Root Bioscience Brands Cited for Marketing CBD and CBG Products as Unapproved Drugs
The U.S. Food and Drug Administration (FDA) recently issued a warning to Root Bioscience Brands, LLC, a North Carolina-based company, for marketing products containing cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) with unapproved drug claims. This warning came after the FDA reviewed the company’s website in August 2024, finding claims that positioned these products as unapproved new drugs. Root Bioscience, through its Naternal brand, offers a range of products including CBD oils, gummies, and topical solutions aimed at both humans and pets.
The FDA’s concern stems from several unsubstantiated claims that Root Bioscience made regarding the therapeutic benefits of CBD and CBG, including their alleged ability to treat conditions ranging from concussions to cancer and skin infections. One of the notable claims cited by the FDA highlighted CBG as an “antibacterial agent” capable of combating Staphylococcus aureus (MRSA) infections. Although the company has since removed these claims from its website, the FDA’s warning is a stark reminder of the need for companies to adhere to strict guidelines when marketing products that contain compounds like CBD and CBG.
The Rise of CBD and CBG in Skincare
Cannabis-derived compounds such as CBD and CBG have gained widespread popularity in recent years for their purported health benefits. Consumers are increasingly turning to these compounds, especially in the form of oils, lotions, and creams, for their supposed anti-inflammatory, anti-bacterial, and pain-relieving properties. The skincare industry, in particular, has seen an influx of CBD-infused products, with manufacturers promoting them as remedies for a variety of skin conditions like acne, eczema, and psoriasis.
However, the FDA has consistently warned that many of these claims are not backed by scientific evidence or approved clinical trials. In the case of Root Bioscience, the company’s suggestion that CBG can fight drug-resistant bacterial infections like MRSA is especially problematic. The FDA’s stance is clear: without FDA approval, companies cannot market products containing CBD, CBG, or CBN as treatments for any disease or condition, whether for humans or animals.
How People Can Be Harmed by Unapproved CBD and CBG Products
While the potential benefits of CBD and CBG continue to be studied, the lack of regulation and clinical approval for these products poses risks to consumers. The danger lies not only in unproven therapeutic claims but also in the variability of product quality. Since CBD and CBG products are not FDA-approved, there is little oversight regarding their manufacturing, labeling, and purity. This can result in products that contain harmful contaminants, incorrect dosages, or misleading information about their effects.
In cases where individuals use these products to treat serious health conditions—like skin infections, chronic pain, or anxiety—they may delay or forego proper medical treatment, worsening their condition. For example, someone using a CBD topical ointment in place of a prescribed antibacterial cream may unknowingly allow a skin infection to spread, leading to more severe health complications. Similarly, the use of CBD and CBG to address mental health issues without medical supervision could potentially interfere with prescribed treatments, causing harm to the individual.
The Legal Path for Consumers Harmed by Unapproved CBD and CBG Products
Consumers who have been harmed by unapproved CBD and CBG products may have legal recourse through product liability lawsuits. These lawsuits allow individuals to seek compensation for injuries or health complications caused by defective or unsafe products. In cases involving CBD and CBG products, the claims may stem from false advertising, failure to warn, or contamination of the product.
To file a lawsuit, the victim would typically need to prove that the product was defective or dangerous, that the company made unsubstantiated claims about the product’s safety or efficacy, and that the victim suffered harm as a result of using the product. A key aspect of these cases is demonstrating that the company’s marketing misled the consumer into believing the product would provide certain benefits, when in fact it did not. This can be especially relevant in cases where the product was marketed as an alternative treatment for serious medical conditions.
The lawsuit process generally begins with gathering evidence, including the product packaging, advertising materials, and medical records showing the injury or harm caused by the product. An attorney can assist with filing the necessary legal documents, negotiating with the company or its insurer, and representing the victim in court if necessary. Given the complexities of product liability law and the nuances involved in cases dealing with unregulated compounds like CBD and CBG, having an attorney is crucial.
Why Victims Need Legal Representation
The legal process for filing a product liability claim can be complicated, particularly when dealing with unapproved products like CBD and CBG. Attorneys experienced in product liability cases can help victims understand their rights, assess the strength of their claims, and gather the necessary evidence to support their case. They can also navigate the legal hurdles associated with proving that a company’s marketing practices were deceptive or that a product was inherently unsafe.
In addition to helping victims recover compensation for medical expenses, pain and suffering, and lost wages, an attorney can ensure that companies are held accountable for their actions. This not only provides justice for the victim but also helps protect other consumers from falling victim to similar deceptive marketing practices.
Types of Compensation in a Product Liability Lawsuit
In a product liability lawsuit related to CBD and CBG products, victims may be able to recover several types of damages. These include:
- Medical expenses: Compensation for the cost of treating the injuries or health conditions caused by the product, including hospital stays, surgeries, medications, and ongoing care.
- Lost wages: If the victim was unable to work due to the injury, they may be compensated for the income they lost during recovery.
- Pain and suffering: Compensation for the physical and emotional distress caused by the injury.
- Punitive damages: In cases where the company’s conduct was especially reckless or harmful, the court may award punitive damages to punish the company and deter similar behavior in the future.
