Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
555 Winderley Pl., Ste. 200
Maitland, FL 32751
January 5, 2009
2020 Seven Springs Blvd
New Port Richey, FL 34655
Dear Mr. Curtis and Mr. Perich:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.bodysaver:org and has determined that your Body Saver products "Dry Eye Saver Formula," "Hearing Saver Formula," "Memory Saver Formula" and "Soothing Colon Formula" 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 website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your web site include:
Body Saver Dry Eye Saver Formula
• "After 7 to 10 days, individuals suffering from mild to moderate dry eye are reducing or eliminating the need for drops. This product has been the 'miracle cure' for many, and provides continued support for these individuals in the relief of itching, burning or irritated eyes."
Body Saver Hearing Saver Formula
• "If your hearing isn't what it used to be and you are not quite ready for a hearing aid, this product was formulated just for you."
•"Hearing Saver is designed to be helpful with mild hearing joss and assists in reducing bothersome ringing in the ears."
• "Tinnitus is often one symptom of Meniere's disease.... Research has found that approximately 35-47% of people suffering from Tinnitus also had vitamin B-12 deficiency. With the addition of Vitamin B-12 [listed as an ingredient of "Body Saver Hearing Saver Formula" on your website] supplementation there was improvement in their Tinhitus."
• "Magnesium [listed as an ingredient of "Body Saver Hearing Saver Formula" on your website] could help shield sensitive ears. Low levels of magnesium combined with noise exposure eventually deplete the cells' energy stores, leading to exhaustion, damage and death of the inner ear cells."
Body Saver Advanced Memory Saver Formula
• "Advanced Memory Saver is a dietary supplement designed to help stabilize chemical imbalances . . . and help to reduce depression."
• "Ginkgo biloba [listed as an ingredient of "Body Saver Advanced Memory Formula" on your website] has been known as one of those dietary supplements used to help . . . delay the progression of Alzheimer's disease . .
• "Clinical uses of Ginkgo include support for early stroke and senility, vertigo, tinnitus, embolism, and some eye disorders including macular degeneration and diabetic vascular disease."
• "The Ginkgo Biloba ... may aid the body in preventing the onset of illness and disease. Some people take one or two capsules a day just to ward off colds and flu."
• "Vinpocetine [listed as an ingredient of "Body Saver Advanced Memory Formula" on your website] . . . allows the brain to survive longer and better after periods of oxygen deprivation."
Body Saver Soothing Colon Formula
• "Soothing Colon Formula is one of a kind product that has had amazing results. Individuals suffering from Crohn's Disease, report being symptom free in as little as 10 days and many have been able to scale down their dosage."
• (Testimonial) "I have had Crohn's Disease for more than 10 years, with severe symptoms of diarrhea, weight loss and other digestive problems over the last nine months. . . . After about ten days of taking the product, my colon has calmed down, and I have been symptom free since."
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. Your products "Dry Eye Saver Formula," "Hearing Saver Formula," "Memory Saver Formula" and "Soothing Colon Formula" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails to, bear adequate directions for use [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 products marketed by your Firm comply with the Act and its implementing regulations. 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 enforcement action without further notice. 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 of the 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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Shari H. Shambaugh, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions regarding any issues in this letter, please contact Ms. Shambaugh at 407-475-4730.
Emma R. Singleton
Director, Florida District