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With passage of the 2018 Farm Bill, the framework was put in place for states to pass laws legalizing the production and distribution of industrial hemp. But what does that mean for CBD and products containing CBD? A search for “CBD” on the website of the U.S. Food & Drug Administration (FDA) brings up a list of warning letters that have been issued to companies. In 2015, the FDA issued 18 warning letters and conducted a study on label claims for CBD content. This study showed that only one product came close to the labeled CBD content, while a number contained no cannabinoids, and many contained THC despite not advising so on the label.
More recently, the FDA issued three warning letters on March 28, 2019 to companies marketing their products as nutritional or dietary supplements, listing them as having healing or curative properties on their website, and/or marketing new drugs to animals. Even though the Farm Bill has passed, CBD is still prohibited from being labeled or marketed as a nutritional or dietary supplement and no compound may be called a drug unless it has gone through the FDA’s review process and has been approved as such (e.g., Epidiolex).
Businesses must be aware of how they are marketing and labeling their products to ensure that they are in compliance with the FDA requirements for CBD and CBD products until the FDA changes its position. In an announcement in the Federal Register on April 3, 2019, the FDA has said that it will be hosting a public hearing and taking comments to obtain scientific data as it relates to the safety, manufacturing, packaging, labeling, and product quality of cannabis and cannabis-derived products.
The American Herbal Products Association (AHPA) recently issued a guidance document to assist herbal companies in evaluating their products and encourages compliance in the following areas:
- Food facility registration
- cGMP and cGAP practices
- Labeling, including:
- Nutritional information
- Allergen information
- Contact information
- Absence of drug claims
- New dietary ingredient and food additive provisions
- Adverse event reporting
Americans for Safe Access created the Patient Focused Certification (PFC) program and worked with AHPA to develop clear and comprehensive regulations. PFC is a third-party certification program that works with all aspects of the industry, including cultivation, manufacturing, distribution, and laboratory operations and has recently begun certifying industrial hemp businesses in addition to cannabis businesses.