Editor's Note

FDA has issued warning letters to Essential Elements (d/b/a Scale Media Inc.), Calroy Health Sciences, Iwi, BergaMet North America, Healthy Trends Worldwide (d/b/a Golden After 50), Chambers' Apothecary and Anabolic Laboratories alleging the companies had made drug claims for their products on their websites and social media, specifically rendering the products in question as intended for use in the cure, mitigation, treatment, or prevention of cardiovascular diseases and related conditions.
 
After reviewing social media sites (including youtube and facebook), product websites and online marketplace entries for the companies, FDA highlighted claims that allegedly established their products as drugs, including misbranded drugs lacking “adequate directions for safe use” due to the fact that certain of the alleged indications are not amenable to self-diagnosis or treatment, rendering the provision of adequate directions impossible:
 
• “Hey there it’s Jared from GoldenAfter50.com and if you have high blood pressure or know someone with high blood pressure then don’t go anywhere because today I’m going to reveal five simple ways you can lower your blood pressure fast…”
• "[P]ine bark extract [an ingredient in CholestAid] has been shown to help reduce blood pressure..."
• “BergaMet Cholesterol Command is clinically proven to improve cholesterol levels. It reduces LDL”
 
The agency advised that the companies should take prompt action to correct the alleged violations cited in the letter and that failure to correct the alleged violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
November 2022
FDA
The U.S. Food and Drug Administration (FDA) issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure). The products cited in these letters are unapproved new drugs and have not been evaluated by the FDA to be safe and effective for their intended use.

According to the Centers for Disease Control and Prevention, cardiovascular disease is the leading cause of death in the United States. In 202o, nearly 700,000 Americans died from cardiovascular disease, accounting for 1 in every 5 deaths.

Consumers who rely on unapproved products claiming to cure, treat, mitigate, or prevent cardiovascular disease or related conditions instead of discussing their symptoms with a health care professional may not receive appropriate treatment and could potentially suffer harm.
Warning letters were sent to the following companies:


Under the Federal Food, Drug, and Cosmetic Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
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