On September 13, 2019, the U.S. Food and Drug Administration (FDA) added or updated hundreds of products and companies to its Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S. This is an abnormally high number of updates and additions for a single day.
An import alert informs FDA staff and the public that a product is eligible for Detention Without Physical Examination (DWPE) for violating FDA regulations. Many of the products in this case made claims on either their packaging or in their marketing that made them eligible to be considered drug products by FDA, thus requiring the products to be registered as drugs and in compliance with applicable drug regulations. FDA has strict rules for what claims a product can make; any deviation can be considered misbranding and result in regulatory action.
Claims for Non-Drug Products
If you are marketing a food product and want to address its health benefits without it being regulated as a drug, there are claims you can make. Food products can make structure/function claims that relate an ingredient to affecting or maintaining the structure or function of the body. Claims about nutrient deficiency related health conditions (e.g. scurvy and Vitamin C) or promoting general well-being can also be used if they are applicable and are not misleading.
A product that claims to diagnose, cure, mitigate, treat, or prevent a disease will be regulated as a drug by FDA. Therefore, any food product making a disease claim about treating or all together preventing a disease would be viewed as a new drug by FDA and would thus require authorization and approval.
Many of the products placed on import alert were being marketed as a food product, a dietary supplement, or a cosmetic. However, these products made claims that qualified them as a drug. Some companies marketed dietary supplements with claims that they could “Help reduce excessive blood sugar” and could act as an “effective ayurvedic medicine.” Another product marketed as a food claims that it “makes stressed erythrocytes ‘Red Blood Cells’ (RBC’s) more flexible.” These claims are about curing and mitigating disease and are therefore considered drugs by FDA and regulated as such.
Products containing active pharmaceutical ingredients are also considered drugs by FDA. One product marketed as a dietary supplement contained the active ingredient Bufotenine, which is classified as a drug. One company marketed its nicotine patch as a cosmetic, but FDA regulates nicotine patches as OTC drugs. Ingredients must be considered before going to market in the U.S. to avoid a similar compliance issue. Registrar Corp’s infographic provides common examples of ingredients that would cause cosmetics to be regulated as drugs.
What does FDA Consider Labeling?
FDA defines labeling as any written, printed, or graphic matter upon any article or any of it containers, wrappers, or accompanying materials. FDA considers an article to be misbranded if either the physical label or any advertising is misleading to the form or function of the product. Advertising can include a wide range of materials from:
- TV, print, or online advertisements
- Content on a product’s website
- Content on a product’s social media (Facebook, Twitter, etc.)
- Published consumer or professional testimonials
Any claims or descriptions from a product’s advertising that are not consistent with the product information on the physical label could be considered misbranding. Some of the products placed on this import alert made claims that qualified their products as drugs on their websites or on social media platforms. FDA still considers these as part of the product’s labeling and reviews them when regulating products. When promoting your product, it is important to remain uniform in claims and descriptions made with what is directly on the label.
How Can Registrar Corp Help?
Registrar Corp is a private company that assists businesses in complying with FDA regulations. Our label review service can help determine if your labels are FDA compliant and evaluate claims made on your labeling. If your company is listed on the import alert, our specialists can help you petition for removal. For products that are appropriately marketed as drugs, we can assist in registering these facilities as drug establishments and create drug listings for these products.
Using our FDA Compliance Monitor, you can track your company and your supplier’s compliance status with FDA, allowing you to see if you or your suppliers are on an import alert, have a warning letter, or an expired registration. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.