| Public Health Service Food and Drug Administration |
| 555 Winderley Pl., Ste. 200 Maitland, Fl 32751 |
Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-10-15
April 5, 2010
Mr. Norman Hem
7Seas LLC
7333 Miami Lakes #588
Hialeah, FL 33014
Dear Mr. Norman Hem:
This is to advise you that the Food and Drug Administration (FDA) reviewed your web sites at the Internet addresses http://www.AlternateCancerCure.com, http://www.CureCancerSource.com, http://www.Treatallcancer.com and http://www.ApricotPower-info.com in March 2010 and has determined that the products Jade Windscreen, Vitamin B17, Ultra-A+E, Apricot Seeds, and Miracle Mineral Supplement (MMS), are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your web site 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. You may find the Act and the Code of Federal Regulations for Dietary Supplements through links at FDA's home page at www.fda.gov.
Examples of some of the claims observed on your web site include:
At www.AlternateCancerCure.com
Miracle Mineral Supplement:
• "MMS Is The Answer To ... Malaria, Hepatitis A, B, and C, Colds, Herpes, TB, Most cancer, Flu, Pneumonia, As well as many other illnesses and diseases ... "
Ultra-A+E - Vitamin A and E Emulsion:
• "Its inhibitory effects are especially potent against leukemia and certain head and neck cancers,"
• "Vitamin A and its analogs have shown the ability to help inhibit cancer cell proliferation and help in returning to normal growth patterns. The first formal studies of the possible anti-tumor effects of emulsified vitamin A were initiated in Germany
• "It was a known fact that lung cancer in Norwegian sailors was less common than in other groups. even though they smoked since childhood."
Jade Windscreen - Prevention for Swine Flu - Chinese Formula:
• "Jade Windscreen has been selected to provide prevention for the H1N1 (Swine Flue) virus."
• "It builds resistance to colds and flu ... "
• "When taken in advance of the cold season, it can prevent colds."
At www.CureCancerSource.com
The Amazing Apricot Seed:
• "Apricot kernels, , . contains amygdalin, also known as vitamin B17, which attacks carcinogenic cells."
• "The b17 tablets come from the apricot seeds and can be used for both prevention and treatment of cancer."
• "The cost for treating cancer with standard medicine is in the multi-thousands, but living cancer free is priceless."
At www.ApricotPower-info.com
• "Vitamin B17 - The Cancer Preventing Vitamin" This website provides cancer information under the name Jonathan (Joni) Bell, with links directly to www.AlternateCancerCure.com to purchase the product.
• "[M]eans that vitamin B17 is truly the only natural cancer killing substance"
• "There is, as of yet, no magical cure for cancer. But eating a diet that is rich in foods containing vitamin B17 can help to prevent your body from developing cancerous cells."
www.Treatallcancer.com
• "The Most Powerful, PROVEN Cancer Treatment and Prevention Products EVER Known to Humankind ... "
• "Start Cancer Treatment or Prevention Today"
• "B17 will attack a cancer cell, if it is present in your body."
• "Laetrile has been proven for decades to kill existing cancer cells in most cases."
• "[W]hen consumed, the B17 would make it 100% impossible to develop cancer."
Your web site at www.Treatallcancer.com also contains disease claims in the form of personal testimonials, including:
• "[M]y mother...was diagnosed with stage 4 ovarian cancer. I began researching and found B-17. [S]he took it ... and we were all impressed with how well her blood counts were ... "
• "That next January, she will be considered cured! [M]y wife was diagnosed with ovarian cancer"
• "My mother-in-law was diagnosed with colon cancer the size of a grapefruit. A few months and less than $500 dollars worth of seeds and pills and it was reduced to a small mass the size of a grape."
Furthermore, these claims are supplemented by the metatags you use to bring consumers to your website. These metatags include the following:
• www.alternatecancercures.com - cure cancer, cancer prevention, treat cancer, alternate cancer cure, cancer treatment
• www.CureCancerSource.com - cancer prevention, how to cure cancer, natural cancer treatment, alternate cancer cures, big cure 4 cancer
• www.Treatallcancer.com - treat cancer, prevent cancer, cancer prevention, big cure 4 cancer
• www.apricotseedstreatcancer.com - treat cancer
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 1ade Windscreen, Vitamin B17, Ultra-A+E, Apricot Seeds, and Miracle Mineral Supplement (MMS) are also misbranded within the meaning of section 502(f)(1) of the Act, in that the 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 or their labeling. It is your responsibility to ensure that all of your products 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 actions without further notice, such as seizure and/or injunction.
You should take prompt action to correct these violations. Please respond to this letter within 15 days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved.
If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to Carla A. Norris, Compliance Officer, 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. Norris at (407)475-4730.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
No comments:
Post a Comment