On March 2, 2018, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA warns of fraudulent and unapproved flu products (“FDA Warning”). Found here, the FDA Warning is aimed at notifying the public of unapproved products claiming to prevent, treat, or cure the flu. According to the FDA, the severity of this year’s flu season raises more concern about consumers being lured into buying these unapproved products, and for this reason FDA is targeting these types of products.
FDA noted that there are no legally marketed over-the-counter (OTC) drugs that prevent nor cure the flu. However, there are legal OTC products that can reduce fever, relieve muscle aches, congestion, and other symptoms associated with the flu. FDA warns that dietary supplements labeled with flu treatments claims would be regulated as drugs by the Agency as products that are intended to treat, prevent, or cure diseases/conditions are deemed drugs under federal law. Accordingly, marketers of products with these claims should be very careful as they may be in violation of FDA laws and regulations.
In sum, when developing a product, it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.
