7 Companies Under Fire for False Claims

FDA warns about products claiming to treat serious heart conditions

(RxWiki News) The US Food and Drug Administration (FDA) issued warning letters to seven companies for selling supplements claiming to treat serious heart conditions.

These companies were selling their products illegally because they were in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These products claimed to cure, treat, mitigate, or prevent heart disease or related conditions, such as atherosclerosis (plaque builds up inside your arteries), stroke and heart failure.

The companies under fire are:

  1. Essential Elements (Scale Media Inc.)
  2. Calroy Health Sciences LLC
  3. Iwi
  4. BergaMet North America LLC
  5. Healthy Trends Worldwide LLC (Golden After 50)
  6. Chambers' Apothecary
  7. Anabolic Laboratories, LLC.

These products have not been evaluated by the FDA. Nor have they been proven to be safe or effective in treating what they claim to treat. That means they may be harmful. Plus, the FDA has not evaluated what the correct dosage would be or whether there are any possible interactions with other medications. 

This is why the FDA is strongly recommending that consumers do not use these or similar products. The agency encourages consumers to be cautious when shopping online or in stores. 

Look for these claims to better identify scam products:

  1. Claiming to be a “miracle cure.” Other claims may include “guaranteed results” or “vaccine alternative.” These are often products that are "too good to be true."
  2. Claiming to treat a wide range of diseases. Unfortunately, there is no such thing as a treatment that cures multiple illnesses.
  3. Personal "success" stories. These stories are easy to fake, especially on online marketplaces and on social media. These stories may look like, "It cured my heart disease!”
  4. Claiming to be a "quick fix." Many conditions and diseases take time to be treated even with an approved treatment. Don't fall for this marketing ploy. 
  5. An "all natural” treatment or cure. This language is included on purpose to grab your attention and suggest it is a safer alternative than what is the standard treatment. But don't be fooled. All natural doesn't necessarily mean it is safer. The FDA has found that some products claiming to be "all natural" contain hidden ingredients (prescription ingredients or other pharmaceutical ingredients) at high doses. In some cases, the FDA has found ingredients that have been taken off the market for safety reasons.

The agency also recommends that consumers talk with a healthcare professional before deciding to buy or use any dietary supplement or drug. One reason is because some supplements can interact with medicines or other supplements.

Your healthcare provider will determine the best course of treatment for you.

"Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Dr. Cara Welch, director of the FDA's Office of Dietary Supplement Programs, in a press release.

If you think you are experiencing a side effect or any issues after taking a supplement sold by any of these companies, the FDA recommends immediately stopping using the product and contacting your healthcare provider. The agency also encourages you to report any adverse reactions associated with FDA-regulated medications  to the agency using MedWatch or the Safety Reporting Portal.

The FDA has given the companies 15 working days to respond by stating how they will address the issues listed in the warning letters. If they do not correct violations promptly, it may result in legal action.