READ THIS NEXT: If You Have Any of These Colgate Toothpastes, Get Rid of Them, FDA Warns. Because of how they’re advertised or packaged, it can be easy to assume that the supplements you see on the shelf are regulated in the same rigorous way that over-the-counter (OTC) or prescription medicines are. But in reality, these products enter the market in a much different way than the pain relievers and cold medicines you regularly rely on. FDA regulations currently require “dietary supplements,” “herbal supplements,” and any other distinctions to be labeled as such. However, products are not required to be proven safe or to verify they provide the health claims printed on the label before they can be sold. The agency says that it’s only after an item hits the shelf and is purchased by the public that it will take action “against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.” And even then, the agency may be slow on the draw: It clarifies that it only reviews product labels, information, and marketing campaigns “as its resources permit.” Unfortunately, the current setup can lead to potentially risky situations for some people’s health—especially if they’re dealing with other conditions. “Supplements may interact with other medications you’re taking or pose risks if you have certain medical conditions, such as liver disease, or are going to have surgery,” Jeffrey Millstein, MD, a physician at Penn Internal Medicine Woodbury Heights, told Penn Medicine. “Some supplements also haven’t been tested in pregnant women, nursing mothers, or children, and you may need to take extra precautions.“ae0fcc31ae342fd3a1346ebb1f342fcb Now, the FDA is warning that one such product could pose a serious health problem. On Sept. 28, the FDA announced that My Stellar Lifestyle brand operator Proper Trade LLC had issued a voluntary recall for two lots of its Wonder Pill dietary supplement. The product is marketed for use in male sexual enhancement and is packaged in 10-count blister cases that come in a carton and in a 60-count bottle. RELATED: For more up-to-date information, sign up for our daily newsletter. The agency warns that consumers with underlying medical issues could experience “serious health risks” by unknowingly taking a product containing tadalafil. It cautions that the ingredient could interact with other prescription drugs such as nitroglycerin, leading to a dangerous drop in blood pressure that could be “life-threatening.” Typically, patients with high blood pressure, diabetes, or heart disease take such nitrates to alleviate their conditions. The FDA advises anyone who may have experienced health problems after taking the affected item to immediately call their doctor or healthcare provider. Anyone with questions about the supplement recall can also contact Proper Trade LLC through the phone number or email address listed on the agency’s notice.
