- About About
Medical Patient Resources Becoming a State-Authorized Patient Talking to your doctor Which conditions qualify? The Medical Cannabis Patient’s Guide for U.S. Travel Patient's Guide to CBD Patient's Guide to Medical Cannabis Guide to Using Medical Cannabis Condition-based Booklets Growing Cannabis Cannabis Tincture, Salve, Butter and Oil Recipes Leaf411 Affordability Program Tracking Treatment & Gathering Data with Releaf App Medical Professional Resources CME for Medical Professionals Cannabis Safety Medical Cannabis Research
- Legal Legal
Advocacy ASA Chapters Start an ASA Chapter Take Action Campaigns No Patient Left Behind End Pain, Not Lives Vote Medical Marijuana Medical Cannabis Advocate's Training Center Resources for Tabling and Lobby Days Strategic Planning Civics 101 Strategic Messaging Citizen Lobbying Participating in Implementation Movement Building Organizing a Demonstration Organizing Turnout for Civic Meetings Public Speaking Media 101 Patient's History of Medical Cannabis
Policy Model Federal Legislation Download Ending The Federal Conflict Public Comments by ASA Industry Standards Guide to Regulating Industry Standards Recognizing Science using the Data Quality Act Fact Sheet on ASA's Data Quality Act Petition to HHS Data Quality Act Briefs ASA Data Quality Act petition to HHS Information on Lawyers and Named Patients in the Data Quality Act Lawsuit Reports 2020 State of the States Medical Cannabis in America Medical Cannabis Access for Pain Treatment
- News News
- Join Join
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.