Department of Health and Human Services
Public Health Service
19900 MacArthur Blvd #300
August 22, 2000
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Susan R. Wix, Owner
Halo Supply Co.
7710 Balboa Ave #330
San Diego, CA 92111
Ref. No. W/L 72-00
Dear Ms Wix:
This letter is in reference to your firm's marketing and distribution of the product EverCLR. Labeling for this product contains therapeutic claims that cause the product to be a drug [section 201(g) of the Federal Food, Drug and Cosmetic Act (the Act)]. Labeling is not limited to the immediate product containers but includes all promotional literature that you distribute in connection with your product.
Objectionable claims for EverCLR include the following:
- All reference to virus, anti-fungal, or fungal host.
- All reference to the prevention or treatment of herpes, cold sores, or fever blisters. All comparisons to antiviral medications and statements, such as,
- A Natural approach to controlling Outbreaks, Stops Outbreaks on Lips and Other Sensitive Areas, energizes your body's defenses to relentlessly search out our HSVI and HAVII and eliminate it, and
- Relief of Skin Eruptions.
EverCLR is a "new drug" [section 201(p) of the Act]. Therefore, it may not be legally marketed in this country without an approved New Drug Application [section 505(a) of the Act].
This drug is also misbranded because its labeling fails to bear adequate directions for the conditions for which it is offered [Section 502(f)(1) of the Act] and its labeling is false and misleading because it suggests that this product is safe and effective for its intended use, when in fact, this has not been established [Section 502(a) of the Act].
This letter is not intended to be an all-inclusive review of all labeling and products your firm may market. It is your responsibility to ensure that all products marketed and distributed by your firm are in compliance with the Act and its implementing regulations.
In addition, labeling for EverCLR provides the Internet address to www.everclr.com. This site also promotes EverCLR with Herpes treatment claims similar to those listed above.
Further, therapeutic claims for additional products are included in your firm's product labeling. Such claims may also cause these products to be misbranded. products and claims include:
- Brain Power Depression Joint Comfort
- joint and connective tissue pain and for rheumatoid and osteo-arthritis
- Cabernet Capsules
- "reduce your cholesterol by as much as 60 points … 1/3 the cost of most prescriptions that don't work as well", chronic diseases, atherosclerosis, heart disease, heart attacks, severe blockage of an artery, regained normal blood flow, plaque, calcification on teeth, gall stones, irregular [heart] beats, angina pectoris, lowers blood pressure, inhibits blood clotting, cardiovascular healill~ secrets, and reducing cardiovascular health risks.
We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug and Cosmetic Act provides for seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.
Please notify this office in writing within fifteen (15) working days of receipt of this letter describing the specific steps that you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within the fifteen working days, state the reason for the delay and the tilme within which the corrections will be completed.
Your written response should be directed to the attention of:
Thomas L. Sawyer
Director, Compliance Branch
Food and Drug Administration
19900 MacArthur Blvd #300
Irvine, CA 92612-2445
Elizabeth A. Keville
Acting District Director
Devine Healing Ministries, Inc.
PO Box 27740
Las Vegas, NV 89126
California Department of Health Services, Food & Drug Branch
601 7th St
Sacramento, CA 94234-7320
Attn: Stuart Richardson, Jr., Chief
This page was posted on August 20, 2006.