| Public Health Service Food and Drug Administration |
Denver District Office |
Department of Health and Human Services
December 30, 2010
Ref: DEN-11-06 CIWL
WARNING LETTER
VIA UPS
Josh Scott
438 South 1680 West
Provo, Utah 84601
Dear Mr. Scott:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses, www.drchristophers.com and www.herbshopconnection.com in December 2010 and has determined that the products “Bilberry Eye Capsule,” “Cayenne Pepper Extract,” “Hawthorn Berry Heart Syrup,” “Blood Circulation Formula,” “Chest Formula,” “Immune System Formula,” “Pancreas Formula,” “Cold Season Formula,” “Garlic Rosehips & Parsley Powder,” and “Lung & Bronchial Capsule” are promoted for conditions that cause the 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 therapeutic claims on your websites establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and FDA’s regulations through links at FDA’s home page at http://www.fda.gov.
Examples of some of the claims observed on your website, www.drchristophers.com, include:
Bilberry Eye Capsule
• “[K]nown to prevent glaucoma ….”
• “[P]revent[s] myopia and slow[s] down or stop[s] progressive myopia….”
• “[A]pplied for the treatment of various types of myopia (including progressive myopia), myopic chorioretinitis [sic] … retinal degeneration, diabetic retinopathy, various inflammatory reactions (retinitis, conjunctivitis, keratitis), macular degeneration … glaucoma ….”
• “[P]revents degenerative processes in the eye.”
• “Cayenne pepper [an ingredient in your product] … has anti-cancer properties and helps in the treatment of ovarian tumors.”
• “Eyebright Herb [an ingredient in your product] … produces a strong anti-inflammatory effect …”
• “Ailments traditionally used for: … Cataracts, Conjunctivitis … Glaucoma, Macular Degeneration … Retinopathy ….”
Cayenne Pepper Extract
• “Ailments traditionally used for: … Arthritis, Atherosclerosis…Bursitis, Cancer …, Cold Sores, Colitis, Common Cold … Constipation, Coronary Artery Disease … Cystitis … Flu … Gout … Heart Disease … Herpes Simplex 1 … Hypercholsterolemia[sic], … Influenza … Irritable Bowel Syndrome … Measles … Mitral Valve Prolapse … Pleurisy … Stroke … Urinary Tract Infection …Yellow Fever.”
Hawthorn Berry Heart Syrup
• “Ailments traditionally used for: Angina … Atherosclerosis … Congestive Heart Failure, Coronary Artery Disease … Glaucoma … Hypercholesterolemia, Hypertension, Macular Degeneration, Mitral Valve Prolapse … Retinopathy … Stroke …. ”
Blood Circulation Formula
• “It [Blood Circulation Formula] has freed many people of … tumors, [and] infections …”
• “Blood Circulation Capsule is irreplaceable in battling the consequences of diabetes.”
• “Ginger Root [an ingredient in your product] … is well known for bactericidal, anti-inflamatory [sic] … properties.”
• “Ginger root [an ingredient in your product] is also known to … treat atherosclerosis.”
• “Garlic Bulb extract [an ingredient in your product] is another excellent antiseptic and antibacterial element .…”
• “It [Garlic Bulb extract (an ingredient in your product)] treats disorders resulting from staphylococcal and streptococcal infections .…”
• “Garlic bulb [an ingredient in your product] … battles atherosclerosis and thrombophlebitis …”
• “Ailments traditionally used for: … Atherosclerosis … Blood Pressure … Congestive Heart Failure, Coronary Artery Disease … Glaucoma … Heart Disease … Hypercholesterolemia … Macular Degeneration, Mitral Valve Prolapse ….”
Chest Formula
• “Chest Formula Capsule is prescribed for the treatment of … viral infections … bronchial asthma, chronic obstructive pulmonary disease ….”
• “The medicine [chest formula capsule] possesses, antiviral, bactericidal and antiseptic properties and is used effectively to treat … laryngitis, bronchitis, pneumonia, influenza, pleurisy, and asthma attacks.”
• “[I]t [chest formula capsule] has a strong antipyretic, anti-inflammatory … effect …”
• “Chest Formula Capsule may be helpful in the treatment of … infections, colitis ….”
• Ginger Root … used in the treatment of cardiovascular diseases … prevent heart failure.”
• “Ailments traditionally used for: … Bronchitis … Chronic Obstructive Pulmonary Disease … Common Cold … Flu … Laryngitis … Periodontal Disease ….”
Immune System Formula
• “[D]esigned … to prevent and treat … cancer and tumors.”
• “Has anti-allergic and anti-inflammatory effect”
• “May help prevent cancer”
• “[R]ecommended in the treatment and prevention of these diseases: …
o Bacterial and viral infections such as influenza or herpes …
o Atherosclerosis of coronary and cerebral arteries …
o Benign and malignant tumors
o Chronic leukemia
o Chronic form of hepatitis B ….”
• “Ailments traditionally used for: Bacterial Infection, Herpes Zoster ….”
Pancreas Formula
• “Prevents the development of diabetes”
• “[D]esigned to … treat infectious and inflammatory diseases in the pancreas and the liver.”
• “Traditional Uses of the Formula: Pancreatitis … Gastric ulcer … duodenitis … Tumors of the stomach and liver, Chronic hepatitis, Early stages of liver cirrhosis, Acute and chronic cholecystitis … Diabetes mellitus”
Examples of some of the claims observed on your website, www.herbshopconnection.com, include:
Cold Season Formula
• “ The [Cold Season] Formula has antiviral and antibacterial properties.”
• “Ailments traditionally used for: … Candidiasis … Cold Sores, Common Cold, Congestive Heart Failure … Flu … Herpes Simplex 1 … Hypercholesterolemia … Laryngitis, Lupus, Mitral Valve Prolapse … Thrush, Ulcer ….”
Garlic Rosehips & Parsley Powder
• “Ailments traditionally used for: … Common Cold, Congestive Heart Failure, Flu … Gastritis … Hypercholesterolemia, Influenza, Laryngitis, Lupus, Mitral Valve Prolapse … Stomach Ulcer ….”
Lung & Bronchial Capsule
• “[The Lung & Bronchial Capsule] has analgesic effect ,,,.”
• “Many people use Lung & Bronchial Capsule to … relieve inflammation in the genitourinary system.”
• “The formula may . . .
o Treat and prevent viral respiratory infections, influenza
o Treat and prevent infectious diseases”
• “Ailments traditionally used for: Asthma, Bronchitis … Chronic Obstructive Pulmonary Disease, Cold … Pleurisy, Sinusitis, Tuberculosis, Whooping Cough.”
Your 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, because your products, Bilberry Eye Capsule,” “Cayenne Pepper Extract,” “Hawthorn Berry Heart Syrup,” “Blood Circulation Formula,” “Chest Formula,” “Immune System Formula,” “Pancreas Formula,” “Cold Season Formula,” “Garlic Rosehips & Parsley Powder,” and “Lung & Bronchial Capsule,” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
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. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
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 the date by which the corrections will be completed.
Please send your reply to the attention of Thomas R. Berry, Compliance Officer, at the above letterhead address.
If you have any questions regarding any issues in this letter, please contact Thomas R. Berry, Compliance Officer, at 303-236-3028.
Sincerely,
/s/
Harry T. Warwick
Director, Denver District Office
cc:
Robert Scott, President
Wholistic Botanicals, L.L.C.
155 W. 2050 N.
Spanish Fork, Utah 84660
No comments:
Post a Comment