FDA warns seven companies over cardiovascular disease claims


The FDA has sent warning letters to the following seven companies that market dietary supplements: Essential Elements (Scale Media Inc.); Calroy Health Sciences LLC; Iwi; BergaMet North America LLC; Healthy Trends Worldwide LLC​ (Golden After 50); Chambers Apothecary; and Anabolic Laboratories, LLC.

“Since cardiovascular disease is the leading cause of death in the United States, it is important that the FDA protect the public from products and companies that illegally claim to treat it. 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 healthcare providers” , said Cara Welch, PhD, director of the Office of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition.

Essential Elements markets a CholestAid-branded supplement that includes pine bark extract, red yeast rice extract, and vitamins among its ingredients. The product is supposed “keep cholesterol levels under control.”

Iwi, which markets an omega-3 supplement derived from a proprietary strain of seaweed, said its products are “Clinically proven to lower cholesterol.”

Attempt to sequester information in studies

Calroy Health Sciences lists a number of ongoing studies on its supplement, under the Arterosil brand. These include studies of arterial plaque, endothelial function and leukocyte adhesion, and have been carried out (or are in progress) at the universities of Peking and Maastricht, the Netherlands, as well as a study conducted by a CRO. The company apparently sought to isolate this medical information by requiring website visitors to provide medical information before gaining access to the studies.

However, the supplement’s website itself claims that it is “Clinically proven to protect and restore the endothelial glycocalyx.” The active ingredient in Arterosil is rhamnan sulfate, a sulfated polysaccharide derived from Monostroma nitidium, a species of algae. The FDA cited these types of claims as evidence that the product was intended for use as a drug.

Bergamet, which markets a supplement based on Bergamot (Citrus bergamia​) extract, also specifically mentioned an effect on cholesterol, stating that the product is “Clinically proven to improve cholesterol levels. This lowers LDL.

CoQ10, Hawthorne supplements

Anabolic Laboratories markets a CoQ10 supplement. On a product page for the supplement, the company appeared to promote it as an adjuvant treatment for patients with heart disease: “Those who received CoQ10 therapy were significantly less likely to require inotropic drugs after surgery and to develop ventricular arrhythmias. In addition, a multicenter randomized controlled trial evaluated CoQ10 as an add-on therapy in 420 patients with chronic heart failure Long-term treatment with CoQ10 has been shown to be safe, improves symptoms, and reduces major adverse cardiovascular events.

Healthy Trends, doing business as Golden After 50, markets a product called BPS-5, which contains hawthorn berry extract and other ingredients. The company claims the product “is used to fight high blood pressure, blood disorders and heart disease.”

Chambers’ Apothecary markets a product that also includes Hawthorne and also claims to lower blood pressure.


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