Monday, April 15, 2019

The Status of CBD

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).

Related Article: Inadequate Regulation Contributes to Mislabeled Online Cannabidiol Products | Cannabis New Journal

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.

From Americans For Safe Access | April 11, 2019 | By Heather Despres

About: Heather Despres, M.Sc., PFC Director
email: phone: (202) 857.4272 x. 6

Heather Despres, M.Sc. is serving as the Director of the Patient Focused Certification (PFC) program. Her prior experience in cannabis testing laboratories, as well as environmental and pharmaceutical labs, brings with it years of working to ensure that the products made for medical marijuana patients is safe. Heather has degrees in chemistry and bio-molecular science from Clarkson University as well as a Master’s in Chemistry from the University of Colorado at Denver. She has recently relocated to California with her family and is looking forward to continuing to grow the Patient Focused Certification Program.

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About Patient Focused Certification:
The Patient Focused Certification (PFC) program offers a variety of services designed to prepare businesses for excellence in the medical cannabis industry. PFC is what patients, healthcare providers, companies, and regulators can depend on to identify reliable, high-quality medical cannabis, businesses, products, and services. PFC offers company certification, consultation services, and industry training for any business regardless of its stage of development or role in the supply chain.

PFC was developed by Americans for Safe Access using the Cannabis Monograph created with the American Herbal Products Association (AHPA) and the American Herbal Pharmacopoeia (AHP). These standards have been directly adopted by nearly half the medical cannabis programs in the US. PFC business certification and professional training are available in all medical cannabis states including the District of Columbia. PFC can help you no matter which state you are in, what you do, or what stage your business is in.

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