Alistrol Health's Disease Claims Net FDA Warning Letter

BOTHELL, Wash.FDA said therapeutic claims put several of Alistrol Health Inc.'s products in the illegal new drug category, according to a letter the agency sent the company. FDA found these claims on websites that promoted the products, such as drophighbloodpressure.com, highbloodpressure-treatment.net and www.depressionfighters.com, and in promotional materials distributed with the products.

According to FDA, the therapeutic claims on the websites and in the promotional materials establish these products as drugs under the Federal Food, Drug and Cosmetic Act because they are intended for use in the cure, mitigation, treatment or prevention of disease. 

FDA said on the sites alistrol.com, highbloodpressure-treatment.net and drophighbloodpressure.com, Alistrol was promoted as regulating high blood pressure, reducing cholesterol and breaking down fat that may contribute to heart disease . The product CLE Vitamin D3 was also promoted for treating high blood pressure,  autoimmune diseases and cancer.

The company also promoted the ingredient garlic seed extract as preventing age-related vascular changes, lowering cholesterol, reducing metabolism of glucose in diabetes and lowering the risk of heart attacks.

The company's Naavudi was promoted as  tool to manage diabetes and lower blood glucose levels on the website naavudi.com. On depressionfighters.com, the product Depression Fighters was marketed as a natural herbal anti depression dietary supplement that provides relief to depression and anxiety disorders.

 FDA noted the sites also had disease claims in the form of personal testimonials. On a webpage titled, Success Stories," a testimonial said Alistol allowed a consumer to stop taking prescription medication for high blood pressure among other blood pressure-related claims. Testimonials  on naavudi.com said the product helped consumers lower and stabilize blood pressure.  And on depressionfighters.com, testimonials said the product relieved anxiety and depression in consumer who took the product.

 FDA noted the metatags on these sites also use drug language to attract consumers. Such metatags include  "High blood pressure remedies, Lower blood pressure, How to lower blood pressure, best depression remedy, Anti Depression, Diabetes Supplement and Diabetes Medicine."

FDA also went to the company's Facebook page and found claims that Alistrol and vitamin D lower blood pressure as well as a link to the testimonial page on the alistrol.com site.

Along with the websites, FDA said promotional materials shipped with the products held disease claims.  FDA noted business cards with the company website addresses and ordering information including the claims, Lower Blood Pressure Naturally," Stop Depression Naturally" and Stop Type 2 Diabetes Naturally."

A promotional pamphlet for Alistrol also said it lowered blood pressure. This pamphlet contained results of a clinical trial conducted on Alistrol. According to the pamphlet, subjects who took Alistrol lowered their systolic blood pressure, on average, from 142.6 mmHg to 128.4 mmHg and lowered their diastolic blood pressure from 91.5 mmHg to 81.6 mmHg in six weeks.  "These data, in conjunction with other claims found in your pamphlet, establish that your Alistrol product is intended for use to treat hypertension," FDA wrote.

INSIDER's Take:

Dietary supplement companies are not allowed to claim they treat, prevent, mitigate or cure diseases, and FDA will make no exceptions. This means companies can't make disease claims even if they have a study backing that claim. Companies cannot make disease claims in website metatages, in social networking circles or through third-party testimonials.  If they do, companies can expect FDA to send an unwelcome warning letter.