Inspections, Compliance, Enforcement, and Criminal Investigations
Herbal Extracts Plus, LLC 1/3/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|900 U.S. Customhouse|
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
January 3, 2012
Mr. Everett Farr
Herbal Extracts Plus, LLC
350 Camer Drive
Bensalem, PA 19020
Dear Mr. Farr:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.herbalextractsplus.com in November 2011 and has determined that your “Cholesterol Reduction Support,” “Support for High Blood Pressure,” and “Kidney and Bladder Support,” products are promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and FDA’s regulations through links in FDA's homepage at www.fda.gov.
Examples of some of the claims observed on your website for these three products include:
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 ….”
Your website also includes disease claims in the form of personal testimonials. 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.”
Your “Cholesterol Reduction Support,” “Support for High Blood Pressure,” and “Kidney and Bladder Support” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your “Cholesterol Reduction Support,” “Support for High Blood Pressure,” and “Kidney and Bladder Support” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Your response should be sent to the attention of Lynn S. Bonner, Compliance Officer, at the address noted above. If you have any questions regarding any issue in this letter, Ms. Bonner can be reached at 215-717-3074 or by email at firstname.lastname@example.org.
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Bureau Director