|Company:||A1 Discount Vitamins|
|Subject:||Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated|
|Issuer:||Dallas District Office|
|Issued:||Sept. 11, 2008||Closed:||
Department of Health and Human Services
Public Health Service
September 11, 2008
RETURN RECEIPT REQUESTED
Al Discount Vitamins
3180 NW 206
Edmond, OK 73003
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.a1discountvitamins.com and has determined that the products "C-1000," "Colloidal Silver," "Graviola," "Red Raspberry Extract," "Juice Complex," " Lycopene," and "Pomegranate" 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)(13)]. 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:
• "(C Vitamin 1000 with Quertin [sic] 50mg! ) To Help Prevent & Fight Cancer."
• "Vitamin C with bioflavonoids is also a powerful anticancer agent that promotes the production of interferon in the body."
• "Vita-Labs has combined Vitamin C, with Queretin [sic) to help prevent and fight cancer."
• "Lab studies suggest that it may have anti-cancer effects, help prevent heart disease by reducing the oxidation of LDL ("bad") cholesterol, and act as an antihistamine."
• "[M]ay help treat or even prevent prostate cancer by blocking male hormones that encourage the growth of prostate cancer cells, according to preliminary laboratory research at the Mayo Clinic."
• "Population studies have found that people with high intakes of foods containing quercetin and other flavonoids tend to have lower rates of heart disease and lung cancer."
• "Colloidal silver appears to be a powerful, natural antibiotic and preventative against infections."
• "The following is a partial list of the more than 650 diseases that colloidal silver has been reputed to be successful against: ... AIDS ... allergies, appendicitis, arthritis, athlete's foot, bladder inflammation, blood parasites, blood poisoning, boils, burns, cancer ... cholera, colitis, conjunctivitis, cystitis, dermatitis, diabetes ... dysentery, eczema, fibrositis; gastritis, gonorrhea, hay fever, herpes, impetigo, indigestion, keratitis, leprosy, leukemia, lupus, lymphangitis, Lyme disease, malaria, meningitis ... parasitic infections: viral, fungal and bacterial pneumonia, pleurisy ... psoriasis, purulent opthalmia, rhinitis, rheumatism, ringworm, scarlet fever, septic conditions of the eyes, ears, mouth, and throat ... septicemia, shingles, skin cancer, staphylococcus and streptococcus infections, stomach flu, syphilis ... tuberculosis, tonsillitis, toxemia, trachoma, all forms of virus, warts, whooping cough, yeast infection, stomach ulcer ..."
• "Dr. Bjorn Nordstrom, of the Karolinska Institute, Sweden, has used silver in his cancer treatment method .... This brought rapid remission in patients given up on by other doctors."
Graviola (650 mg)
• "Graviola All Natural Cancer Treatment From South America ... Can Help Prevent and Fight Cancer!"
• "Graviola Cancer Fighting Herb From South America!"
• "Graviola, the powerful herb . .. is helping millions of people fight through their cancer treatment."
• "Can help kill cancer cells!"
• "Can help slow tumor growth!"
• "Purdue University researcher Jerry McLaughlin, working with doctoral student Nicholas Oberlies, found compounds in the Graviola tree that have shown preliminary success in fighting some drug-resistant cancers. The studies, published in two separate journal articles, show that the Graviola ... compounds not only are effective in killing tumors that have resistance to anticancer agents, but also seem to have a special affinity for such resistant cells. The findings were detailed in the journal Cancer Letters and the Journal of Medicinal Chemistry."
• "Graviola contains Annonaceous Acetogenins which have remarkable cytotoxic, anti-tumor activities .... [R]esearch identified more than 40 compounds with anti-cancer properties capable of killing cancer cells."
• "Excellent studies and information exists about Graviola's cancer killing abilities such as conducted at Purdue University in West Lafayette Ind, Health Science Institutes press release, the Skaggs Scientific Report from the Scripps Research Institute, Kaohsiung Medical University in Taiwan ... In a study conducted in 1976 by the National Cancer Institute, the leaves and stem of Graviola showed active cytotoxicity against cancer cells."
• "Scientists doing in vitro tests discovered that graviola was capable of killing the malignant cells of twelve different types of cancer."
• "Graviola is effective against all types of cancer, and is a broad spectrum anti-microbial for bacterial and fungal infections, internal parasites, and worms."
• "Graviola main uses: 1. Cancer (all types)."
• "CONQUER CANCER SAFELY and effectively with an all-natural therapy that doesn't cause extreme nausea, weight loss and hair loss."
• "EFFECTIVELY TARGET AND KILL MALIGNANT CELLS in 12 different types of cancer, including colon, breast, prostate, lung, and pancreatic cancer"
• "BE 10,000 TIMES STRONGER IN KILLING COLON CANCER CELLS than Adriamycin, a commonly used chemotherapeutic drug"
• "SELECTIVELY HUNT DOWN AND KILL CANCER CELLS without harming healthy cells, unlike chemotherapy."
Red Raspberry Extract
• "Red Raspberry Complex ... Powerful Cancer Fighter -'Ellagic Acid' - Helps Prevent & Fight Cancer!"
• "Ellagic Acid may be one of the most potent ways to fight Cancer. Ellagic Acid, a phenolic compound, is a proven anti-carcinogen, anti-mutagen, and anti-cancer initiator!"
• "Clinical tests conducted at the Hollings. Cancer Institute at the Medical University of South Carolina (MUSC) show that ellagic acid, a naturally occurring plant phenol with highest concentrations in red raspberries may be the most potent way to prevent cancer, inhibit the growth of cancer cells, and arrest the growth of cancer in persons with a genetic predisposition for the disease."
• "Dr. Daniel Nixon, MUSC, began studying the ellagic acid in red raspberries in 1993. His recently published results show:
o Cervical Cancer Cells -„HPV (human papilloma virus) exposed to ellagic acid from red raspberries experienced apoptosis (normal cell death).
o Ellagic acid leads to G1 arrest of cancer cells, thus inhibiting and stopping mitosis (cancer cell division).
o Ellagic acid from red raspberries prevents destruction of the P53 gene by cancer cells. P53 is regarded as the safeguard of mutagenic activity in cervical cells.
o Tests reveal similar results for breast, pancreas, esophageal, skin, colon, and prostate cancer cells.
o Consuming one cup (150 grams) of red raspberries per day prevents the development of cancer cells."
• "ELLAGIC ACID REDUCES THE INCIDENCE OF CANCER! Ellagic acid acts as a scavenger to bind cancer-causing chemicals, making them inactive!
...[E]Ilagic Acid from red raspberries prevents binding of carcinogens to DNA, and reduces the incidence of cancer in cultured human cells exposed to carcinogens."
• "Ellagic Acid is also considered to be a cancer inhibitor which has the ability to cause apoptosis or normal cell death in cancer cells."
• "Ellagic acid may be one the most [sic] potent substances yet found to help fight and prevent Cancer!"
• "Multiple studies have discovered that phytonutrients found in raspberries can protect us from cancer and can even shrink some types of cancer tumors."
• "Recent work (2001), published by Dr. Gary Stoner at Ohio State University, showed that components in the seeds and berry, but particularly ellagitannins, inhibited the initiation and promotion/progression stages of esophageal cancer."
In addition, the "Graviola & Ellagic Acid" page of your website lists several claims that promote your "Graviola" and "Red Raspberry Extract" products together for the treatment or prevention of cancer. Examples of some of the claims observed on this
• "(Cancer Fighting Combination)' Graviola & Ellagic Acid - Natural Cancer Fighting Products That Can Help Fight Cancer!"
• "Now you can help fight cancer with the combination of the two most powerfully know [sic] natural cancer fighting supplements 'Graviola 650 mgs 100 capsules and Ellagic Acid (Red Raspberry) 700 mg 120 capsules ..."
• "In an [sic] 1976 plant screening program by the National Cancer Institute, graviola leaves and stem showed active cytotoxicity against cancer cells and researchers have been following up on these findings since .... Three separate research groups have isolated these acetogenin compounds in graviola which have demonstrated significant antitumorous and anticancerous properties, and selective toxicity against various types of cancer cells (without harming healthy cells) publishing eight clinical studies on their findings. Many of the acetogenins have demonstrated selective toxicity to tumor cells at very low dosages as little as 1 part per million."
• "Four studies were published in 1998 which further specify phytochemicals and acetogenins which are demonstrating the strongest anticancerous, antitumorous, and antiviral properties. Thus far, specific acetogenins in graviola have been reported to be selectively toxic to these types of tumor cells: lung carcinoma cell lines; human breast solid tumor lines; prostate adenocarcinoma; pancreatic carcinoma cell lines; colon adenocarcinoma cell lines; liver cancer cell lines; human lymphoma cell lines; and multi-drug resistant human breast adenocarcinoma."
• "Benefits You Can Have By Taking Juice Complex! ...
o Fights cancerous cells
o Alleviates diabetes
o Normalizes and regulates cholesterol levels
o Minimizes inflammation
o Prevents artherosclerosis [sic]"
• "(Lycopene Maximum Strength 25mg Per Tab - 21 Century!)' Reduces The Risk of Many Cancers Including Prostate Cancer!"
• "Studies have shown that lycopene may reduce the risk of many cancers and may greatly reduce the risk of prostate cancer in men."
• "Epidemiological studies have shown that high intake of lycopene-containing vegetables is inversely associated with the incidence of certain types of cancer. For example, habitual intake of tomato products has been found to help decrease the risk of cancer of the digestive tract among Italians."
• "Ongoing research suggests that lycopene may help reduce the risk of macular degenerative disease, serum lipid oxidation and cancers of the lung, bladder, cervix and skin."
• "In 2002, a Harvard Medical School follow-up study confirmed the previous results revealing frequent tomato product consumption is associated with a lower risk of prostate cancer. Data compiled from 1986 to 1998 show two or more servings a week of tomato sauce is associated with up to a 36 per cent lower risk of prostate cancer."
• "Researchers from the University of Illinois suggest tomato sauce, and possibly the lycopene present in tomato sauce, may play a role in the prevention and treatment of prostate cancer. In 32 prostate cancer patients, recruited from the Westside Department of Veterans Affairs Hospital in Chicago, the consumption of tomato sauce-based pasta dishes for three weeks (30 mg of lycopene per day) resulted in reduced oxidative DNA damage in prostate tissue and leukocytes."
• "There is evidence that the intake of lycopene may positively impact chronic health concerns that are important to women. These include breast cancer, ovarian cancer, cervical cancer, cardiovascular disease ...."
Further, the "Lycopene" product page of your website www.a1discountvitamins.com cites numerous articles about studies of the "lycopene" ingredient used in your products. These articles concern the use of this ingredient for treatment or prevention of cancer.
When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of reference citations used to market your "Lycopene" product for disease treatment and prevention on your website:
• "American Cancer Society. Cancer Facts & Figures 2002, 4"
• "Zhang S, Tang G, Russell RM, Mayzel KA, Stampfer MJ, Willett WC, Hunter DJ. Measurement of retinoids and carotenoids in breast adipose tissue and a comparison of concentrations in breast cancer cases and control subjects. Am J Clin Nutr 1997; 66:626-632."
• "Levy J, Bosin E, Feldman B, Giat Y, Miinster, Daniienko M, Sharoni Y. Lycopene is more potent inhibitor, of human cancer cell proliferation than either Aâ€"carotene or betaâ€"carotene. Nutr Cancer 1995; 24:257-266"
• Levi F, Pasche C, Lucchini F, La Vecchia C. Dietary intake of selected micronutrients and breast-cancer risk. Int'l J. of Cancer 2001; 91:260-263."
• "Dorgan JF, Sowell A, Swanson CA, Potischman N, Miller R, Schussler N, Stephenson HE Jr. Relationships of serum carotenoids, retinal, a-tocopherol and selenium with breast cancer risk: results from a prospective study in Columbia, Missouri. Cancer Causes Control 1998; 9:89-97."
• "Cramer DW, Kuper H, Harlow BL, Titus-Ernstoff L. Carotenoids, antioxidants, and ovarian cancer risk in pre- and postmenopausal women. Int'l J. of Cancer 2001; 94: 128-134"
• "Goodman MT, Kiviat N, McDuffie K, Hankin JH, Hernandez B, Wilkens LR, Franke A, Kuypers J, Kolonel LN, Nakamura J, Ing G, Branch B, Bertram CC, Kamemoto L, Sharma S, Killeen. J. The association of plasma micronutrients with the risk of cervical dysplasia in Hawaii. Cancer Epidemiol Biomark Prev 7:537-544, 1998"
• "Kanetsky PA, Gammon MD, Mandelblatt J, Zhang ZF, Ramsey E, Dnistrian A, Norkus EP, Wright TC Jr. Dietary intake and blood levels of lycopene: association with cervical dysplasia among non-hispanic, black women. Nutr Cancer 31 :31-40, 1998."
• "Powerful Anti-Oxidant To Fight Cancer ..."
• "Keep Prostate Cancer From Returning"
o "A study found that pomegranate juice may help fight the return of prostate cancer among men who have had surgery or radiation for the disease....'Pomegranate juice contains antioxidant chemicals that may have cancer-preventing benefits,' the researchers said."
• "Fight Breast Cancer"
o "Israeli researchers found that pomegranate seed oil causes breast cancer cells to self-destruct, while leaving healthy cells unharmed."
Finally, your website promotes the products listed above for cancer treatment or prevention through the "Cancer Fighting Products" link on the home page of your website as well as the "Cancer Supplements," "Natural Cancer Products," and "Prevent Cancer Products" links in the "Products Menu" listing on the left side of each page. Clicking on any of these links brings you to a product directory where these products are offered for sale. You also promote "Colloidal Silver," "Graviola," "Red Raspberry Extract," "Juice Complex," "Lycopene," and "Pomegranate" on the "Cancer Prevention" page of your website.
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 "C1000," "Colloidal Silver," "Graviola," "Red Raspberry Extract," "Juice Complex," "Lycopene," and "Pomegranate" 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. While reviewing your website, we noticed that you were promoting these products for treatment and/or prevention of diseases other than cancer and that you were also promoting other products for disease treatment and/or prevention. 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 Sherrie L. Krolczyk, Compliance Officer, at the letterhead address.
Reynaldo R. Rodriquez Jr
Dallas District Director