CBD FDA Labeling Requirements Remains a Grey Area Filled with Concerns
The U.S. Food and Drug Administration (FDA) has increased its scrutiny of CBD labeling and marketing practices. Hemp-based product uses are increasing, and many investors and consumers are unaware of the grey areas of the industry.
Stakeholders in the industry have pushed for clarity and an increase in CBD FDA regulations as cannabidiol demands rise. Legal frameworks have, thus far, lacked the support needed for the industry to continue growing without some concern by state and federal legislators as well as stakeholders in the industry.
A systematic push has occurred, with an effort to push the FDA to provide CBD FDA labeling requirements and guidelines for:
• Marketing
• Sales
• Labeling
• Approval processes
FDA officials have signaled that a legal structure should be in place, but it has been slow to implement key changes. The regulations are slowly being developed, as FDA officials leverage the Food, Drug and Cosmetic Act against manufacturers of certain CBD products.
2018 Agricultural Improvement Act
The 2018 Act, commonly called the 2018 Farm Bill, is responsible for the rise in CBD product sales after hemp was removed from the Controlled Substances Act. The removal allows hemp to be used in products as long as they don’t contain more than 0.3% THC.
The Farm Bill also clarified the FDA’s authority in regulating CBD when it’s added to:
• Cosmetics
• Drugs
• Foods
Approval of CBD in pharmaceutical use has remained almost non-existent with the exception of one product designed to treat seizure disorders: Epidiolex. A major concern among manufacturers is that the FDA has not labeled CBD as “generally recognized as safe” under the Food, Drug and Cosmetic Act.
Instead, the ingredient or additive has become a mark in which the FDA has decided to target businesses for their labeling and marketing practices.
Over 50 warning letters have been sent to companies on the basis that their marketing and labeling practices. The number of warning letters has increased in recent years, with a rise between 2019 and 2020.
Major concerns from the FDA include marketing therapeutic benefits of CBD in the following product categories:
• Eye drops
• Nasal sprays
• Inhalant products
The FDA claims that the rise in products marketing these benefits is a concern and a public health risk. CBD FDA regulations seem to be aimed primarily on products that market CBD products as being treatments for medical issues, including but not limited to arthritis, anxiety, insomnia, stress, cancer and other health conditions.
COVID-19 further saw companies promoting their CBD products as a potential treatment for COVID.
Labeling has also been noted in many warning letters, with the major FDA concern being that CBD products lack the proper labeling and instructions on how to safely use products. Some labeling has encouraged users to ignore the advice of their healthcare providers when using their products.
Companies have also been caught labeling or marketing their hemp-based products as dietary supplements or health foods. These products do not meet the proper classification under the Food, Drug and Cosmetic Act.
FDA officials, until date, have shown a tendency to send warning letters to manufacturers when their products made health-related claims in their marketing material or on their labeling.
CBD FDA Regulations and Guidance
FDA officials are increasing enforcement of CBD products and has stated that legal CBD products have a lot of potentials. Enforcement has been the practical guide to marketing and labeling CBD products, with companies adhering to what the FDA has punished other companies for doing.
The main takeaway for product developers is that any product containing CBD should:
• Remove deceptive claims that CBD can treat serious medical conditions
• Remove claims that are not scientifically backed
• Focus on marketing that is accurate
• Focus on the labeling that is accurate
CBD companies should continually monitor regulatory changes and adhere to them as quickly as possible. FTC officials have also started to crack down on CBD product deceit under what is known as Operation CBDeceit, which was announced in December 2020.
FTC sanctions have led to fines of $20,000 to $85,000 for the companies sanctioned so far.
CBD FDA marketing and labeling requirements remain in a grey area, with the best, current, advice being that companies selling these products only listing factual, scientific claims for their products. Foods, drugs, and cosmetics are all being targeted by FDA officials, albeit containing legal CBD ingredients, for deceptive marketing and labeling practices.
Avoid these deceptive practices to reduce the risk of a warning letter.
If you have doubts on CBD FDA Labeling Requirements, Cosmereg can assist you in each step. For more information about just contact us +17273509380 or through our contact form.
