On September 23, 2014, the U.S. Food & Drug Administration (“FDA”), in conjunction with the Federal Trade Commission (“FTC”), issued a Warning Letter to Natural Solutions Foundation in Newton, New Jersey. FDA representatives allege the FDA warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic Act by promoting the use of several products to cure, treat, mitigate, or prevent disease. According to the letter, Dr. Rima Laibow promoted Nano Silver as a “natural therapy” or “cure” for the Ebola virus. Additionally, Laibow’s website contained claims referring to the product as a “universal infection solution” and “powerful natural protection” against disease.
Because several products promoted on the website are not generally recognized as safe and effective for eradicating the Ebola virus, the FDA considers them new drugs under §505(a) of the Federal Food, Drug, and Cosmetic Act. Under this act, a drug may not be introduced or delivered for introduction into interstate commerce unless the FDA has determined it is safe for consumers.
The FDA also alleges the products promoted by Dr. Laibow are misbranded under §502(f)(1) of the Federal Food, Drug, and Cosmetic Act. These products are considered misbranded because they are offered for conditions that cannot be self-diagnosed or treated by someone who is not a medical professional. As a result, there is no way to provide adequate instructions for using the products safely and for their intended use. The Warning Letter gives Dr. Laibow 15 working days to submit a list of steps taken to correct these violations.
The FTC alleges Dr. Laibow violated the FTC Act by making product claims without reliable scientific evidence. Under the FTC Act, it is unlawful to claim that a product can treat, prevent, or cure disease in humans unless there is competent and reliable scientific evidence to support those claims. The FTC advised Dr. Laibow to carefully review all claims and ensure there is scientific evidence to support them. Dr. Laibow has 15 working days to respond to the FTC’s concerns.
Although a FDA Warning Letter constitutes an informal action on the part of the FDA, it is a sign that a formal enforcement action may happen if a company does not address the alleged deficiencies. This is why it is so important to take these warnings seriously. The FDA often targets companies making claims related to highly publicized outbreaks. Since the Ebola outbreak made the news, the Agency has also sent FDA warning letters to Young Living Essential Oils and doTERRA Essential Oil because their independent consultants allegedly promoted essential oils as an effective treatment for the Ebola virus.
If you have any questions about complying with the Federal Food, Drug, and Cosmetic Act, or you have received a FDA warning letter, contact us at email@example.com to discuss your concerns with counsel.