FDA warns seven companies over cardiovascular disease claims

By Hank Schultz contact

- Last updated on GMT

©Getty Images - Rasi Bhadramani
©Getty Images - Rasi Bhadramani

Related tags: Fda, Dietary supplement, Dietary supplement industry, Food and drug administration, cardiometabolic health, Cardiovascular disease, disease claims

Seven companies have been warned by the US Food and Drug Administration over claims of treating cardiovascular disease, the Agency announced yesterday.

FDA 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​.

“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims 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 health care providers,” ​said Cara Welch, PhD, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition.

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

Iwi, which markets an omega-3 supplement derived from a proprietary strain of algae, claimed its products are “Clinically shown to decrease cholesterol.”

Attempt to sequester information in studies

Calroy Health Sciences lists a number of ongoing studies on its supplement, branded as Arterosil.  Those include studies on arterial plaque, endothelial function and leucocyte adhesion, and were conducted (or are underway) at universities in Beijing and Maastricht, Netherlands as well as a study conducted by a CRO.  The company apparently sought to insulate this medical information by requiring website visitors to supply medical credentials before being given access to the studies.

However, the website for the supplement itself claims it is “clinically proven to protect and restore the endothelial glycocalyx.” ​ The active ingredient in Arterosil is rhamnan sulfate, a sulfated polysaccharide that derived from Monostroma nitidum, ​a species of seaweed.  FDA cited these kind of claims as being evidence that the product was intended to be used as a drug.

Bergamet, which markets a supplement based on a Bergamot (Citrus bergamia​) extract, also specifically mentioned a cholesterol effect, claiming the product is “clinically proven to improve cholesterol levels. It reduces LDL.”

CoQ10, Hawthorne-based supplements

Anabolic Laboratories markets a CoQ10 supplement.  On a product page for the supplement the company appeared to be promoting it as an adjuvant therapy for heart disease patients: “those receiving CoQ10 treatment were significantly less likely to require inotropic drugs after surgery and to develop ventricular arrhythmias. Also, a randomized controlled multicenter trial evaluated CoQ10 as adjunctive treatment in 420 patients with chronic heart failure. Long-term CoQ10 treatment was found to be safe, improve symptoms, and reduce major adverse cardiovascular events.”

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

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

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