FDA, FTC Crack Down On CBD Co.s For Marketing 'Unapproved New Drugs,' Making Unsubstantiated Health Claims
This article was originally published on Hoban Law Group, and appears here with permission.
Both the Food & Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”), continue to monitor the hemp and CBD industry for making illegal and unsubstantiated health claims. Recently, FDA issued yet another set of Warning Letters in response to various CBD products being marketed as “unapproved drugs.” Of course, as in similar letters issued by the FDA in the past, the types of medical claims cited by the FDA are nothing new.
FTC Regulation Violations
Separately, FTC charged, and recently issued fines against, several companies similarly violating FTC regulations by making similar marketing claims. Nicknamed ‘Operation CBDeceit,’ this crackdown was triggered by claims which the FTC contends are “unsubstantiated” about the ability of CBD-containing products to treat health conditions and diseases such as Alzheimer’s disease, cancer, chronic pain, diabetes, and glaucoma, among others. Fines charged range from $20,000 to 85,000. Read more about the FTC charges here.
FDA and CBD
As to the Warning Letters issued by the FDA last month, claims related to CBD and other ingredients in the products reducing anxiety, depression, pain, and inflammation are cited by the FDA. Additionally, claims which boast CBD’s effectiveness in treating a host of health conditions and diseases, such as ADHD, PTSD, rheumatoid arthritis were cited in the letters, in addition to CBD and other ingredients’ properties as a potential antibacterial, antifungal, antitumoral, anticonvulsant, antipsychotic, etc., among many other various express and implied disease claims.
Of course, as most of the industry understands by now, these types of claims cannot be included in the labeling of any product which has not been pre-approved by the FDA as a “drug” — and hemp-derived and/or CBD products are no exception.
Importantly, however, the FDA noted some concerns which the agency has not focused heavily upon in recent years, which concerns center on less traditional methods of application of CBD, such as inhalers and vape products. In discussing these types of products, the FDA reasoned that the ingredients and potential impurities in oral inhalation products may trigger laryngospasm and bronchospasm in users and may be toxic to the tissues in the upper or lower airways, which appears to be the primary basis for the FDA’s concerns, in conjunction with the illegal drug claims. The agency further emphasized that products which are intended to act locally in the respiratory system may be absorbed and exert undesirable systemic effects, such as increased heart rate or elevated blood pressure.
Additionally, several CBD products positioned as eye drops were cited by the FDA as especially concerning from a public health perspective because ophthalmic drug products can pose a serious risk of harm to humans and/or animals if toxic substances are introduced directly into the eye because irreversible damage, including vision loss, can result.
Additionally, the FDA cited similar concern over certain products which are being marketed for use in children. For example, one letter cited a company’s social media page referencing “CBD for Childhood ADD/ADHD.” With respect to such claims made explicitly in the context of use by children, the FDA reiterated that such products have not been evaluated by the FDA for safety, effectiveness, and quality, and the use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations, such as children. The FDA explained that children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
Hemp and CBD Derived Products
As a result, hemp-derived and/or CBD products with novel or less conventional application methods, such as eye drops, vapes, inhalers, etc., should be evaluated with particular attention paid to those concerns noted by the FDA and FTC cited above. Moreover, companies marketing products which are expressly directed for use in children should proceed with caution.
If you need guidance or have questions regarding how to position your hemp-derived and/or CBD products, particularly those with less conventional methods of application or for use in children, please contact our office today for a consultation. Our attorneys at HLG are here to help!
Read the original Article on Hoban Law Group.
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