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U.S. Department of Health and Human Services

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Enforcement Actions

Sharp Labs Inc, 7/9/08

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  555 Winderley Place, Suite 200
Maitland, FL 32751

CERTIFIED MAIL
RECEIPT REQUESTED

WARNING LETTER

FLA-08-23

July 9, 2008

Stephen C. Sharp, President
Sharp Labs Inc
1648 Taylor Road #363C
Port Orange, FL 32128

 

Dear Mr. Sharp:

 

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.sharpweblabs.com and has determined that the products "Acai Juice," "Alkaline Herb Drops," "Ph Drops," "Cesium Bladder Package," "Cesium Breast Support Package," "Cesium Colon Package," "Cesium Liver Health Package," "Cesium PH Antioxidant Package," "Cesium Prostate Package," "Cesium Skin Package," "Chlorophyll with Aloe Vera Juice," "Cranberry Drops," "Flax Complete 3000," "Green Tea Extract," "Healthy Greens," "Liquid Cesium Ionic," "Liquid . CoQ10 - 8 oz," "Liquid CoQ10 Natures Answer," "Liquid Germanium," "Liquid Selenium,' ;' "Liquid Vitamin* C (Dynamic Health)," "Molybdenum," "Pau Darco [sic] - Alta Health," j"Shark Cartilage," "Vitalica Broccoli," and "Wheatgrass Drops" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, 4nd 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 website include:

Acai Juice

• "In addition to the benefits of Acai berries, this dynamic blend also contains:

Pomegranate Juice Concentrate
-Helps prevent cancer . . .

Organic Raspberry Juice Concentrate

~ Raspberry Juice can help to inhibit the growth of cancerous cells

~ Blueberry Juice Concentrate

~ May be helpful in fighting certain types of cancers, heart disease, and urinary tract infections"

Alkaline Herb Drops and Ph Drops

• "Our exclusive Alkaline Herb Drops [or Ph Drop's] from www.SharpWebLabs.com have been used by thousands of men and women young and old to help naturally boost and maintain Ph levels at 7.0 and higher . . . At a pH slightly above 7.0 cancer cells become dormant and at pH 8.5 cancer cells will die . . . ." [citation omitted]

• "There are two factors that are ALWAYS present with cancer . . . . Acid pH . . . . Cancer needs an acid . . . environment to survive and flourish within. Terminal cancer patients are around 1000 times more acidic than normal healthy people. . . .Our bodies simply can not fight disease if our body pH is not properly balanced . . . . In other words . . . alkaline or die."

Cesium Bladder Package, Cesium Breast-Support Package, Cesium Colon Package, Cesium Liver Health Package, Cesium PH Antioxidant Package, Cesium Prostate Package, Cesium Skin Package

• "Research by Keith Brewer, PhD and H.E. Sartori has shown that raising the pH, or oxygen content, range of a cell to 8.0 creates a deadly environment for cancer. . . . When cesium is taken up by cancer cells, it raises the pH, or oxygen content, of the cell. The cells that die are absorbed and eliminated by the body."

• "Cesium Chloride has been used . . . for breast cancer, lung cancer, prostate cancer, colon cancer, pancreatic cancer, liver cancer, skin cancer, ovarian cancer, stomach cancer, cervical cancer, brain cancer, kidney cancer, testicular cancer, bone cancer, throat cancer, thyroid cancer, gastrointestinal cancer, cancers of the bladder and
gallbladder, metastatic melanoma . . . ."

Chlorophyll with Aloe Vera Juice (also referred to on your website as "Aloe with Chlorophyll")

• "Some of the traditional benefits of Chlorophyll are as follows: . . . Traditionally used in the treatment of certain types of cancers"

Cranberry Drops

• "Suggested Health Benefits [of] Cranberries . . . Anti-Cancer Activity - Based on evaluation of several vitro screening tests, it has been suggested that the proanthocyanidin compounds found in cranberry may exhibit some anti-carcinogenic activity."

• "Recent scientific research shows that cranberries and cranberry products contain significant amounts of antioxidants and other phytonutrients that may help protect against heart disease, cancer and other diseases."

Flax Complete 3000

• "Flax seeds contain over a hundred times more of a phytonutrient, known as lignin, than any of its closest competitors . . . . Lignins have received a lot of attention lately because of possible anti-cancer properties, especially in relation to breast and colon cancer. Lignins seem to flush excess estrogen out of the body, thereby reducing the incidence of estrogen-linked cancers, such as breast cancer. Besides anti-tumor properties, lignins also seem to have anti-bacterial, anti-fungal, and antiviral properties."

Green Tea Extract

• "Green tea extract contains a potent antioxidant, EGCG . . . . This important ingredient . . . protects against digestive and respiratory infections, helps to block the cancer promoting actions of carcinogens, protects against high total and LDL cholesterol levels, and blocks the attachment of the, bacteria associated with dental cavities to the teeth."

Healthy Greens

• "Some of the traditional benefits of each key ingredient : . . . Wheat Grass . . .[h]as traditionally been used to fight many forms of cancer. . . .*

Liquid Cesium Ionic

• "Is Cesium The First Step Towards Curing Cancer? "

• "Proponents claim that the intracellular pH of tumor cells is usually very low (acidic) compared to normal cells, and that cesium chloride supplements increase the pH level of tumor cells back to a normal level, which may be detrimental to the cancer's growth."

• "Studies conducted in several experimental tumor models in the 1980s found that the administration of cesium or cesium chloride led to reductions in tumor growth and mortality in certain tumor-bearing mice such as those with sarcoma or breast cancer."

Liquid CoQ10 - 8 oz

• "Although CoQ1O is best documented in the treatment of heart failure, two recent medical journals suggest tremendous promise in the treatment of cancer. In Biochemical and Biophysical Research Communications (April 15, 1993; 192:241-5),

Folkers described 10 cancer patients given CoQ10 for heart failure. One of the patients, a 48-year-old man diagnosed in 1977 with inoperable lung cancer, has been [sic] not had any signs of either cancer and heart failure symptoms while taking CoQ10 for 17 years!

Knud Lockwood, M.D., a cancer specialist in Copenhagen, Denmark, recently described his treatment of 32 `high-risk' breast cancer patients with antioxidant vitamins, essential fatty acids, and CoQ10. `No patient died and all expressed a feeling of well-being,' he wrote in Biochemical and Biophysical Research Communications (March 30,1994;199:1504-8) . . .

Six of the 32 patients showed partial tumor remission, and two benefited from very high doses of CoQ10. One, a 59-year-old woman with a family history of breast cancer, had a tumor removed from her left breast . The cancer returned, but `stabilized' at about 1.5-2 centimeters (about. 1/2 tb 3/4-inch) in diameter when the patient took 90 mg. of CoQ10 daily. One month after increasing the CoQ10 intake to 390 mg. daily, the tumor disappeared. Mammography confirmed its absence.

Another patient, age 74, had a small tumor removed from her right breast . She refused a second operation to remove additional growths and began taking 300 mg of CoQ10 daily. Three months later, an examination and mammography revealed no evidence of the tumor or metastases.

Lockwood, who has treated some 7,000 cases of breast cancer over 35 years, wrote that until using CoQ10, he had `never seen a spontaneous complete regression of a 1.5-2.0 centimeter breast tumor, and has never seen a comparable regression on any conventional anti-tumor therapy."'

Liquid CoQ10 Natures Answer

• "Heart disease. Cancer. AIDS. As unbelievable as it might sound, each of these deadly diseases often responds to a coenzyme Q10, a little known nutrient that can make a big difference in your health."

• "Although CoQ10 is best documented in the treatment of heart failure, two recent medical journals suggest tremendous promise in the treatment of cancer . . . ."

Liquid Germanium

• "Some symptoms of Germanium deficiency: Asthma, cancer (breast, lung, bladder), cardiac insufficiency, hypertension, hepatic cirrhosis, leukemia, neuralgia, nephritis, neurotic disorders, and softening of brain tissue."

Liquid Selenium

• "[T]here is evidence that Selenium can help the body fight cancer ."

• "Some symptoms of Selenium Deficiency: . .. Alzheimer's, anemia, cancer, cardiomyopathy, cirrhosis of the liver, Cystic Fibrosis . . . fibromyalgia, heart disease . . . HIV (AIDS), Sudden Infant Death Syndrome (S ID S) . . . immune deficiencies, infertility, Multiple Sclerosis, Muscular Dystrophy . . . . pancreatic atrophy, pancreatitis, Parkinson's Disease . . . scoliosis, and-sickle-cell anemia ."

Liquid Vitamin C (Dynamic Health)

• "Some of the other functions of vitamin C are: . . .. helps prevent cancer and protects against infection . . . may reduce cholesterol levels and high blood pressure . . . promotes the healing of wounds and bums . . . ."

• "This double-duty nutrient has been shown to prevent many illnesses, from everyday ailments such as the common cold to devastating diseases such as cancer."

Molybdenum

• "Symptoms of a Molybdenum deficiency . . . Cancer . . . "

Pau Darco [sic] - Alta Health (Caps and Ointment)

• "Pau D'Arco is used for: Slowing and inhibiting the growth of cancer and tumors, for skin diseases. Pau D'arco seems to first eliminate the pain caused by the disease . . . . [T]he range of its curative action is phenomenal ."

• "It is good for ulcers, diabetes, rheumatism, osteomyelitis, leukemia, various cancers, ringworm, bronchitis, and other respiratory problems"

Shark Cartilage

• "Shirk Cartilage became popular . . . a few years ago, based on the claim that sharks do not get cancer and that this substance must therefore be useful for the prevention and treatment of cancer."

Vitalica - Broccoli

• "[T]he crucifers-broccoli, cauliflower, and cabbage-have been shown rich in natural substances that could support the body's own defense systems while also suppressing tumor development. The photochemicals in the crucifers, particularly sulforaphane, appear to offer specific anti-cancer benefits. Since the early 1990s, more than 200 scientific studies have supported the protective effects of broccoli and its phytochemicals in particular."

Wheatgrass Drops

• "Wheatgrass distributors and health-food advocates claim that it . . . has numerous health benefits, such as: neutralizing toxins and carcinogens in the body . . . aiding in the prevention and curing of 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 "Acai Juice," "Alkaline Herb Drops," "Ph Drops,""Cesium Bladder Package," "Cesium Breast Support Package," "Cesium Colon Package,""Cesium Liver Health Package," "Cesium PH Antioxidant Package," "Cesium Prostate Package," "Cesium Skin Package," "Chlorophyll with Aloe Vera Juice," "Cranberry Drops,""Flax Complete 3000," "Green Tea Extract," "Healthy Greens," "Liquid Cesium Ionic,""Liquid CoQ10 - 8 oz," "Liquid CoQ10 Natures Answer," "Liquid Germanium," "Liquid Selenium," "Liquid Vitamin C (Dynamic Health)," "Molybdenum," "Pau Darco - Alta Health," "Shark Cartilage," "Vitalica - Broccoli," and "Wheatgrass Drops" 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)(I)] .

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your web site, we noticed that you were promoting many of the products listed above for the treatment and/or prevention of diseases other than cancer and that you were also promoting other products for disease treatment and/or prevention. The disease treatment and prevention claims on your website that cause your products to be unlawful were too numerous to list in this letter.

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.

Sincerely,

/s/

Emma R. Singleton
Director, Florida District