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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted November 21, 2022
6 Supplement Companies Warned by FDA for Making Cholesterol Claims
On May 4, 2022, the FDA issued warning letters to six supplement companies following review that found statements made on company websites and Walmart purchase pages suggesting the products could lower cholesterol to be drug claims, which are not permitted for dietary supplements.
The products, which contain ingredients such as CoQ10, red yeast rice, and magnesium, were promoted to lower cholesterol and/or for lowering blood pressure, with statements such as, “BergaMet Cholesterol Command is clinically proven to improve cholesterol levels. It reduces LDL.” and “May lower blood pressure.”
(See ConsumerLab’s article about Supplements for Lowering Cholesterol for its take on a recent study that found five popular supplements to be ineffective for lowering cholesterol.)
Use the links below to view the FDA’s warning letter for each company:
- Anabolic Laboratories Inc (CoQ10 Ubiquinol Prime, Policosanol Microtabs)
- BergaMet North America LLC (Cholesterol Command)
- Chambers’ Apothecary (Blood Pressure Support, CoEnzyme Q10)
- Essential Elements (CholestAid)
- Healthy Trends Worldwide, LLC (BPS-5)
- iwi (iwi Cholesterol)
The companies are required to respond in writing to the FDA within 15 days of receipt of the warning letter, outlining steps taken to address any violations.
See ConsumerLab’s Reviews of CoQ10 and Ubiquinol Supplements, Red Yeast Rice, Magnesium Supplements, and Cholesterol-Lowering Supplements for more information and tests of related products.
See related recalls and warnings:
FDA Warns Seller of Magnesium, CBD, Herbal Extracts & More
FDA Warns Seller of Vision, Calcium & Magnesium Supplements and More
Seller of Cholesterol, Weight Loss Products, and More Warned for Claims
FDA Warns Seller of Curcumin and Cholesterol Supplements
Seller of Cholesterol-Lowering Supplements Warned for Drug Claims
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
Thank you for submitting your report.
Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
Thank you for submitting your report.
