On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and other federal laws. The products, sold online and in retail stores, include dietary supplements, over-the-counter (OTC) drugs, and unapproved prescription drugs. You can read the announcement here. Also, a list of the warning letters is available at this link.
The FDA issued the warning letters as part of an initiative to remove illegal diabetes products from the market and thereby protect consumers from potential harm. Particularly, the targeted products make claims to cure, treat, mitigate, or prevent diabetes and related complications but have not been evaluated or approved by the FDA as safe and effective in treating diabetes, which causes them to be classified as unapproved new drugs as defined by Section 201(p) of the FDCA. Accordingly, many of these products have been targeted as unapproved new drugs simply for the claims made in product labeling, including product labels and other marketing materials.
In addition, as explained by the FDA, unapproved drugs may present safety risks such as possible contamination, harmful ingredients, and hidden active ingredients. For example, certain products that the FDA identified contained active pharmaceutical ingredients (APIs) that were not disclosed on the labeling. Products containing undisclosed APIs often make false claims as all-natural alternatives to FDA-approved drugs but may actually present a significant risk of harm. Additionally, many of the companies were illegally marketing and selling prescription drugs to consumers without a prescription, causing the drugs to be deemed misbranded under Section 503(b)(1) of the FDCA.
In sum, the companies have 15 business days from the date that they received the warning letters to submit written responses to the FDA. The responses to the warning letters must describe all the actions that have been or will be taken in a timely manner to correct the violations. Otherwise, the companies could be subject FDA enforcement actions such as injunction, criminal prosecution, and/or product seizure. More information about warning letters and ensuring adequate responses thereto may be found here.
If you have any questions about compliance with FDA requirements concerning the marketing of FDA-regulated products, please contact us at: contact@sglawfl.com.
