on the box's label or packaging that the product comes in aside from the container itself, like the glass vial or bottle.
Here are some examples of CBD FDA disclaimers that are commonly used:
- The Food and Drug Administration has not evaluated this product. It is not intended to diagnose, treat, cure, or prevent any disease.
- The Food and Drug Administration has not evaluated these statements.
The Role of Manufacturers in Adhering to FDA Packaging Guidelines
Manufacturers play a significant role in ensuring that consumers are provided with quality cannabidiol products that comply with the Food and Drug Administration regulations and requirements. It is the responsibility of manufacturers to guarantee these products’ efficacy and safety, so it is expected of them to follow the current Good Manufacturing Practices set by the FDA.
The cGMPs are federal regulations established by the FDA to ensure that manufacturers adhere to the requirements and standards expected of them to uphold the safety, efficacy, quality, and purity of the products they manufacture. The word “current” is part of the regulations because it assesses whether companies and manufacturers have the updated technologies, equipment, and systems to produce the products they are to market. New companies can keep themselves updated with the FDA's current Good Manufacturing Practices by reading through their official website for more information.