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Online Claims Enough to Cause FDA Action
January 12, 2012
3 Min Read
PHILADELPHIAHerbal Extracts Plus LLC is in hot water with FDA for website marketing claims. The agency sent company owner Everett Farr a warning letter on Jan. 3, 2012, notifying him that HerbalExtractsPlus.com contained drug claims for the Cholesterol Reduction Support," Support for High Blood Pressure" and Kidney and Bladder Support" products.
This letter shows FDA will warn companies for inappropriate claims made on websites, and this alone can trigger regulatory action. Further, FDA warned the company that testimonials on the website also violate the law, underscoring the need for companies to be sure all endorsements comply to regulatory demands. For more on what companies need to know about testimonies and endorsements, read this INSIDER article by attorney Justin Prochnow.
The warning letter said FDA reviewed the site in November 2011 and found claims that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(g)(1)(B)] because they say the products are intended for use in the cure, mitigation, treatment or prevention of disease.
FDA called out the following claims:
From the Proprietary Herbal Remedies" link under a heading titled Cholesterol Reduction Support":
The herbs in Cholesterol Reduction Support can reduce the risk of heart disease."
Apple Pectin significantly decreases the concentration of serum cholesterol levels. [R]educing the risk of arteriosclerosis, heart ailments and stroke."
Hawthorne Leaf reduces cholesterol and regulates blood pressure (both high and low) . This is also beneficial in the treatment of arteriosclerosis, high blood pressure, heart attack and strokes."
Psyllium helps to reduce the risk of heart disease."
Garlic is said to prevent heart disease ."
Turmeric has been used effectively for the treatment of arthritis, high cholesterol ...."
From the Proprietary Herbal Remedies" link under a heading titled Support for High Blood Pressure":
Support for High Blood Pressure is a formulation to counteract hypertension ."
Olive Leaf may significantly decrease blood pressure helping to ward off heart attacks.
Ginger Root may help to prevent strokes, heart attacks ."
Korean Ginseng (Panax ginseng) will lower LDL or "bad" cholesterol and raise HDL (beneficial) cholesterol."
Skull Cap helpful for treating cardiovascular disease."
From the Proprietary Herbal Remedies" link under a heading titled Kidney and Bladder Support":
Carrot is a potent antiseptic that relieves bladder and urinary infection, including chronic cystitis."
Corn Silk effective diuretic used to treat acute and chronic cystitis, urethritis, prostatitis (and other prostate disorders) ."
Cranberry is known for killing the bacteria that cause kidney and bladder infections ."
Gravel Root relieve[s] inflammatory infections and other ailments common to the urinary tract, including cystitis, prostatitis, urethritis, vaginitis and leukorrhoea."
Goldenrod helpful in treating bacterial urinary infections."
Hydrangea combats infection helpful in treating inflamed or enlarged prostate and bladder infection, including cystitis, urethritis and prostatitis, etc."
Uva Ursi helps to ease rheumatism and other diseases such as gout, arthritis, nephritis (inflammation of the kidneys) and kidney stones. [U]va Ursi helpful in dissolving kidney stones."
Juniper Berry treats infection of the urinary tract ."
FDA also noted disease claims in personal testimonials highlighted on the website. Examples include:
From the homepage Blog" link under a heading titled Customer Testimonials":
[M]y Dad has been taking the Cholesterol Reduction Support for a year now. [H]is cholesterol has come down from about 200 to 91!"
I found your Kidney and Bladder Support formula and bought some. I haven't even been on it for two weeks and already my blood glucose level has stabilized."
[Y]our product, Support for High Blood Pressure, has helped to normalize my blood pressure."
FDA gave the company 15 working days from the receipt of the warning letter to outline the specific steps it has taken to correct the violations and assure that similar violations do not occur.
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