The interest in CBD by businesses and the general public has skyrocketed since December of 2018 when the Farm Bill passed. The authority of the FDA was preserved by Congress regarding the regulation of products containing CBD to make certain all claims are valid and the products are safe. Federal law currently allows CBD products derived from hemp to be distributed under certain conditions. The product must contain a maximum of 0.3 percent THC.
Clarity was provided by the FDA stating hemp seed oil, hemp protein powder, and hulled hemp seed is legal when used for foods. The other products containing CBD are regulated by the FD&C Act and the laws of the individual states. Pre-market approval is required by the FDA for all products containing CBD. Other than specific exceptions, CBD products meant for the consumption of animals or humans are unable to be distributed unless prior approval has been granted.
The Regulatory Efforts of the Federal Government and the FDA
Due to the Farm Bill, steps have been taken to create a better regulatory regime. In March of 2019, a Working Group was created by the FDA to determine potential legislative solutions for the regulation of CBD. These recommendations will be subjected to the decision of Congress. On May 31st of 2019, a public hearing was held by the Working Group for stakeholders. Their challenges and experiences relating to CBD products, including their views and all information regarding public safety, were discussed.
More than 2000 participants and 100 speakers attended the public hearing. The public was invited by the Working Group to submit their comments in writing by July 16th of 2009. The head of the Working Group is Dr. Amy Abernethy. In a recent tweet, she stated CBD products must balance the therapeutic benefits with safety. To gather data and understand the issues, the medical literature has been reviewed during a public hearing with an open docket.
On July 25th of 2019, testimony was given by Dr. Abernethy that, although more clarity was required, the review of the first approved drug containing CBD showed there were risks to using CBD. She stated, according to the knowledge of the FDA, more studies are required. The FDA does not have enough information to make a decision based on science regarding CBD. Information is currently being collected to fill in any gaps, and medical literature is being reviewed by the Working Group.
On July 29th of 2019, more than 4400 comments were received by the FDA through the public docket. These will be added to the active review of the Working Group. Federal and state agencies, patent groups, and trade organizations are meeting with the FDA in an attempt to locate additional data. The FDA is standing by its statement that a scientifically-based approach would be applied regarding current CBD regulations. A report is expected to be released by the FDA later in the year.
The Enforcement Efforts of the FDA and Federal Government
Opportunities to provide clarity are being researched. Warning letters were issued in 2019 to four companies selling and marketing CBD products. These companies sell products without the approval of the FDA for the treatment of numerous diseases. The passive stance of the FDA regarding CBD products has shifted due to the current federal regulations. The most current warning letter was issued by the FDA on July 22nd of 2019 regarding unapproved products marketed with improper labeling according to the FD&C Act.
The FDA stated these products were advertised on social media sites and an online store for the cure, diagnosis, prevention, treatment, or mitigation of diseases impacting the functions or structures of the body. The FDA stated the claims for the marketing of these products were unsubstantiated. The products were advertised for numerous diseases and conditions including Alzheimer’s disease, anxiety, pain, opioid withdrawal, and cancer.
The offending company stated CBD has the capability of decreasing the symptoms of anxiety either alone or with other treatments. The company was given fifteen working days to take the necessary steps to remedy all violations. The FDA stated if prompt action was not taken, the result may be legal action including injunctions and seizures. The company responded on July 26th of 2019 stating steps had been taken for the review of any inaccurate statements on social media and their website regarding their CBD products.
The company has since removed all products identified from their site. The products were also removed by one of the biggest drugstore chains in the nation. The question is what steps the federal government intends to take in the future.
The Future of CBD Products
Regulations regarding CBD guidance are being anticipated by the FDA. There are a lot of complex issues currently under consideration by the federal and state governments. Active measures are being taken by Congress and the states regarding the deregulation of cannabis. This would have a significant impact on the use of CBD products. The FDA is being pressured by the fragmented laws of the states to respond to the confusion surrounding the legality of CBD.
The legislation is pending in Congress for stricter guidelines regarding the testing, labeling, and ingredients for personal care products and cosmetics containing CBD. There are two important pieces of legislation from both chambers of Congress regarding the use of topical CBD products. The Personal Care Safety Act was reintroduced by Susan Collins and Sens. Dianne Feinstein in March of 2019. This would allow for amendments to the FD&C Act, which is now eighty years old.
The FDA would be required to review a minimum of five ingredients each year to ensure safety. Ingredient statements would be mandatory for all fragrances and cosmetics, including statements and warnings on professional products. The information on the label would have to include contact information for the manufacturer, including all sales made online. Another bill is pending from Representative Jan Schakowsky, also directed at the FD&C Act. This would require all personal care and beauty products to list every ingredient in the product.